The Venus Legacy BX Device 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 and rhytides in Fitzpatrick skin types I-IV

Device Description

The Venus Legacy BX device is a non-invasive, non-ablative medical aesthetic device. It is designed to deliver RF (Radio Frequency, 1MHz) energy and PMF (Pulsed Magnetic Field, 15Hz) energy to the skin. RF energy heats the tissue to trigger cellular changes for the intended use. The RF treatment is supplemented with an adjunct magnetic energy for the reduction of the downtime healing process.

The device consists of an RF Power Module, a Pulsed Magnetic Field (PMF) module, two hand piece applicators, and a console with control electronics and an LCD touch screen.

AI/ML Overview

The document provided is a 510(k) premarket notification for the Venus Legacy BX Device, which seeks to demonstrate substantial equivalence to a previously cleared predicate device. It is not a study that proves a device meets specific acceptance criteria through clinical performance data. Therefore, many of the requested details about acceptance criteria derived from clinical studies, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of submission.

The document primarily focuses on demonstrating that the new device has "substantially equivalent" technological characteristics and performance to its predicate.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence claim based on non-clinical testing and comparison to a predicate, formal "acceptance criteria" for clinical performance are not explicitly stated or demonstrated with clinical data. Instead, the "acceptance criteria" are implied as matching the specifications and performance of the predicate device.

Acceptance Criterion (Implied)	Reported Device Performance (Venus Legacy BX)
Functional Equivalence to Predicate Device:
RF Output Parameters match Predicate Venus Freeze (MP)2	Bench test demonstrated same RF output specifications as predicate.
PMF Output Parameters match Predicate Venus Freeze (MP)2	Bench test demonstrated same PMF output specifications as predicate.
Temperature Stability match Predicate Venus Freeze (MP)2	Bench test demonstrated same temperature stability profile as predicate.
Safety (Electrical, Mechanical) and EMC	Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Similar safety features and compliance to predicate.
Biocompatibility of Patient Contact Materials	Complies with ISO10993 Standard; similar materials to predicate.
Device Specifications Match Predicate Capabilities:
Maximal RF Output Power (150W)	Matches specification.
RF Output Frequency (1MHz)	Matches specification.
Magnetic Frequency (Pulse, 15Hz)	Matches specification.
Maximal Magnetic Field (15 Gauss)	Matches specification.
Inner Design and Components	Similar to the predicate device (console with power supply, RF generator, controller, display panel, and handpiece applicators).
Methods and Parameters of Treatment (energy levels, treatment area, duration)	Similar to the respective methods and parameters in the predicate device.
Software Validation	Software validation testing (provided in Section 12, though Section 12 is not included in the provided text).
Intended Use/Indications for Use	Non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV (for females), which is substantially equivalent to predicate.

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

Test Set Sample Size: Not applicable. No clinical test set data is provided or referenced in the document for the Venus Legacy BX device. The evaluation was based on non-clinical bench testing comparing the device to its predicate.
Data Provenance: Not applicable. The "data" presented comes from internal bench testing (RF output, PMF output, temperature stability, safety standards compliance) of the Venus Legacy BX device, compared against the specifications of the predicate device (Venus Freeze (MP)2).

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

Not applicable. There was no clinical test set requiring expert-established ground truth. The comparison was to the technical specifications and proven performance of a predicate device.

4. Adjudication method for the test set

Not applicable. No clinical test set was conducted that would require an adjudication method.

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 aesthetic medical device (RF and PMF energy delivery), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or is relevant.

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

Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical parameters and energy delivery capabilities.

7. The type of ground truth used

For the "performance" verification: The "ground truth" was effectively the established technical specifications, safety standards compliance, and proven performance of the predicate device (Venus Freeze (MP)2), which the Venus Legacy BX device aimed to match or demonstrate equivalence to through bench testing.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm that requires a training set.

Summary of the Study (as described in the document):

The "study" conducted for the Venus Legacy BX Device was a non-clinical bench test to demonstrate substantial equivalence to the predicate Venus Freeze (MP)2 device (K111670).

Objective: To show that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device, despite minor design modifications (outer design only).
Methodology:
- Bench testing was performed on the Venus Legacy BX device to measure its RF output parameters, PMF output parameters, and temperature stability.
- These measurements were then compared to the reported (or known) RF output measurements, PMF output parameters, and temperature stability of the predicate Venus Freeze (MP)2 device.
- Compliance with voluntary recognized safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) was also assessed.
- Biocompatibility of patient contact materials was confirmed against ISO10993.
- Software validation testing was mentioned as being performed but results not detailed in the provided text.
Findings: The bench tests demonstrated that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device. The inner design and components, safety features, compliance with safety standards, and intended use/indications for use were found to be similar or substantially equivalent to the predicate.
Conclusion: Based on the performance testing comparing the Venus Legacy BX device to the predicate device, it was concluded that the Venus Legacy BX device is substantially equivalent for the stated intended use. This means the device met the "acceptance criteria" of being functionally and safely equivalent to the established predicate.

