WBWRF300Neurostimulator

TUV Rheinland of North America, Inc. 1279 Quarry Lane Suite A Pleasanton, CA 94566 Tel 925-249-9123 Fax 925-249-9124 Member of TÜV Rheinland Group February 7, 2012 Federal Communication Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: FCC Submittal for FCC ID WBWRF300 To Whom It May Concern: On the behalf of NeuroPace, Inc. I am submitting for the authorization grant on FCC ID WBWRF300. The exhibit section contains the following documents; Submitted Date File Name Exhibit Type Confidentiality Feb. 7 th , 2012 RNS-300M Block Diagram Block Diagram Permanent Feb. 7 th , 2012 Authorization Requesting Letter Cover Letter No Feb. 7 th , 2012 Agent Authorization Letter Cover Letter No Feb. 7 th , 2012 Authorization Letter for Erica Lundmark Cover Letter No Feb. 7 th , 2012 RNS-300M Request of Confidentiality Cover Letter No Feb. 7 th , 2012 RNS-300M Request Alt Identifier Location Cover Letter No Feb. 7 th , 2012 RNS-300M External Photo External Photo No Feb. 7 th , 2012 RNS-300M Label Artwork and Location ID Label/ Location Info No Feb. 7 th , 2012 RNS-300M Internal Photos Internal Photo Permanent Feb. 7 th , 2012 RNS-300M Operational Description Operational Description Permanent Feb. 7 th , 2012 RNS-300M Device Sealed Operational Description Permanent Feb. 7 th , 2012 Inquiry 352454 -Longterm Conf on Int Photo and User Manual Operational Description Permanent Feb. 7 th , 2012 RNS-300M_inquiry664750_relevance Operational Description Permanent Feb. 7 th , 2012 Inquiry 664750 -RF Exposure Eval Excluded Operational Description Permanent Feb. 7 th , 2012 RNS-300M RF Exposure Exhibit RF Exposure Info No Feb. 7 th , 2012 RNS-300M Schematic Schematic Permanent Feb. 7 th , 2012 RNS-300 Test Report Test Report No Feb. 7 th , 2012 RNS-300M Test Setup Photo Test Setup Photo No Feb. 7 th , 2012 RNS-300M User Manual User Manual Permanent For any matter regarding to this submittal, please contact me at the below contact information Sincerely Sarbjit Shelopal Regional Operations Manager - West (925) 249-9123 Ext. 129 Email: [email protected]

NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 1 of 7 Neurostimulator in a Ferrule with Connector Cover and Lead Strain Relief - Top View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 2 of 7 Neurostimulator in a Ferrule with Connector Cover and Lead Strain Relief - Bottom View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 3 of 7 Neurostimulator in a Ferrule with Connector Cover and Lead Strain Relief - Side View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 4 of 7 Neurostimulator with Connector Cover and Lead Strain Relief - Top View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 5 of 7 Neurostimulator with Connector Cover and Lead Strain Relief - Bottom View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 6 of 7 Neurostimulator with Connector Cover and Lead Strain Relief - Left Side View NeuroPace Model RNS-300M Neurostimulator FCC ID: WBWRF300 External Photographs NeuroPace Confidential Rev 1 Page 7 of 7 Neurostimulator with Connector Cover and Lead Strain Relief - Right Side View

NeuroPace Neurostimulator FCC ID: Label Artwork and Model RNS-300M WBWRF300 Location Photographs NeuroPace Confidential Rev 1 Page 1 of 5 Implantable Medical Device – Not Desirable or Feasible for FCC ID Label NeuroPace Neurostimulator FCC ID: Label Artwork and Model RNS-300M WBWRF300 Location Photographs NeuroPace Confidential Rev 1 Page 2 of 5 Label Locations - Packaging Tray and RNS-300M Kit Box (Note that the RNS-300M is placed inside Packaging Tray which is placed inside of RNS-300M Kit Box. ) Packaging Tray Label Location RNS-300M Kit Box Label Location NeuroPace Neurostimulator FCC ID: Label Artwork and Model RNS-300M WBWRF300 Location Photographs NeuroPace Confidential Rev 1 Page 3 of 5 Label Artwork (Top of Packaging Tray) View Showing FCC ID Location of FCC ID on inner packaging. NeuroPace Neurostimulator FCC ID: Label Artwork and Model RNS-300M WBWRF300 Location Photographs NeuroPace Confidential Rev 1 Page 4 of 5 Label Artwork (Top of RNS-300M Kit Box) View Showing FCC ID Location of FCC ID on packaging box NeuroPace Neurostimulator FCC ID: Label Artwork and Model RNS-300M WBWRF300 Location Photographs NeuroPace Confidential Rev 1 Page 5 of 5 Part 15.19 (Labeling Requirement) and Part 15.21 (Information to User) in Manual found in two parts 1) immediately following the title page 2) on page 91 of the Manual

