The SLENDERTONE® connect Abs is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. The SLENDERTONE® connect Abs, Type 570 is intended for over-the-counter use.

Device Description

The SLENDERTONE® Connect Abs, Type 570 is a portable neuromuscular electrical stimulator intended to deliver electrical stimulation to the abdominal muscles. The device includes a control unit, abdominal garment, 3 adhesive gel pads (electrodes), USB cable and instructions for use. It contains one pre-installed program called 'Essential Toning'.

The SLENDERTONE® Connect Abs incorporates a Bluegiga BLE113 Bluetooth module to enable wireless communication and can be paired with a Bluetooth enabled iOS smart device running a Slendertone Connect iOS App, available from the Apple App store. The App implements a virtual control panel on the screen of the smart device where on-screen buttons are provided to the user.

The control unit is connected to the abdominal belt garment via an 8-pin interface. The control unit contains the primary controls for operation of the device and push buttons are available for switching the unit on or off and to increase or decrease the stimulation intensity. These controls remain active while the control unit is wirelessly paired with a smart device and can be used in the event of loss of Bluetooth connection. The SLENDERTONE® connect Abs contains light emitting diodes (LED) which indicate status relating to battery charge, stimulation and bluetooth activity. Power is derived from a 3.7V Li-Po rechargeable battery pack and the unit can be recharged by using the supplied USB cable.

The SLENDERTONE® Connect Abs, Type 570 is rated as IP22 for ingress protection. The user has no access to the wiring or connectors within the garment. For purposes of hygiene, the garment may be cleaned and instructions for garment care are included in the user manual.

AI/ML Overview

This document is a 510(k) premarket notification for a muscle stimulator device, the Slendertone® connect Abs, Type 570. The purpose of this notification is to demonstrate that the new device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in the typical format of quantitative performance targets (e.g., sensitivity, specificity, accuracy) for clinical outcomes. Instead, the acceptance criteria are implicitly defined by compliance with a set of international safety and performance standards for medical electrical equipment and the demonstration of "substantial equivalence" to predicate devices. The reported "performance" is the demonstration of compliance with these standards and the comparison of technological characteristics to predicate devices.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety and Essential Performance (General): Compliance with IEC 60601-1: 2005/A1:2012	Performance testing was conducted in accordance with IEC 60601-1: 2005/A1:2012. (Implicitly, the device met the requirements.)
Usability: Compliance with IEC 60601-1-6:2010	Performance testing was conducted in accordance with IEC 60601-1-6:2010. (Implicitly, the device met the requirements.)
Electromagnetic Compatibility (EMC): Compliance with EN 60601-1-2:2007	Performance testing was conducted in accordance with EN 60601-1-2:2007. (Implicitly, the device met the requirements.)
Safety of Nerve and Muscle Stimulators (Specific): Compliance with IEC 60601-2-10:2012	Performance testing was conducted in accordance with IEC 60601-2-10:2012. (Implicitly, the device met the requirements.)
Home Healthcare Environment: Compliance with IEC 60601-1-11:2010	Performance testing was conducted in accordance with IEC 60601-1-11:2010. (Implicitly, the device met the requirements.)
Biocompatibility (Cytotoxicity): Compliance with ISO 10993-5:2009	Performance testing was conducted in accordance with ISO 10993-5:2009. (Implicitly, the device met the requirements.)
Biocompatibility (Irritation & Skin Sensitization): Compliance with ISO 10993-10:2010	Performance testing was conducted in accordance with ISO 10993-10:2010. (Implicitly, the device met the requirements.)
Wireless Co-existence (Bluetooth/Wi-Fi): Device functions as specified in an environment with other ISM band equipment.	The performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band (Bluetooth, Wi-Fi, cellphones, cordless phones). The device met all specified requirements.
Bluetooth Module Safety: Compliance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013 (Safety of Technology Equipment) and FCC Rule Part 15.247:2012 (Radio Frequency Devices)	BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013 and FCC Rule Part 15.247:2012. (Implicitly, the device met the requirements.)
Battery Safety: Compliance with IEC 62133:2012 (Secondary cells and batteries, safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications).	Battery testing was conducted in accordance with IEC 62133:2012. (Implicitly, the device met the requirements.)
Substantial Equivalence (General): Same principles of operation, differences in technological characteristics do not raise new issues of safety or effectiveness.	"The SLENDERTONE® connect Abs, Type 570 has the same principles of operation as its predicate devices and any differences in technological characteristics do not raise new issues of safety or effectiveness." Comparison tables (Table I and II) detail similarities and differences with predicates.
Indications for Use: Differences in Indications for Use do not alter intended therapeutic use or affect safety/effectiveness.	"The Indications for Use statement is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device."

