This 510(k) summary (K070250) for the Nutritone™ Facial Beauty System does not contain information about acceptance criteria or a dedicated study to prove the device meets specific performance criteria.

Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Face Master Facial Toning System, K040871). This means the manufacturer argues that their new device is as safe and effective as the predicate device, primarily by comparing their intended use and technological characteristics.

Therefore, many of your requested points cannot be answered based on the provided text, as they pertain to a type of performance study that was not conducted or documented here.

Here's a breakdown of what can be extracted and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document focuses on a comparison of specifications between the new device and the predicate device, not on pre-defined acceptance criteria for performance or a study demonstrating achievement of those criteria.

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

This information is not applicable/provided. No "test set" in the context of a performance study is mentioned. The submission is based on a comparison of device specifications, not on clinical performance data derived from a test set.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable/provided. Ground truth, in the context of a clinical study, is not established because no such study is described. The "ground truth" for this submission is the established safety and efficacy of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable/provided. No test set or clinical performance data requiring adjudication is presented.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided document. The device is a "Stimulator, Transcutaneous Electrical, for Cosmetic Use," which typically doesn't involve image interpretation by human readers.

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

This information is not applicable/provided. The device is a physical, battery-powered hand-held stimulator; there are no "algorithms" in the sense of AI or software-only performance that would undergo a standalone performance study. The document explicitly states "Software or microprocessor: None is used".

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established regulatory clearance and presumed safety and effectiveness of the legally marketed predicate device (Face Master Facial Toning System, K040871).

8. Sample Size for the Training Set

This information is not applicable/provided. There is no mention of a training set as would be used for an AI/ML algorithm. The device does not utilize software or a microprocessor for AI or machine learning.

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

This information is not applicable/provided for the same reasons as point 8.

Summary of the 510(k) Approach:

The K070250 submission for the Nutritone™ Facial Beauty System is a substantial equivalence (SE) submission. This regulatory pathway primarily involves demonstrating that a new device is as safe and effective as a predicate device that is already legally marketed. The evidence provided is a detailed comparison of the new device's intended use and technological characteristics (electrical properties, materials, design, etc.) to those of the predicate device. The conclusion explicitly states: "Since the intended use is the same and the technological characteristics are so similar we believe that this pre-market submission demonstrates substantial equivalence (SE) to a legally marketed predicate device." This approach does not typically require new clinical studies with defined acceptance criteria or ground truth establishment in the way an AI/ML device might.

Summary

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K070250
SEP - 4 2008

510(k) Summary

NutritoneTM Facial Beauty System

Common/Classification Name:

Stimulator, Transcutaneous Electrical, for Cosmetic Use

21 CFR 882.5890

Sponsor:

Isomers Laboratories, Inc. Attn: Dariush Majlessi, President 105 Tycos Drive, Toronto, ON, M6B 1W3 Canada

Contact:

RegTech Solutions, LLC Attn: Robert Mazzaferro, Manager 11 Dellcastle Court Montgomery Village, MD 20886

Prepared: September 9, 2007

LEGALLY MARKETED PREDICATE DEVICE

For its indication for use, the Nutritone™ Facial Beauty System is substantially equivalent to the Face Master Facial Toning System cleared by FDA under K040871.

DEVICE DESCRIPTION

The Nutritone™ Facial Beauty System is a battery-powered hand-held non-prescription device. Its output is a series of electrical pulses that are delivered to the user's face via electrodes that are built into the body of the device. A table comparing the intended was and mechanical and electrical properties of this device is presented below.

SUBSTANTIAL EQUIVALENCE SUMMARY

A comparison of the Nutritone™ Facial Beauty System and the Face Master Facial Toning System is presented in the table below.

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Specification	New Device - IsomersNutritone™ Facial BeautySystem	Predicate - Face MasterK040871
Intended Use	The device is intended tostimulate the face and it isindicated for cosmetic use.	The device is intended tostimulate the face and it isindicated for cosmetic use.
Size: Body	45mm wide x 30mm thick x131.5mm long	Not known
Weight	Mass is about 95 grams	Not known
User interface	Treatment area slide switchthumbwheel output control and alighted "on" indicator.	LCD display, on-off switch, andprogram & intensity selectors
Housingmaterials andconstruction	Housing made from ABS plastic& output contacts made frombrass with a conductive silvercoating.	Housing material not known.Device has external probes thatplug into it.
OutputChannel	Single	Single
Energy source	One 9V alkaline battery	One 9V battery
Timer range	Stimulation time controlledmanually. Maximum fixed "on"time is 3- or 12-minutesdepending on the selectedtreatment area	Stimulation time controlledmanually. No apparent maximumfixed "on" time
Max Vo-pk into10kΩ	7.5	7.0
Waveform	Rectangular bipolar pulses	Rectangular bipolar pulses
Frequency &Pulse Width	Either 0.6Hz & 400ms or 5.3Hz &50ms depending on treatmentarea	Either 0.6Hz & 400ms or 5.3Hz& 50ms depending on treatmentarea
Duty cycle	50%	50%
User controls	Uncalibrated thumbwheel on-off/amplitude & mode (treatmentarea) slide switch	On-off switch and program &amplitude selectors
Software ormicroprocessor	None is used	Not known
Compliancewith 21 CFR898	Not applicable. Device does nothave external leads.	Complies with this standard.

Table 1 Comparison of New Device & Predicate Device

Comparison of the toning gels and solutions used by the Nutritone™ & FaceMaster devices plus one other similar cleared device revealed the composition of each product is very similar.

CONCLUSION: Since the intended use is the same and the technological characteristics are so similar we believe that this pre-market submission demonstrates substantial equivalence (SE) to a legally marketed predicate device.

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Image /page/2/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 stripes forming its wing and tail. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 4 2008

Isomer Laboratories, Inc. % Regtech Solutions, LLC Mr. Robert Mazzaferro 11 Dellcastle Court Montgomery Village, Maryland 20886

Re: K 070250

Trade/Device Name: Nutritone™ Beauty System Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: June 5, 2008 Received: June 6, 2008

Dear Mr. Mazzaferro:

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 indictions for use stated in the enclosure) to legally marketed predicate devices marketed in introlled 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, I inte not devices, good manufacturing practice, labeling, and prohibitions against misbrandijng 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 - Mr. Robert Mazzaferro

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 Comrinions at (240) 276-0120. 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 the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systeros 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 toll-free number (800) 638-2041 or (240) 276-3150 or Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark N. Millman

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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510(k) Number (if known):

Device Name: Nutritone™ Facial Beauty System

Indications for Use: The Nutritone™ Facial Beauty System is intended to stimulate the face. The device is indicated for cosmetic use.

Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use × (Per 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1.

Mark M. Milkenon

(Division Sign-Off) Division of General, Restorative, and Neurological Devices 070250 510(k) Number

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).