The Venus Freedom device is intended for the treatment of the following medical conditions; using the Pearl, Diamond and Slim applicators for delivery of non-thermal RF combined with massage and magnetic field pulses:
• 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

The Venus Freedom device, part of the Family of Venus RF devices, is a noninvasive, non-ablative device that delivers Radiofrequency (RF) energy, along with the Pulsed Electro-Magnetic Field (PEMF), into the skin to generate heat through electrical impedance in the epidermis, dermis, subcutaneous layers, and muscular tissue.
The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).
The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Venus Freedom device, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device (Venus Heal, K182094), rather than setting specific quantifiable acceptance criteria against a defined clinical endpoint like accuracy (e.g., sensitivity, specificity for a diagnostic device). The performance data presented is focused on verification of technical specifications and safety.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance (Venus Freedom)
Technical Specification Verification	- Max RF power output met. - Max PEMF power density met.
Safety - Temperature Control	- Bench test demonstrated the ability to maintain a safe treatment temperature on the surface of human skin using the same protocol as the predicate device, Venus Heal (K182094).
Electrical Safety and Electromagnetic Compatibility (EMC)	- Complied with IEC 60601-1, IEC 60601-1-6, IEC 60601-2-2, and IEC 60601-1-2. All results were "passing."
Software Functionality	- Software verification and validation testing performed; device functioned as intended, and results were as expected.
Biocompatibility	- Disposable tip materials tested per FDA Guidance and ISO 10993-1, 10993-5, 10993-10. Testing included cytotoxicity, sensitization, and irritation. All testing "passed."
Clinical Effect (Equivalent to Predicate)	The Venus Freedom device is stated to be for the "Relief of minor muscle aches and pain, relief of muscle spasm, Temporary improvement of local blood circulation, Temporary reduction in the appearance of cellulite." The basis for this is substantial equivalence to the Venus Heal, which had these indications. No new clinical study data is presented to prove these effects for the Venus Freedom.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The provided document describes a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than conducting new, full-scale clinical trials to prove efficacy from scratch. Therefore, the "study" is primarily a set of verification and validation (V&V) tests designed to show that the new device (Venus Freedom) performs comparably to its predicate (Venus Heal) and meets essential safety and performance standards.

The key studies and tests performed are:

Verification Tests: To ensure the device adheres to its technical specifications for RF power output and PEMF power density.
Bench Test (Temperature Maintenance): This test specifically aimed to demonstrate the device's ability to maintain a safe treatment temperature on human skin. This was done using a protocol identical to that used for the predicate device, K182094 (Venus Heal).
Electrical Safety and EMC Testing: Conformance to recognized international standards (IEC 60601 series).
Software Verification and Validation: To ensure software functions as intended.
Biocompatibility Testing: On new disposable tip materials, following ISO 10993 standards.

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

Sample Size: The document does not specify a "sample size" in the context of human subjects or cases for a clinical test set. The performance data described are primarily bench tests and engineering verification tests. For the bench test on temperature, it's a simulation rather than a human subject study.
Data Provenance: The data originates from internal testing conducted by Venus Concept (the manufacturer) as part of their device development and regulatory submission process. There is no mention of country of origin for data generation specifically, but the company is Venus Concept USA Inc. The tests are prospective in the sense that they were conducted specifically for the Venus Freedom device to support the 510(k) submission.

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

This information is not applicable to the type of studies presented. The "ground truth" here is adherence to technical specifications, safety standards, and functional performance, which are assessed through engineering and bench testing, not expert consensus on clinical findings.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving multiple readers for diagnostic or prognostic tasks to resolve disagreements. The reported studies are technical verification and validation, not clinical efficacy studies requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a therapeutic electrosurgical device, not a diagnostic AI-assisted imaging device. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.

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

This is not applicable as the device is not an AI algorithm but a physical electrosurgical system. Its performance is inherent in its operation and effect on tissue, rather than an "algorithm-only" output.

7. The Type of Ground Truth Used:

The "ground truth" used for the reported performance tests are:
- Technical specifications: For RF power, PEMF power density.
- Safety standards: For temperature maintenance and electrical/EMC performance (e.g., safe temperature limits, IEC standard compliance).
- Biocompatibility standards: For material safety (ISO 10993 series).
- Functional requirements: For software performance.

