Q4D-SC5270DB-5270, SC-5270

WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 Content: MP92395224-01 REV A CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Information for Prescribers WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 ii of iv Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks Wavewriter Alpha™ and Wavewriter Alpha™ Prime are registered trademarks of Boston Scientific Corporation or its affiliates. All other trademarks are the property of their respective owners. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston Scientific Neuromodulation Corporation is under license. Additional Information For Indications and related information, see the Indications DFU. For other device-specific information not included in this manual, labeling symbols, and warranty information, refer to the appropriate DFU for your SCS System as listed on your Reference Guide. Throughout this document, the WaveWriter Alpha™ and WaveWriter Alpha™ 16 Systems will be referred to as the WaveWriter Alpha System. WaveWriter Alpha™ Prime, and WaveWriter Alpha™ Prime 16 Systems will be referred to as the WaveWriter Alpha Prime Systems. The WaveWriter Alpha System includes a rechargeable Implantable Pulse Generator (IPG). References to the Charging System or charging process are applicable only for rechargeable IPGs. The WaveWriter Alpha Prime System includes a non-rechargeable IPG. Labeling Symbols For an explanation of labeling symbols, refer to the Labeling Symbols document. Warranty For device warranty information, visit (www.bostonscientific.com/warranty). WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 iii of iv Table of Contents Device and Product Description ...................................................................1 Essential Performance ...................................................................................1 System Clinical Summary .............................................................................1 Subperception Therapy - Clinical Summary ................................................5 Contraindications ...........................................................................................5 Safety Information ..........................................................................................5 Instructions for the Patient ..................................................................................................6 Adverse Effects ...................................................................................................................9 Instructions for the Physician ............................................................................................10 Quality of Wireless Service ...............................................................................................10 Wireless Security ..............................................................................................................11 Telemetry Information .......................................................................................................12 Wireless Charging Information .........................................................................................12 Electromagnetic Compatibility - EN 60601-1-2 Classification Information ........................12 Sterilization .......................................................................................................................16 FCC Rules .....................................................................................................17 FCC ID ..............................................................................................................................17 Technical Service .........................................................................................17 End of Programmed Service .......................................................................18 IPG Battery Life ................................................................................................................19 Information for Prescribers WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 iv of iv This page intentionally left blank Device and Product Description WaveWriter Alpha™ & WaveWriter Alpha™ Prime Systems Information for Prescribers 92395224-01 1 of 23 Device and Product Description The WaveWriter Alpha™ and WaveWriter Alpha™ Prime Systems consist of an Implantable Pulse Generator (IPG), temporary and permanent Percutaneous Leads, Surgical Paddle Leads, Lead Extensions, OR Cables, External Trial Stimulator (ETS), Remote Control, and Clinician Programmer, each packaged as a separate kit. Single use accessories and disposable tools are also included in these kits. Features of the WaveWriter Alpha and WaveWriter Alpha Prime System include: • Automatic program cycling • MicroBurst capability between 0 to 1 second range • Programming of multi-areas at rates greater than 130 Hz • Patient-provided Therapy Rating • Stimulation electrode field navigation • Up to thirty-two independent current-controlled electrodes • Four programmable stimulation areas per program; sixteen possible programs • Long-life operation • High-range parameter capability • Small size and rounded shape • Wireless programming capabilities • This product contains no detectable latex. Essential Performance External Trial Stimulator The stimulation pulse shall meet the requirements for charge balance and amplitude while stimulation is on. Other External Devices Failure of the external electrical components will not result in an unacceptable risk to th…

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92366224-01 Content: MP92366224-01 REV A Vercise™ Deep Brain Stimulation Systems Information for Prescribers CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Vercise™ Deep Brain Stimulation Systems Information for Prescribers Vercise™ Deep Brain Stimulation Systems Information for Prescribers 92366224-01 ii of iv How to Use this Manual This manual provides information about the Boston Scientific Deep Brain Stimulation (DBS) System. Throughout this manual, the name “Boston Scientific DBS System” refers to the following Systems: Vercise Genus TM , Vercise Gevia TM , and Vercise TM PC. Read all instructions carefully before using the DBS System. For other device‑specific information not included in this manual, refer to the appropriate DFU for your Boston Scientific DBS System as listed in your DBS Reference Guide. Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Boston Scientific Neuromodulation Corporation is under license. Technical Support There are no user serviceable parts. If you have a specific question or issue, please contact your sales representative or call (833) DBS‑INFO or (833) 327‑4636. Registration Information Device registration information must be provided to Boston Scientific following device implantation. The purpose of this registration is to maintain traceability of all products and to secure warranty rights. It also allows the institution involved in the evaluation or replacement of a specific implanted DBS Lead, accessory, or device to gain quick access to pertinent data from the manufacturer. To complete device registration, follow the instructions provided by your local sales representative or fill out the registration form included in the package contents. A device registration form is included with each Boston Scientific DBS Lead, DBS Extension, and some DBS Stimulators. Return one copy to the Boston Scientific Customer Service Department, keep one copy for patient records, provide one copy to the patient, and save one copy for the physician. Boston Scientific Neuromodulation Corporation Attention: Customer Service Department 25155 Rye Canyon Loop Valencia, CA 91355, USA Patient Identification Card Ensure that the patient receives a completed Temporary Identification Card after their surgery. Permanent ID cards will be mailed directly to the patient following patient registration. Vercise™ Deep Brain Stimulation Systems Information for Prescribers 92366224-01 iii of iv Table of Contents Device Description ..........................................................................................1 Intended Use / Indications for Use ..........................................................................1 Safety Information ...........................................................................................2 Contraindications.....................................................................................................2 Warnings .................................................................................................................3 Precautions .............................................................................................................6 Adverse Events .......................................................................................................12 Service and Maintenance................................................................................14 External Trial Stimulator (ETS) Maintenance ..........................................................14 Cleaning the Charging System ................................................................................15 Cleaning the Remote Control ..................................................................................15 Cleaning the Programming Wand ...........................................................................15 Electromagnetic Compatibility .......................................................................16 EN 60601‑1‑2 Classification Information .................................................................16 Essential Performance ............................................................................................22 Telemetry Information ..............................................................................................22 Quality of Wireless Service .....................................................................................23 Troubleshooting Wireless Coexistence Issues ........................................................24 Wireless Security .....................................................................................................25 FCC Compliance .....................................................................................................27 Rechargeable Stimulator Battery ...................................................................28 Stimulator Battery ....................................................................................................28 Recharge Estimate ..................................................................................................28 Non‑Rechargeable Stimulator Battery...........................................................29 Stimulator Battery ....................................................................................................29 Elective Replacement ..............................................................................................29 End of Service .........................................................................................................29 Vercise™ Deep Brain Stimul…

