The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Device Description

The Venus Freeze is a noninvasive, non-ablative device consisting of:

Main Unit (console)
Touch Screen user interface
RF Power module
Controller unit
Two treatment applicators:
(1) Octipolar M applicator - for large treatment areas, composed of 8 RF electrodes
(2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes.
The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings.
The Controller Unit provides the operational and safety function of the system.
Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms.
The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

AI/ML Overview

The provided text states that for the Venus Freeze device, "Venus-Concept believes that animal and clinical studies are not required to determine the safety and efficacy of the device" due to previously published scientific research and clinical studies on similar radiofrequency devices. Therefore, a specific study proving the device meets acceptance criteria as typically outlined in an FDA submission with performance data, sample sizes, and ground truth establishment was not conducted for this 510(k) submission.

Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for safety.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable:

Acceptance Criteria and Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Adherence to recognized safety standards for medical electrical equipment (e.g., ANSI AAMI 60601-2-2 for safety of high-frequency surgical equipment, EN 60601-1, IEC 60601-1-2).	The Venus Freeze complies with ANSI AAMI 60601-2-2, EN 60601-1, and IEC 60601-1-2.
Substantial equivalence to predicate devices for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.	The Venus Freeze is found substantially equivalent to the EndyMed Imagine TC Skin Treatment System (K083461), Lumenis Aluma (K051214), and Syneron Polaris (K031671) based on its intended use, power, and frequency being within previously cleared values.
Safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz and power of 37 to 150 W (as established in scientific research and clinical studies on similar systems).	The device operates within these parameters (1MHz signal, power not explicitly stated but implied to be within the 37-150W range of established devices). The submitter states that safety and efficacy are "well established in scientific research and clinical studies" for devices with these characteristics. The submitter cites "comprehensive animal and clinical study performed in scientific research and published in the literature" for similar devices.

Study Details (As per the provided document, studies were not conducted for this specific device's 510(k) submission to establish safety and efficacy directly.)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data from a clinical or animal study was generated for this 510(k) submission. The safety and efficacy relied on existing literature for similar devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No new ground truth was established for a test set specific to the Venus Freeze device in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new test set requiring adjudication was used.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a non-AI electrosurgical device for dermatologic procedures; therefore, an MRMC study related to readers and AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an AI algorithm. Its performance is inherent in its operation and not separate from human-in-the-loop (operator) performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the purpose of this 510(k) submission, the "ground truth" for safety and efficacy for the device type (radiofrequency devices for wrinkle treatment) was established through "comprehensive animal and clinical study performed in scientific research and published in the literature" of similar devices, rather than new evidence for the Venus Freeze itself.
The sample size for the training set:
- Not applicable. No training set for an algorithm was used or mentioned. The device's design implicitly relies on established engineering principles and prior research of similar devices.
How the ground truth for the training set was established:
- Not applicable. No training set was used.

Summary

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VENUSCORCEPT

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510(K) SUMMARY

Venus Freeze System 510(k) Number K | 09 58 b

Applicant's Name: Venus Concept Ltd. 62 HaHermesh Street Karmiel, 21652, Israel Tel: (972)3-644-6656 Fax: (972)3-644-6319

Contact Person: Yoram Levy, Qsite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com

Trade Name: Venus Freeze

Preparation Date: February 28, 2010

Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery

Device Description:

The Venus Freeze is a noninvasive, non-ablative device consisting of:

Main Unit (console) -
Touch Screen user interface -
-RF Power module
Controller unit -
Two treatment applicators:

(1) Octipolar "M applicator - for large treatment areas, composed of 8 RF electrodes

(2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes.

2-2

Venus Freeze - 510k submission

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Venusconcept

The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings.

The Controller Unit provides the operational and safety function of the system.

Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms.

The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.

Intended Use Statement:

The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

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

Device Name	510k No	Date of Clearance
EndyMed Imagine TC SkinTreatment System	K083461	Jul 24 2009
Lumenis Aluma	K051214	Oct 24 2005
Syneron Polaris	K031671	Dec 01 2003

Performance Standards

Venus Freeze complies with ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment,

In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:

. EN 60601-1 (Medical Electrical Equipment-Part 1: General Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).

IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: Collateral . Standard: Electromagnetic Compatibility - Requirements and Tests)
A detailed description appears in Section 14.

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VENUSCONCEPT

Summary of Clinical performance data

The safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz and power of 37 to 150 W is well established in scientific research and clinical studies. Multiple studies with these and similar systems have shown safety in dermatologic therapy and the devices were cleared by the FDA for therapy of wrinkles and rhytides.

Due to the comprehensive animal and clinical study performed in scientific research and published in the literature, and since the power and frequency of the Freeze are well within the previously cleared values, Venus-Concept believes that animal and clinical studies are not required to determine the safety and efficacy of the device.

2-4 Venus Freeze - 510k submission

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

NOY 2 9 2010

Venus Concept Ltd. % Qsite Mr. Yoram Levy 31 Haavoda Street Binyamina, Israel 30500

Re: K100586

Trade/Device Name: Venus Freeze Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 27, 2010 Received: November 16, 2010

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. Iisting 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 mav 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

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Page 2 - Mr. Yoram Levy

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 of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark M Millkenss

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VENUSCORCEPT

INDICATIONS FOR USE STATEMENT 100586

510(k) Number (if known):

Device Name:

Venus Freeze

Indications for Use:

The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Nilber Doyle for mxm
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100586

1-2 Venus Freeze - 510k Notification

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.