MINNIE

K133405 · Elettronica Valseriana Srl · GEI · May 23, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K133405
• Device Name: MINNIE
• Applicant: Elettronica Valseriana Srl
• Product Code: GEI · General, Plastic Surgery
• Decision Date: May 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-ablative treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.

Device Story

MINNIE is a portable, noninvasive radiofrequency (RF) system for facial wrinkle reduction. System comprises touch screen interface, programmable microcontroller, RF power module, and four handpieces (one bipolar, three unipolar). Operator (clinician) selects parameters to deliver 550–800 kHz RF energy (up to 30W) and thermal energy to treatment site. Energy delivery induces thermal effects in skin tissue to improve appearance of wrinkles and rhytides. Output is controlled via handpiece application; clinical effect monitored by provider via visual assessment (Fitzpatrick Wrinkles Scale). Benefits include non-surgical improvement of facial skin texture.

Clinical Evidence

Prospective clinical study of 52 subjects (36 female, 16 male). Groups: Control (n=8), Sham (n=11), Active (n=33). Active group received 4 treatments 2 weeks apart (550-800 kHz, max 30W RF/thermal). Primary endpoint: ≥2 point decrease in Fitzpatrick Wrinkles Scale (FWS). Results: 100% of active group met success criterion at 1 month. Follow-up at 3 and 6 months showed sustained improvement. Adverse events: 4 cases of moderate erythema, resolved with topical treatment. No improvement in control/sham groups.

Technological Characteristics

Portable RF system; 550-800 kHz frequency; max 30W RF/thermal output. Includes touch screen, microcontroller, and 4 handpieces (1 bipolar Ø 36mm, 3 unipolar Ø 36/60/80mm). Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Software-controlled energy delivery.

Indications for Use

Indicated for non-ablative treatment of mild to moderate facial wrinkles and rhytides in patients. Note: device not tested on darker skin subjects.

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

• Accent™ (K070004)
• Imagine TC Skin Treatment System (K083461)
• Venus Freeze system (K100586)

Submission Summary (Full Text)

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

K133405

MAY 2 3 2014

Page 1 of 3

# 510(k) SUMMARY

| Applicant name: | Elettronica Valseriana srl<br>Via San Carlo 45/47<br>24020 Casnigo (BG) - Italy<br>Tel.: [phone]<br>Fax: [phone] | | | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact person: | Sergio Ghersini<br>Via San Carlo 45/47<br>24020 Casnigo (BG) - Italy<br>Tel.: [phone]<br>Fax: [phone] | | | | |
| Trade Name: | MINNIE | | | | |
| Preparation Date: | May 21st, 2014 | | | | |
| Classification: | Name: Electrosurgical, cutting & coagulation device & accessories<br>Product code: GEI<br>Regulation: 878.4400<br>Class: II<br>Panel: General and Plastic Surgery | | | | |
| Device Description: | MINNIE is a noninvasive radiofrequency device consisting of:<br>• Touch Screen User interface<br>• Programmable Microcontroller<br>• RF Power Module<br>• 4 Treatment Handpieces with following characteristics<br>o Bipolar Handpiece Ø 36mm<br>o Unipolar Handpieces Ø 36mm, 60mm and 80mm<br>MINNIE is a portable system used to deliver radiofrequency energy to the<br>patient treatment site via a delivery handpiece. | | | | |

Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This Indications for Use: device has not been tested on darker skin subjects.

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

| Device Name | 510(k)<br>Number | Clearance<br>Date | Name | Product<br>code | Regula-<br>tion | Class | Panel |
|-------------------------------------------|------------------|-------------------|----------------------------------------------------------------------|-----------------|--------------------|-------|---------------------------------|
| Accent™ | K070004 | 2007.04.23 | Electrosurgical,<br>cutting &<br>coagulation device<br>& accessories | GEI | 21 CFR<br>878.4400 | II | General &<br>Plastic<br>Surgery |
| Imagine TC<br>Skin<br>Treatment<br>System | K083461 | 2009.07.24 | Electrosurgical,<br>cutting &<br>coagulation device<br>& accessories | GEI | 21 CFR<br>878.4400 | II | General &<br>Plastic<br>Surgery |
| Venus Freeze<br>system | K100586 | 2010.11.29 | Electrosurgical,<br>cutting &<br>coagulation device<br>& accessories | GEI | 21 CFR<br>878.4400 | II | General &<br>Plastic<br>Surgery |

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

An extended comparison is presented in Document Substantial equivalence discussion.