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

The document describes performance testing against engineering and electrical standards, not a clinical study involving human subjects to evaluate muscle performance outcomes. Therefore, there is no "test set" in the context of a clinical study, no data provenance (country of origin, retrospective/prospective), and no "sample size" of patients/cases used for a clinical evaluation. The sample size for the engineering tests would refer to the number of devices tested, which is not specified but is typically a small, representative sample for such regulatory submissions.

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

Since there is no clinical "test set" with ground truth requiring expert adjudication for diagnosis or outcome, this information is not applicable to this submission. The "ground truth" here is compliance with established international engineering and safety standards, determined by testing procedures.

4. Adjudication Method for the Test Set

As there is no clinical "test set" requiring human interpretation or agreement on a diagnosis or outcome, an adjudication method is not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not performed as part of this submission. This type of study is typically used to evaluate the diagnostic accuracy or effectiveness of an AI system (often in image-based diagnostics) compared to human readers, with or without AI assistance. This device is a muscle stimulator, and the submission focuses on engineering, electrical, and biocompatibility safety and performance, and substantial equivalence to predicates, not diagnostic accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study in the context of diagnostic accuracy or clinical outcomes for an algorithm was not performed. The device itself is an electrical muscle stimulator, and while it has a "smart device" app, the "performance data" provided relates to the physical and electrical safety and functionality of the device, not an AI algorithm's standalone clinical performance.

7. Type of Ground Truth Used

The "ground truth" used for this submission is established international and national engineering, electrical, safety, and biocompatibility standards. Compliance is demonstrated through physical testing, measurements, and comparison to predicate device specifications. There is no pathology, expert consensus on clinical outcomes, or patient outcomes data presented in this context for "ground truth."

8. Sample Size for the Training Set

This submission does not involve an AI algorithm that requires a "training set" of data in the typical sense (e.g., for machine learning). The software/firmware in the device controls the electrical stimulation, but it's likely based on predefined programs and parameters, not a learned model from a large dataset. Therefore, there is no training set sample size described.

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

As there is no "training set," the method for establishing its ground truth is not applicable. The "ground truth" for the device's functional logic (i.e., how it's programmed to stimulate muscles) would stem from scientific understanding of neuromuscular stimulation and established therapeutic protocols, not from a data-driven training process for an AI.

Summary

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Image /page/0/Picture/1 description: The image shows the logo of the Department of Health & Human Services - USA. The logo features a stylized human face in profile, with three curved lines representing the hair or head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the logo.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 6, 2015

Bio-Medical Research Ltd. Attn: Ms. Anne-Marie Keenan Regulatory Affairs Specialist Parkmore Business Park West. Galway, IRELAND

Re: K151903 Trade Name: Slendertone® connect Abs, Type 570 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: October 6, 2015 Received: October 9, 2015

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

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 27f 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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151903

Device Name SLENDERTONE connect Abs, Type 570

Indications for Use (Describe)

The SLENDERTONE connect Abs is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 201 Subpart D)
Over-The-Counter Use (21 CFR 201 Subpart G)

_ | Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Bio-Medical Research Ltd.

Parkmore Business Park West, Galway, Ireland

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

I. SUBMITTER

Name:	Anne-Marie Keenan,Regulatory Affairs Specialist
Address:	Bio-Medical Research Ltd.,Parkmore Business Park West,Galway, IRELAND
Telephone:	+353 91 774316
Fax:	+353 91 774301 or +353 91 774302
E-Mail:	akeenan@bmr.ie
Prepared:	October 6, 2015

II. DEVICE

Trade Name of Device:	SLENDERTONE® Connect Abs, Type 570
Common Name:	Powered muscle stimulator
Regulation Number:	21 CFR 890.5850
Regulation Description:	Stimulator, muscle, powered, for muscle conditioning
Product Code:	NGX
Device Class:	2

III. PREDICATE DEVICES

510(k) Number:	K100320
Manufacturer:	Bio-Medical Research Ltd.
Trade Name:	Slendertone System Ultra, Type 390, Model E70/X70
510(k) Number:	K143551
Manufacturer:	DJO LLC.
Trade Name:	Compex Wireless USA

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These predicates have not been subject to a design-related recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The SLENDERTONE® connect Abs, Type 570 is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. It is indicated for the improvement of abdominal muscle tone, for the strengthening of the abdominal muscles and for the development of a firmer abdomen. The SLENDERTONE® connect Abs, Type 570 is intended for over-thecounter use.

