(87 days)
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.
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.
The provided document is a 510(k) premarket notification for a medical device called the "Kneehab XP Conductive Garment." This submission aims to demonstrate substantial equivalence to previously cleared devices.
Based on the content, here's the information regarding acceptance criteria and the study:
1. Table of Acceptance Criteria and the Reported Device Performance:
The document states: "No clinical or non clinical tests were performed to support substantial equivalence." This means there are no specific acceptance criteria or reported device performance metrics established for this particular submission. The basis for clearance is substantial equivalence to predicate devices, not performance against pre-defined criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable, as no new clinical or non-clinical tests were performed.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC study: No, an MRMC study was not done, as no clinical tests were performed. This device is not an AI-based system.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: No, a standalone study was not done. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not applicable, as no new clinical or non-clinical tests were performed for this submission. The ground truth for the predicate devices would have been part of their original clearance process, but that information is not provided here.
8. The sample size for the training set:
- Sample size for training set: Not applicable, as this device submission did not involve a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Ground truth establishment: Not applicable.
Summary of the Study:
The document explicitly states: "No clinical or non clinical tests were performed to support substantial equivalence." This 510(k) submission relies entirely on demonstrating that the "Kneehab XP Conductive Garment" is substantially equivalent to legally marketed predicate devices (Kneehab XP Conductive Garment, Type 411 - K083105 and Lumbofix™ Conductive Garment - K091317) by showing that it has the same intended use and similar technological characteristics, with the only difference being that it is not packaged with a battery pack, charger, or control unit. Therefore, no new studies, acceptance criteria, or performance data were generated or required for this particular submission.
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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, WestGalway, 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
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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).