(50 days)
No
The description focuses on basic electrical muscle stimulation with pre-set programs and does not mention any adaptive or learning capabilities.
No.
The intended use is to stimulate healthy muscles to improve or facilitate muscle performance, which is not considered a therapeutic effect for treating a disease or condition.
No
The device is intended to stimulate healthy muscles to improve or facilitate muscle performance, not to diagnose a condition.
No
The device description clearly outlines hardware components including a control unit, arm garments, electrodes, and a battery pack.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles." This is a therapeutic or performance-enhancing use, not a diagnostic one.
- Device Description: The device is a muscle stimulation system that uses electrical impulses to stimulate muscles. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or screen for any disease or condition.
IVD devices are specifically designed to perform tests on samples from the body to provide information for diagnosis, monitoring, or screening. This device's function is entirely external and focused on muscle stimulation for performance improvement.
N/A
Intended Use / Indications for Use
System Arms, Type 390, Model X60 is intended for use by healthy adults to apply Neuromuscular Electrical Simulation (NMES) via adhesive electrodes to healthy muscles of the upper arms in order to improve or facilitate the muscle performance of the triceps and biceps muscles.
Proposed indications for use: System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.
System Arms, Type 390, Model X60 is intended for over-the-counter use.
Product codes
NGX
Device Description
System Arms, Type 390, Model X60 is a two-channel, battery powered, muscle stimulation system. It is supplied with two arms garments (left & right arm), a hand-held rechargeable control unit, a pack of 4 adhesive backed gel based electrodes, instructions for use and a carry pouch.
The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments (i.e. System-Abs Type 390, Model E10/X10, System-Shorts
Type 390, Model E20, System-Mini, Type 390, E30 and also System Arms Type 390, Model E60).
There are three programs available to users of the System Arms, Type 390, X60. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit.
All the internal connections 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.
For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Upper arms (triceps and biceps muscles)
Indicated Patient Age Range
Healthy adults
Intended User / Care Setting
Over-The-Counter Use
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)
No new clinical studies have been submitted as part of this premarket notification.
The System Arms, Type 390, X60 device has been CE marked under the Medical Device Directive 93/42/EEC (NB No. 0366) and also complies with the following international safety standards:
- IEC 60601-1:1988 & A1:1991, A2:1995 Medical electrical equipment Part 1: l General requirements for safety
- IEC 60601-2-10:1987 & Al 2001 Medical electrical equipment Part 2-10: 사 Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-2:2001 (EN 60601-1-2:2001) Medical electrical equipment Part 1-2: " General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- CISPR 22:2003/CFR 47 Part 15:2005 제
- IEC 60601-1-6:2004 (EN 60601-1-6:2001) Medical electrical equipment Part 1-6: . General requirements for safety - Collateral standard: Usability
The battery charger complies to safety standards IEC 60950 and UL 1950
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 1 6 2008
Image /page/0/Picture/1 description: The image shows the logo for BMR. The logo consists of the letters "BMR" in a bold, sans-serif font. To the left of the letters is a curved shape that resembles a crescent or a stylized "C", which partially encloses the letters. The entire logo is in black and white.
l Research Ltd.
usiness Park West, Galway, Ireland - Fax: +353 (0)91 774301 353 (0)91 774300
KOr3164
This 510(k) 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 | |
| Telephone: | +353 91 774300 |
| Fax: | +353 91 774301 |
| E-Mail: | akeenan@bmr.ie |
| Prepared: | 24th October 2008 |
| Revised: | 2nd December 2008 |
2. Device Name
| Trade Name of Device: | System Arms, Type 390, Model X60 |
|---|---|
| Common Name: | Muscle Stimulator |
| Classification Name: | Stimulator, muscle, powered, for muscle conditioning |
| Product Code: | NGX |
3. Identification of Equivalent Legally Marketed Device
| Device Trade Name: | EnerVive, Type 561 | System-Arms Type 390, E60 |
|---|---|---|
| Manufacturer: | Bio-Medical Research Ltd | Bio-Medical Research Ltd |
| 510(k) Nos: | K071666 | K072553 |
4. Description of Device
System Arms, Type 390, Model X60 is a two-channel, battery powered, muscle stimulation system. It is supplied with two arms garments (left & right arm), a hand-held rechargeable control unit, a pack of 4 adhesive backed gel based electrodes, instructions for use and a carry pouch.
The control unit is interchangeable between all the cleared System models from the Slendertone® range of garments (i.e. System-Abs Type 390, Model E10/X10, System-Shorts
1
Type 390, Model E20, System-Mini, Type 390, E30 and also System Arms Type 390, Model E60).
There are three programs available to users of the System Arms, Type 390, X60. Power is derived from a 3.6V NiMH rechargeable battery pack pre-installed in the unit.
All the internal connections 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.
For purposes of hygiene, the garment may be cleaned and instructions for belt care are included in the user manual.
5. Statement of Intended Use/Indications for Use
System Arms, Type 390, Model X60 is intended for use by healthy adults to apply Neuromuscular Electrical Simulation (NMES) via adhesive electrodes to healthy muscles of the upper arms in order to improve or facilitate the muscle performance of the triceps and biceps muscles.
Proposed indications for use: System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.
System Arms, Type 390, Model X60 is intended for over-the-counter use.
6. Technological Characteristics
The System Arms (Type 390, X60) incorporates the control unit and garment technology of the existing predicate System Arms (K072553).
7. Clinical and Non-Clinical Tests
No new clinical studies have been submitted as part of this premarket notification.
The System Arms, Type 390, X60 device has been CE marked under the Medical Device Directive 93/42/EEC (NB No. 0366) and also complies with the following international safety standards:
Page 2 of 3
2
- IEC 60601-1:1988 & A1:1991, A2:1995 Medical electrical equipment Part 1: l General requirements for safety
- IEC 60601-2-10:1987 & Al 2001 Medical electrical equipment Part 2-10: 사 Particular requirements for the safety of nerve and muscle stimulators
- IEC 60601-1-2:2001 (EN 60601-1-2:2001) Medical electrical equipment Part 1-2: " General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
- CISPR 22:2003/CFR 47 Part 15:2005 제
- IEC 60601-1-6:2004 (EN 60601-1-6:2001) Medical electrical equipment Part 1-6: . General requirements for safety - Collateral standard: Usability
The battery charger complies to safety standards IEC 60950 and UL 1950
Page 3 of 3
3
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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, bold line drawing style. The text is in all caps and appears to be in a sans-serif font.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Biomedical Research Limited % Ms. Anne-Marie Keenan Parkmore Business Park, West Galway Ireland
DEC 1 6 2008
Re: K083164
Trade/Device Name: System Arms (Type 390, X60) Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: December 2, 2008 Received: December 4, 2008
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 such 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); 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
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,
00 Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known):
Device Name:
System Arms (Type 390, X60)
Indications for Use:
System Arms (Type 390, X60) is intended to stimulate healthy muscles in order to improve or facilitate muscle performance of the triceps and biceps muscles.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use X 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 General, Restorative, and Neurological Devices
510(k) Number K083164