(87 days)
Not Found
No
The description focuses on a conductive garment for electrical stimulation and does not mention any AI/ML components or functionalities.
No.
The device is a conductive garment used with a stimulator; it is not itself a therapeutic device but a component that facilitates therapy.
No
This device is described as a conductive garment used with a stimulator to facilitate positioning of stimulation sites for neuromuscular electrical stimulation. It does not perform diagnostic functions such as detecting, monitoring, or predicting a disease or condition. Its purpose is therapeutic or facilitative, not diagnostic.
No
The device description explicitly states it is a "thigh wrap garment" and is supplied with "adhesive pads," indicating it is a physical, hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the positioning of stimulation sites for neuromuscular electrical stimulation (NMES) on the quadriceps. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a garment designed to hold electrodes for electrical stimulation. It does not involve the analysis of biological samples (blood, urine, tissue, etc.), which is a key characteristic of IVDs.
- No mention of diagnostic testing: There is no indication that this device is used to diagnose a disease or condition.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Neurotech Kneehab XP Conductive Garment 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 quadriceps area of the leg.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
quadriceps muscles of the thigh
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)
No clinical or non clinical tests were performed to support substantial equivalence.
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
kug2793
Image /page/0/Picture/1 description: The image shows a logo with the letters "BMR" in a bold, sans-serif font. A stylized, curved shape resembling a bracket or parenthesis is positioned to the left of the letters, partially enclosing the "B". The logo has a slightly distressed or textured appearance, giving it a somewhat vintage or worn look. The overall design is simple and impactful, with a focus on the bold letters and the unique curved element.
I Research Ltd.
Parkmore Business Park West, Galway, Ireland
Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301
This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details
DEC - 7 2009
| Name: | Anne-Marie Keenan. |
|---|---|
| Address: | Bio-Medical Research Ltd., |
| Parkmore Business Park, West | |
| Galway, Ireland | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | 20th November 2009 |
2. Device Name
| Trade Name of Device: | Kneehab Conductive Garment |
|---|---|
| Common Name: | Conductive Garment |
| Classification Name: | Cutaneous Electrode |
| Regulation Number: | 21 CFR 882.1320 |
| Product Code: | GXY |
3. Identification of Equivalent Legally Marketed Device
| Name: | Kneehab XP Conductive Garment, Type 411 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K083105 |
| Name: | Lumbofix™ Conductive Garment |
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K091317 |
4. Description of Device
The proposed Kneehab XP Conductive Garment is an integrated thigh wrap garment designed to be used in conjunction with a Neurotech stimulator and custom electrodes for the application of neuromuscular electrical stimulation (NMES) to the quadriceps muscles of the
1
thigh. The garment is supplied with a set of four custom designed adhesive pads which may positioned on the inner garment outlines according to fit of the user. Instructions are provided in the user instructions for correct electrode placement. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
5. Statement of Intended Use/Indications for Use
The Neurotech Kneehab XP Conductive Garment 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 quadriceps area of the leg.
6. Technological Characteristics
This submission differs from the Kneehab XP cleared under K083105 in that it is not packaged with the battery pack, charger or a control unit.
7. Clinical and Non-Clinical Tests
No clinical or non clinical tests were performed to support substantial equivalence.
Page 2 of 2
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Bio-Medical Research Ltd. c/o Ms. Anne-Marie Keenan Quality/Regulatory Engineer Parkmore Business Park West Galway, Ireland -
DEC - 7 2009
Re: K092793
Trade/Device Name: Kneehab XP Conductive Garment, Model 411 Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: September 3, 2009 Received: September 11, 2009
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.
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 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.
3
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kesia Alexander Jr.
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
4
Indications for Use
510(k) Number (if known):
0927923
Device Name:
Kneehab XP Conductive Garment
Indications for Use:
The Neurotech Kneehab Conductive Garment 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 quadriceps area of the leg.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K092793