(802 days)
The device is indicated for the following:
- Muscle re-education of the quadriceps.
- Maintaining or increasing range of motion of the knee joint.
- Prevention or retardation of disuse atrophy in the quadriceps.
The NeuroTech© Kneehab™ is a battery operated, portable neuromuscular electrical stimulator. The device is intended to provide a non-invasive, prescriptive therapy.
In use, the device delivers brief electrical pulses through the skin contact adhesive electrodes. It uses constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses cause muscular contraction the quadrie application of stimulation to the peripheral nervous system.
The NeuroTech© Kneehab™ is a garment based solution comprising of a two-piece construction, worn above the knee. It is a one-programme unit.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary for the NeuroTech© Kneehab™ device, focusing on its description, intended use, and substantial equivalence to a predicate device, as required for FDA clearance.
The summary outlines:
- Device Description: A battery-operated, portable neuromuscular electrical stimulator.
- Intended Use: Muscle re-education of the quadriceps, maintaining or increasing range of motion of the knee joint, and prevention or retardation of disuse atrophy in the quadriceps.
- Technological Comparison: Compares the NeuroTech© Kneehab™ to a predicate device, the Staodyn EMS+2, noting similar electrical outputs and compliance with various IEC standards for medical electrical equipment, EMC, and radiated emissions.
- Non-clinical Tests: Mentions that comparisons of electrical outputs show similar results to the predicate device and that both have been independently tested to specific IEC and EN standards. It also states that a hazard analysis, risk analysis, and failure mode effects analysis have been carried out.
Missing Information:
The document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for any test sets.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes of human reader improvement with AI.
- Information on a standalone algorithm performance study.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for a training set.
- How ground truth for a training set was established.
This document is a regulatory submission demonstrating substantial equivalence, not a clinical study report or a performance validation study. Therefore, the detailed information requested regarding acceptance criteria and performance studies is not available within the provided text.
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MAR 4 - 2005
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Bio-Medical Research Ltd Parkmore Business Park, West Galway Ireland
510 (k) Summary of Safety and Effectiveness.
This summary is submitted in accordance with 21 CFR 807.92
| a) | 1 | Submitted by | Bio-Medical Research LtdBMR HouseParkmore Business Park, WestGalwayRepublic of Ireland |
|---|---|---|---|
| Establishment RegistrationNumber | 8020867 | ||
| Contact Person | Anne-Marie Keenan | ||
| Phone | +353 91 774350 | ||
| Fax | +353 91 774301/302 | ||
| akeenan@bmr.ie | |||
| Title | Quality/Regulatory Engineer | ||
| Date of Preparation | December 2002 | ||
| Date of Update | February 2005 | ||
| 2 | Trade Name of Device | NeuroTech© Kneehab™ | |
| Common Name | Muscle Stimulator | ||
| Classification name | External functional neuromuscularstimulator. (822.5810) | ||
| 3 | Identification of predicate device | Stoadyn EMS +2 |
4 Description of Device
The NeuroTech© Kneehab™ is a battery operated, portable neuromuscular electrical stimulator. The device is intended to provide a non-invasive, prescriptive therapy.
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In use, the device delivers brief electrical pulses through the skin contact adhesive electrodes. It in use, the uevice delivers brief clochou. paros in the quadriceps area of the body. These uses constant current pulses to dimaiation of stimulation to the peripheral nervous system.
The NeuroTech© Kneehab™ is a garment based solution comprising of a two-piece construction, The Neuro recile Kneendo - 10 a games above the knee. It is a one-programme unit.
Intended Use 5
The device is indicated for the following:
- Muscle re-education of the quadriceps. . A
- Maintaining or increasing range of motion of the knee joint. ﻣﻨﺰ
- Prevention or retardation of disuse atrophy in the quadriceps. ﺣﺰ
Technological Comparison ్ని
There are many powered muscle stimulators with similar technological characteristics. We are not, There are many powered muscle stimulator with identical indications to the NeuroTech© Kneehab™ product, i.e. specific for stimulation of the quadriceps muscles.
