The Kneehab XP Controller 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.

Device Description

The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body. The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Kneehab XP Controller (Type 411), a powered muscle stimulator. This type of submission is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials. Therefore, the document does not contain information about specific acceptance criteria, device performance metrics, or a study designed to explicitly meet such criteria in the way a clinical trial would.

Instead, the "study" described is a demonstration of compliance with established electrical safety and electromagnetic compatibility (EMC) international standards, and an assertion of substantial equivalence to a previously cleared device.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, this document does not present "acceptance criteria" in the typical sense of a clinical trial (e.g., target diagnostic accuracy, sensitivity, specificity) nor does it report performance against such metrics. Instead, the device's "performance" and "acceptance" are demonstrated by its compliance with relevant safety standards and its technological equivalence to a predicate device.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with Electrical Safety Standard IEC 60601-1 (1998) + A1: 1991, A2: 1995	"The Kneehab XP Controller, Type 411 unit complies with... IEC 60601-1"
Compliance with EMC Standard IEC 60601-1-2 (2001)	"The Kneehab XP Controller, Type 411 unit complies with... IEC 60601-1-2"
Compliance with Particular Safety Standard for Nerve and Muscle Stimulators IEC 60601-2-10 (1987) + A1: 2001	"The Kneehab XP Controller, Type 411 unit complies with... IEC 60601-2-10"
No new technological characteristics affecting safety/effectiveness compared to predicate device	"There are no new technological characteristics that could affect safety or effectiveness of the Kneehab XP Controller, Type 411 device."

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a test set or data provenance in the context of a clinical performance study. The "test" involved demonstrating compliance with technical standards through engineering evaluations and documentation, not through patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not applicable. There was no "test set" requiring ground truth established by experts as part of a clinical evaluation. Compliance with standards is verified by testing laboratories and regulatory bodies.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" requiring expert adjudication.

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

Not applicable. This device is a muscle stimulator, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical muscle stimulator, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the existence of established international safety and EMC standards (e.g., IEC 60601 series). Compliance with these standards serves as the benchmark against which the device's technical specifications and test results are evaluated.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device and regulatory submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no concept of a "training set" or "ground truth" for it in this context.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the letters "BMR" in bold, sans-serif font. A stylized, incomplete circle or arc is positioned to the left of the letters, partially enclosing the "B". The logo is rendered in black against a white background, creating a high-contrast visual. The overall design is simple and modern.

(0)91 774300

This summary is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Contact Details

Name:	Anne-Marie Keenan
Address:	Bio-Medical Research Ltd.,Parkmore Business Park, WestGalway, Ireland	DEC 30 2009
Telephone:	+353 91 774300
Fax:	+353 91 774301
E-Mail:	akeenan@bmr.ie
Prepared:	3rd September 2009

2. Device Name

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Trade Name of Device:	Kneehab XP Controller (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

Name:	Kneehab XP Conductive Garment, Type 411
Manufacturer:	Bio-Medical Research Ltd.
510(k) No:	K083105

4. Description of Device

· The Kneehab XP Controller is a portable, two-channel transcutaneous electrical muscle stimulator incorporating multipath®, a patented technology developed by neurotech®. It is designed to work in conjunction with the Kneehab XP. Conductive Garment and electrodes to deliver highly focused and accurate quadriceps contractions by using constant current pulses to stimulate the nerves in the quadriceps area of the body.

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The Kneehab XP controller is supplied with a rechargeable control unit, battery charger and instructions for use. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. The controller may be only be connected to the garment/electrodes or the charger due to the utilisation of a single custom connector. All the internal connections of the unit are over-molded to prevent moisture ingress. There are three treatment programs in total with duration of 20 minutes each and details of these are included in the instructions for use.

5. Statement of Intended Use/Indications for Use

The Kneehab XP Controller 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.

6. Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the Kneehab XP Controller, Type 411 device. The Kneehab XP Controller is substantially equivalent to the predicate device Kneehab XP Conductive Garment cleared under K083105.

7. Clinical and Non-Clinical Tests

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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.

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The Kneehab XP Controller, Type 411 unit complies with the following electrical safety and EMC international standards:

O IEC 60601-1 (1998) + A1: 1991, A2: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety
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

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling an emblem. The emblem is a stylized depiction of an eagle, with three curved lines representing its wings and body.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Bio-Medical Research Ltd., % Ms. Anne-Marie Keenan Parkmore Business Park, West Galway, Ireland

Re: K092791

Trade/Device Name: Kneehab XP Controller, Type 411 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF DEC 30 2009 Dated: November 25, 2009 Received: December 2, 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/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,

David Krane

C 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 Controller, Type 411

Indications for Use:

트 Muscle re-education of the quadriceps,
트 Maintaining or increase range of motion of the knee joint,
트 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. 사

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)

FOR M.MELKERSON

(Division Sign-Off), Division of Surgical, Orthopedic, and Restorative Devices

K092791 510(k) Number _

Regulation Number and Section

§ 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).