(261 days)
No
The document describes a device that uses radiofrequency (RF) and pulsed magnetic field (PMF) technology with manual parameter adjustments via a touchscreen interface. There is no mention of AI, ML, image processing, or any data-driven decision-making or learning capabilities.
No
The device is described as non-invasive and intended for cosmetic purposes (treatment of moderate to severe facial wrinkles and rhytides), not for treating or preventing disease.
No
The device is described as a non-invasive treatment system for facial wrinkles and rhytides, and its description focuses on emitting RF energy and PMF for this purpose, not for diagnosing conditions.
No
The device description clearly outlines multiple hardware components including a main unit, RF power module, controller unit, and treatment applicators with electrodes and coils.
Based on the provided information, the Venus Freeze (MP)2 system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for non-invasive treatment of facial wrinkles and rhytides in dermatologic and general surgical procedures. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description details a system that delivers RF and PMF energy to the skin. It does not involve analyzing biological samples (like blood, urine, or tissue) which is characteristic of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Venus Freeze (MP)2 system's function is to treat a condition (wrinkles), not to diagnose it.
N/A
Intended Use / Indications for Use
The Venus Freeze (MP)2 system 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.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:
- Main Unit (console)
- Touch Screen user interface
- RF Power module
- Controller unit
- Two treatment applicators:
(1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).
(2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils).
Touch screen user interface provides: - Applicator selection (Octipolar™ / Diamondpolar™)
- RF Power Output and Treatment Time parameter adjustments to fit individual patient's skin condition and anatomical site treated.
- Current treatment parameters display.
The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction.
No unexpected adverse side effects were detected or reported.
The data reported in this study clearly indicate that the Venus Freeze (MP) System that simultaneously use RF and PMF technology, combines the well established safe and effective Freeze RF technology with the PMF technology.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
VENUSCONCEPT
Page 1 of 3
510(K) SUMMARY
MAR - 2 2012
.
Venus Freeze (MP)2 System 510(k) Number K111670
Applicant's Name: Venus Concept Ltd. 62 HaHermesh Street Karmiel, 21652, Israel Tel: (972)3-644-6656 Fax: (972)3-644-6319
- Contact Person: Yoram Levy, Osite 31 Haavoda St. Binyamina, Israel 30500 Tel (972)4-638-8837; Fax (972)4-638-0510 Yoram@gsitemed.com
Venus Freeze (MP)2 Trade Name:
Summary May 12, 2011 Preparation Date:
Classification: Name: Electrosurgical, cutting & coagulation device & accessories Product Code: GEI Regulation No: 21 CFR 878.4400 Class: II Panel: General and Plastic Surgery
Device Description:
The Venus Freeze (MP)2 is a noninvasive, non-ablative device consisting of:
- Main Unit (console) 1
- -Touch Screen user interface
- RF Power module -
- Controller unit ﮯ
- Two treatment applicators:
(1) Octipolar™ applicator - for large area treatments, composed of 8 RF electrodes, 8 electrode coils assembled over electrodes and 1 central coil (the RF is emitted through the electrodes. The PMF is generated by the coils).
1
670
VENUSCONCEPT
ﻴﺴﺎﺳ
Page 2 of (3)
(2) Diamondpolar™ applicator - for small area treatments, composed of 4 RF electrodes, 4 electrode coils (the RF is emitted through the electrodes. The PMF is generated by the coils). .
Touch screen user interface provides:
- Applicator selection (Octipolar™ / Diamondpolar™) -
- RF Power Output and Treatment Time parameter adjustments to fit . individual patient's skin condition and anatomical site treated.
- Current treatment parameters display. -
The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.
Intended Use Statement:
The Venus Freeze (MP)2 system is a non-invasive device intended for use in dermatologic and general surgical procedures for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I- IV.
Predicate Devices: Substantial equivalence to the following predicate device is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Venus Freeze System | K100586 | Nov 29, 2010 |
The Venus Freeze (MP)2 magnetic flux safety claim is based on the following devices:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| NeuroStar® TMS Therapy System | K083538 | Dec 16, 2008 |
| CIRRUS OPEN Magnetic | ||
| Resonance Diagnostic Device | K090080 | March 23, 2009 |
| OPER Series Open Type | ||
| Permanent-Magnet MRI | K092899 | Nov 10, 2009 |
These devices are not considered predicate devices for the Venus Freeze (MP)2. They are presented as devices that apply much higher magnetic flux densities than the Venus Freeze (MP)2 onto the same parts of the body, to support the claim that there are no questions of safety with this energy in the proposed device.
Venus Freeze – 510k Notification
2
KIII 670
VENUSCORCEPT
. * *
Page 3 of (3)
Performance Standards
Venus Freeze (MP)2 complies with ANSI AAMI 60601-2-2 for safety of high frequency surgical equipment.
In addition, the device complies with the European Medical Directive 93/42/EEC concerning medical devices (Annex II) and with the following voluntary standards:
EN 60601-1 (Medical Electrical Equipment-Part 1: General . Requirements for Safety-1. Collateral Standard: Safety Requirements for Medical Electrical Systems).
- IEC 60601-1-2 (Medical Electrical Equipment Part 1-2: ● Standard: Electromagnetic Compatibility -Collateral Requirements and Tests)
A detailed description appears in Section 14.
Summary of Clinical performance data
Patients were treated with the Venus Freeze (MP)2 System for face wrinkle reduction.
No unexpected adverse side effects were detected or reported.
The data reported in this study clearly indicate that the Venus Freeze (MP) System that simultaneously use RF and PMF technology, combines the well established safe and effective Freeze RF technology with the PMF technology.
Venus Freeze - 510k Notification
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAR - 2 2012
Venus Concept Ltd % Osite Yoram Levy 31 Haavoda St. Binyamina, Israel 30500
Re: K111670
Trade/Device Name: Venus Freeze (MP)2 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 3, 2012 Received: February 7, 2012
Dear Yoram Levy:
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
4
Page 2 - Yoram Levy
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
VENUSCONCEPT
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K11670
Device Name:
Venus Freeze (MP)"
Indications for Use:
The Venus Freeze (MP)2 system 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-off) Division of General, Restorative and Neurological Devices 510(k) Number
Nil Re Ogde for mkm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number_K111670
Venus Freeze - 510k Notification