MINNIE is a noninvasive radiofrequency device consisting of:
• Touch Screen User interface
• Programmable Microcontroller
• RF Power Module
• 4 Treatment Handpieces with following characteristics
o Bipolar Handpiece Ø 36mm
o Unipolar Handpieces Ø 36mm, 60mm and 80mm
MINNIE is a portable system used to deliver radiofrequency energy to the patient treatment site via a delivery handpiece.

AI/ML Overview

MINNIE Device Performance Study

This response outlines the acceptance criteria and study details for the MINNIE device, based on the provided 510(k) summary (K133405).

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Effectiveness: At least a 2-point decrease in Fitzpatrick Wrinkle Scale (FWS) score	Immediate Post-Treatment: All 33 subjects in the active treatment group (Group C) met the success criterion. 3-Month Follow-up: All subjects in Group C demonstrated an improvement from baseline. In 42% of cases, there was no change in FWS score recorded at the completion of the treatment cycle
Safety: Monitoring for adverse events	Reported Adverse Events: 4 cases of moderate skin erythema, which resolved within a maximum of 3 days with antihistamines/topical corticosteroids/skin emollients.

2. Sample Size and Data Provenance

Test Set (Clinical Study): 52 subjects
- Group A (Control): 8 subjects
- Group B (Sham): 11 subjects
- Group C (Radiofrequency Treatment): 33 subjects
Data Provenance: Not explicitly stated, but the applicant (Elettronica Valseriana srl) is based in Italy, suggesting the study may have been conducted there. The study appears to be prospective as subjects were randomly assigned to groups and followed up.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

Number of Experts: 3 physicians
Qualifications: "Blind to the randomization group," implying independence and impartiality. Specific years of experience or subspecialty (e.g., dermatologist, plastic surgeon) are not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Implicitly, consensus or strong agreement. The summary states, "There were no differences in the scoring of the evaluators," suggesting that the 3 physicians' evaluations (on clinical photographs) matched the in-vivo scores made by the investigator. If there were discrepancies, an adjudication method was not explicitly described, but their agreement eliminates the need for one.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

**No, a specific MRMC comparative effectiveness study comparing human readers with and without AI assistance was not done.
The study involved human readers (3 blinded physicians and the investigator) assessing wrinkles using a standardized scale. The device itself is an energy delivery system, not an AI-based diagnostic or assistive reader tool. Therefore, an MRMC study in the typical AI context is not applicable here.

6. Standalone Performance Study (Algorithm Only)

**No, a standalone (algorithm only) performance study was not done.
The MINNIE device is a medical device that delivers radiofrequency energy, not an algorithm that interprets data or provides diagnostic output. The clinical study assessed the effect of the device on human subjects.

7. Type of Ground Truth Used

Ground Truth Type: Expert consensus (for evaluations from photographs by blinded physicians that confirmed the in-vivo scores by the investigator) and clinical assessment using a standardized scale (Fitzpatrick Wrinkle Scale - FWS).

8. Sample Size for the Training Set

Training Set Sample Size: A separate training set for an algorithm is not applicable as the MINNIE device is a hardware-based radiofrequency treatment system, not an AI software. The provided document describes a clinical study to evaluate the device's safety and effectiveness in treating wrinkles, not to train a machine learning model.

9. How Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training Set: Not applicable as there is no training set for an algorithm. The clinical study used the FWS as a measure to assess the device's effects on human subjects.

Summary

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K133405

MAY 2 3 2014

Page 1 of 3

510(k) SUMMARY

Applicant name:	Elettronica Valseriana srlVia San Carlo 45/4724020 Casnigo (BG) - ItalyTel.: +39.035.726301Fax: +39.035.740758
Contact person:	Sergio GhersiniVia San Carlo 45/4724020 Casnigo (BG) - ItalyTel.: +39.035.726301Fax: +39.035.740758
Trade Name:	MINNIE
Preparation Date:	May 21st, 2014
Classification:	Name: Electrosurgical, cutting & coagulation device & accessoriesProduct code: GEIRegulation: 878.4400Class: IIPanel: General and Plastic Surgery
Device Description:	MINNIE is a noninvasive radiofrequency device consisting of:• Touch Screen User interface• Programmable Microcontroller• RF Power Module• 4 Treatment Handpieces with following characteristicso Bipolar Handpiece Ø 36mmo Unipolar Handpieces Ø 36mm, 60mm and 80mmMINNIE is a portable system used to deliver radiofrequency energy to thepatient 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)Number	ClearanceDate	Name	Productcode	Regula-tion	Class	Panel
Accent™	K070004	2007.04.23	Electrosurgical,cutting &coagulation device& accessories	GEI	21 CFR878.4400	II	General &PlasticSurgery
Imagine TCSkinTreatmentSystem	K083461	2009.07.24	Electrosurgical,cutting &coagulation device& accessories	GEI	21 CFR878.4400	II	General &PlasticSurgery
Venus Freezesystem	K100586	2010.11.29	Electrosurgical,cutting &coagulation device& accessories	GEI	21 CFR878.4400	II	General &PlasticSurgery

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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.

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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.

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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

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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 (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 Small Manufacturers, International and Consumer Assistance 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 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

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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: 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)

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1244 Kr. 1

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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.