· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

· Treatment of benign cutaneous vascular lesions including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Description

The Venus Versa System is comprised of a console (controller/CPU) and applicators that deliver Intense Pulsed Light (IPL) optical energy to the treatment area. Four IPL handpieces (SR515, SR580, HR650, HR690) are included with the device system. The Versa device provides individual adjustment of light fluency and pulse duration, and has integrated skin cooling features. Using the IPL applicators, the light energy delivered to the patient's skin is used to treat various conditions via the mechanism of selective photothermolysis.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for the "Venus Versa System", an Intense Pulsed Light (IPL) device used in aesthetic procedures. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria and performance metrics for a specific AI/ML medical device.

Therefore, I cannot fully address your request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, as this document does not contain that type of information. Specifically, it does not include:

A table of acceptance criteria and reported device performance for an AI/ML model.
Sample sizes for test sets used for AI/ML model validation.
Information about data provenance (e.g., country of origin, retrospective/prospective) for AI/ML data.
Number of experts and their qualifications for establishing ground truth for AI/ML test sets.
Adjudication methods for AI/ML test sets.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI+human vs. human-only.
Standalone (algorithm only) performance metrics for AI/ML.
Type of ground truth used for AI/ML (e.g., pathology, outcomes data).
Sample size for training sets for an AI/ML model.
How ground truth for a training set was established for an AI/ML model.

However, based on the provided text, I can infer some aspects related to general device performance and regulatory acceptance for a non-AI/ML device.

The document describes the regulatory review for the Venus Versa System, focusing on its substantial equivalence to predicate IPL devices. The "performance data" mentioned is primarily related to engineering and safety standards, rather than clinical efficacy studies with specific acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/ML device would be evaluated.

Here's what can be extracted from the document regarding performance and "acceptance":

General Device Performance and Acceptance (as presented in this document for a non-AI/ML device):

The acceptance criteria are implicitly defined by compliance with recognized standards and the demonstration that the device's technological characteristics and performance are "substantially equivalent" to legally marketed predicate devices, and that it "performs as intended for the indicated uses."

1. Table of Acceptance Criteria and Reported Device Performance (as inferred from the document for this non-AI/ML device):

Acceptance Criterion (Implicit)	Reported Device Performance (Summary from text)
Safety:
a. Electromagnetic Compatibility (EMC)	Testing conducted per IEC 60601-1-2. All results were passing.
b. Electrical Safety	Testing conducted per AAMI/ANSI ES60601-1 and IEC 60601-2-57. All results were passing.
c. Biocompatibility of Patient-Contacting Materials	Patient contacting materials are biocompatible per ISO 10993-5.
d. Cleaning and Disinfection Validation	Cleaning and disinfection validation testing has been completed.
Effectiveness/Performance:
a. Software Validation	Software validation conducted. Results demonstrate that the software was appropriate for release.
b. Energy Output Specifications	Bench testing confirmed that the energy outputs of the Versa met specifications.
c. Technological Equivalence to Predicate Devices (Implied clinical "effectiveness")	The Venus Versa System has similar technological characteristics (IPL type, wavelengths, fluence levels, light guide, cooling system) to its predicates. Key parameters affecting treatment outcomes (IPL wavelengths, fluence levels) are the same or encompassed within the range of predicate devices. Minor differences (spot size, frequency, pulse duration) do not present new safety/effectiveness issues. Concluded to be substantially equivalent to predicate devices for its intended and indicated uses.
Regulatory Compliance (Overall "Acceptance" for market clearance)	The device is substantially equivalent to legally marketed predicate devices, implying it meets general controls provisions of the Act (e.g., annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding/adulteration). 510(k) cleared.

2. Sample size used for the test set and the data provenance:

Not Applicable / Not provided for clinical performance: This document does not describe a clinical study with a "test set" in the context of an AI/ML model for accuracy evaluation. The "testing" mentioned refers to engineering and safety compliance tests, and the "sample size" for such tests is typically governed by engineering standards (e.g., number of units tested for electrical safety or energy output consistency).
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: This document does not describe the establishment of ground truth for a clinical test set as would be done for an AI/ML device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not Applicable: This document does not describe this type of clinical adjudication process.

5. 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 an IPL system, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable: There is no AI algorithm being evaluated for standalone performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable: As there is no AI/ML model here, there is no need for this type of clinical "ground truth." The "ground truth" for the engineering tests would be the established specifications and regulatory standards.

8. The sample size for the training set:

Not Applicable: This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

Not Applicable: This is not an AI/ML device, so there is no training set ground truth to establish.