8. The Sample Size for the Training Set:

This information is not applicable. The Venus Freedom device is not described as an AI/ML-driven device that requires a "training set" in the context of machine learning model development. The design and operation are based on established RF and PEMF physics and engineering principles.

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

This is not applicable for the same reason as above (no AI/ML training involved).

Summary

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October 14, 2021

Venus Concept USA Inc. Yoni Iger VP Regulatory, Science & Technology 1880 N Commerce Pkwv. Suite 2 Weston, Florida 33326

Re: K211461

Trade/Device Name: Family of Venus RF Systems - Venus Freedom Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: August 10, 2021 Received: August 17, 2021

Dear Yoni Iger:

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 ffor 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020

See PRA Statement below.

510(k) Number (if known) K211461

Device Name

Family of RF Systems - Venus Freedom

Indications for Use (Describe)

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)

| Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C)

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VI. 510(k) SUMMARY

VENUS FREEDOM DEVICE - K211461

Applicant Name: Venus Concept USA Inc. 1880 N Commerce Pkwy, Ste 2 Weston, FL33326, USA Tel: +1 888 907-0115
Contact Person: Dr. Yoni Iger VP Regulatory, Science & Technology Venus Concept USA Inc. Yoni@venusconcept.com Tel: +1 888 907-0115

Date Prepared: October 13, 2021

Trade Name: Venus Freedom Device

Classification Name: 21 CFR 878.4400 Electrosurgical cutting and coagulation device and accessories

Product Code: PBX

Classification: Class II Medical Device

Classification Panel: General & Plastic Surgery Panel

Predicate Device: Venus Heal device (K182094)

Intended Use/Indication for Use:

·Relief of minor muscle aches and pain, relief of muscle spasm

·Temporary improvement of local blood circulation

· Temporary reduction in the appearance of cellulite

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K211461

Device Description:

The device consists of a console (main unit) and three applicators (Pearl, Diamond and Slim).

The Venus Freedom RF energy, PEMF and tissue manipulation (massage), are utilized to trigger changes in the tissue which result in local blood circulation improvement, muscle spasm relief along with pain relief. Temporary reduction in the appearance of cellulite is similarly achieved by the combination of these three main mechanisms: tissue manipulation (massage), RF delivery and PEMF delivery.

Consistent with the previous clearance, the device is intended to be used in professional healthcare facilities (prescription use) just as the predicate.

Comparison of Technological Characteristics:

The following table compares the subject Venus Freedom device to its predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

