(410 days)
Not Found
No
The device description mentions a "DTC (Derma Temperature Control) technology" which instantly detects skin temperature and regulates power emissions. While this involves automated control based on sensor data, the description does not use terms like AI, ML, deep learning, or neural networks, nor does it describe a system that learns or adapts over time based on data. It appears to be a rule-based or algorithmic control system, not AI/ML.
Yes
The device is intended for the non-invasive treatment of wrinkles and rhytides, which are medical conditions, and clinical studies confirm its efficacy in improving these conditions.
No
The device is described as a non-invasive device intended for "treatment procedures of wrinkles and rhytides." It delivers thermal energy to the skin and monitors skin temperature to regulate power emissions during treatment. There is no mention of it being used to diagnose conditions or diseases.
No
The device description clearly outlines hardware components including handpieces, electrodes, a grounding reference plate, and a temperature sensor. While it mentions dedicated software, it is integrated into a physical device that delivers thermal energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "non-invasive treatment procedures of wrinkles and rhytides." This describes a therapeutic or aesthetic treatment applied directly to the patient's body, not a test performed on a sample taken from the body.
- Mechanism of Action: The device works by delivering thermal energy to subcutaneous tissue and the deep dermis using radiofrequency (RF) waves. This is a physical interaction with the body, not a diagnostic test.
- Lack of Diagnostic Purpose: The device is used to treat wrinkles and rhytides, not to diagnose a disease or condition.
- No mention of samples: IVD devices typically involve analyzing biological samples (blood, urine, tissue, etc.). This description does not mention the use of any samples.
In summary, the Medical RF device is a therapeutic device used for aesthetic purposes, not a diagnostic device used for testing samples.
N/A
Intended Use / Indications for Use
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.
The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF).
Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment.
The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment.
The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.
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
trained and qualified personnel only
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)
Clinical Evaluation:
- Sample Size: 40 samples (two samples from each of the 20 patients)
- Study Population: both genders, within the age range of 33 to 68, in good health.
- Evaluation Method: Improvement of wrinkles was evaluated by a score value assessed by doctors, following examination of treated areas and related photos, before and after treatments, in accordance with the Fitzpatrick Wrinkle Assessment (for I to IV Fitzpatrick Skin Types) or Glogau scale.
- Success Metric: Any wrinkle score improvement (downgrade score >1) following the last treatment and at the follow-up visit, relative to pre-treatment wrinkle (baseline) score, was considered a success.
- Key Results:
- No adverse events. during the follow up of 4 to 6 months after the conclusion of the treatment.
- Almost all patients marked the pain level with a 0 or 1 score, corresponding to a slight sensation of discomfort and/or pain.
- All 20 patients enrolled had successfully completed the treatments.
- Analysis of photographic results reveals improvements in facial wrinkles (downgrade of at least 1 score, according to the Fitzpatrick scale) in all (100%) patients according to the clinical assessment.
- Score differences were found to be statistically significant while comparing baseline scores to the scores obtained at the end of treatment (p
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
November 6, 2020
Triworks Group S.r.l. % Parul Chansoria Elexes Medical Consulting 453 West San Carlos Street San Jose, California 95110
Re: K192621
Trade/Device Name: Medical RF Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 2, 2020 Received: October 2, 2020
Dear Parul Chansoria:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K192621
Device Name Medical RF
Indications for Use (Describe)
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K192621
5.1 Submitter's Information
Triworks Group S.r.l. Registered Office: Via L.Belpulsi 3-86100 Campobasso. Italy Operating Office: Via Don G.Mucciardi 5-86020 Campochiaro (CB), Italy
Contact Person
Parul Chansoria Elexes Medical Consulting Telephone: 408-475-8091 E-mail: parul@elexes.com
Summary Prepared: Nov 3, 2020
5.2 Device Information
Common/ Usual Name: Electrosurgical, cutting and coagulation and device and accessories Trade Name: Medical RF Regulation Name: Electrosurgical, Cutting & Coagulation & Accessories Regulatory Class: Class II Classification Panel: General & Plastic Surgery Product Code: GEI Regulation Number: 21 CFR 878.4400
5.3 Predicate Device Information
The Medical RF (Subject Device) is substantially equivalent to the following cleared devices:
| Company | Predicate Priority | Product | 510(k) Number |
|---|---|---|---|
| Alma Lasers, Ltd. | Primary Predicate | Accent | K070004 |
| Lumenis, Inc | Secondary Predicate | Aluma Skin Renewal System | K051214 |
| BTL Industries, Ltd. | Tertiary Predicate | Exilis | K092191 |
5.4 Device Description
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.
The mechanism of action of the Subject Device involves the delivery of thermal energy to the subcutaneous tissue and the deep dermis. The Device utilizes the electromagnetic waves originated from two poles: a single electrode on the handpiece that contacts the skin and a
4
grounding reference plate (monopolar RF), or two electrodes of the handpiece placed over the treatment area (bipolar RF).
