The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm
· Temporary improvement of local blood circulation
· Temporary reduction in the appearance of cellulite.

Device Description

EndyMed's EndyMed Contour Handpiece is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (Imagine K08346). The EndyMed Contour Handpiece combines suction module that creates vacuum energy and emits bipolar RF energy that flows between the electrodes to create thermal heating of the tissue.

The Vacuum is used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue.

AI/ML Overview

The provided document is a 510(k) premarket notification for the EndyMed Contour Handpiece. It details the device's intended use, technological characteristics, and a claim of substantial equivalence to predicate devices. However, this document does not contain the specific information requested regarding acceptance criteria for an AI/ML device study, and the detailed study description you've outlined.

The document discusses performance tests for the EndyMed Contour Handpiece itself (e.g., power output, temperature, vacuum pressure), but this is validation of a physical medical device, not a study proving an AI/ML algorithm meets acceptance criteria.

Here's why the requested information cannot be found in the provided text:

No AI/ML Component: The EndyMed Contour Handpiece is described as an electrosurgical cutting and coagulation device accessory that uses RF energy and vacuum mechanical manipulation. There is no mention of an AI/ML component or algorithm in its description or intended use.
Study Type: The "performance data" and "summary of clinical performance data" refer to lab performance tests, design validation, and software verification and validation for the physical device, and a claim that no clinical studies were necessary to show substantial equivalence with its predicate devices because it has the same intended use, clinical indication, and technology. This explicitly states new clinical studies were not performed for this submission.
Ground Truth: Since no clinical studies were performed, there is no discussion of establishing ground truth, expert consensus, pathology, or outcomes data for a test set.
Sample Sizes/Experts/Adjudication/MRMC: These are all concepts relevant to clinical or performance studies evaluating an AI/ML algorithm's effectiveness against a ground truth, which were not conducted for this submission.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study proving device meets acceptance criteria, as the provided text does not describe such a study for an AI/ML-driven medical device.

The document is a regulatory submission for a physical medical device (EndyMed Contour Handpiece), focusing on its technical specifications and substantial equivalence to existing devices, rather than the performance evaluation of a novel AI/ML algorithm.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

August 1, 2016

Endymed Medical Ltd. % Mr. Yoram Levy QSite 31 Haavoda St. Binyamina, Israel 30500 Israel

Re: K161199

Trade/Device Name: Endymed Contour Handpiece Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX Dated: Julv 6, 2016 Received: July 12, 2016

Dear Mr. Levy:

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.

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

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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 Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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,

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161199

Device Name EndyMed Contour Handpiece

Indications for Use (Describe)

The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:

· Relief of minor muscle aches and pain, relief of muscle spasm
· Temporary improvement of local blood circulation
· Temporary reduction in the appearance of cellulite.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for EndyMed, a company specializing in 3DEEP technology. The logo features a grid of dots on the left, followed by the company name "EndyMed" in a stylized font. Below the name, the tagline "THE 3DEEP COMPANY" is displayed in smaller letters. The overall design is clean and professional, reflecting the company's focus on advanced technology.

K161199 510(K) SUMMARY

EndyMed Contour Handpiece 510(k) Number K161199

Applicant's Name: EndyMed Medical Ltd. 12 Leshem Street, North Industrial Park, Caesarea, 3088900 Israel Tel: (972)4-630-9100 Fax: (972)4-630-9101
Contact Person: Yoram Levy, Qsite 31 Haavoda Street Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@qsitemed.com

Trade Name: EndyMed Contour Handpiece

Preparation Date: April 14. 2016

Classification: Name: Electrosurgical cutting and coagulation device and accessories Product Code: PBX Regulation No: 21 CFR 878.4400 Regulation Description: Electrosurgical cutting and coagulation device and accessories Class: II

Classification Panel: General & Plastic Surgery

Device Description:

Intended Use Statement:

The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour

EndyMed Contour Applicator 510k Notification

Page 1 of 3

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Image /page/4/Picture/0 description: The image is a logo for EndyMed, a company that specializes in 3DEEP technology. The logo features a grid of blue dots on the left, followed by the company name "EndyMed" in a stylized blue font. Below the company name is the tagline "THE 3DEEP COMPANY" in a smaller, lighter font.

