QHJ-10001001AImplantable Generator

Physician’s Manual Paired VNS Therapy ® Serenity System ® Model 1000 Generator & Model 3000 Lead For Healthcare Professionals September 2012 CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use. NOTE: This identifies the parts included in this Physician’s Manual. The information contained in any one part is not intended to serve as a substitute for a complete and thorough understanding of the material presented in all of the physician’s manual sections for the Paired VNS Therapy Serenity System and its component parts, nor does this represent full disclosure of all pertinent information concerning use of this product, potential safety complications, or efficacy outcomes. Copies of all Paired VNS Therapy Serenity System manuals must be included for full disclosure; copies are available from MicroTransponder Inc. Released Version A 26‐0001‐0000‐ ENG © Copyright November 2012 MicroTransponder Inc. Austin, TX all rights reserved. MicroTransponder, Paired VNS Therapy, Serenity System, are registered trademarks of MicroTransponder. Inc. 2 | Page Table of Contents 1. BRIEF DEVICE DESCRIPTION ............................................................ P. 5 1.1. Symbols and Definitions ..................................................................... P. 9 2. INTENDED USE / INDICATIONS ......................................................... P. 10 3. CONTRAINDICATIONS ......................................................................... P. 10 4. WARNINGS ........................................................................................... P. 10 5. PRECAUTIONS ..................................................................................... P. 13 5.1. General ............................................................................................... P. 13 5.2. Sterilization, Storage, and Handling .................................................... P. 15 5.3. Lead Evaluation and Connection ........................................................ P. 15 5.4. Environmental and Medical Therapy Hazards ................................... P. 16 6. DETAILED DEVICE DESCRIPTION ..................................................... P. 19 6.1. Physical Characteristics ...................................................................... P. 19 6.2. Biological Compatibility ....................................................................... P. 19 6.3. Power Source ....................................................................................... P. 19 7. DIRECTIONS FOR USE ........................................................................ P. 20 7.1. IPG Specifications and Product Information ....................................... P. 20 7.2. Lead Specifications and Product Information ...................................... P. 22 7.3 Operating Characteristics (Communication, Check Status, etc.) ......... P. 23 7.4 IPG Replacement ................................................................................. P. 27 7.5 Lead Lifetime and Replacement ......................................................... P. 27 7.6 Signs of End of Life .............................................................................. P. 27 7.7. Replacement Based on Battery Status Indicators .............................. P. 28 8. TROUBLESHOOTING ............................................................................ P. 28 9. SAFETY INFORMATION (from VNS Studies of Depression) ................ P. 29 9.1 Device Performance.............................................................................. P. 29 9.2 Adverse Events ..................................................................................... P. 29 9.3 Serious Adverse Events ........................................................................ P. 30 9.4 Safety Considerations specific to depressed patients .......................... P. 32 9.5 AE Relationship to VNS Therapy and Duration of Events .................... P. 33 9.6 Severity ................................................................................................. P. 34 9.7 VNS Therapy Continuation Rates ......................................................... P. 34 10.0 EPILEPSY SAFETY INFORMATION ................................................. P. 34 10.1 Device Performance............................................................................ P. 34 10.2 Adverse Events Observed in Studies ................................................. P. 34 10.3 Potential AEs ....................................................................................... P. 36 11. BIBLIOGRAPHY ................................................................................... P. 37 12. GUIDELINES FOR PATIENT FOLLOW UP ......................................... P. 37 13. PATIENT COUNSELING INFORMATION ........................................... P. 38 14. MECHANISM OF ACTION .................................................................. P. 38 15. PHYSICIAN TRAINING/INFORMATION .............................................. P. 39 16. PAIRED VNS THERAPY SERENITY SYSTEM DEVICES .................. P. 39 3 | Page 16.1 IPG Package Contents ....................................................................... P. 39 16.2 Lead Package Contents ..................................................................... P. 40 16.3 Other MicroTransponder Products ..................................................... P. 40 16.4 Surgical Materials ............................................................................... P. 40 16.5 Open Package ................................................................................... P. 40 17. RECOMMENDATIONS FOR IMPLANTATION .................................... P. 41 17.1. Check the Device and Input Patient Data .......................................... P. 41 17.2 Procedure Overview............................................................................ P. 42 17.3 Prepare for Surgery...…