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Figure 1: RC5 External Photo – Frontside Figure 2: RC5 External Photo – Backside Figure 3: RC5 External Photo – Sideview (Lock-button) Figure 4: RC5 External Photo – Sideview (Home-button) Figure 5: RC5 External Photo – Top Figure 6: RC5 External Photo – Bottom

Label Location Remote Control Back panel For statement of compliance to part 15 of the FCC Rules: Refer to Page 27 of the Vercise Deep Brain Stimulation System Information for Prescribers Refer to Page 17 of the WaveWriter Alpha and WaveWriter Alpha Prime Systems Information for Prescribers DB-5270 SC-5270

Figure 1: RC5 Internal Photo – Frontside Figure 2: RC5 Internal Photo – Frontside (radio circuit outlined) Antenna Radio Circuit Figure 3: RC5 Internal Photo – Backside Figure 4: RC5 Internal Photo – PCBA Backside

RC5 Antenna Info Device Antenna Manufacturer Antenna/PCB Model Gain (dBi) Description FCC 15.203 Compliance Antenna Photo RC5 BSN PCB: 92166118 B.2 0.44 Meandered PIFA Antenna implemented on printed circuit board.

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. More: https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/14-commerce-country-chart/fileT Boston Scientific Neuromodulation RC5 (SC-5270, DB-5270) FCC 2.1093:2019 Bluetooth Low Energy Report # BOSN0133 Rev 1 NVLAP Lab Code: 200630-0 CERTIFICATE OF EVALUATION 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: Thursday, October 24, 2019 Boston Scientific Neuromodulation EUT: RC5 (SC-5270, DB-5270) RF Exposure Evaluation Standards Specification Method FCC 2.1093:2019 FCC 447498 D01 General RF Exposure Guidance v06 Results Method Clause Description Applied Results Comments 4.3.1 SAR Test Exclusion Yes Pass None Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. BOSN0133 Rev 1EAR-Controlled Data2/9 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None 01 Removed reference to model that is still under development 2020-04-30 1,2,7 Report No. BOSN0133 Rev 1EAR-Controlled Data3/9 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. BOSN0133 Rev 1EAR-Controlled Data4/9 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. BOSN0133 Rev 1EAR-Controlled Data5/9 RF Exposure Condition 2018-07-17 The following RF Exposure conditions were used for the assessment documented in this report: Intended Use Portable Location on Body (if applicable) Limb How is the Device Used The RC5 is used close to the limbs (2.5 mm). Radios Contained in the Same Host Device Bluetooth Low Energy 125 kHz Inductive (disabled in this model) Simultaneous Transmitting Radios None Body Worn Accessories NA Environment General Population/Uncontrolled Exposure Report No. BOSN0133 Rev 1EAR-Controlled Data6/9 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment Under Evaluation Information Company Name: Boston Scientific Neuromodulation Address: 25155 Rye Canyon Loop City, State, Zip: Santa Clarita, CA 91355 Evaluation Requested By: Habet Ter-Petrosyan EUT: …

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This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Boston Scientific Neuromodulation RC5 FCC 15.247:2019 Bluetooth LE Radio Report # BOSN0134.3 NVLAP LAB CODE: 200676-0 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: October 21, 2019 Boston Scientific Neuromodulation EUT: RC5 Radio Equipment Testing Standards Specification Method FCC 15.247:2019 ANSI C63.10:2013, KDB 558074 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions No N/A Not required for a battery powered EUT. 6.5, 6.6, 11.12.1, 11.13.2 Spurious Radiated Emissions Yes Pass 11.6 Duty Cycle Yes N/A 11.8.2 Occupied Bandwidth Yes Pass 11.9.1.1 Output Power Yes Pass 11.9.1.1 Equivalent Isotropic Radiated Power Yes Pass 11.10.2 Power Spectral Density Yes Pass 11.11 Band Edge Compliance Yes Pass 11.11 Spurious Conducted Emissions Yes Pass Deviations From Test Standards None Approved By: Victor Ratinoff, Operations Manager Report No. BOSN0134.22/42 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. BOSN0134.23/42 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. BOSN0134.24/42 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. BOSN0134.25/42 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document QM205.4.6. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) can be found included as part of the applicable test description page. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-2 as applicable), and are available upon request. The following table represents the Measurement Uncertain…

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photo PSA-ESCI 2019.05.10 photos PSA-ESCI 2019.05.10 SEB (RC5) (1).JPG SEB (RC5) (2).JPG (RC5) (2) SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2019.05.10 photos PSA-ESCI 2019.05.10 SEB (RC5) (3).JPG SEB (RC5) (4).JPG (RC5) (4) SPURIOUS RADIATED EMISSIONS XMit 2019.09.05 RC5 (1).JPG RC5 (2).JPG DIRECT CONNECT