## Performance Standards:

MINNIE complies with the following Recognized standards:

- · IEC 60601-2-2:2009 Medical Electrical Equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories (with US/Canada deviations)
- IEC 60601-1-2:2007 Medical Electrical Equipment Part 1 General requirements for safety 2. Collateral standard: Electromagnetic compatibility - Requirements and tests and the following voluntary standard
- IEC 60601-1:2005 Medical Electrical Equipment Part 1 General requirements for safety .

In addition it complies with European Directive 93/42/EEC for Medical Devices (Annex IX - Rule 9).

## Clinical Performance Study:

A clinical study has been carried out in order to assess the safety and effectiveness of MINNIE. To measure effectiveness, success criterion was defined as at least 2 points decrease in in the FWS score. Adverse events were monitored to evaluate safety.

The population included 52 subjects (36 females, 16 males). At the enrollment visit, their condition was evaluated using Fitzpatrick Wrinkles Scale (FWS) and they were randomly assigned to 3 groups:

Group A: control (only visit, no stimulation), 8 subjects Group B: sham (electrical stimulation), 11 subjects Group C: radiofrequency treatment, 33 subjects. (active treatment group)

Evaluations were performed by the investigator on live study subjects and documented with clinical photographs. To confirm the in-vivo scores, evaluations from a team of 3 physicians blinded to the randomization group were carried out on photographs. There were no differences in the scoring of the evaluators.

Subjects in Group A received no treatment, and subjects in Group B received electrical stimulation (sham treatment). All the subjects included in Group C received a cycle of 4 treatments 2 weeks apart. The treatments for Group C were applied using monopolar and bipolar electrodes delivering 550 kHz to 800 kHz energy up to a maximum 30 W radiofrequency energy and 30 W thermal energy for specified duration.

At 1 month after the end of the cycle, a new evaluation was carried out using the FWS scale. Data analysis showed a substantial improvement, as all the subjects treated met the above success criterion (at least 2 points decrease on the FWS).

The initial clinical protocol did not include a scheduled follow up visit for clinical evaluation at 3 and 6 months after last treatment. Upon FDA request clinical information with FWS scores and clinical photographs as well as investigators evaluation were submitted, the results are summarized below:

All subjects were followed up at 3 and 6 month time points. Outcomes for Group C at the 3 and 6 months follow-up visit are:

- י all of the patient population treated demonstrated an improvement from baseline.
- at 3 months, in 42% of cases in the C group there was no change in the FWS score recorded at the completion of the treatment cycle.
- at 6 months, 44% of the subjects in the C group showed an improvement with respect to the FWS score recorded at 3 months, confirming the continuation of the treatment effect.

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

30% of the requested study subject photographs at 6 months were not provided to the Agency for review due to patient privacy privilege.

The only adverse events reported in this study were 4 cases of moderate skin erythema which resolved with the use of antihistamines and/or topical corticosteroids and skin emollients for a short period of time (maximum of 3 days).

No decrease in FWS was noticed in any subject in Group A (control) or Group B (sham) at the 3 or 6 month follow-up time points.

## Rationale for substantial equivalence:

A comparison of Indicated Use Statement and technological characteristics to other predicates has been performed. The indications for use of the MINNIE device were found to be equivalent to the predicate devices and do not raise new questions of safety and effectiveness. Performance testing further demonstrated that the device can output the listed monopolar and bipolar energy, and therefore demonstrated that the technological characteristics can be considered substantially equivalent. As summarized above, clinical performance data was collected to demonstrate safety and effectiveness. These data show that subjects obtained an improvement in the FWS immediately following treatment, and maintenance of that improvement was obtained at 3 and 6 months. Therefore, the indications for use, technical characteristics and clinical study information provided demonstrates that MINNIE is substantially equivalent to the predicate devices.

### Conclusion:

The MINNE device shares the same indications for use, similar design and functional features, thus is substantially equivalent to the predicate devices.

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

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, with three stylized wing shapes and a flowing tail.

# 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

May 23, 2014

Elettronica Valseriana Srl Mr. Sergio Ghersini Regulatory Affairs Manager Via South Carlo 45/47 24020 Casnigo (BG) Italy

Re: K133405

Trade Name: Minnie Regulatory Class: Class II Product Code: GEI Dated: December 6, 2013 Received: April 21, 2014

Dear Mr. Ghersini:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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

Page 2 - Mr. Sergio Ghersini

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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 Small Manufacturers, International and Consumer Assistance 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 2014.05.23 16:3 3-31 -04'00'

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement befow.

510(k) Number (if known) K133405

Device Name MINNIE

Indications for Use (Describe)

Non-ablative treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects

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)

ું જિંદ્

1244 Kr. 1

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

" " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " "

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."