(277 days)
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, Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening, Increasing local blood circulation.
The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system. The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged. All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. For purposes of hygiene, the garment may be cleaned and instructions for device care are included in the user manual.
The provided text is a 510(k) premarket notification for the Kneehab XP Conductive Garment, Type 411. This document primarily focuses on establishing substantial equivalence to previously marketed devices and does not contain detailed information about a study that describes acceptance criteria and device performance in the format requested.
Specifically, the document does not provide the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or its data provenance.
- The number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Standalone (algorithm-only) performance results.
- Specific ground truth types used for evaluation (beyond the general indication that a clinical study was submitted).
- Sample size for a training set.
- How ground truth for a training set was established.
The document does mention:
- A clinical study: "A clinical study, 'The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction'', has been submitted as part of this 510k premarket notification." (Page 2, Section 7)
This indicates that a clinical study was performed and submitted, but the detailed results, methodology, and performance metrics are not included in this summary. The 510(k) summary is designed to demonstrate substantial equivalence, often by referencing conformance to standards and the content of such studies, rather than providing the full study report itself.
Therefore, I cannot populate the requested table and answer the questions based on the provided text alone. The document confirms that a clinical study exists and was submitted, but it does not detail its findings in the manner you've asked for.
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This summary is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Contact Details -
JUL 2 4 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: | 15th June 2009 |
2. Device Name
| Trade Name of Device: | Kneehab XP Conductive Garment (Type 411) |
|---|---|
| Common Name: | Muscle Stimulator |
| Classification Name: | Powered Muscle Stimulator |
| Regulation Number: | 21 CFR 890.5850 |
| Product Code: | IPF |
3. Identification of Equivalent Legally Marketed Device
| 1. Name: | Kneehab, Type 410 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No: | K024258, March 2005 |
| 2. Name. | System Shorts, Type 390, Model E20 |
|---|---|
| Manufacturer: | Bio-Medical Research Ltd. |
| 510(k) No.: | K070142, March 2007 |
4. Description of Device
The Kneehab XP Conductive Garment is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. This technology enables the Kneehab XP Conductive Garment to deliver highly
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focused and accurate quadriceps contractions and operates by using constant current pulses to stimulate the nerves in the quadriceps area of the body. These pulses are designed to cause muscular contractions through the application of electrical stimulation to the peripheral nervous system.
The Kneehab XP pack consists of a rechargeable control unit, a left or right universally sized garment, a pack of custom adhesive electrodes, a battery charger and instructions for use. The garment is fastened around the thigh and above the kneecap and contains a connector socket into which the control unit is plugged. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. A battery charger is included with the device. This device cannot be used while being charged.
All internal connections of the unit are over molded to prevent moisture ingress. The user has no access to the wiring or connectors within the garment and is unable to alter the current path. There are three treatment programs in total with duration of 20 minutes each. Program details are included in the instructions for use. 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
Kneehab XP applies muscle and nerve stimulation by using the principles of Neuromuscular Electrical Nerve Stimulation (NMES). NMES is the application of electrical stimulation of the peripheral nervous system to contract a muscle either through the direct activation of the motor neurons in the mixed peripheral nerve, or indirectly through reflex recruitment. Kneehab XP applied brief electrical pulses through skin surface adhesive electrodes.
The Kneehab XP conductive garment, type 411 is indicated for 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, early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening and increasing local blood circulation.
6. Technological Characteristics
There are no new technological characteristics that could affect safety or effectiveness of the Kneebab XP Conductive Garment, Type 411 device. Substantial Equivalence has been demonstrated as part this 510k submission.
.
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7. Clinical and Non-Clinical Tests
Bio-Medical Research Ltd. ("BMR") has over 30 years experience in the research, design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. BMR has two divisions - Slendertone, which develops and markets a range of consumer health and fitness products and Neurotech, which provides a range of neuromuscular stimulators for pain management and rehabilitation. Bio-Medical Research Ltd. complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003 Medical Device Quality Management System for the design, manufacture and distribution of electro-medical devices.
Kneehab XP Conductive Garment complies with the following electrical safety and EMC international standards:
- · ロ IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety
- D IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility Requirements & Tests.
- D IEC 60601-2-10 (1987) + A1: 2001 Medical electrical equipment Part 2-10: Particular requirements for the safety of nerve and muscle stimulators
A clinical study, "The effectiveness of the Kneehab™ in strengthening the quadriceps of patients in rehabilitation after anterior cruciate ligament reconstruction'', has been submitted as part of this 510k premarket notification.
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Image /page/3/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three talons, representing service, science, and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Bio-Medical Research, Ltd. % Ms. Anne-Marie Keenan Parkmore Business Park West Galway, Ireland
JUL 8 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Re: K083105
Trade/Device Name: Kneehab XP Conductive Garment, Type 411 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF Dated: July 15, 2009 Received: July 21, 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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Page 2 - Ms. Anne-Marie Keenan
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,
Mark H. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
Kneehab XP Conductive Garment, Type 411
Indications for Use:
Muscle re-education of the quadriceps,
모 Maintaining or increase range of motion of the knee joint,
전 Prevention or retardation of disuse atrophy in the quadriceps,
프 Early post-surgical quadriceps strengthening and improved post-surgical knee stability secondary to quadriceps strengthening,
Increasing local blood circulation. 필
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Vannell, Vane
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K083105
§ 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).