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The Indications for Use statement for the SLENDERTONE® connect Abs, Type 570 is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicates.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following tables summarizes the similarities and differences between the technological characteristics of the new device versus the listed predicate devices;

Table I	Unit Characteristics of new vs. predicate devices, Slendertone System Ultraand Compex Wireless USA
Table II	Output Characteristics of new vs. predicate device Compex Wireless USA(new device values representing maximum power limit of 180mW)

In future, users may securely download additional treatment programs through the mobile app. The program parameters and resulting outputs for any such program are limited in accordance with the Table II.

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Table IBasic Unit Characteristics	New DeviceSlendertone Connect Abs	Predicate DeviceSlendertone System Ultra	Predicate Device -Compex Wireless USA
1. 510(k) Number	To be assigned	K100320	K143551
2. Device Name, Model	Slendertone Connect Abs, Type 570	Slendertone System UltraType 390, E70/X70	Compex Wireless USA
3. Manufacturer (Contract)	Blue Ocean Innovation LtdRM 1813, Fo Tan Industrial Centre26-28 Au Pui Wan StreetFo Tan, Hong Kong	China Turnkey Solutions Logistics(Shenzhen) Co.,Futian Free Trade ZoneCHINA 518038	DJO LLC
4. Power Source	3.7V Lithium Polymer Single CellRechargeable	3.6V NiMh Battery PackRechargeable	3.7V Lithium Polymer Single Cell.
- Method of line Isolation	No line connection possible whenconnected to body	No line connection possible whenconnected to body	No line connection possible whenconnected to body
- Patient Leakage Current	Not applicable, no line connection, noAC charger connection or operation.Connection method does not allow ACcharger connection to Patient.	Not applicable, no line connection, noAC charger connection or operation.Connection method does not allow ACcharger connection to Patient.	Not applicable, no line connection, noAC charger connection or operation.Connection method does not allow ACcharger connection to Patient.
5. No. of Output Modes	1 (Symmetric, Pulsed, Biphasic)	1 (Symmetric, Pulsed, Biphasic)	1 (Symmetric, Pulsed, Biphasic)
6. Number of Output Channels	2	2	2
- Synchronous/Alternating?	Synchronous	Synchronous	Synchronous
- Method of channel isolation	Transistor	Transistor	Transistor
7. Regulated Current or RegulatedVoltage	Constant Current	Constant Current	Constant Current
8. Software/Firmware/MicroprocessorControl?	Yes	Yes	Yes, with Wireless control
9. Automatic overload Trip?	Yes	Yes	Yes
10. Automatic No-Load Trip?	Yes	Yes	Yes
11. Automatic Shut Off	Yes	Yes	Yes
12. Patient Override Control?	Yes, pause button stops treatmentimmediately.	Yes, pause button stops treatmentimmediately.	Yes, pause button stops treatmentimmediately.
13. Indicator Display- On/Off Status?	Yes, Unit LED and Smart device	Yes, LCD	Yes, LCD
Table IBasic Unit Characteristics	New DeviceSlendertone Connect Abs	Predicate DeviceSlendertone System Ultra	Predicate Device -Compex Wireless USA
- Low Battery?	Yes, Unit LED and Smart device	Yes, LCD	Yes, LCD
- Voltage/Current Level?	Yes, via Smart device	Yes, LCD	Yes, LCD
14. Timer range (minutes)	20-30 minutes	20-40 minutes	20-40 minutes
15. Compliance with VoluntaryStandards?	IEC 60601-1: 2005 & A1:2012IEC 60601-2-10:2012EN 60601-1-2: 2007IEC 60601-1-11:2010IEC 60601-1-6:2010IEC 62133:2012FCC Rule Part 15.247:2012	IEC 60601-1:1988 & A1:1991,A2:1995IEC 60601-2-10:1987 & A1 2001IEC 60601-1-2:2001 (EN 60601-1-2:2001)CISPR 22:2003/CFR 47 Part 15:2005IEC 60601-1-6:2004 (EN 60601-1-6:2001)Battery Charger: IEC 60950 and UL1950CC Rules Subpart B
16. Compliance with CFR 21 898?	Yes	Yes	Yes
17. Weight (unit)	37g (inc batteries)	116g (inc. batteries)	2x60g
18. Dimensions (un.){W x H x D}	70 x 50 x 14 mm approx.	60 x 23 x 115mm approx.	65 x 20mm
19. Housing Materials and Construction	Injection moulded thermosetting plastic	Injection moulded thermosetting plastic	plastic

