The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

Device Description

The SLENDERTONE® Evolve Abs, Type 735 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 twelve pre-installed programs.

The control unit is connected to the abdominal belt garment via three magnetic connectors. 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. The SLENDERTONE® Evolve Abs, Type 735 contains an Organic Light-Emitting Diode (OLED) display which indicates status relating to battery charge and stimulation. 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® Evolve Abs, Type 735 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

The provided document is a 510(k) summary for the SLENDERTONE® Evolve Abs, Type 735, a powered muscle stimulator. It does not contain information about a clinical study or acceptance criteria based on human performance or AI performance.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (SLENDERTONE® Corefit Abs8, Type 734) by comparing technological characteristics and citing compliance with safety standards.

Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this specific device based on the given text.

The document states:

Indications for Use: Improvement of abdominal muscle tone, strengthening of abdominal muscles, and development of a firmer abdomen.
Performance Data (Safety Standards): The device complies with several international safety standards (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11, and IEC 62133 for batteries). These standards typically involve engineering and electrical safety tests, not clinical efficacy studies for the stated indications.
Conclusion: The device is considered substantially equivalent to the predicate device, and any differences in technological characteristics do not raise new issues of safety or effectiveness.

To answer your request, a clinical study demonstrating the efficacy of this specific device for its indications would be required, which is not present in this 510(k) summary. The document explicitly states "Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type 735 is as safe and effective as the predicate device and is substantially equivalent," but this "performance data" refers to compliance with electrical and safety standards, not a clinical trial proving its effectiveness in improving muscle tone or firmness.

Summary

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February 10, 2021

Bio-Medical Research Ltd. Eoin Keating Official Correspondent Parkmore Business Park West Galway, H91 NHT7 Ireland

Re: K203513

Trade/Device Name: SLENDERTONE Evolve Abs, Type 735 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: November 25, 2020 Received: November 30, 2020

Dear Eoin Keating:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, 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 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203513

Device Name SLENDERTONE® Evolve Abs, Type 735

Indications for Use (Describe)

The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

Type of Use (Select one or both, as applicable)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 Limited, Parkmore Business Park West, Galway, Ireland. Tel: +353 (0)91 774300 Fax: +353 (0)91 774301

Image /page/3/Picture/2 description: The image shows the logo for BIO-MEDICAL Research Limited. The logo consists of a cluster of green and blue circles on the left, arranged in a pattern that resembles a molecule or a cell structure. To the right of the circles, the words "BIO-MEDICAL" are written in a large, sans-serif font, with "BIO-" in blue and "MEDICAL" in gray. Below "BIO-MEDICAL", the words "Research Limited" are written in a smaller, gray, sans-serif font.

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

I. SUBMITTER

Name:	Mike Kilkelly
Address:	Bio-Medical Research Ltd.,Parkmore Business Park West,Galway, IRELAND
Telephone:	+353 91 774395
Fax:	+353 91 774301 or +353 91 774302
E-Mail:	mkilkelly@bmr.ie
Prepared:	November 25, 2020

II. DEVICE

Trade Name of Device:	SLENDERTONE® Evolve Abs, Type 735
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:	K180688
Manufacturer:	Bio-Medical Research Limited.
Trade Name:	SLENDERTONE® Corefit Abs8, Type 734

This predicate has not been subject to a design-related recall.

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IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The SLENDERTONE® Evolve Abs, Type 735 is indicated for the improvement of abdominal muscle tone, for strengthening of abdominal muscles, and for the development of a firmer abdomen.

The Indications for Use statement for the SLENDERTONE® Evolve Abs, Type 735 is identical to the predicate device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The following table summarizes the similarities and differences between the technological characteristics of the new device and predicate device SLENDERTONE® Corefit Abs8, Type 734.