In summary, the provided document is a 510(k) clearance letter and summary for a non-AI/ML medical device (IPL system). It focuses on demonstrating substantial equivalence through technological comparison and compliance with engineering and safety standards, rather than clinical performance based on AI model evaluation and ground truth establishment.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Public Health Service

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

January 20, 2016

Venus Concept Ltd. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th FL Philadelphia, Pennsylvania 19103

Re: K152790

Trade/Device Name: Venus Versa System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and In Dermatology Regulatory Class: Class II Product Code: ONF Dated: December 21, 2015 Received: December 21, 2015

Dear Ms. Hogan:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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,

Jennifer R. Stevenson -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) K152790

Device Name Venus Versa System

Indications for Use (Describe)

The Venus Versa System is a multi-application device intended to be used in aesthetic procedures.

The SR515 and SR580 IPL applicators are indicated for the following:

· Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Venus Concept's Venus Versa System

Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Venus Concept USA Ltd. 4556 N. Hiatus Road Sunrise, FL 33351 Telephone: 416.907.0115 Fax: 954.572.5680

Contact Person: Tal Bresler-Stramer, Ph.D., RAC VP QA/RA Venus Concept, Ltd.

Date Prepared: December 21, 2015

Trade Name of Device

Venus Versa System

Classification Regulation, Name, Product Code

Laser surgical instrument for use in general and plastic surgery and in dermatology (21 CFR 878.4810), Product Code: ONF

Predicate and Reference Devices

Predicate Devices: Danish Dermatologic Development A/S's Ellipse I PL System (K060516) (Primary Predicate), MATTIOLI Pulse TWO/THREE Plus Family (K100053)

Reference Devices: Alma Laser's Harmony Lite Multi-Application Platform (K141237); Emvera Diolux (K123257); Lumenis Inc.'s LightSheer Duet Laser System (K053628); Venus Legacy CX (K143554); Palomar Medical Products, Inc.'s StarLux Pulsed Light System (K041086); Beijing KES Biology's IPL System (K122995); BTL Industries, Inc.'s Exilite (K150051); Beijing Syntech Laser Co.'s APOLLO V+ (K113018); Syneron's ePlus Treatment System (K113868); Cynosure's Icon (K142376); Lynton Lumina (K063427)

Intended Use / Indications for Use

The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.

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The SR515 and SR580 IPL applicators are indicated for the following:

Treatment of benign pigmented epidermal and cutaneous lesions, including: . hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
. Treatment of benign cutaneous vascular lesions, including: port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations,

The HR650 and HR690 IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.

Device Description

Technological Characteristics

The Venus Versa System has similar technological characteristics to its predicates. All three devices are IPL systems requlated under 21 CFR 878.4810 as class II devices. The Versa is a multi-application system that allows delivery of IPL enerqy, similar to its predicates. The Versa and the predicate devices are each designed as a system console with a user interface and applicator(s) indicated for the desired treatment effects. The technological characteristics of the Venus Versa as a system and when used for each of the three proposed indications (vascular lesions, pigmented lesions, hair removal/reduction) are similar to the corresponding parameters of the predicate devices. The technological differences between the Venus Versa and its predicates are minor, including some differences in terms of the spot size, frequency, and pulse duration. However, the kev parameters of the Versa affecting treatment outcomes (i.e., IPL wavelengths, fluence levels) are the same or encompassed within the range of the predicate devices. In addition, each of the systems utilizes a light quide and cooling system in delivering treatment. See Table 1 below.

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Medical Device	Venus Concept Ltd.'s Venus VersaSystem (K152790)	Danish Dermatologic Development A/SEllipse I²PL System (K060516)	Mattioli Pulse TWO/THREE Plus Family(K100053)
Class, ProductCode, Regulation	Class II, ONF, 21 CFR 878.4810	Class II, GEX, 21 CFR 878.4810	Class II, ONF, 21 CFR 878.4810
Indications forUse	The Venus Versa System is a multi-application device intended to be used inaesthetic and cosmetic procedures.The SR515 and SR580 IPL applicatorsare indicated for the following:· Treatment of benign pigmentedepidermal and cutaneous lesionsincluding: hyperpigmentation, melasma,ephelides (freckles), lentigines, nevi, andcafe-au-lait macules.· Treatment of benign cutaneous vascularlesions including port wine stains,hemangiomas, facial, truncal and legtelangiectasias, rosacea, angiomas andspider angiomas, poikiloderma of civatte,leg veins and venous malformations.The HR650 and HR690 IPL applicatorsare indicated for the removal of unwantedhair and to effect stable long-term orpermanent hair reduction for skin types I-IV. Permanent hair reduction is definedas the long-term stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 months after thecompletion of a treatment regimen.	Ellipse I²PL System is intended for use indermatology:* Hair removal (permanent hair reduction).* Treatment of benign pigmented lesions(including, but not limited to solarlentigines, ephilides, mottledpigmentation) and benign vascular lesions(including but not limited to diffuseredness, telangiectasias, port winestains).* Treatment of inflammatory acne.[Table included in indications for use formnot included here.]	The MATTIOLI PULSE TWO/THREEPLUS is an Intense Pulse Light (IPL)device family indicated for use in aestheticapplications (based on selectivephotothermolysis), in the treatment ofvarious benign pigmented lesions and hairremoval and that produce different effectsdepending on the applicator that is used:SA APPLICATOR:Model SN: Wavelengths from 560 - 1200nm are indicated for treatment of benignpigmented (epidermal and cutaneous)lesions, including hyperpigmentation,warts, lentigines, nevi, melasma, andcafe-au-lait.VA APPLICATORModel VN: Wavelengths from 510 - 1200nm are indicated for the treatment ofbenign vascular lesions including portwine stains, hemangiomas, facial, truncaland leg telangiectasias, rosacea,melasma, angiomas and spiderangiomas, poikiloderma of civatte; legveins, facial veins and venousmalformations.HR APPLICATORS indicated for thetreatment of unwanted hair (i.e. hairremoval).Model HN: Wavelengths from 650-1200nm for skin types I-IV;Model HE: Wavelengths from 710 - 1200

