(110 days)
Not Found
No
The description focuses on electrical stimulation technology and pre-programmed treatment programs, with no mention of AI or ML capabilities.
Yes
The device is indicated for muscle re-education, maintaining or increasing range of motion, preventing atrophy, post-surgical strengthening, improving stability, and increasing blood circulation, all of which are therapeutic purposes.
No
The device description and intended use outline therapeutic functions such as muscle re-education, strengthening, and circulation improvement, not diagnostic functions like identifying or characterizing a disease or condition.
No
The device description explicitly states it is a "portable, two-channel transcutaneous electrical muscle stimulator" and includes hardware components like a control unit, battery charger, and battery pack.
Based on the provided information, the Kneehab XP Controller is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device that is applied externally to the body to stimulate muscles and improve knee function. This is a therapeutic or rehabilitative purpose, not a diagnostic one.
- Device Description: The description details an electrical muscle stimulator that delivers current pulses to the body. This is consistent with a physical therapy or rehabilitation device, not a device that analyzes samples from the body (which is the core function of an IVD).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Kneehab XP Controller does not fit this definition.
N/A
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.
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.
Indications for Use:
-
- 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.
Product codes (comma separated list FDA assigned to the subject device)
IPF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
quadriceps area of the body, knee joint
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)
Not Found
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
§ 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).
0
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, West | ||
| Galway, Ireland | DEC 30 2009 | |
| Telephone: | +353 91 774300 | |
| Fax: | +353 91 774301 | |
| E-Mail: | akeenan@bmr.ie | |
| Prepared: | 3rd September 2009 |
2. Device Name
く ・
2 - 1
| 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.
1
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.
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.
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
| :
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.
2
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
3
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.
4
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
5
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 _