Report Number: 31051315.002 Page 1 of 3 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 2/3/2012 FCCID: WBWRF300 RF Exposure Exhibit EUT Name: NeuroPace® RNS® Neurostimulator Model No.: RNS-300M CFR 47 Part 2.1093 Prepared for: Barbara Gibb NeuroPace Inc. 1375 Shorebird Way Mountain View, CA 94043 Tel: (650) 237-2700 Fac: (650) 237-2701 Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane Pleasanton, CA 94566 Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ Report/Issue Date: February 2, 2011 Report Number: 31051315.001 TUV Rheinland RF Exposure 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.002 Page 2 of 3 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 2/3/2012 FCCID: WBWRF300 RF Exposure Exhibit ________________________________________________________ 1 1 RF Exposure _____________________________________________________________ 3 TUV Rheinland RF Exposure 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.002 Page 3 of 3 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 2/3/2012 FCCID: WBWRF300 1 RF Exposure 1.1 Exposure Requirements The NeuroPace® RNS® Neurostimulator Model RNS-300M is an implant device. It is powered by the primary cell, and it has no charging capability. According to CFR47 Part 2.1093(c) the NeuroPace® RNS® Neurostimulator Model RNS-300M is categorically excluded from routine environmental evaluation for RF exposure. Base on the commission’s recommendation of PBA Inquiry for the related device, Wand W-02, the antenna coil dimension and feeding current information is stated in the RNS-300M Operation Description. Please refer to Page 4 to 6 of the document. The related PBA inquiry is attached as an operational description exhibit. 1.2 Test Procedure Test is not required. 1.3 Evaluation Na 1.4 Conclusion SAR data is not required for FCC since the NeuroPace® RNS® Neurostimulator Model RNS-300M is categorically excluded.