Medical RF is equipped with three types of handpieces: Two monopolar handpieces (small and medium) and one bipolar handpiece; all of them contain a sensor temperature used by the DTC (Derma Temperature Control) technology. The DTC is an innovative system that instantly detects the temperature of the skin and regulates the power emissions to maintain (at the same value) the transferred temperature of RF during the treatment.
The DTC system allows the operator to know the real-time temperature of the skin surface, there is no further need to manually regulate the power according to the temperature changes during the treatment session. DTC technology ensures the safety and effective functioning of the Subject Device. The user always knows the real-time temperature on the skin during the treatment and does not have to manually change the power emissions in relation to the patient's perception of heat, thereby improving the efficacy of the treatment.
The Subject Device is recommended to be used by trained and qualified personnel only and includes a dedicated software (interface RS-232), installed by the manufacturer in the device's memory.
5.5 Indications for use
The Medical RF is a non-invasive device intended for use in Dermatologic and General Surgical non-invasive treatment procedures of wrinkles and rhytides for I to IV Fitzpatrick Skin Types.
5.6 Technological Characteristics w.r.t Predicate Devices
The Indications for Use, key technological characteristics, and operating principle of the Subject Device (Medical RF) are equivalent to the Primary and the Secondary Predicate Devices.
| Table 2: Substantial Equivalence w.r.t. Predicates | |||||
|---|---|---|---|---|---|
| Title | Subject device | Primary | |||
| Predicate | Secondary | ||||
| Predicate 1 | Tertiary Pred | ||||
| icate 2 | Comparison | ||||
| Manufacturer | Triworks Group | ||||
| S.r.1 | Alma Lasers | ||||
| Ltd. | Lumenis Inc. | BTL Industries | |||
| Ltd. | --- | ||||
| Device Name | Medical RF | Accent | Aluma Skin | ||
| Renewal | |||||
| System | Exilis | --- | |||
| 510(k) Number | K192621 | K070004 | K051214 | K092191 | --- |
| Product Code | GEI | GEI | GEI | GEI | Equivalent |
| Regulatory | |||||
| Number | 878.4400 | 878.4400 | 878.4400 | 878.4400 | Equivalent |
| Regulatory Class | II | II | II | II | Equivalent |
| Indications for | |||||
| Use | The Medical RF | ||||
| is a non-invasive | |||||
| device intended | |||||
| for use in | |||||
| Dermatologic | |||||
| and General | |||||
| Surgical | |||||
| non-invasive | |||||
| treatment | |||||
| procedures of | |||||
| wrinkles and | |||||
| rhytides for I to | |||||
| IV Fitzpatrick | |||||
| Skin Types. | The Accent is | ||||
| intended for use | |||||
| in Dermatologic | |||||
| and General | |||||
| Surgical | |||||
| procedures for | |||||
| non-invasive | |||||
| treatment of | |||||
| wrinkles and | |||||
| rhytides using | |||||
| combined | |||||
| treatment with | |||||
| Unipolar and | |||||
| Bipolar. | The Aluma | ||||
| Skin | |||||
| Renewable | |||||
| System is a | |||||
| non-invasive | |||||
| device intended | |||||
| for use in | |||||
| Dermatologic | |||||
| and General | |||||
| Surgical | |||||
| procedures | |||||
| non-invasive | |||||
| treatment of | |||||
| wrinkles and | |||||
| rhytides. | The EXILIS | ||||
| device | |||||
| is indicated for | |||||
| use in | |||||
| non-invasive | |||||
| dermatologic | |||||
| and general | |||||
| surgical | |||||
| procedures. | Equivalent | ||||
| Performance Characteristics | |||||
| Energy source | Radiofrequency | Radiofrequency | Radiofrequency | Radiofrequency | Equivalent |
| RF Power | 200 W | 200 W-300 W | 2 W-10 W | 170 W | Same as |
| Primary | |||||
| Predicate and | |||||
| similar to | |||||
| Tertiary | |||||
| Predicate | |||||
| Output | |||||
| Radiofrequency | 470 KHz | 40680 KHz | |||
| (±2 KHz) | 468 KHz | 3400 KHz | Similar with | ||
| Primary and | |||||
| Secondary | |||||
| Predicates as | |||||
| it falls within | |||||
| the range of | |||||
| the Primary | |||||
| Predicate, and | |||||
| the range of | |||||
| Secondary | |||||
| Predicate is | |||||
| slightly lower | |||||
| than the | |||||
| Subject | |||||
| Device. | |||||
| Input Voltage | 110-240 VAC | ||||
| 50-60 Hz | 100-120 VAC, | ||||
| 5 A, | |||||
| 50-60 Hz | |||||
| 208-240 VAC, | |||||
| 5 A, 50-60 Hz | 120 VAC ± | ||||
| 10%, 60 Hz, | |||||
| 12A | 110-240 VAC | ||||
| 50-60 Hz | Equivalent | ||||
| RF Handpiece | Bipolar, | ||||
| Monopolar | |||||
| (small and | |||||
| medium) | Bipolar, | ||||
| Unipolar | |||||
| (monopolar) | Bipolar (small | ||||
