WEARABLE THERAPY GARMENTS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it, topped by a horizontal bar. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 14, 2014 Axiobionics, LLC Attn: Ms. Nancy Lincé Regulatory Affairs Consultant for Axiobionics, LLC 6111 Jackson Road Suite 200 Ann Arbor, MI 48103 Re: K141342 Trade Name: AxioBionics Wearable Therapy Garments Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: October 13, 2014 Received: October 15, 2014 Dear Ms. Lincé: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical {1}------------------------------------------------ device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # Felipe Aguel -S Carlos L. Peña. PhD. MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K141342 Device Name AxioBionics Wearable Therapy Garments ### Indications for Use (Describe) The AxioBionics® Wearable Therapy® Garments with cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin via electro conductive media gel. Example of electrical stimulation applications of the garment are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief b) Neuromuscular Electrical Stimulation (NMES) for: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion c) Functional Electrical Stimulation (FES) Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ## FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. #### Name, Address, Phone and Fax Number of Applicant A. AxioBionics, LLC 6111 Jackson Road, Suite 200 Ann Arbor, MI 48103 Philip Muccio, President Phone: 734-327-2946 Fax: 734-327-3715 #### в. Contact Person Nancy Lincé, President Lincé Consulting Phone: (650) 759-6186 nlince@linceconsulting.com #### C. Date Prepared October 13, 2014 #### D. Device Name | Trade Name: | AxioBionics® Wearable Therapy Garments | |----------------------|-----------------------------------------------------------| | Common Name: | Cutaneous Electrode | | Classification Name: | Electrode, cutaneous (21 CFR§ 882.1320, Product Code GXY) | #### E. Predicate Devices The AxioBionics® Wearable Therapy Garments are substantially equivalent to: - o Bioflex Garments, Assorted Models (K944543) #### ﺎﻧﺎ Device Description The AxioBionics Wearable Therapy Garments that are garments that are made of nylon/spandex and neoprene fabric that hold and position the system's electrodes. Channels are built into the garments to allow the wiring of the electrodes to be managed for the patient. The garments can be worn as produced or altered (tailored) as needed for user fitment. The conducting element is contained in a positionable electrode for electro-conductivity. The gel permeable electrode pocket is on the inside of the garment. The garment is re-usable and washable as is the electrode Page 1 of 3 {4}------------------------------------------------ #### G. Indications for Use The AxioBionics® Wearable Therapy® Garments with cutaneous electrodes are intended to be used to apply electrical stimulation current to the patient's skin via electro-conductive media gel. Examples of electrical stimulation applications of the garment are: a) Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief b) Neuromuscular Electrical Stimulation (NMES) for: - Relaxation of muscle spasms - - Prevention or retardation of disuse atrophy - - Increasing local blood circulation - - Muscle re-education ー - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion c) Functional Electrical Stimulation (FES) #### H. Technological Comparison - | Manufacturer | Device Name | 510(k) Number | |----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | AxioBionics, LLC | Wearable Therapy Garments | K141342 | | AxioBionics, LLC | Bioflex Garments | K944543 | | Intended Use | Provide repeatable placement of multiple electrodes to conduct electrical stimulation from commercially available nerve stimulation devices to the patient's skin. Single patient use (re-usable, re-positionable). | Same | | Product Code | GXY | Same | | Resistivity/Impedance (electrode) | $≤$ 10 ohm | Not specified | | Electrode Area (surface area in contact with skin) | 1-600 in2 | Not specified | | Average Tissue Electro-conductive Media Gel | Commercially available electro-conductive media gel | Same | | Conductive Electrode Element | Silver Fabric or Silver Paper | Silver Fabric | Page 2 of 3 {5}------------------------------------------------ | Manufacturer | AxioBionics, LLC | AxioBionics, LLC | |-------------------------------------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Device Name | Wearable Therapy Garments | Bioflex Garments | | 510(k) Number | K141342 | K944543 | | Electrode Top Cover | Non-conductive Vinyl spandex – with<br>one layer of spandex with vinyl layer | Non-conductive Vinyl spandex – with<br>two layers of spandex (one on both<br>sides with vinyl layer between) | | Electrode Lead Wire | Single conductor cable, 24 AWG<br>tinned copper conductors with PVC<br>jacket | Same | | Electrical Energy<br>Patient Preparations<br>for electrode<br>placement | Not applicable – electrode contained<br>within garment | Same | | Electrode Placement | Positionable placement within<br>garment | Fixed placement within garment | | Max No. of<br>Electrodes/Garment | 40 | Same | | Usage | Disposable | Same | | Replacement<br>Electrode Packaging | Sealed Pouch | Same | | Replacement<br>Electrodes per<br>Package | 2 | Not specified | | Latex Content | Not made with natural rubber latex | Same | #### Summary of Non-Clinical Performance Testing l. Dispersion testing has demonstrated that the electrodes used in the AxioBionics Wearable Therapy Garments have uniform current distribution with no evidence of "hot spots" that could cause patient discomfort or injury. The predicate electrodes used in the AxioBionics Bioflex Garment were included in the dispersion testing for comparison purposes. Additional comparison testing to the predicate device electrodes included simulated use, high-resolution dispersion evaluation, impedance, and wash cycles. Additional testing was performed on the subject device to assess the domatrode-toelectrode connection performance. Test results demonstrated that the AxioBionics Wearable Therapy Garments electrodes perform as intended and did not raise any new issues of safety or efficacy when compared to the predicate device electrodes. #### .J. Conclusion AxioBionics considers the AxioBionics Wearable Therapy Garment electrodes to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, non-clinical test results, and established medical use.