(198 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on standard hardware components like a microcontroller and RF power module.
Yes.
The device is intended for "Noninvasive treatment of mild to moderate facial wrinkles and rhytides," which describes a therapeutic purpose.
No
The device is described as a "Noninvasive treatment of mild to moderate facial wrinkles and rhytides." Its purpose is to deliver radiofrequency energy for treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components such as a Touch Screen User interface, Programmable Microcontroller, RF Power Module, and Treatment Handpieces.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Description and Intended Use: The provided information clearly states that the MINNIE device is a noninvasive radiofrequency device used for the "Noninvasive treatment of mild to moderate facial wrinkles and rhytides." It delivers energy to the patient treatment site via a handpiece. This is a direct treatment applied to the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any components or processes related to sample collection, analysis of biological samples, or diagnostic testing.
The MINNIE device is a therapeutic device used for cosmetic treatment, not a diagnostic device.
N/A
Intended Use / Indications for Use
Noninvasive treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects.
Non-ablative treatment of mild to moderate facial wrinkles and rhytides. This device has not been tested on darker skin subjects
Product codes
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
facial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 2 3 2014
Page 1 of 3
510(k) SUMMARY
| Applicant name: | Elettronica Valseriana srl
Via San Carlo 45/47
24020 Casnigo (BG) - Italy
Tel.: +39.035.726301
Fax: +39.035.740758 | | | | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|
| Contact person: | Sergio Ghersini
Via San Carlo 45/47
24020 Casnigo (BG) - Italy
Tel.: +39.035.726301
Fax: +39.035.740758 | | | | |
| Trade Name: | MINNIE | | | | |
| Preparation Date: | May 21st, 2014 | | | | |
| Classification: | Name: Electrosurgical, cutting & coagulation device & accessories
Product code: GEI
Regulation: 878.4400
Class: II
Panel: 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 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. | | | | |
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 | Clearance
Date | Name | Product
code | Regula-
tion | Class | Panel |
|-------------------------------------------|------------------|-------------------|----------------------------------------------------------------------|-----------------|--------------------|-------|---------------------------------|
| Accent™ | K070004 | 2007.04.23 | Electrosurgical,
cutting &
coagulation device
& accessories | GEI | 21 CFR
878.4400 | II | General &
Plastic
Surgery |
| Imagine TC
Skin
Treatment
System | K083461 | 2009.07.24 | Electrosurgical,
cutting &
coagulation device
& accessories | GEI | 21 CFR
878.4400 | II | General &
Plastic
Surgery |
| Venus Freeze
system | K100586 | 2010.11.29 | Electrosurgical,
cutting &
coagulation device
& accessories | GEI | 21 CFR
878.4400 | II | General &
Plastic
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 (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
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
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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