Summary

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

December 19, 2014

Venus Concept USA Incorporated % Ms. Ahava Stein A. Stein - Regulatory Affairs Consulting LTD % MEDX Ventures Group LLC 175 Derby Street, Unit 27 Suite 1 Hingham, Massachusetts 02043

Re: K142910

Trade/Device Name: Venus Legacy BX Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: November 19, 2014 Received: November 24, 2014

Dear Ms. Stein:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K 142910

Device Name

Venus Legacy BX Device

Indications for Use (Describe)

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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510(K) SUMMARY VENUS LEGACY BX DEVICE

510(k) Number K_______________________________________________________________________________________________________________________________________________________________

Applicant Name:

Company Name:	Venus Concept USA Inc.
Address:	4556 N. Hiatus Road,Sunrise, FL 33351United States
	Tel: +1-416-907-0115
	Fax: +954-572-5680
	E-mail: lilia@venus-concept.com

Contact Person:

Official Correspondent:	Ahava Stein
Company Name:	A. Stein - Regulatory Affairs Consulting Ltd.
Address:	C/O MEDX Ventures Group LLC175 Derby St., Unit 27 Suite 1Hingham, MA 02043USATel: 1-888-4433867Fax: 1-718-374-6529E-mail: ahava@asteinrac.com
Date Prepared:	September 30, 2014
Trade Name:	Venus Legacy BX Device
Classification Name:	CFR Classification section 878.4400; (Product code GEI)
Classification:	Class II Medical Device

Predicate Device:

The Venus Legacy BX Device is substantially equivalent to the previously cleared, Venus Freeze (MP)2 device, also manufactured by Venus Concept Ltd.

Device	Manufacturer	510(k) No.
Venus Freeze(MP)2	Venus Concept Ltd.	K111670

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Device Description:

The device consists of an RF Power Module, a Pulsed Magnetic Field (PMF) module, two hand piece applicators, and a console with control electronics and an LCD touch screen.

Device Specifications:

Maximal RF Output Power: 150W RF Output Frequency: 1[MHz] Magnetic Frequency: Pulse, 15Hz Maximal Magnetic Field: 15 Gauss Dimension: 40cm W x 40cm D x 100cm H (15.7' W x 15.7'' D x 39.4'' H) Weight: 40 Kg (88 lbs) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC

Intended Use/Indication for Use:

The Venus Legacy BX device 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 and rhytides in Fitzpatrick skin types I- IV.

Performance Standards:

The Venus Legacy BX device has been tested and complies with the following voluntary recognized standards:

IEC 60601-1, (Third Edition, 2005 / 2006), Medical Electrical Equipment Part 0 1: General requirements for basic safety and essential performance
IEC 60601-1-2. (Third Edition, 2007). Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests
IEC 60601-2-2 (Fifth Edition, 2009): Medical Electrical Equipment Part 2: . Particular requirements for the safety of high frequency surgical equipment.

Non-Clinical (Bench) Performance Data:

A bench test was performed to measure the RF output parameters; PMF output parameters and temperature stability in the Venus Legacy BX device and compare them to the RF output measurements, PMF output parameters and temperature stability in the Venus Freeze (MP) device. The results of the bench test demonstrated that the Venus

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Legacy BX device has the same RF and PMF output specifications and temperature stability profile as those reported for the predicate device and therefore, is substantially equivalent to the predicate device.

Pre-Clinical (Animal Study) Performance Data:

Not Applicable

Clinical Performance Data:

Not Applicable

Substantial Equivalence:

The indications for use and technological characteristics of the Venus Legacy BX device are substantially equivalent to the indications for use and technological characteristics of the Venus Freeze (MP)2 device.

The Venus Legacy BX device is a modified device of the Venus Freeze (MP)2 device, previously cleared under 510k No. K111670. The modifications are exclusively design related with a new outer design yet with the same technology and components as in the Venus Freeze (MP)2 device.

The inner design and components in the Venus Legacy BX device, including the console (with power supply, RF generator, controller and display panel) and the hand piece applicators (with cable, connector to console) are similar to the design and components found in the Venus Freeze (MP) device. The safety features and compliance with safety standards in the Venus Legacy BX device are similar to the safety features and compliance with safety standards found in the predicate devices (provided in Section 7). The patient contact materials are biocompatible in compliance with ISO10993 Standard and similar to materials found in the Venus Freeze (MP)device. The Venus Legacy BX device underwent performance testing, including software validation testing (provided in Section 12) and electrical and mechanical safety testing according to IEC 60601-1 and electromagnetic compatibility testing according to IEC 60601-1-2 (provided in Section 12). The performance specifications (including RF electrical power output, PMF output and temperature stability) of the Venus Legacy BX device are substantially equivalent to those in the Venus Freeze (MP) device, as shown in the performance bench tests provided in section 12. The results of the tests demonstrate that the specifications are similar to those of the predicate device. These performance tests demonstrate that the device specifications meet the system requirements and that the minor differences in design do not raise new safety or effectiveness concerns.

The general method of treating the patient's skin, the levels of energies used in treatment of skin, the size of treatment area and treatment zone, the active electrode area, durations of treatment, total energies delivered, are all similar to the respective methods and parameters in the predicate device.

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Consequently, it can be concluded that the Venus Legacy BX device is substantially equivalent to the predicate Venus Freeze (MP)2 device, cleared under 510(k) K111670; and therefore, may be legally marketed in the USA.

Conclusions:

Based on the performance testing and comparison to predicate devices, the Venus Legacy BX device is substantially equivalent to the Venus Freeze (MP)2 predicate device for the mentioned 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.