The Venus Swan (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.

Device Description

The Venus Swan (MP)2 TM System uses Radiofrequency (RF) energy in (MP)2 technology for treatment. (MP)2 technology is a Multi-Polar array of Bi-Polar RF electrodes together with Pulsed Magnetic Field (PMF). The Venus Swan(MP)2 TM is a modification to the previously cleared Venus Concept's Venus Swan system (K100586). The Venus Swan (MP)2 is a noninvasive, non-ablative device consisting of Main Unit (console) - Touch Screen user interface, RF Power module, Controller unit, and Two optional treatment applicators: Octipolar-MTM applicator for medium sized treatment areas, composed of 8 (1) RF electrodes, 8 electrode coils assembled over the electrodes and a central coil (the RF is emitted through the electrodes. The PMF is generated by the coils), and (2) Diamondpolar™ applicator for small treatment areas, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).

AI/ML Overview

Here's the breakdown of the acceptance criteria and the study that supports the Venus Swan (MP)2 System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What the device was tested against)	Reported Device Performance (How the device performed)
Safety of high frequency surgical equipment (ANSI AAMI 60601-2-2)	Complies with standard
General Requirements for Safety of Medical Electrical Equipment (EN 60601-1)	Complies with standard
Electromagnetic Compatibility - Requirements and Tests (IEC 60601-1-2)	Complies with standard
RF Energy Test: Validate power control and accuracy	Test results show the system performs according to specifications.
Power Failure Safety Test: Validate power control after external power failure	Test results show the system performs according to specifications.
STBY Mode Power Test: Validate power control in STBY mode	Test results show the system performs according to specifications.
Electrode Safety Test: Validate safety by short-circuiting and open-circuiting electrodes	Test results show the system performs according to specifications.
Magnetic flux density Test: Measure magnetic flux density at tissue level	Test results show the system performs according to specifications.
Biocompatibility (ISO 10993-1)	Parts in contact with patient/user are identical to previously cleared Venus Swan parts, thus biocompatible.
Clinical effectiveness (non-invasive treatment of moderate to severe facial wrinkles and rhytides)	Improvement in 83% of study subjects based on photographic analysis.
Patient satisfaction (treatment met expectations)	Met expectations of 93% of subjects.
Clinical safety (unexpected adverse side effects)	No unexpected adverse side effects detected or reported.
Pain during treatment	All subjects reported no pain during treatments.

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

Sample Size (Clinical Study): 31 subjects
Data Provenance: Not explicitly stated, but clinical studies for FDA clearance are typically prospective. The country of origin for the data is not specified in the document, but the applicant is based in Israel, so it could potentially be an international study or a study conducted in Israel.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Number of Experts: "Uninvolved reviewers" performed the photographic analysis. The exact number of reviewers is not specified.
Qualifications: Not specified. It only states they were "uninvolved reviewers."

4. Adjudication Method for the Test Set

The document mentions "Photographic analysis of pre-and post treatment of the digital images was conducted by uninvolved reviewers." This indicates that reviewers were used to assess improvement, but it does not specify an adjudication method like 2+1 or 3+1 for conflicting assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The document describes a clinical study focused on the safety and effectiveness of the device itself, not comparing human readers with and without AI assistance. The device in question is not an AI-assisted diagnostic tool but a therapeutic medical device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable as the Venus Swan (MP)2 is a physical medical device (RF and PMF system), not an algorithm or AI system. Its performance is measured directly through its physical output and clinical outcomes, not as a standalone algorithm.

7. The Type of Ground Truth Used

Clinical Efficacy: Photographic analysis by uninvolved reviewers (likely a visual assessment of wrinkle and rhytide improvement).
Patient Experience: Subject reporting (for pain and expectation fulfillment).
Safety: Direct observation for adverse events.

8. The Sample Size for the Training Set

Not applicable. As this is a physical medical device, there isn't a "training set" in the context of machine learning or AI. Performance is based on engineering specifications and clinical trials.

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

Not applicable. See point 8.

Summary

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K140629 Page 1 of 4

VENUSCONCEPT

510(K) SUMMARY

Venus Swan (MP)2 System

510(k) Number K140629

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 Swan (MP)2 Common Name: Swan (MP)2

Summary Preparation Date: March 4, 2014

Classification: 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 Swan(MP)2 TM is a modification to the previously cleared Venus Concept's Venus Swan system (K100586).

