System from Slendertone is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes. Indications for used are as follows:

System-Abs, Type 390, E10/X10

The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

System-Shorts, Type 390, E20

Strengthening, toning and firming of the bottom and thigh region.

Device Description

System-Abs and System-Shorts are the newest product offerings from Slendertone (division of Bio-Medical Research Ltd.). The products include an interchangeable, rechargeable handheld controller, which can be used with a garment from the System range, to exercise specific areas of the body. The System-Abs belt is used to exercise the abdominal muscles and the System-Shorts is used to exercise the bottom and thigh muscles.

The overall product consists of a garment (shorts for System-Shorts and belt for System-Abs), control unit, a pack of adhesive backed gel based electrodes (6 for System-Shorts and 3 for System-Abs), battery charger and instruction manual.

System is a two-channel EMS product and offers 7 programs to the user of the belt and 4 programs to users of the shorts. Electrodes are applied to the inner surface of the garment to cover the silver studs and the garment is fitted (sizing options are given for a best fit) using the hook and loop patches. Each System garment contains an ID chip, which is programmed to determine the different model types and treatment parameters and is connected to the electronic controller unit via a lead and connector. The control unit generates the required stimulation signals and the garment connects these signals to the skin electrodes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit.

There is no current passed from side to side. Because the user has no access to the wiring or connectors within the garment, he/she cannot alter the current path and so the possibilities for misuse are greatly reduced.

The product cannot be used whilst in charge mode.

Materials:
(Belt): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Foam -- 100% Polyurethane

(Shorts): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Non-Elastic Hook and Loop - 100% Polyethylene, Foam - 100% Polyurethane, Stitch String - 100% Nylon.

AI/ML Overview

This document is a 510(k) summary for muscle stimulator devices (System-Abs and System-Shorts). It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing acceptance criteria and conducting a new study to prove device performance against those criteria.

Therefore, the requested information elements related to specific acceptance criteria, a study proving performance against them, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or not provided in this document.

However, I can extract information regarding the clinical and non-clinical tests that were performed to support substantial equivalence, which is a form of demonstrating safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not explicitly stated as new, quantitative performance criteria for the proposed devices. The acceptance criteria for this submission revolve around demonstrating substantial equivalence to the predicate devices and compliance with relevant safety standards.
Reported Device Performance: The document does not present new performance data for improvement of muscle tone or strengthening from the proposed devices themselves. Instead, it relies on the clinical information submitted for the predicate devices to support the stated Indications for Use.

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

Test Set Sample Size: Not applicable. No new clinical studies were conducted for the proposed devices. The submission leverages previous clinical information.
Data Provenance: The clinical information is from the original predicate submissions (K010335 for Slendertone Flex, Type 512, and K022855 for Slendertone Flex Bottom and Thigh Toning System, Type 511). The document does not specify whether these predicate studies were retrospective or prospective, or their country of origin.

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

Not applicable. No new clinical studies or ground truth establishment processes are described for the proposed devices.

4. Adjudication Method:

Not applicable.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This type of study is not relevant to a muscle stimulator device and was not performed.

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

Not applicable. These are physical muscle stimulator devices, not AI algorithms.

7. The Type of Ground Truth Used:

For the predicate devices' clinical information, the "ground truth" would have been objective measurements of muscle tone/strength improvement or subjective assessments by participants or clinicians. The document does not detail the specific methodology for ground truth establishment for the predicate studies.

8. The Sample Size for the Training Set:

Not applicable. No "training set" in the context of an algorithm.

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

Not applicable.

Summary of what was reported to demonstrate safety and effectiveness for the proposed devices in this 510(k) submission:

Clinical Tests:
- No new clinical studies were submitted.
- The submission relies on clinical information from the original predicate submissions (K010335 and K022855) to support the Indications for Use.
Non-Clinical Tests:
- The proposed devices (System-Abs and System-Shorts) were designed and independently tested to comply with several international electrical safety and electromagnetic compatibility (EMC) standards:
  - EN 60601-1-2:2001 (Medical electrical equipment - EMC)
  - CISPR 22:2003 & CFR 47 Part 15:2005 (Radio disturbance characteristics)
  - DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995 (General requirements for safety)
  - IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995 (General requirements for safety)
  - DIN EN 60601-2-10; IEC 60601-2-10 (Particular requirements for nerve and muscle stimulators)
  - Battery Charger complies with IEC 60950 and UL 1950 (Safety standards for information technology equipment, which the charger falls under).
Risk Management:
- A risk management plan was carried out according to EN ISO 14971:2001.
Quality System:
- Bio-Medical Research Ltd. is registered to IS EN ISO 13485:2003 (Quality management systems for medical devices).
CE Mark:
- The devices are CE marked in Europe and comply with the Medical Device Directive 93/42/EEC.

Conclusion:

This 510(k) submission primarily demonstrates substantial equivalence through a comparison of technological characteristics to predicate devices and adherence to recognized safety and EMC standards. It explicitly states that no new clinical studies were performed for the proposed devices, relying instead on the clinical evidence of the predicate devices. Therefore, a direct answer to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of new clinical performance data is not provided in this document.

Summary

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510(k) Summary

MAR 2 3 2007

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
Address:	Bio-Medical Research Ltd.,Parkmore Business Park, WestGalway, Ireland
Telephone:	+353 91 774300
Fax:	+353 91 774301
E-Mail:	akeenan@bmr.ie
Prepared:	13th March 2007.