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TRA SPONDER 2802 Flintrock Trace, Suite 226 Austin, TX 78738 emo To: Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 From: Chester Burress Date: 11/0812012 Re: FCC IDs: QHJ-1001001A & QHJ-2000A Gentlemen: This is your letter of authorization to accept our appointment of Elliott Laboratories, LLC. as Agent for MicroTransponder, Inc, 2802 Flintrock Trace Suite 226, Austin, TX 78738, to sign applications before the Commission and to make representations to you on our behalf. Elliott Laboratories is to receive and exchange data between our company and the Commission. This authorization is made pursuant to Section 2.911(c) of the FCC Rules and expires on October 17,2013. I hereby certify on behalf of MicroTransponder, Inc, 2802 Flintrock Trace Suite 226, Austin, TX 78738 ("Applicant") that neither Applicant nor any party to the application (officers, directors, and 5% shareholders) is subject to a denial of Federal benefits that includes FCC benefits pursuant to section 5301 of the Anti-Drug Abuse Act of 1988. 21 U.S.C. 853a. s~~ Chester Burress Directorof Technical Operations, GMQ

FCC 7435 Oakland Mills Road Columbia, Maryland, 21046 To whom it may concern: The enclosed documents constitute a formal submittal and application for Equipment Authorization for the MicroTransponder, Inc. implantable neurostimulator. This device is intended to stimulate the vagus nerve through one bipolar lead. It is being submitted pursuant to the following rules: Part 95 of FCC Rules (MedRadio) The implantable neurostimulator communicates with a programmer which is being submitted separately. Elliott Laboratories, as duly authorized agent prepared this submittal. A copy of the letter of our appointment as agent is included with the application. If there are any questions or if further information is needed, please contact Elliott Laboratories for assistance. Sincerely, David W. Bare Chief Engineer

TRANSPONDER 2802 Flintrock Trace, Suite 226 Austin, TX 78738 Memo To: Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 F~ ChesrerBurress Date: 11/0812012 Re: FCC IDs: QHJ-1001001A & QHJ-2000A Dear Examiner: I am writing to avoid the possibility of an inadvertent disclosure of proprietary information. The accompanying Form 731 is being filed with the commission on our behalf by Elliott Laboratories, LLC., a conSUlting and testing laboratory. Included as exhibits with the enclosed application are block diagrams, schematics, parts lists and a detailed description of the theory of operation of the device. It is our intention to provide the commission with a full disclosure of our product so that its merits can be evaluated. Indeed, we are pleased to provide any further information that the commission might wish to see. It is not our intention, however, to make our proprietary process a matter of public record. In view of the fact that the block diagrams, schematics, and associated theory of operation disclose the mechanism of our process, we ask that these portions (block diagrams, schematics, parts lists and theory of operation) of our application be withheld from public inspection as provided under FCC 47 CRF O.457(d) and 0.459. These documents contain details of the proprietary operation of product. These details are not readily discemible -even to technically sophisticated individuals -from our hardware and constitute trade secrets. We request therefore that these documents be segregated from the body of our evaluation report and withheld from public inspection. Thank you for your attention. Please let the undersigned know if the Commission disagrees with our position or reqUires further justification. Sincerely,

MicroTransponder Serenity model 1000 Why there is no tuning of RF circuitry in production: The tests in production are performed using a GTEM cell (TESCOM, TC‐5062A). The IPG is placed inside the cell and a reference programmer is connected to the cell’s port through an adjustable attenuator. The tests are the following: 1) Communication through 8 channels. a. Shall pass when adjusting the attenuator to 18 dB b. Shall fail when adjusting the attenuator to 32 dB 2) Reception . Attenuation to the minimum. Programmer transmits a CW through channels 0, 3, 6 and 9, one at a time. IPG shall receive the appropriate sequence through those channels. SNR shall be high enough. 3) Transmission . Attenuation to the minimum. IPG transmits a CW through channels 2 and 7, one at a time. Programmer measures signal level in channels 1 to 8 each time: a. Signal level in selected channel shall be high enough b. Signal level in not selected channels shall be low: at least 20 dB less than the selected channel. The following table tries to explain why there is no need for tuning in production: Tunable characteristic Limit Fact Test in Production Tx Power ‐16 dBm ‐22.6 dB margin for unit tested in NTS Production test #3. Test focuses on detecting Tx power too weak in selected channel. The maximum allowed Tx power is considered unachievable when the device is implanted. Frequency 100 ppm Information provided by the manufacturer of the transceiver: < 70 ppm between programmer and IPG frequencies for correct communication Production test #1. Regarding frequency stability, voltage monitor is tested (must reset @ 2.3V ± 50mV). Spurious emissions Several requirements See test results. Production test #3 checks levels inside the MedRadio band.