The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. Report Number: 31051315.001 Page 1 of 44 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M, intended for FCC ID “WBWRF300” EMC / Rev 2/6/2012 Emissions Test Report EUT Name: NeuroPace® RNS® Neurostimulator Model No.: RNS-300M CFR 47 Part 15.205, 15.207, 15.209: 2010 Prepared for: Barbara Gibb NeuroPace Inc. 1375 Shorebird Way Mountain View, CA 94043 Tel: (650) 237-2700 Fax: (650) 237-2701 Prepared by: TUV Rheinland of North America, Inc. 1279 Quarry Lane Pleasanton, CA 94566 Tel: (925) 249-9123 Fax: (925) 249-9124 http://www.tuv.com/ Report/Issue Date: 15 October 2010 Report Number: 31051315.001 Statement of Compliance The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. Report Number: 31051315.001 Page 2 of 44 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M, intended for FCC ID “WBWRF300” EMC / Rev 2/6/2012 Manufacturer: NeuroPace Inc. 1375 Shorebird Way Mountain View, CA 94043 (650) 237-2700 Requester / Applicant: Barbara Gibb Name of Equipment: NeuroPace® RNS® Neurostimulator Model No. RNS-300M Type of Equipment: Intentional Radiator Application of Regulations: CFR 47 Part 15.205, 15.207, 15.209: 2010 Test Dates: 4 October 2010 to 12 October 2010 Guidance Documents: Emissions: ANSI C63.10: 2009 Test Methods: Emissions: ANSI C63.10: 2009 The electromagnetic compatibility test and documented data described in this report has been performed and recorded by TUV Rheinland, in accordance with the standards and procedures listed herein. As the responsible authorized agent of the EMC laboratory, I hereby declare that the equipment described above has been shown to be compliant with the EMC requirements of the stated regulations and standards based on these results. If any special accessories and/or modifications were required for compliance, they are listed in the Executive Summary of this report. This report must not be used to claim product endorsement by NVLAP or any agency of the U.S. Government. This report contains data that are not covered by NVLAP accreditation. This report shall not be reproduced except in full, without the written authorization of TUV Rheinland of North America. Jeremy Luong 18 October 2010 Conan Boyle 28 October 2010 Test Engineer Date NVLAP Signatory Date Industries Canada 100411-0 US5251 2932D-1 Table of Contents The test results contained in this report refer exclusively to the product(s) presented for testing. No liability may be assumed for models or products not referred to herein. This test report may not be published or duplicated in part without permission of the testing body. This test report by itself does not constitute authorization for the use of any TUV Rheinland test mark. This report must not be used by the applicant to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the federal government. Report Number: 31051315.001 Page 3 of 44 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M, intended for FCC ID “WBWRF300” EMC / Rev 2/6/2012 1 Executive Summary _______________________________________________________ 7 1.1 Scope______________________________________________________________________ 7 1.2 Purpose____________________________________________________________________ 7 1.3 Summary of Test Results _____________________________________________________ 7 1.4 Special Accessories __________________________________________________________ 7 1.5 Equipment Modifications _____________________________________________________ 7 2 Laboratory Information ____________________________________________________ 8 2.1 Accreditations & Endorsements _______________________________________________ 8 2.1.1 US Federal Communications Commission _______________________________________________ 8 2.1.2 NIST / NVLAP ____________________________________________________________________ 8 2.1.3 Canada – Industry Canada ___________________________________________________________ 8 2.1.4 Japan – VCCI _____________________________________________________________________ 8 2.1.5 Acceptance by Mutual Recognition Arrangement _________________________________________ 8 2.2 Test Facilities _______________________________________________________________ 9 2.2.1 Emission Test Facility ______________________________________________________________ 9 2.2.2 Immunity Test Facility ______________________________________________________________ 9 2.3 Measurement Uncertainty ____________________________________________________ 9 2.4 Calibration Traceability _____________________________________________________ 10 3 Product Information ______________________________________________________ 11 3.1 Product Description ________________________________________________________ 11 3.2 Equipment Configuration ___________________________________________________ 11 3.3 Operating Mode ___________________________________________________________ 11 3.4 Unique Antenna Connector __________________________________________________ 12 3.4.1 Results _________…

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TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.001 Page 1 of 5 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 1/31/2012 FCC ID: WBWRF300 1 Photo 1.1 Test Setup Photo Figure 1: Test Setup for 9 kHz to 30 MHz Radiated Emission (Front View) – Loop Facing Away TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.001 Page 2 of 5 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 1/31/2012 FCC ID: WBWRF300 Figure 2: Test Setup for 9 kHz to 30 MHz Radiated Emission (Rear View) – Loop Facing EUT TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.001 Page 3 of 5 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 1/31/2012 FCC ID: WBWRF300 Figure 3: Test Setup for 30 MHz to 1000 MHz Radiated Emission (Front View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.001 Page 4 of 5 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 1/31/2012 FCC ID: WBWRF300 Figure 4: Test Setup for 30 MHz to 1000 MHz Radiated Emission (Rear View) TUV Rheinland Test Setup Photo 1279 Quarry Lane, Ste. A, Pleasanton, CA 95466 Tel: (925) 249-9123, Fax: (925) 249-9124 Report Number: 31051315.001 Page 5 of 5 EUT: NeuroPace® RNS® Neurostimulator Model: RNS-300M EMC / Rev 1/31/2012 FCC ID: WBWRF300 Figure 5: Setup Photo of NeuroPace® Wand and NeuroPace® RNS® Neurostimulator NeuroPace® RNS® Neurostimulator NeuroPace® Wand