(266 days)
Not Found
No
The device description and intended use focus on the physical properties and function of a conductive garment for electrode placement and compression, with no mention of AI or ML technologies.
No.
The device is a garment that aids in the placement and securing of electrodes for use with Neurotech Stimulator devices (TENS/NMES), but it does not directly provide a therapeutic effect itself. Its function is to facilitate the correct positioning of electrodes for a separate therapeutic device (the stimulator).
No
The device is described as an aid for electrode placement and securement for TENS and NMES, which are therapeutic rather than diagnostic modalities.
No
The device description explicitly states it is a "garment" constructed of "fabric," which are physical, non-software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The AvivaFix Conductive Garments are external garments designed to aid in the placement and securement of electrodes for electrical stimulation (TENS and NMES). They are applied to the body and do not involve the analysis of biological specimens.
- Intended Use: The intended use clearly states the purpose is to facilitate electrode placement and securement for use with Neurotech Stimulator devices. This is a therapeutic or supportive function, not a diagnostic one.
Therefore, the AvivaFix Conductive Garments fall under the category of medical devices used for external application and support, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The AvivaFix Conductive Garment – Knee, AvivaFix Conductive Garment – Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.
The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment -- Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). The garments aid in the placement of electrodes and secure the electrodes in place. The inner layer of the garment is constructed of Breathoprene", which is a breathable, stretchable fabric developed by AccuMed Technologies as a neoprene substitute to keep skin cooler and drier by wicking away perspiration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, upper back (cervical)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinician
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)
No new clinical studies have been submitted as part of this premarket notification.
The AvivaFix Conductive Garments (Knee, Shoulder and Upper Back) complies with the following standards:
- 21 CFR 898 Performance standard for electrode lead wires and patient cables .
- ISO 14971:2007 Medical Devices Application of risk management to medical . devices
- . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2002/Amd. 1:2006 Biological evaluation of medical devices -- Part . 10: Tests for irritation and skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
510(k): K102614
Image /page/0/Picture/1 description: The image shows a logo for BMR Bio-Medical Research LTD. The logo features a stylized, curved shape resembling a bracket or partial circle on the left side. To the right of this shape are the letters "BMR" in a bold, sans-serif font. Below the letters "BMR" is the text "BIO-MEDICAL RESEARCH LTD" in a smaller, sans-serif font.
JUN - 3 2011
Bio-Medical Research Ltd.
Parkmore Business Park West, Galway, Ireland Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301
This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
| Name: | Anne-Marie Keenan,
Quality/Regulatory Engineer |
|------------|-------------------------------------------------------------------------------|
| Address: | Bio-Medical Research Ltd.,
Parkmore Business Park, West
Galway, Ireland |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774302 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | April 22, 2011 |
2. Device Name
| Trade Names of Devices: | AvivaFix Conductive Garment - Knee, Type 420
AvivaFix Conductive Garment - Shoulder, Type 420
AvivaFix Conductive Garment - Upper Back, Type 420 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Cutaneous Electrode |
| Classification: | Class II |
| Product Code: | GXY |
3. Identification of Equivalent Legally Marketed Devices
| Device Trade Name: | Lumbofix Conductive Garment, Type 420 Back |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd |
| 510(k) No: | K091317 |
| Device Trade Name: | Kneehab XP Conductive Garment, Type 411 |
| Manufacturer: | Bio-Medical Research Ltd |
Directors: T. Kirwan (Chairman), Dr. P.A. Smith (Managing), Dr. B. Collins, P.K. McDonnell, C. Minogue, P. McGrath
1
4. Description of Device
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment -- Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use in conjunction with transcutaneous electrical nerve stimulation (TENS) and neuromuscular electrical stimulation (NMES). The garments aid in the placement of electrodes and secure the electrodes in place. The inner layer of the garment is constructed of Breathoprene", which is a breathable, stretchable fabric developed by AccuMed Technologies as a neoprene substitute to keep skin cooler and drier by wicking away perspiration.
5. Indications for Use
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and to secure them in place.
The AvivaFix Conductive Garment -- Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.
The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.
6. Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the AvivaFix Conductive Garments. Substantial Equivalence has been demonstrated as part this 510k submission.
2
7. Clinical and Non-Clinical Tests
No new clinical studies have been submitted as part of this premarket notification.
The AvivaFix Conductive Garments (Knee, Shoulder and Upper Back) complies with the following standards:
- 21 CFR 898 Performance standard for electrode lead wires and patient cables .
- ISO 14971:2007 Medical Devices Application of risk management to medical . devices
- . ISO 10993-5 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2002/Amd. 1:2006 Biological evaluation of medical devices -- Part . 10: Tests for irritation and skin sensitization
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Bio-Medical Research, Ltd. c/o Ms. Anne-Marie Keenan Quality / Regulatory Affairs Engineer Parkmore Business Park West Galway, Ireland
JUN - 3 2011
Re: K102614
Trade/Device Names: AvivaFix Conductive Garment Knee Type 420, AvivaFix Conductive Garment Upper Back Type 420, AvivaFix Conductive Garment Shoulder Type 420
Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: May 25, 2011 Received: May 31, 2011
Dear Ms. Keenan:
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
4
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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Debnal Falls
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K102614
Device Names:
AvivaFix Conductive Garment - Knee, Type 420 AvivaFix Conductive Garment -- Shoulder, Type 420 AvivaFix Conductive Garment - Upper Back, Type 420
Indications for Use:
The AvivaFix Conductive Garment – Knee, AvivaFix Conductive Garment – Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices are intended for use with Neurotech Stimulator devices. It is intended to aid in the repeatable placement of electrodes (under the guidance of a clinician) and secure them in place.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices also maintain a level of compression in the areas of electrode placement to maintain electrode placement during treatment.
The AvivaFix Conductive Garment - Knee, Type 420 is intended for use on the knee. The AvivaFix Conductive Garment - Shoulder, Type 420 is intended for use on the shoulder. The AvivaFix Conductive Garment - Upper Back, Type 420 is intended for use on the upper back (cervical) area.
The AvivaFix Conductive Garment - Knee, AvivaFix Conductive Garment - Shoulder, and AvivaFix Conductive Garment - Upper Back (all Type 420) devices and associated accessories are indicated for use with Neurotech Stimulators to facilitate the frequent and correct positioning and repositioning of large, multiple, and/or difficult to reach stimulation sites associated with the shoulder, knee and upper back (cervical) areas.
Prescription Use X
(Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K102614
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