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Table IIOutput Characteristics	New DeviceSlendertone Connect Abs	Predicate DeviceCompex Wireless USA
Waveform	Pulsed, Symmetrical, Biphasic	Pulsed, Symmetrical, Biphasic
Shape	Rectangular, with interphase interval	Rectangular, with interphase interval
Maximum Output Voltage (RMSV) (+/-10%)$\frac{Vp^2 x 2 x PW}{\sqrt{\frac{1}{freq}}}$	9.47V @ 500Ω17.5V @ 2kΩ6.2V @ 10kΩ	15.5V @500Ω62.0V @2kΩunknown
Maximum Output Current (RMSA) (+/-10%)	18.9mA @ 500Ω8.75mA @ 2kΩ620μA @ 10kΩ	31mA@ 500Ω (estimated)31mA@ 2kΩ (estimated)unknown
Pulse Width	900 μs	900μs
Baseline to peak current @500Ω	80mA	120mA
Frequency (Hz)	10 to 80 Hz	1 to 120 Hz
- Phase Duration	100 - 400μS	300 to 400 μS
Net Charge (µC per pulse)	0@500ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse	0@500ΩSymmetric, biphasic and leading polarity alternatesfor each successive pulse
Maximum Phase Charge (μC)C= Ip*PW	1 phase 32 µC @500Ω2 phase 64 µC @500Ω	1 phase 48 µC @500Ω2 phase 96 µC @500Ω
Maximum Current Density (mA/cm²)	0.28 mA/cm² @500Ω	1.49 mA/cm² @500ΩElectrode 50mm square
Maximum Power Density (W/ cm²)Using smallest electrode conductivesurface area	2.57 mW/ cm² @500Ω	27.6 mW/cm² @500Ω
Contraction Time	0.5 - 5 sec	4.5 - 11.0 sec
Table IIOutput Characteristics	New DeviceSlendertone Connect Abs	Predicate DeviceCompex Wireless USA
Relaxation Time	0.5 - 6 sec	4.5 - 31 secs
Additional Features (if applicable)	N/A	N/A

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VII. PERFORMANCE DATA

Performance testing was conducted in accordance with the following international standards for safety:

IEC 60601-1: 2005/A1:2012	Medical electrical equipment. General requirements for basicsafety and essential performance
IEC 60601-1-6:2010	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability
EN 60601-1-2:2007	Medical electrical equipment - part 1-2: general requirementsfor safety -collateral standard: electromagnetic compatibility- requirements and tests
IEC 60601-2-10:2012	Medical Electrical equipment - Part 2-10: Particularrequirements for the safety of nerve and muscle stimulators
IEC 60601-1-11:2010	Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance -Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in the homehealthcare environment
ISO 10993-5:2009	Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity
ISO 10993-10:2010	Biological evaluation of medical devices. Tests for irritationand skin sensitization

In addition, the performance of SLENDERTONE® Connect Abs for wireless co-existence was evaluated in an environment with equipment operating in the ISM band i.e. Bluetooth and Wi-Fi devices, cellphones, cordless phones etc.. The device met all specified requirements.

BLE module testing was conducted in accordance with EN 60950-1:2006+A11:2009 +A1:2010+A12:2011+A2:2013. Safety of Technology Equipment and FCC Rule Part 15.247:2012.

Battery testing was conducted in accordance with IEC 62133:2012 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them, for use in portable applications.

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VIII. CONCLUSION

. The SLENDERTONE® connect Abs, Type 570 has the same principles of operation as it's predicate devices and any differences in technological characteristics do not raise new issues of safety or effectiveness.
. The Indications for Use statement is not identical to the predicate devices; however, the differences do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device.
. Performance data has demonstrated that the SLENDERTONE® Connect Abs, Type 570 is as safe and effective as the predicate devices and is substantially equivalent.

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).