Legacy BX

K142910 · Venus Concept USA, Inc. · GEI · Dec 19, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142910
• Device Name: Legacy BX
• Applicant: Venus Concept USA, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 19, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Non-invasive, non-ablative aesthetic device; delivers 1MHz Radio Frequency (RF) energy and 15Hz Pulsed Magnetic Field (PMF) energy to skin. RF energy heats tissue to trigger cellular changes; PMF energy acts as adjunct to reduce healing downtime. System comprises RF power module, PMF module, two handpiece applicators, and console with LCD touch screen. Operated by clinician in clinical setting. Output provides thermal energy to skin; healthcare provider monitors treatment via console interface. Device intended to improve facial wrinkles and rhytides, potentially benefiting patient through non-surgical skin rejuvenation.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing comparing RF output parameters, PMF output parameters, and temperature stability to the predicate device.

Technological Characteristics

Non-ablative aesthetic device. RF output: 1MHz, 150W max. PMF output: 15Hz, 15 Gauss max. Materials: Biocompatible per ISO 10993. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-2 (high-frequency surgical equipment). Form factor: Console (40cm x 40cm x 100cm, 40kg) with two handpiece applicators. Connectivity: Standalone system with LCD touch screen control.

Indications for Use

Indicated for females with moderate to severe facial wrinkles and rhytides, Fitzpatrick skin types I-IV.

Regulatory Classification

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.

Predicate Devices

• Venus Freeze (MP)2 (K111670)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

{1}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

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)

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

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(K) SUMMARY VENUS LEGACY BX DEVICE

## 510(k) Number K_______________________________________________________________________________________________________________________________________________________________

## Applicant Name:

| Company Name: | Venus Concept USA Inc. |
|---------------|------------------------------------------------------------|
| Address: | 4556 N. Hiatus Road,<br>Sunrise, FL 33351<br>United States |
| | Tel: [phone] |
| | Fax: [phone] |
| | E-mail: [e-mail] |

## Contact Person:

| Official Correspondent: | Ahava Stein |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name: | A. Stein - Regulatory Affairs Consulting Ltd. |
| Address: | C/O MEDX Ventures Group LLC<br>175 Derby St., Unit 27 Suite 1<br>Hingham, MA 02043<br>USA<br>Tel: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
| 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<br>(MP)2 | Venus Concept Ltd. | K111670 |

{4}------------------------------------------------

### 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.

#### 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

{5}------------------------------------------------

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.

{6}------------------------------------------------

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.