K161199

applicator for delivery of non-thermal RF combined with massage:

Relief of minor muscle aches and pain, relief of muscle spasm
Temporary improvement of local blood circulation
. Temporary reduction in the appearance of cellulite.

Predicate Devices: Substantial equivalence to the following predicate devices is claimed:

Device Name	510(k) No.	Date of Clearance
Venus Legacy CX	K143554	August 4, 2015
Viora V10 System	K150035	May 1, 2015

Venus Legacy CX (K143554) - in respect to intended use and technological characteristics;
Viora V10 System (K150035) in respect to intended ● use and technological characteristics;

Reference Devices:

EndyMed Medical Ltd. Imagine (K083461) - in respect to technological characteristics;

Performance Standards:

EndyMed Contour Handpiece complies with the following standards:

IEC 60601-1:2005 / EN 60601-1:2006 Medical electrical equipment - part 1 General requirements for basic safety and essential performance, 3td edition
· IEC/EN 60601-1-2:2014 Medical Electrical Equipment -Part 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard; Electromagnetic Compatibility - Requirements and Tests 4th edition
· IEC 60601-2-2:2009 Medical Electrical Equipment Part 2-2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories

Summary of Technologies:

EndyMed Contour Handpiece implements RF energy and vacuum mechanical manipulation to achieve its intended use. The components of the EndyMed Pro, includes the console (with power supply, RF generator, suction module, CPU and display panel) and the applicators (with cable, connector to console, and vacuum pump).

EndyMed Contour Applicator 510k Notification

Page 2 of 3

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Image /page/5/Picture/0 description: The image shows the logo for EndyMed. The logo consists of a grid of dots on the left, followed by the word "EndyMed" in a stylized font. Below the word "EndyMed" is the text "THE 3DEEP COMPANY" in a smaller font. The color of the logo is a muted blue.

K161199

Performance Data:

The safety and efficacy of the EndyMed Contour Handpiece were established by a series of performance tests. Lab performance tests, design validation and software verification and validation.

The EndyMed Contour Handpiece was validated for its power increase to 85W while maintaining a temperature between 40℃ and 45℃ and vacuum pressure of up to 500mBar.

Verification and testing have shown that the EndyMed Contour Handpiece device performs according to its specifications.

Summary of Clinical performance data:

safety and efficacy of the EndyMed Contour The -Handpiece was evaluated by performance testing.

The EndyMed Contour Handpiece has the same intended use, clinical indication and technology and no clinical studies were necessary to show substantial equivalency with its predicate devices.

Substantial Equivalence:

EndyMed Contour Handpiece device has the same intended use, clinical indication and basic technology as its predicate devices.

The envelope of power, frequency and vacuum parameters of the submitted EndyMed Contour Handpiece is covered by the envelopes of its predicate devices.

The EndyMed Contour Handpiece, the Venus Legacy CX device and the K150035 Viora V10 System are based on the same core technology of RF heating and vacuum massaging for the same indications for use. The design and components in the subject device including the console and the applicators are the same. The minor technological differences do not alter device core technology or performance. The performance of the EndyMed Contour Handpiece is substantially equivalent to that of the Venus Legacy CX device and the K150035 Viora

V10 System, as demonstrated in testing. Any minor differences in the human interface and accessories design do not raise any new types of safety and effectiveness issues, as verified by performance testing. Therefore the EndyMed Contour Handpiece is substantially equivalent to its predicate devices.

Conclusions:

The EndyMed Contour Handpiece is based on the same intended use and indications for use, technological characteristics, and principles of operation. As a result the EndyMed Contour Handpiece device is substantially equivalent to the Venus Legacy CX and the K150035 Viora V10 System predicate devices

EndyMed Contour Applicator 510k Notification

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Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.