(177 days)
Not Found
No
The summary describes a wearable garment with electrodes for electrical stimulation (TENS, NMES, FES). There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the physical garment, electrodes, and electrical stimulation delivery.
Yes
The device is intended to apply electrical stimulation for various therapeutic purposes such as pain relief (TENS), muscle relaxation, prevention of atrophy, increasing blood circulation, and muscle re-education (NMES, FES).
No
The device is intended to apply electrical stimulation for therapeutic purposes, such as pain relief, muscle re-education, and prevention of muscle atrophy. It does not mention recognizing or analyzing a disease or condition.
No
The device description explicitly details physical components like garments, electrodes, and wiring, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The AxioBionics Wearable Therapy Garments apply electrical stimulation to the patient's skin. This is a form of therapy applied to the living body (in vivo), not a diagnostic test performed on a sample taken from the body.
- Intended Use: The intended uses listed (TENS, NMES, FES) are all therapeutic applications of electrical stimulation, not diagnostic procedures.
- Device Description: The description focuses on the garment's structure, electrodes, and how it delivers electrical current to the skin. There is no mention of collecting or analyzing biological samples.
Therefore, the AxioBionics Wearable Therapy Garments are a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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)
Product codes
GXY
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
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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
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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)
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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
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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
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| 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 | |
| one layer of spandex with vinyl layer | Non-conductive Vinyl spandex – with | |
| two layers of spandex (one on both | ||
| sides with vinyl layer between) | ||
| Electrode Lead Wire | Single conductor cable, 24 AWG | |
| tinned copper conductors with PVC | ||
| jacket | Same | |
| Electrical Energy | ||
| Patient Preparations | ||
| for electrode | ||
| placement | Not applicable – electrode contained | |
| within garment | Same | |
| Electrode Placement | Positionable placement within | |
| garment | Fixed placement within garment | |
| Max No. of | ||
| Electrodes/Garment | 40 | Same |
| Usage | Disposable | Same |
| Replacement | ||
| Electrode Packaging | Sealed Pouch | Same |
| Replacement | ||
| Electrodes per | ||
| 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.