Parameter	Proposed Device:Venus FreedomVenus Concept Inc.	Predicate Device:Venus HealVenus Concept Inc.(K182094)	SubstantialEquivalence
Product Class, Code	Class II, PBX	Class II, PBX	Same
Indications for Use	The Venus Freedom device isintended for the treatment ofthe following medicalconditions; using the Pearl,Diamond and Slimapplicators for delivery ofnon-thermal RF combinedwith massage and magneticfield pulses:• Relief of minor muscle achesand pain, relief of musclespasm• Temporary improvement oflocal blood circulation• Temporary reduction in theappearance of cellulite.	The Venus Heal deviceis intended for the treatmentof the following medicalconditions; using the Largeand Small applicators fordelivery of non-thermal RFcombined with massage andmagnetic field pulses:• Relief of minor muscle achesand pain, relief of musclespasm• Temporary improvement oflocal blood circulation• Temporary reduction in theappearance of cellulite.	Same
Parameter	Proposed Device:Venus FreedomVenus Concept Inc.	Predicate Device:Venus HealVenus Concept Inc.(K182094)	SubstantialEquivalence
Energy Used/Delivered	RF EnergyPulsed Electro-Magnetic Field (PEMF)	RF EnergyPulsed Electro-Magnetic Field (PEMF)	Same
Tissue ManipulationMechanism	Massage mechanism	Massage mechanism	Same
Design	Use of RF and PEMF combinedenergies delivered through applicatorand massage of the skin.	Use of RF and PEMF combinedenergies delivered through applicatorand massage of the skin.	Same
Components	Console, including:- Power supply- RF generator- Main CPU- Display panel- PEMF generatorApplicators:- Pearl- Diamond- SlimFootswitch	Console, including:- Power supply- RF generator- Main CPU- Display panel- PEMF generatorApplicators:- Large- Small	SameNewApplicatorAddition ofFootswitch
Applicators	Pearl Applicator:6 electrodes1 PEMF coilDiamond Applicator:4 electrodes1 PEMF coilSlim Applicator:6 electrodes1 PEMF coil	Large Applicator:8 electrodes8 PEMF coilsSmall Applicator:4 electrodes4 PEMF coils	Samedelivery ofBipolar RFand PEMF,althoughdifferentnumber ofelectrodesand coilsNewApplicator
Applicator'sdisposable tip	Single use disposable per applicator:- Pearl disposable tip- Diamond disposable tip- Slim disposable tip	None, all applicators are reusable	Different
Parameter	Proposed Device:Venus FreedomVenus Concept Inc.	Predicate Device:Venus HealVenus Concept Inc.(K182094)	SubstantialEquivalence
Device Dimensions	16.5x16.5x10.4 in (W × D × H)42x42x26.5 cm (W × D × H)	16.5x16.5x10.4 in (W × D × H)42x42x26.5 cm (W × D × H)	Same
Performance	Frequency: 1MHzMax. RF output power:80W (Pearl, Diamond and Slimapplicators)	Frequency: 1MHzMax. RF output power:100W (Large and Small applicators)	Same
	PEMF Power: 15 Gauss (15Hz)	PEMF Power: 15 Gauss (15Hz)	Same
			Different
Power density pereffective treatmentarea (Watt/cm²)	Pearl Applicator:3.75W/cm²Diamond Applicator:24.24W/cm²Slim Applicator:4.5W/cm² (1 pair of electrodes)	Large Applicator:2.6W/cm²Small Applicator:20.4 W/cm²	Different
			Different
Materials	Biocompatible materials per ISO10993-1	Biocompatible materials per ISO10993-1	Same

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Performance Data:

Venus Concept conducted several performance tests to demonstrate that the subject Venus Freedom device complies with performance standards and that it functions as intended per its design.

Verification test demonstrating that the Venus Freedom device meets the system's technical specification for the max RF power output and max PEMF power density.
A Bench test which demonstrated the ability of the subject device to maintain a safe treatment temperature on the surface of the human skin with the same protocol that was used for the predicate device, Venus Heal (K182094).

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K211461

Electrical Safety and Electromagnetic Compatibility: The Venus Freedom system was tested per the applicable electrical safety and electromagnetic compatibility standards listed below, and all results were passing.

IEC 60601-1: (2005) and A1:2012, Medical Electrical Equipment Part 1-1: General requirements – for basic safety and essential performance
IEC 60601-1-6: (2010/AMD2013), Medical Electrical Equipment Part 1-6, General requirements for basic safety and essential performance
IEC 60601-2-2:2017, Medical Electrical Equipment Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
IEC 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
IEC 62304: (2006/AMD2015) Medical device software Software life cycle processes -

Software Testing:

Software verification and validation testing has been performed; the device functioned as intended and the results observed were as expected.

Biocompatibility:

Biocompatibility testing was performed on the Venus Freedom's disposable tip's materials according to the FDA Guidance and ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. Testing included cytotoxicity, sensitization and irritation according to standards set forth in ISO 10993- 5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity and ISO 10993-10 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization. All testing passed.

Conclusions:

The Venus Freedom device is as safe and effective as its predicate device, Venus Heal, cleared under K182094 for the same requested intended use. The Venus Freedom device has the same intended use and indications for use, similar technological characteristics, and the same principle of operation as its predicate device. Performance data demonstrated that the technological differences in the Venus Freedom do not raise any issues of safety or effectiveness in comparison to the predicate device. Thus, the Venus Freedom device is substantially equivalent to its predicate, Venus Heal (K182094) for the requested intended use.

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.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

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VI. 510(k) SUMMARY

VENUS FREEDOM DEVICE - K211461

Intended Use/Indication for Use:

K211461

Device Description:

Comparison of Technological Characteristics:

Performance Data:

K211461

Software Testing:

Biocompatibility:

Conclusions:

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.