2. Device Name

Trade Name of Device:	System-Abs, Type 390, E10/X10System-Shorts, Type 390, E20
Common Name:	Muscle Stimulator
Classification Name:	Stimulator, muscle, powered, for muscle conditioning(NGX)

3. Identification of Equivalent Legally Marketed Device

System-Abs, Type 390, E10/X10

Name:	Slendertone Flex, Type 515	Slendertone Flex, Type 512
Manufacturer:	Bio-Medical Research Ltd.	Bio-Medical Research Ltd.
510(k) No:	K030708, June 2003	K010335, Sept. 2001

System-Shorts, Type 390, E20

Name:	Slendertone Flex Bottom and Thigh Toning System, Type 51
Manufacturer:	Bio-Medical Research Ltd.
510(k) No:	K022855, March 2003

4. Description of Device

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The product cannot be used whilst in charge mode.

Materials:

(Belt): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Foam -- 100% Polyurethane

(Shorts): Outer -100% Nylon, Binding - 82% Nylon, 18% Elastane, Hook and Loop - 100% Nylon, Non-Elastic Hook and Loop - 100% Polyethylene, Foam - 100% Polyurethane, Stitch String - 100% Nylon.

5. Statement of Intended Use/Indications for Use

Indications for use are the same as the listed predicate devices. System from Slendertone is intended for use by healthy persons to apply trans-cutaneous electrical muscle stimulation (EMS) through skin contact electrodes. Indications for used are as follows:

System-Abs, Type 390, E10/X10

The improvement of abdominal muscle tone, for the strengthening of the abdominal 0 muscles and for the development of a firmer abdomen.

System-Shorts, Type 390, E20

Strengthening, toning and firming of the bottom and thigh region. o

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6. Summary of Technological Characteristics

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

	Proposed Device	Predicate Devices
	System-Abs, Type 390, E10/X10	Flex, Type 515 (K030708),Slendertone Flex, Type 512 (K010335)
	System-Shorts, Type 390, E20	Flex Bottom and ThighToning System, Type 511 (K022855)
Design	Handheld controllerconnected to the garment viaa lead. Control unit isinterchangeable between theSystem range of garments.	Unit is contained withinholster on garment
	Rechargeable battery	Disposable AAA (LR03)batteries
	ID chip contained ingarment.	Program parameterscontained in controllermemory.
Material	(Belt): Outer -100% Nylon,Binding - 82% Nylon, 18%Elastane, Hook and Loop -100% Nylon, Foam - 100%Polyurethane(Shorts): Outer -100%Nylon, Binding - 82%Nylon, 18% Elastane, Hookand Loop - 100% Nylon,Non-Elastic Hook and Loop- 100% Polyethylene, Foam- 100% Polyurethane, StitchString - 100% Nylon.	Same
Chemical Composition	N/A	N/A
Energy Source	Rechargeable Battery (3.6V)	3 x LR03 batteries (4.5V)

7. Clinical and Non-Clinical Tests

Clinical Tests: No new clinical studies have been submitted as part of this Premarket Notification. Clinical information submitted as part of the original predicate submissions K010335 Flex, Type 512 and K022855 Flex Bottom and Thigh Toning System, Type 511 are applicable to this Premarket Notification.

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Non-Clinical Tests: System has been designed and 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).
ClSPR 22:2003 Information technology equipment Radio disturbance characteristics - Limits and methods of measurement & CFR 47 Part 15:2005 -Radio Frequency Devices.
ロ DIN EN 60601-1:1996; EN 60601-1:1990+A1:1993+A2:1995 Medical electrical equipment - Part 1: General requirements for safety
IEC 60601-1:1988, IEC 60601-1/A1:1991, IEC 60601-1/A2:1995 o
DIN EN 60601-2-10 Medical electrical equipment Part 2-10; Particular requirements for the safety of nerve and muscle stimulators, IEC 60601-2-10
Battery Charger complies to safety standards IEC 60950 and UL 1950 a

8. Safety and Effectiveness

System has been designed and developed under design project D188 to minimize risks and to ensure efficacy. Bio-Medical Research Ltd. (Division Slendertone) is registered to IS EN ISO 13485:2003 for the design, manufacture and distribution of electro-medical devices.

A risk management plan was carried out to EN ISO 14971:2001.

Independent EMC and Electrical Safety testing has been carried out.

In Europe (EU), System has been CE marked and complies with the Medical Device Directive 93/42/EEC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 its wings spread, facing left. The eagle is composed of thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2007

BioMedical Research Ltd. % Ms. Anne-Marie Keenan Quality/Regulatory Engineer Parkmore Business Park West Galway, Ireland

Re: K070142

Trade/Device Name: System-Abs, Type 390, E10/X10 System-Shorts, Type 390, E20 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: NGX Dated: January 9, 2007 Received: January 16, 2007

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

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Page 2 - Ms. Anne-Marie Keenan

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Ion D. Rumm

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):

Device Name:

System-Abs, Type 390, E10/X10

Indications for Use:

The improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

D.A.A.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices 510(k) Number

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)

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Indications for Use

510(k) Number (if known):

Device Name:

System-Shorts, Type 390, E20

Indications for Use:

System-Shorts Type 390, E20 is indicated for the strengthening, toning and firming of the bottom and thigh region.

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)

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).