BMR Face. Type 371/372* (* Type 372 is simply a black version of Type 371) is a twochannel, battery operated cosmetic device which is intended for use on the face. The device consists of a rechargeable electronic device which connects to an applicator. Each side paddle of the applicator contains a set of replaceable twin conductive gel pads which deliver electrical impulses to the face. The BMR Face device operates by applying Transcutaneous Electrical Nerve Stimulation (TENS) to the facial area. Low-level electrical impulses are sent from the stimulator unit via an applicator to gel pads that are positioned anterior to each ear and strategically over the cranial nerve #7 of the face, 3 programs are available to the user and these vary in treatment times from 10 to 20 minutes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit and there is no capability for charging the unit whilst any treatment is ongoing. All internal connections of the unit are over molded to prevent moisture ingress.

AI/ML Overview

The provided text describes a 510(k) submission for the "BMR Face, Type 371 & Type 372" device. It focuses on demonstrating substantial equivalence to a predicate device ("Rejuvenique® System") rather than presenting a study to prove the device meets specific acceptance criteria for performance in a clinical outcome.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets them in the context of clinical effectiveness or performance as an AI/ML device.

Here's a breakdown of why this information isn't available in the provided text:

Device Type: This is a physical, electrical stimulator, not an AI-powered diagnostic or therapeutic device. The submission is for a medical device seeking clearance based on substantial equivalence to a legally marketed predicate device.
Focus of the Submission: The 510(k) submission primarily focuses on comparing the technological characteristics of the new device to the predicate device to demonstrate that it is as safe and effective. It highlights aspects like intended use, indications for use, anatomical site utilized, energy used, materials, biocompatibility, electrical safety, mechanical safety, and adherence to various electrical and safety standards.
Absence of Clinical Performance Data: The document explicitly states: "Clinical Tests: No new clinical studies have been submitted as part of this Premarket Notification." This confirms that no studies were conducted to measure specific performance metrics (like sensitivity, specificity, accuracy, etc.) against acceptance criteria for a clinical outcome.
"Acceptance Criteria" in this context: The "acceptance criteria" here refer to the regulatory requirements and standards the device must meet (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility) to be deemed substantially equivalent and safe for marketing, not performance metrics related to a diagnostic or therapeutic outcome.

Based on the provided text, I cannot complete the requested tables and information because the document does not present a study proving the device meets performance-based acceptance criteria in the way typically expected for AI/ML devices or studies evaluating clinical effectiveness metrics.

The text only provides a summary of non-clinical tests demonstrating compliance with safety standards and a comparison of technological characteristics to a predicate device.

Summary

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NOV 1 0 2011

K10303/

Image /page/0/Picture/2 description: The image shows the logo for "bmr bio-medical research ltd.". The letters "bmr" are in a bold, sans-serif font, with a curved line running through the letters. Below the letters, the words "bio-medical research ltd." are written in a smaller, sans-serif font.

Bio-Medical Research Ltd.

· Parkmore Business Park West, Galway, Ireland Tel: +353 (0)91 774300 - Fax: +353 (0)91 774301

This 510k 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 774302
E-Mail:	akeenan@bmr.ie
Prepared:	November 8, 2011

2. Device Name

Trade Name of Device:	BMR Face, Type 371 & Type 372*
Common Name:	Facial Stimulator
Regulation Number:	21 CFR 882.5890
Regulation Description:	Transcutaneous electrical nerve stimulator for pain relief.
Product Code:	NFO
Device Class:	2

3. Identification of Equivalent Legally Marketed Device

510(k) Number:	K011935
Manufacturer:	Salton, Inc.
Trade Name:	Rejuvenique® System
Product Codes:	NFO and GYB

4. Description of Device

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paddle of the applicator contains a set of replaceable twin conductive gel pads which deliver electrical impulses to the face.