The following device has been chosen as the predicate as it is a general-purpose stimulator with indications, which include prevention and retardation of muscle atrophy and muscle re-education :
Manufactured by Staodyn Inc, Longmount,Co. K926510 Staodyn EMS+2
Non clinical Tests 7
Comparisons of electrical outputs for the two devices show similar results. They have both been designed and independently tested to the following requirements;
- IEC 60601-1.1990 Medical electrical equipment Part 1: General requirements for . safety.
- IEC 60601-2-10 .
- IEC 601-1-1 and appendices A1:1991,A2:1995 . IEC 601-1-2: EMC requirements
- IEC 61000-4-2:1995: Electromagnetic compatibility .
- IEC 61000-4-3:1997: Electromagnetic compatibility .
- DD ENV 50204:1996: Electromagnetic compatibility .
- EN 55011:1998: radiated emissions. .
Bio-Medical Research Ltd (BMR) of which NeuroTech© is a trading division, adheres to recognised and established industry practice, and all devices are subject to final performance testing.
A hazard analysis, a risk analysis and a failure mode effects analysis have been carried out for the device.
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Section 2. Descriptive information.
2.1 Intended use.
The NeuroTech© Kneehab™ is a battery operated, portable neuromuscular electrical stimulator. The device is intended to provide a non-invasive, prescriptive therapy.
The device is indicated for:
-
Muscle re-education of the quadriceps.
-
Maintaining or increase range of motion of the knee joint.
-
Prevention or retardation of disuse atrophy in the quadriceps.
The device is more fully described in section 4.
In use, the device delivers brief electrical pulses through the skin contact adhesive electrodes. It uses constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses cause muscular contraction the quadrie application of stimulation to the peripheral nervous system.
The NeuroTech© Kneehab™ is a garment based solution comprising of a two-The Nearo roofis Rhonab knee. It is a one-programme unit.
The device is for prescriptive use.
2.2 System components.
- Kneehab™ control unit. .
- Kneehab™ under garment. .
- 3 x 1.5 V type LR03 (AAA) batteries. .
- Adhesive electrode pads (Type; 613 x 1/614 x 1/615 x 1/616 x 2) .
- User instruction manual. .
- Cardboard insert for storage. .
A more detailed description is provided in section 4.
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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 features a stylized eagle with three horizontal lines representing its wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
Mrs. Anne-Marie Keenan Quality/Regulatory Engineer Bio-Medical Research Ltd. Parkmore Business Park West Galway. Ireland
Re: K024258
R024236 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: IPF Dated: February 24, 2005 Received: February 28, 2005
Dear Mrs. Anne-Marie Keenan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaren b re(s) presses in substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use stated in the encreate) to regary to regary the Medical Device Amendments, or 10
commerce prior to May 28, 1976, the enactment date of the Medical Device Art 10 comments provision to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (710) that as nevice, subject to the general controls provisions of the Act. The 1 ou may, mercere, manel and include requirements for annual registration, listing of general controll provisioning 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 If your device is onestined (toor as ontrols. Existing major regulations affecting your device can may be subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may oc found in the Oous ceenents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I LT Has made a and regulations administered by other Federal agencies. You must or any it cacal stututes and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quinny by rovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 -- Mrs. Anne-Marie Keenan
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark A. Millikan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and
Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) number (if known):
Device Name:
NeuroTech® Kneehab™ Type 410.
Sponsor Name:
Bio-Medical Research Ltd.
The device is intended for prescriptive use.
Indications for Use:
-
Muscle re-education of the quadriceps
-
Maintaining or increasing range of motion of the knee joint
-
Prevention or retardation of disuse atrophy in the quadriceps
Do Not Write Below This Line -Continue on Another Page if Needed.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use
Over –The –Counter- Use
for Mark A. Milkarsen
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
102458 510(k) Number
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).