SYSTEM-ARMS, MODEL 390,E60

K072553 · Bio-Medical Research, Ltd. · NGX · Dec 14, 2007 · Physical Medicine

Device Facts

• Record ID: K072553
• Device Name: SYSTEM-ARMS, MODEL 390,E60
• Applicant: Bio-Medical Research, Ltd.
• Product Code: NGX · Physical Medicine
• Decision Date: Dec 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5850
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

System-Arms, Type 390, Model E60 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the muscles of the upper arms. Indications for use: Toning of the triceps muscles of the upper arms. System-Arms, Type 390, Model E60 is intended for over-the-counter use.

Device Story

System-Arms, Type 390, Model E60 is a two-channel, battery-powered transcutaneous electrical muscle stimulation (EMS) system for home use. The device consists of a handheld control unit, two arm garments, and four adhesive gel-based electrodes. The control unit is interchangeable with other Slendertone garments. Operation involves connecting the control unit to the garment; an integrated EEPROM (ID chip) in the garment connector identifies the garment type and specific stimulation parameters to the control unit. The user selects from three programs (beginner, intermediate, advanced). The device delivers electrical signals to the triceps muscles via the electrodes to induce muscle contraction. The control unit displays the model number on an LCD. The device is powered by a 3.6V NiMH rechargeable battery and cannot be used while charging. The system is designed to exercise upper arm muscles, potentially benefiting the user through improved muscle tone.

Clinical Evidence

A single-blind, prospective, randomized, controlled trial was conducted to measure the efficacy of the Slendertone Arm toning product, assessing muscle strength, arm anthropometrics, triceps brachii skinfold, and psychometric measures. The device also underwent independent bench testing for electromagnetic compatibility (EN 60601-1-2), radio disturbance (CISPR 22, CFR 47 Part 15), and general safety (DIN EN 60601-1, IEC 60601-1, DIN EN 60601-2-10).

Technological Characteristics

Two-channel EMS system; 3.6V NiMH rechargeable battery; SATA 7-pin connector with integrated EEPROM ID chip. Garments constructed of nylon, polyester, polyurethane, EVA foam. Electrodes (50x50mm) manufactured by Axelgaard (K000947). Complies with IEC 60601-1, IEC 60601-2-10, and IEC 60950. Connectivity via proprietary garment-to-controller interface.

Indications for Use

Indicated for healthy persons for toning of the triceps muscles of the upper arms.

Regulatory Classification

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.

Predicate Devices

• System-Abs, Type 390, Model E10 and X10 (K070142)

Submission Summary (Full Text)

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#### 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of 21 CFR 807.92.

# 1. Contact Details

| Name: | Anne-Marie Keenan | DEC 1 4 2007 |
|------------|-----------------------------------------------|--------------|
| Address: | Bio-Medical Research Ltd., | |
| | Parkmore Business Park, West | |
| | Galway, Ireland | |
| Telephone: | [phone] | |
| Fax: | [phone] | |
| E-Mail: | [e-mail] | |
| Prepared: | 5th September 2007, Revised 5th December 2007 | |

# 2. Device Name

| Trade Name of Device: | System-Arms, Type 390, Model E60 |
|-----------------------|------------------------------------------------------|
| Common Name: | Muscle Stimulator |
| Classification Name: | Stimulator, muscle, powered, for muscle conditioning |
| | (NGX) |

# 3. Identification of Equivalent Legally Marketed Device

| Name: | System-Abs, Type 390, Model E10 and X10 |
|---------------|-----------------------------------------|
| Manufacturer: | Bio-Medical Research Ltd |
| 510(k) No: | K070142, March 2007 |

### 4. Description of Device

System-Arms, Type 390, Model E60 is a two-channel, battery powered muscle stimulation system. The System-Arms accessory pack consists of two arms garments (left and right arm), four straps, a pack of 4 adhesive backed gel based electrodes, instructions for use (manual and separate quick start guide) and a carry pouch. The hand-held control unit, which may be purchased separately, is interchangeable between all the System models from Slendertone® range of garments (i.e. System-Abs Type 390, Model E10/X10, System-Shorts Type 390, Model E20, System-Mini, Type 390, Model E30 and System Arms Type 390, Model E60).

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The four equal sized electrodes (approx. size 50 x 50 mm) are attached to the inner surface of the garments to cover stainless steel studs by using the electrode outlines to ensure correct placement. The garments are connected to the control unit by leads and an over-molded SATA 7-pin connector, which also incorporates the EEPROM (ID chip) device.

As with the predicate System-Abs, the ID chip contains the data that identifies the garment type and the stimulation parameters intended for that garment. The model number of the garment itself is displayed on the LCD at power-on and on a label on the garment. When the control unit is connected to the garment combination, the data is read, identifying the specific garment type and also the stimulation parameters. The appropriate signals are then delivered to the garment electrodes. Three programs in total (beginner, intermediate and advanced) are available to the System-Arms user. All internal connections are over-molded to prevent moisture ingress and the user has no access to the wiring or connectors within the garments and is unable to alter the current path.

Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit. As with the predicate System-Abs, System-Arms cannot be used when charging.

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

System-Arms, Type 390, Model E60 is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation ("EMS") through skin contact electrodes for the purpose of exercising the muscles of the upper arms.

Indications for use: Toning of the triceps muscles of the upper arms.

System-Arms, Type 390, Model E60 is intended for over-the-counter use.

#### 6. Technological Characteristics

A summary of the technological characteristics of the proposed System-Arms compared to the predicate System-Abs device in terms of design, material, chemical composition and energy source is given below:

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| | Proposed Device | Predicate Device |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Name | System-Arms | System-Abs |
| Type | Type 390, E60 | Type 390, E10/X10 |
| 510k No. | Not Assigned | K070142 |
| Design | | |
| Garment | 2 arms garments with ID Chip | 1 belt-shaped garment with ID Chip |
| | | |
| Control Unit | System from Slendertone® Controller<br>Handheld, Rechargeable | Same |
| Electrodes | 4 in total<br>Size: 50mm x 50mm | 3 in total<br>Size: 1 x center electrode approx.<br>100mm x 100mm, 2 x side electrodes<br>approx. 70mm X 100mm |
| | Manufacturer: Axelgaard<br>Manufacturing Co.<br>510k No. K000947 | Same |
| Material | 2 x arms garments constructed of<br>Outer Material - 80% Nylon, 20%<br>Polyester, Inner Material - 100%<br>Polyester laminated to 100%<br>Polyurethane, Binding - 100% Nylon,<br>Hook & Loop - 100% Nylon, Foam -<br>EVA, Elasticated Straps - 100%<br>Nylon | 1 x abdominal garment constructed of<br>Outer Material-100% Nylon, Binding<br>- 82% Nylon, 18% Elastane, Hook<br>and Loop - 100% Nylon, Foam -<br>100% Polyurethane |
| Chemical<br>Composition | N/A | N/A |
| Energy Source | Rechargeable Battery (3.6V)<br>Charger: US/Japan Charger<br>BMR p/n 2504-0302 | Same |

# 7. Clinical and Non-Clinical Tests

A single-blind, prospective, randomized, controlled trial "The effect of triceps brachii electrical muscle stimulation training on muscle strength, arm anthropometrics, triceps brachii

.

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skinfold and psychometric measures" used to measure the efficacy of the Slendertone Arm toning product has been included as part of this submission.

System from Slendertone® has also been independently tested to the following requirements:

- EN 60601-1-2:2001 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2001).
- . CISPR 22:2003 - Information technology equipment -- Radio disturbance characteristics - Limits and methods of measurement & CFR 47 Part 15:2005 -Radio Frequency Devices.
- . DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993 +A2:1995 Medical electrical equipment - Part 1: General requirements for safety
- l IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995
- DIN EN 60601-2-10 Medical electrical equipment Part 2-10: Particular 트 requirements for the safety of nerve and muscle stimulators, IEC 60601-2-10
- 피 Battery Charger complies to safety standards IEC 60950 and UL 1950

#### 8. Conclusion

Bio-Medical Research Ltd., of which a subsidiary is Slendertone, is registered to IS EN ISO 13485:2003 for the design, manufacture and distribution of electro-medical devices. In the EEEA, System-Arms is CE marked and complies with the Medical Device Directive 93/42/EEC.

Both the proposed System-Arms and predicate System-Abs use identical electronic hardware. The principal physical difference, duc to the difference in the targeted muscles, is the garment offering and the number, size and positioning of the electrodes.

The predicate device, System-Abs was shown to be effective for the improvement of strength, firmness and tone of the abdominal muscles. The proposed device, System-Arms delivers effective toning component of the therapy.

In conclusion, it can be determined that the new device System-Arms, Type 390, Model E60 is substantially equivalent to System-Abs, Type 390, Model E10/X10.

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Image /page/4/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 three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2007

Biomedical Research Ltd % Anne-Marie Keenan Parkmore Business Park West Galway Ireland

> K072553 Trade/Device Name: System-Arms Type 390, E60 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: November 12, 2007 Received: November 15, 2007

Dear Ms. Keenan:

Re:

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.

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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 [phone]. 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 Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson 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

510(k) Number (if known): _K072553______________________________________________________________________________________________________________________________________________________________________

System-Arms, Type 390, Model E60 Device Name:

Indications for Use:

Toning of the triceps muscles of the upper arms.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (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)


**(Division Sign-Off)**

Division of General, Restorative, and Neurological Devices

**510(k) Number** K072553