The BMR Face device operates by applying Transcutaneous Electrical Nerve Stimulation (TENS) to the facial area. Low-level electrical impulses are sent from the stimulator unit via an applicator to gel pads that are positioned anterior to each ear and strategically over the cranial nerve #7 of the face,

3 programs are available to the user and these vary in treatment times from 10 to 20 minutes. Power is derived from a 3.6V NiMH rechargeable battery pack that is pre-installed in the unit and there is no capability for charging the unit whilst any treatment is ongoing. All internal connections of the unit are over molded to prevent moisture ingress.

5. Statement of Intended Use/Indications for Use

BMR Face is intended for facial stimulation and is indicated for over the counter cosmetic use

6. Summary of Technological Characteristics

There are no new technological characteristics that could affect safety or effectiveness of the BMR Face device. Substantial Equivalence has been demonstrated as part of this 510k submission. Table 5.1 provides a summary comparison of technological characteristics of BMR Face versus that of the predicate "Rejuvenique® System".

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Table 5.1	BMR Face, Type 371 (New Device)	Rejuvenique System (Predicate)
Intended Use	Same	Stimulation of the Face
Indications for Use	BMR Face is intended for facial stimulation and is indicated forover the counter cosmetic use.	Cosmetic Use (OTC)
Target Population	Healthy adults	Healthy adults
Anatomical Site	Same	Face
Where Used	Same	Portable, may be used at home
Energy Used/Delivered	3.6V (rechargeable battery). Symmetric. Pulsed, Biphasic	9V battery (standard or rechargeable)
Human Factors	Validation Testing conducted in accordance with the DraftGuidance Document Applying Human Factors and UsabilityEngineering to Optimize Medical Device Design, and the AAMI'sHE75 Human factors engineering-design of medical devices	Ref: K011935
Materials	Same for unit. Applicator constructed of PC-141R. 2 applicatorpaddles contain carbon impregnated silicone rubber. The pads aremanufactured by Axelgaard Manufacturing Company, Fallbrook,California and are composed of a skin conductive adhesivehydrogel layer (Axelgaard MultiStick® MG-1500) which containsglycerin, water and a polyacrylate co-polymer. Each gel pad issupplied with protective liners for both skin and the paddleadhesive faces. The charger is constructed of PC/ABS.	Unit constructed of ABS Plastic, Face Mask is a PBC maskwith 26 fixed-position, gold-plated brass electrodes.
Biocompatibility	Gel pads comply to ISO 10993-5 Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity & ISO 10993-10	Ref: K011935

Table 5.1 Summary Comparison of Technological Characteristics of BMR Face Versus Rejuvenique® System (Predicate)

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Table 5.1	BMR Face. Type 371 (New Device)	Rejuvenique System (Predicate)
	Biological evaluation of medical devices - Part 10: Tests forirritation and delayed-type hypersensitivity
Compatibility with theenvironment/other devices	Complies to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard:Electromagnetic compatibility - Requirements and tests	Ref: K011935
Sterility	N/A	N/A
Electrical Safety	Complies to IEC 60601-1 Medical electrical equipment - Part 1:General requirements for safety & IEC 60601-2-10 Medicalelectrical equipment - Part 2-10: Particular requirements for thesafety of nerve and muscle stimulators	Ref: K011935
Mechanical Safety	Complies to IEC 60601-1 & IEC 60601-2-10	Ref: K011935
Chemical Safety	MSDS Sheet provided for conductive gel pads	Ref: K011935
Design	Device contains a control unit, applicator, gel pads, charger andinstructions for use.	Device contains a control unit, facial mask, adjustableheadband, connecting cable, toning gel, and instructions foruse.
	The unit may be recharged (charger supplied).12 twin conductive gel pads usedApplicator used to apply stimulation (gel pads placed ontwo paddles of applicator)	Device may not be charged, rechargeable batteriesmay be used however.Toning gel suppliedFacial mask used to apply stimulation (toning gelused on the gold-plated brass contact points).
User Interface	The user interfaces with the control unit, applicator and gel pads.The user attaches the gel pads to the two paddles of the applicator	The user interfaces with the control unit, face mask andconductive gel. The user applies a pea sized amount of the

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Image /page/4/Figure/0 description: This image shows Table 5.1, which compares the BMR Face, Type 371 (New Device) and the Rejuvenique System (Predicate). The table includes images of the control units for each device, with labels pointing to different features such as the display, buttons, and cable connection. Additionally, the table provides information on the modes of operation for the BMR Face device, including the treat time, frequency, pulse width, ramp-up, contr, ramp-down, and relax settings for three different programs. The Rejuvenique System has one program, and the intensity may be adjusted on the control unit.