Table 1: Venus Versa System Substantial Equivalence Comparison

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Medical Device	Venus Concept Ltd.'s Venus VersaSystem (K152790)	Danish Dermatologic Development A/SEllipse I²PL System (K060516)	Mattioli Pulse TWO/THREE Plus Family(K100053)
			nm for skin type VThe equipment should only be used undermedical supervision.
Energy Type	IPL	IPL	IPL
IPL Spectrum	515-950 nmo Lesions: 515-950 nm (SR515); 580-950 nm (SR580)▪ Pigmented Lesions: 515-950 nm(SR515); 580-950 nm (SR580)▪ Vascular Lesions: 515-950 nm(SR515); 580-950 nm (SR580)o Hair Removal: 650-950 nm (HR650);690-950 nm (HR690)	400-950o Lesions:▪ Pigmented Lesions: 400-720 nm(PL)▪ Vascular Lesions: 555-950 nm (VL);530-750 nm (PR)o Hair Removal: 600-950nm (HR, HR-S);645-950 nm (HR-D)	510-1200 nmo Lesions: 560-1200 nm (SA); 510-1200nm (VA)o Hair Removal: 650-1200 nm (HN);710-1200 nm (HF)
Frequency	Up to 3 Hz	1.5-2.0 s charge time/repetition rate	Up to 1 Hz
Spot Size	10 x 30 mm	10 x 48 mm	10 x 40 mm15 x 50 mm
Pulse Duration	Up to 50 mso Lesions (SR515, SR580): 5-20 ms▪ Pigmented Lesions: 10-20 ms▪ Vascular Lesions: 10-20 mso Hair Removal (HR650, HR690): 20-50ms	1.5-100 ms	14-35 ms
Energy Density(Fluence)	Up to 25 J/cm²o Lesions:▪ Pigmented Lesions: 5-20 J/cm²▪ Vascular Lesions: 6-22 J/cm²o Hair Removal: 6-20 J/cm²	Up to 26 J/cm²o Lesions:▪ Pigmented Lesions: up to 18 J/cm²▪ Vascular Lesions: up to 26 J/cm²o Hair Removal: up to 21 J/cm²	Up to 30 J/cm²o Skin Rejuvenation (SR): 6-30 J/cm²o Hair Removal (HR): 6-25 J/cm²
Components	System console (with user interface)ApplicatorsUltrasonic gel	System console (with user interface)ApplicatorsOptical coupling gel	System console (with user interface)Applicators
Light guide	Sapphire light guide	Light guide	Crystal Light Guide
Cooling system	Cooling system	Cooling system (circulating water)	Cooling system (water cooling)

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Therefore, the dimensional differences and other minor technological differences between the Versa and its predicates do not present any new or different issues of safety or effectiveness. Therefore, the Venus Versa System presents similar technological characteristics as its predicates, in support of substantial equivalence.

Performance Data and Standards

The performance of the Venus Versa has been demonstrated in testing. Electromagnetic Compatibility and Electrical Safety testing was conducted per AAMI/ANSI ES60601-1, IEC 60601-1-2, and IEC 60601-2-57. All results were passing. In addition, the patient contacting materials are biocompatible per ISO 10993-5. Cleaning and disinfection validation testing has also been completed.

The Venus Versa System also underwent software validation and results demonstrate that the software was appropriate for release. Bench testing further confirmed that the energy outputs of the Versa met specifications.

Substantial Equivalence

The Venus Versa has the same intended use and similar indications for use, technological characteristics and principles of operation as its predicate devices. The minor technological differences between the Venus Versa and its predicate devices do not raise any new or different issues of safety or effectiveness, given that the key energy parameters are the same or similar for the devices.

Conclusions

The tests outlined above demonstrate that the device performs as intended for the indicated uses of each applicator. Minor differences between the subject and predicate devices do not present any new or different types of safety or effectiveness questions, as confirmed by device performance evaluations. In sum, the Venus Versa System is substantially equivalent to its predicate devices.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.