| and large) | Unipolar | ||||
| (monopolar) | Same as | ||||
| primary | |||||
| Predicate and | |||||
| similar to | |||||
| Secondary | |||||
| and tertiary | |||||
| Predicates. | |||||
| Waveforms | Radiofrequency | ||||
| currents having | |||||
| frequency, time, | |||||
| modulation, and | |||||
| circulation as | |||||
| decided by the | |||||
| operator | |||||
| according to the | |||||
| specific medical | |||||
| protocol defined | |||||
| by the therapy. | Radiofrequency | ||||
| currents having | |||||
| frequency, time, | |||||
| modulation, and | |||||
| circulation as | |||||
| decided by the | |||||
| operator | |||||
| according to the | |||||
| specific medical | |||||
| protocol defined | |||||
| by the therapy. | Radiofrequency | ||||
| currents having | |||||
| frequency, | |||||
| time, | |||||
| modulation, | |||||
| and circulation | |||||
| as decided by | |||||
| the operator | |||||
| according to the | |||||
| specific | |||||
| medical | |||||
| protocol | |||||
| defined by the | |||||
| therapy. | Radiofrequency | ||||
| currents having | |||||
| frequency, time, | |||||
| modulation, and | |||||
| circulation as | |||||
| decided by the | |||||
| operator | |||||
| according to the | |||||
| specific medical | |||||
| protocol | |||||
| defined by the | |||||
| therapy. | Equivalent | ||||
| Programmable | |||||
| Logic | |||||
| Controller | PIC | ||||
| (Programmable | |||||
| Interface | |||||
| Controller) | |||||
| providing the | |||||
| safety function | |||||
| of the system | Programmed | ||||
| treatment | |||||
| protocols | PLC providing | ||||
| the safety | |||||
| function of the | |||||
| system | DTC providing | ||||
| the safety | |||||
| function | |||||
| of the system | Different but | ||||
| does not | |||||
| raise new | |||||
| questions of | |||||
| safety or | |||||
| efficacy | |||||
| because the | |||||
| DTC of the | |||||
| Subject | |||||
| Device | |||||
| (Medical | |||||
| RF) detects | |||||
| instantly the | |||||
| temperature | |||||
| of the skin | |||||
| surface and | |||||
| consequently | |||||
| regulates the | |||||
| power | |||||
| emission. |
5
6
5.7 Performance Data
Medical RF complies with the applicable standards for Electrical Safety, Electromagnetic Compatibility, and Biocompatibility to demonstrate the safety and effectiveness of the device.
7
Results of the clinical testing demonstrated that the Subject Device is safe and effective for its intended use. The supplied Instructions for Use provide the user with the applicable warnings and cautions during use. There are no new safety or effectiveness issues related to this device.
5.8 Clinical Evaluation
The clinical evaluation was conducted on a total of 40 samples (two samples from each of the 20 patients, performed by two physicians). The study population consisted of both genders, within the age range of 33 to 68, in good health. The study was designed by considering the real scenario of the aesthetic treatments with RF energy, and to include all types and degrees of skin wrinkles, rhytides, and other imperfections. An improvement of wrinkles was evaluated by a score value which was assessed by the doctors, following the examination of the treated areas and the related photos, before and after treatments, in accordance with the Fitzpatrick Wrinkle Assessment (for I to IV Fitzpatrick Skin Types) or Glogau scale. Anv wrinkle score improvement (downgrade score >1) following the last treatment and at the follow-up visit, relative to pre-treatment wrinkle (baseline) score, was considered a success. The study revealed no adverse events. during the follow up of 4 to 6 months after the conclusion of the treatment.
The assessment for side effects was made by visually assessing skin responses, including edema, erythema, scarring, hypopigmentation, hyperpigmentation, and textural changes immediately after the treatment. Adverse event outcomes were calculated by each physician according to the level of pain perceived by the patients; the subjects were asked to rate their pain on a 0 to 4 scale. Almost all patients marked the pain level with a 0 or 1 score, which corresponds to a slight sensation of discomfort and/or pain.
All the 20 patients enrolled had successfully completed the treatments. Analysis of photographic results reveals improvements in facial wrinkles (downgrade of at least 1 score, according to the Fitzpatrick scale) in all (100%) patients according to the clinical assessment. Score differences were found to be statistically significant while comparing baseline scores to the scores obtained at the end of treatment (p