(99 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on RF energy and mechanical vacuum, not AI/ML algorithms.
Yes
The device, specifically the ST applicator, is indicated for therapeutic uses such as the "treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation."
No
The V-Touch system and its ST applicator are described as being used for dermatological procedures, and for the treatment of relief of minor muscle aches and pain, muscle spasm, and temporary improvement of local blood circulation. These are all therapeutic applications, not diagnostic ones. There is no mention of the device being used to identify or characterize medical conditions.
No
The device description explicitly states that the V-Touch system combines CORE™ technology with mechanical vacuum massage and utilizes an ST applicator that uses RF bipolar energy through electrodes. This indicates the presence of hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "dermatological procedures" and the ST applicator is for "relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation." These are therapeutic and aesthetic applications, not diagnostic tests performed on samples taken from the body (which is the definition of an IVD).
- Device Description: The description focuses on the technology (CORE™ RF energy, vacuum massage) and the applicator's function in applying this energy to the body. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the V-Touch system, as described, is a therapeutic/aesthetic device, not an IVD.
N/A
Intended Use / Indications for Use
The V-Touch is intended for dermatological procedures.
The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
Product codes
GEI
Device Description
Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following specially-designed applicator: The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
The V-Touch successfully passed validation and verification testing, including testing for RF power accuracy. Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device.
Key Metrics
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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping profiles creating a sense of depth.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 21, 2014
Viora Ltd. % Yoram Levy Qsite 31 Haavoda Street Binyamina. Israel 30500
Re: K141904
Trade/Device Name: V-Touch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 1, 2014 Received: October 3, 2014
Dear Mr. 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141904
Device Name V-Touch
| Indications for Use (Describe) | The V-Touch is intended for dermatological procedures. |
|---|---|
| -------------------------------- | -------------------------------------------------------- |
temporary improvement of local blood circulation.
The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and
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)
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510(K) SUMMARY
V-Touch
510(k) Number K141904
| Applicant's Name: | Viora Ltd.
3 Maskit Street
Herzliya, Israel 46733
Tel: +972 9955 1344
Fax: +972 9955 1345 |
|-------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda Street
Binyamina, Israel 30500
Tel +(972)4-638-8837; Fax (972)4-638-0510
Yoram@gsitemed.com |
- Trade Name: V-Touch
- Common Name: Multi application RF Device
- Preparation Date: July 08, 2014
- 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:
Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator:
The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
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Intended Use Statement:
The Viora V-Touch is intended for dermatological procedures.
The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.
Predicate Devices:
Substantial equivalence to the following predicate devices is claimed:
| Device Name | 510k No | Date of Clearance |
|---|---|---|
| Viora Reaction | K090221 | July 1, 2009 |
Substantial Equivalence to Predicate Devices
The Viora V-Touch includes the ST applicator that is the same applicator that was cleared with the Viora Reaction (K090221).
Performance Standards:
V-Touch complies with
- IEC 60601-1 Medical Electrical Equipment-Part 1: General Requirements for Safety. Collateral Standard: Safety Requirements
for Medical Electrical Systems.
IEC 60601-1-2 Medical Electrical Equipment Part 1-2: ● Collateral Electromagnetic Compatibility - -Standard: Requirements and Tests.
IEC 60601-2-2 - Medical Electrical Equipment-Part 2: ● Particular requirements for the safety of high frequency surgical equipment.
Performance Bench Tests and Conclusions
The V-Touch successfully passed validation and verification testing, including testing for RF power accuracy. Predicate comparison of the handpiece was unnecessary, since the predicate device uses the same handpiece. Bench testing demonstrated that the V-Touch is as safe and effective as the cleared predicate device.