Page 5 of 8

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Table 5.1	BMR Face, Type 371 (New Device)	Rejuvenique System (Predicate)
Performance Testing	Comparison basic unit characteristics and output specificationstables, using the "Guidance Document on Powered MuscleStimulator 510(k)s. 1999"and the draft guidance document "ClassSpecial Controls Guidance Document: TranscutaneousElectrical Stimulator with Limited Output for Aesthetic Purposes"April 5, 2010, have been included as part of this submission.	Ref: K011935
Thermal Safety	Complies to IEC 60601-1 & IEC 60601-2-10	Ref: K011935
Radiation Safety	N/A	N/A
Standards Met	IEC 60601-1:1988 +A1:91, A2:95, Corrigendum 95EN 60601-1-2:2007EN 60601-2-10:2000 + A1:2001 (IEC 60601-2-10:1987/A1:2001)Charger: UL 60950 & CSA-C22.2 No. 60950-00ISO 14971:2007	Ref: K011935
Software	Completed based on the "Guidance for the Content ofPremarket Submissions for Software Contained in MedicalDevices" 2005.	Ref: K011935

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and the state of the state of the state of the states of the states and

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7. Clinical and Non-Clinical Tests

Clinical Tests: No new clinical studies have been submitted as part of this Premarket Notification.

Non-Clinical Tests: BMR Face has been designed and independently tested to the following requirements:

. EN 60601-1: 1990 + A1: 93 + A11: 93 ++ A12: 93, A2:95, A13: 96, Corrigendum 94 Medical Electrical Equipment - Part 1: General Requirements for Safety.
IEC 60601-1:1988 +A1:91, A2:95, Corrigendum 95 Medical Electrical Equipment -. Part 1: General Requirements for Safety
. EN 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (IEC 60601-1-2:2007 Modified)
. EN 60601-2-10:2000 + A1:2001 Medical electrical equipment - Part 2-10: Particular requirements for the safety of nerve and muscle stimulators (IEC 60601-2-10:1987/A1:2001

In addition, the power supply unit complies with the following:

. UL 60950 - Information Technology Equipment Safety - Part 1: General Requirements
CSA-C22.2 No. 60950-00 Information Technology Equipment Safety Part 1: . General Requirements

8. Safety and Effectiveness

Bio-Medical Research Ltd. ("BMR") has over 30 years experience in the research. design, manufacture and marketing of medical grade products for both muscle strengthening and pain relief. BMR has two divisions - Slendertone, which develops and markets a range of consumer health and fitness products and Neurotech, which provides a range of neuromuscular stimulators for pain management and rehabilitation.

Bio-Medical Research Ltd. complies with 21 CFR 820 and is registered to I.S. EN ISO 13485:2003 Medical Device Quality Management System for the design, manufacture and distribution of electro-medical devices.

A risk management plan was carried out to EN ISO 14971:2007. .

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Independent EMC and Electrical Safety testing has been carried out. .
.

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

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Image /page/8/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white.

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

Bio-Medical Research Ltd. c/o Ms. Anne-Marie Keenan Quality and Regulatory Engineer Parkmore Business Park West Galway Ireland El

NOV 1 0 2011

Re: K103031

Trade/Device Name: BMR Face Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: October 27, 2011 Received: October 31, 2011

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 of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Anne-Marie Keenan

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.

Kesia Alexander

for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

_K103031

Device Name:

BMR Face, Type 371 & Type 372

Indications for Use:

BMR Face is intended for facial stimulation and is indicated for over the counter

cosmetic use

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)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103031

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).