The Venus Swan (MP)2 is a noninvasive, non-ablative device consisting of

Main Unit (console) -
-Touch Screen user interface
RF Power module -
Controller unit -

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VENUSCONCEPT

Two optional treatment applicators:
Octipolar-MTM applicator for medium sized treatment areas, composed of 8 (1) RF electrodes, 8 electrode coils assembled over the electrodes and a central coil (the RF is emitted through the electrodes. The PMF is generated by the coils)
(2) Diamondpolar™ applicator for small treatment areas, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).

Touch screen user interface provides:

Applicator selection (Octipo!ar-MTM / Diamondpolar™) -
RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated.
Interval timer. -
Current treatment parameters display. -

Controller unit

Two optional treatment applicators

The RF power module provides RF energy to the selected applicator, producing a 1 MHz signal.
The magnetic field portion provides Pulsed Magnetic Field with magnetic flux

density of 1.5mTesla (0.0015 Tesla or 15 Gauss). The frequency of the PMF

is 15Hz.

Intended Use Statement:

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

Device Name	510kNo	Date of Clearance
Venus Freeze (MP)2System	K111670	March 2, 2010
Venus Swan System	K111784	October 7, 2011

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Venuscollicept

Performance Standards

ﺐ ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Venus Swan (MP)2 complies with

ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment. .
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)

Non clinical Performance Testing

The following performance tests were conducted:

Test Name	Purpose
RF Energy Test	Validate Venus Swan (MP)2 power control andaccuracy in reference to the user's input.
Power Failure Safety Test	The goal for this test is to validate Venus Swan(MP)2 power control after external power failure.
STBY Mode Power Test	The goal for this test is to validate the Venus Swan(MP)2 power control in STBY mode.
Electrode Safety Test	The goal for this test is to validate the safety of theVenus Swan (MP)2 applicators by short-circuitingand open-circuiting the electrodes.
Magnetic flux density Test	Measure the magnetic flux density at the tissuelevel

Testing results show that the Venus Swan (MP)2 System is safe and performs according to its specifications.

Materials and Biocompatibility

The Venus Swan (MP)2 parts that come in contact with the patient or the user are identical to these parts in the cleared Venus Swan and therefore are biocompatible according to ISO 10993-1.

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VENUSCONCEPT

Summary of Clinical performance data

The Venus Swan (MP)2 implies the exact same RF frequency and power as the Venus Swan and the exact same RF frequency and magnetic field as the Venus Freeze (MP)2. The applicators of Venus Swan (MP)2 are the same as those of Venus Swan, excluding Venus Swan's Octipolar-L applicator, except that the magnetic coils that are exactly the same as in the Venus Freeze (MP)2 applicators. Venus Swan (MP)2 uses power up to 120W whereas the Venus Swan and Venus Freeze (MP) may use power up to 150 W. The maximum power difference is within the maximum power of the predicate devices and thus does not raise any new questions of safety and efficacy.

Venus conducted a clinical study with 31 subjects to support the effectiveness and safety of the subject Venus Swan (MP)2 System and were followed for 3 months post last treatment. No unexpected adverse side effects were detected or reported. All subjects participating in the study reported no pain during the treatments.

Photographic analysis of pre-and post treatment of the digital images was conducted by uninvolved reviewers. Analysis revealed improvement in 83% of study subjects. The treatment met the expectations of 93% of the subjects enrolled.

Summary of Substantial Equivalence

The Venus Swan (MP)2 like the Venus Freeze (MP)2 System (K111670) combines the RF energy with Pulsed Magnetic Field (PMF) energy.

The power density and frequency of RF power parameters of the submitted Venus Swan (MP)2 System are the same as in its predicate devices - Venus Freeze (MP)2 System (K111670) and Venus Swan (K111784).

Thus the Venus Swan (MP)2 is substantial equivalence to its predicate devices without raising new questions of safety and efficacy.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

June 25, 2014

Venus Concept Ltd. Yoram Levy Quality Assurance/Regulatory Affairs Consult 62 Hallermesh Street Karmiel, 21652 Israel

Re: K140629

Trade/Device Name: Venus Swan (MP)2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 26, 2014 Received: May 26, 2014

Dear 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

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Page 2 - Yoram Levy

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 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/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

David Krause -S

Radiological Health

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
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140629

Device Name

Venus Swan (MP)2

Indications for Use (Describe)

The Venus Swan (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles in Fitzpatick skin types I-IV.

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)

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

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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.