(105 days)
Not Found
No
The summary does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development and validation. The device description focuses on standard electrosurgical technology.
Yes
The device is intended for dermatologic and general surgery procedures that require electrocoagulation and hemostasis, which directly relates to treating medical conditions. Additionally, it uses energy to coagulate tissue, which is a therapeutic action.
No
The device is an electrosurgical unit used for dermatologic and general surgery procedures requiring electrocoagulation and hemostasis, which are therapeutic functions, not diagnostic ones.
No
The device description clearly outlines hardware components including a console with an RF generator, electronics, a touchscreen, handpieces, a power cord, footswitch, cryogen canister, return pad, and coupling fluid. This is not a software-only device.
Based on the provided information, the Finiff System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "Dermatologic and General Surgery procedures that require electrocoagulation and hemostasis." This describes a device used on a patient's body during a surgical procedure, not a device used to test samples outside of the body (in vitro).
- Device Description: The description details a high-frequency electrosurgical unit with handpieces that deliver energy to tissue. This is consistent with a surgical device, not an IVD device that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue samples, etc.)
- Detecting or measuring substances in samples
- Providing diagnostic information based on sample analysis
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Finiff System's function is to directly interact with tissue during surgery for therapeutic purposes (coagulation and hemostasis).
N/A
Intended Use / Indications for Use
The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Finiff System is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The Finiff System consists of a console that houses an RF generator as well as the electronics. The user interface is a touchscreen that is located on the console. There are two handpieces that attach to the console:
• The VertoRF Handpiece is a microneedling handpiece that delivers energy in 2 frequencies: 1mHz and 2mHz. The VertoRF has one disposable tip configuration that consists of 25 needles and penetrates the tissue up to 4mm in depth.
• Ther VitaRF Handpiece delivers noninvasive RF energy at a frequency of 6.78 MHz. The VitaRF handpice has 2 Treatment Tips: the VitaRF F-Tip and the VitaRF E-Tip
In addition to the console and the 2 handpieces, there are accessories as follows:
• Power Cord
• Footswitch (optional)
• Cryogen canister
• Return Pad
• Coupling fluid
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing and histology testing was conducted to show the performance of the Finiff System and its applicators. There are no new concerns for safety or efficacy raised. Therefore, the Finiff System is substantially equivalent to the predicate device.
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.
Not Found
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
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 & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 20, 2024
SKINGRAB Co., Ltd. Mr. Oskar Lee CEO 1306-1307, KM TOWER, 95, Gasan digital 2-ro, Geumcheon-gu Seoul. Korea, South
Re: K242688
Trade/Device Name: Finiff System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: November 26, 2024 Received: November 26, 2024
Dear Mr. Oskar Lee:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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-regulatory
2
assistance/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 H. Chen -S -s
Digitally signed by Long H. Chen
Date: 2024.12.20 11:47:52 -05'00'
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
3
Indications for Use
Submission Number (if known)
Device Name
Finiff System
Indications for Use (Describe)
The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| K242688 | ||||||
|---|---|---|---|---|---|---|
| 510(k) #: | K242688 | |||||
| 510(k) Summary | ||||||
| Prepared on: 2024-11-26 |
| Contact Details | |
|---|---|
| 21 CFR 807.92(a)(1) | |
| Applicant Name | SKINGRAB Co., Ltd. |
| Applicant Address | 1306-1307, KM TOWER, 95, Gasan digital 2-ro, Geumcheon-gu Seoul Korea, South |
| Applicant Contact Telephone | 070-7954-1388 |
| Applicant Contact | Mr. Oskar Lee |
| Applicant Contact Email | ceo@skingrab.co.kr |
| Device Name | |
|---|---|
| 21 CFR 807.92(a)(2) | |
| Device Trade Name | Finiff System |
| Common Name | RF Generator |
| Classification Name | Electrosurgical Device |
| Regulation Number | 21 CFR 878.4400 |
| Product Code(s) | GEI |
| Legally Marketed Predicate Devices | ||
|---|---|---|
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K201685 | Potenza | GEI |
| K170758 | Thermage FLX System | GEI |
| Device Description Summary | |
|---|---|
| 21 CFR 807.92(a)(4) |
The Finiff System is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The Finiff System consists of a
console that houses an RF generator as well as the electronics. The user interface is a touchscreen that is located on the console. There
are two handpieces that attach to the console:
• The VertoRF Handpiece is a microneedling handpiece that delivers energy in 2 frequencies: 1mHz and 2mHz. The VertoRF has one
disposable tip configuration that consists of 25 needles and penetrates the tissue up to 4mm in depth.
• Ther VitaRF Handpiece delivers noninvasive RF energy at a frequency of 6.78 MHz. The VitaRF handpice has 2 Treatment Tips: the
VitaRF F-Tip and the VitaRF E-Tip
In addition to the console and the 2 handpieces, there are accessories as follows:
• Power Cord
• Footswitch (optional)
• Cryogen canister
• Return Pad
• Coupling fluid
5
Intended Use/Indications for Use
The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
Indications for Use Comparison
The Indications for Use are the same.
Technological Comparison
The FINIFF shares the same indications for use, mode of operation, and overall design as the predicate device. The differences between the systems are small and do not have any impact on safety or efficacy. The predicate device has three sizes of electrodes whereas the FINIFF has two. The predicate functions in bipolar modes while the FINIFF has only a monopolar function. There are slight differences in the RF duration but they are not large enough to impact the device. The FINFF and the predicate device can therefore be considered substantially equivalents.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Bench Testing and histology testing was conducted to show the performance of the Finiff System and its applicators. There are no new concerns for safety or efficacy raised. Therefore, the Finiff System is substantially equivalent to the predicate device.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)