Page 1 of 1 December 7, 2012 FCC 7435 Oakland Mills Road Columbia, Maryland, 21046 RE: MicroTransponder, Inc FCC ID: QHJ-10001001A Corresopndence Reference Number: 43026 Form 731 Confirmation Number: EA150093 To whom it may concern: Based upon output power, the MicroTransponder, Inc. implantable neurostimulator qualifies for SAR exclusion per Section 4.2.4 of KDB publication 447498. Please supersede the SAR reports. Sincerely, David W. Bare Chief Engineer

Juliana IPG Final Packaging Top Label Juliana IPG Final Packaging Blister Label Wolfgang IPG Final Packaging Top Label Wolfgang IPG Final Packaging Blister Label

File: R89106 Page 1 Radio Test Report FCC Part 95 MedRadio Transmitter Serenity model 1000 FCC ID: QHJ-10001001A COMPANY: MicroTransponder Inc. 2802 Flintrock Trace, Suite 225 Austin, TX 78738 TEST SITE(S): NTS Silicon Valley 41039 Boyce Road. Fremont, CA. 94538-2435 REPORT DATE: October 30, 2012 FINAL TEST DATES: August 13, 14, 15 and 27, 2012 TOTAL NUMBER OF PAGES: 32 PROGRAM MGR / QUALITY ASSURANCE DELEGATE / TECHNICAL REVIEWER: FINAL REPORT PREPARER: ______________________________ ______________________________ David W. Bare David Guidotti Chief Engineer Senior Technical Writer NTS Silicon Valley is accredited by the A2LA, certificate number 0214.26, to perform the test(s) listed in this report, except where noted otherwise. This report and the information contained herein represent the results of testing test articles identified and selected by the client performed to specifications and/or procedures selected by the client. National Technical Systems (NTS) makes no representations, expressed or implied, that such testing is adequate (or inadequate) to demonstrate efficiency, performance, reliability, or any other characteristic of the articles being tested, or similar products. This report should not be relied upon as an endorsement or certification by NTS of the equipment tested, nor does it represent any statement whatsoever as to its merchantability or fitness of the test article, or similar products, for a particular purpose. This report shall not be reproduced except in full NTS Silicon Valley -- EMC Department Test Report Report Date: October 30, 2012 File: R89106 Page 2 REVISION HISTORY Rev# Date Comments Modified By - 10-30-2012 First release NTS Silicon Valley -- EMC Department Test Report Report Date: October 30, 2012 File: R89106 Page 3 TABLE OF CONTENTS REVISION HISTORY ................................................................................................................................................ 2 TABLE OF CONTENTS ............................................................................................................................................ 3 SCOPE .......................................................................................................................................................................... 4 OBJECTIVE ................................................................................................................................................................ 5 STATEMENT OF COMPLIANCE ........................................................................................................................... 5 DEVIATIONS FROM THE STANDARDS .............................................................................................................. 5 TEST RESULTS .......................................................................................................................................................... 6 FCC PART 95............................................................................................................................................................ 6 EXTREME CONDITIONS ...................................................................................................................................... 6 MEASUREMENT UNCERTAINTIES .................................................................................................................... 7 EQUIPMENT UNDER TEST (EUT) DETAILS ...................................................................................................... 8 GENERAL ................................................................................................................................................................ 8 OTHER EUT DETAILS ........................................................................................................................................... 8 ENCLOSURE ........................................................................................................................................................... 8 MODIFICATIONS ................................................................................................................................................... 8 SUPPORT EQUIPMENT ......................................................................................................................................... 8 EUT INTERFACE PORTS ...................................................................................................................................... 8 EUT OPERATION ................................................................................................................................................... 8 TESTING ..................................................................................................................................................................... 9 GENERAL INFORMATION ................................................................................................................................... 9 BANDWIDTH MEASUREMENTS ........................................................................................................................ 9 FREQUENCY STABILITY ..................................................................................................................................... 9 RADIATED EMISSIONS MEASUREMENTS ...................................................................................................... 10 INSTRUMENTATION .......................................................................................................................................... 11 FILTERS/ATTENUATORS .................................................................................................................................. 11 ANTENNAS ........................................................................................................................................................... 11 ANTENNA MAST AND EQUIPMENT TURNTABLE ...................…

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