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10.2 Output Specifications

Table I	New Device	Predicate Device	Comparison
Basic Unit Characteristics	SLENDERTONE® Evolve Abs,Type 735	SLENDERTONE® CoreFit Abs 8,Type 734
1. 510(k) Number	(To be Assigned)	K180688	N/A
2. Device Name, Model	SLENDERTONE® Evolve Abs,Type 735	SLENDERTONE® CoreFit Abs 8,Type 734	N/A
3. Manufacturer (Contract)	China Turnkey Solutions Logistics(Shenzhen) Co.,Futian Free Trade ZoneCHINA 518038	China Turnkey Solutions Logistics(Shenzhen) Co.,Futian Free Trade ZoneCHINA 518038	Identical
4. Power Source	3.7V Lithium Polymer Single CellRechargeable	3.7V Lithium Polymer Single CellRechargeable	Identical
- Method of line Isolation	No line connection possible whenconnected to body	No line connection possible whenconnected to body	Identical
- 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,no AC charger connection oroperation. Connection method doesnot allow AC charger connection toPatient.	Identical
5. No. of Output Modes	1 (Symmetric, Pulsed, Biphasic)	1 (Symmetric, Pulsed, Biphasic)	Identical
6. Number of Output Channels	2	2	Identical
- Synchronous/Alternating?	Synchronous	Synchronous	Identical
- Method of channel isolation	Transistor	Transistor	Identical
7. Regulated Current orRegulated Voltage	Constant Current	Constant Current	Identical
8.Software/Firmware/Microprocessor Control?	Yes	Yes	Identical
Table I	New Device	Predicate Device
Basic Unit Characteristics	SLENDERTONE® Evolve Abs,Type 735	SLENDERTONE® CoreFit Abs 8,Type 734	Comparison
9. Automatic overload Trip?	Yes	Yes	Identical
10. Automatic No-Load Trip?	Yes	Yes	Identical
11. Automatic Shut Off	Yes	Yes	Identical
12. Patient Override Control?	Yes, pause button stops treatmentimmediately.	Yes, pause button stops treatmentimmediately.	Identical
13. Indicator Display- On/Off Status?- Low Battery?- Voltage/Current Level?	Yes, OLED DisplayYes, OLED DisplayYes, OLED Display	Yes, OLED DisplayYes, OLED DisplayYes, OLED Display	Identical
14. Timer range (minutes)	2 - 45 minutes	20-40 minutes	Different but no impact on safetyor effectiveness.
15. Compliance with VoluntaryStandards?	IEC 60601-1IEC 60601-2-10EN 60601-1-2IEC 60601-1-11IEC 60601-1-6IEC 62133FCC (47 CFR Part 15, Subpart B)	IEC 60601-1IEC 60601-2-10EN 60601-1-2IEC 60601-1-11IEC 60601-1-6IEC 62133FCC (47 CFR Part 15, Subpart B)	Identical
16. Compliance with CFR 21898?	Yes	Yes	Identical
17. Weight (unit)	37g (incl. batteries)	37g (incl. batteries)	Identical
18. Dimensions (un.){W x H x D}	57 x 57 x 15 mm approx.	57 x 57 x 15 mm approx.	Identical
10.2 Output Specifications
The following information has been compiled using the “Guidance Document on Powered Muscle Stimulator 510(k)s, 1999”.
Table IBasic Unit Characteristics	New DeviceSLENDERTONE® Evolve Abs,Type 735	Predicate DeviceSLENDERTONE® CoreFit Abs 8,Type 734	Comparison
19. Housing Materials andConstruction	Injection moulded thermosetting plastic,with a thermoplastic elastomer (TPE) keypad	Injection moulded thermosetting plastic,with a thermoplastic elastomer (TPE) keypad	Identical

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10.2 Output Specifications

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10.2 Output Specifications

Tabel IIOutput Characteristics	New DeviceSLENDERTONE® Evolve Abs,Type 735	Predicate DeviceSLENDERTONE® CoreFit Abs 8,Type 734	Comparison
WaveformShape	Pulsed, Symmetrical, BiphasicRectangular, with interphase interval	Pulsed, Symmetrical, BiphasicRectangular, with interphase interval	IdenticalIdentical
Maximum Output Voltage (RMSV)(+/-10%)	8.36V @ 500Ω15.56V @ 2kΩ@ 10kΩ: no output for 10kΩresistance	7.58V @ 500Ω14.4V @ 2kΩ@ 10kΩ: no output for 10kΩresistance	Different but no impact onsafety or effectiveness.*See note below reMaximum output current
$Vp2x2xPW$ $\sqrt{\frac{1}{freq}}$
Maximum Output Current (RMSA)(+/-10%)	16.72mA @ 500Ω7.78mA @ 2kΩ@ 10kΩ: no output for 10kΩresistance	15.16mA @ 500Ω7.2mA @ 2kΩ@ 10kΩ: no output for 10kΩresistance	Different but no impact onsafety or effectiveness*The values are wellbelow safety limits ofTable 201.101 “Pulsefrequency versus appliedcurrent limits” of IEC60601-2-10.
Pulse Width	800 μs	730 μs	Different but no impact onsafety or effectiveness.
Baseline to peak current @500Ω	72mA	72mA	Identical
Frequency (Hz)	50-75 Hz	50-70 Hz	Identical
For interferential modes:- Beat Frequency	N/A	N/A	Identical
Tabel II	New Device	Predicate Device
Output Characteristics	SLENDERTONE® Evolve Abs,	SLENDERTONE® CoreFit Abs 8,	Comparison
	Type 735	Type 734
For multiphasic waveforms only:- Symmetrical phases	Yes	Yes	Identical
- Phase Duration	200 - 350μs	200 - 315μs	Different but no impact onsafety or effectiveness.
Net Charge (µC per pulse)	0@500ΩSymmetric, biphasic and leading polarityalternates for each successive pulse	0@500ΩSymmetric, biphasic and leading polarityalternates for each successive pulse	Identical
Maximum Phase Charge (µC)C= Ip*PW	1 phase 25.2 µC @500Ω	1 phase 22.8 µC @500Ω2 phase 45.6 µC @500Ω	Different but no impact onsafety or effectiveness.
Maximum Current Density (mA/cm²)	0.279 mA/cm² @500Ω	0.216 mA/cm² @500Ω	Different but no impact onsafety or effectivenessThe values are well below the2mA/cm2 value stated inClause 201.7.9.2.101 item (g) ofIEC 60601-2-10.
Maximum Power Density (W/ cm2)	2.33 mW/ cm² @500ΩUsing smallest electrode conductivesurface area	1.64 mW/ cm² @500Ω	Different but no impact onsafety or effectiveness.The value is well below themaximum power density of0.25 Watts/cm2 to reduce riskof thermal burns. FDAGuidance documentReference FDA GuidanceDocument for Powered MuscleStimulator 510(k)s
Tabel IIOutput Characteristics	New DeviceSLENDERTONE® Evolve Abs,Type 735	Predicate DeviceSLENDERTONE® CoreFit Abs 8,Type 734	Comparison
Contraction Time	1.0 - 60.0 s	1.0 - 5.5 s	Different but no impact onsafety or effectiveness.
Relaxation Time	1.0 - 10.0 s	1.0 – 7.0 s	Different but no impact onsafety or effectiveness.
Burst Mode	N/A	N/A	Identical
Additional Features (if applicable)	N/A	N/A	Identical
Maximum Charge Current	300mA @ 5V	300mA @ 5V	Identical

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10.2 Output Specifications

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10.2 Output Specifications

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VII. PERFORMANCE DATA

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

IEC 60601-1	Medical electrical equipment. General requirements for basicsafety and essential performance
IEC 60601-1-6	Medical electrical equipment - Part 1-6: General requirementsfor basic safety and essential performance - Collateralstandard: Usability
IEC 60601-1-2	Medical electrical equipment - part 1-2: general requirementsfor safety -collateral standard: electromagnetic compatibility- requirements and tests
IEC 60601-2-10	Medical Electrical equipment - Part 2-10: Particularrequirements for the safety of nerve and muscle stimulators
IEC 60601-1-11	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

Battery testing was conducted in accordance with IEC 62133 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® Evolve, Type 735 has the same principles of operation as . it's predicate device and any differences in technological characteristics do not raise new issues of safety or effectiveness.
. The Indications for Use statement is identical to the predicate device.
Performance data has demonstrated that the SLENDERTONE® Evolve Abs, Type . 735 is as safe and effective as the predicate device 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).