The CELFIRM™ includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the hand-piece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, CELFIRM™ creates heat within the target skin tissue via needle electrodes from the consumable tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CELFIRM™ device, which is an electrosurgical cutting and coagulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (INFINI Radiofrequency System) through various non-clinical performance tests.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with corresponding performance metrics for the CELFIRM™ device. Instead, it describes various non-clinical tests conducted and generally states that the "test results met the pre-set criteria" or that the device is "substantially equivalent."

However, we can infer some criteria and reported performance from the "Performance Tests (Non-clinical)" section:

Test Type	Acceptance Criteria (Inferred from text)	Reported Device Performance
Sterilization Validation	Sterility Assurance Level (SAL) of 10^-6 for EtO sterilization, in accordance with ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2012.	Validation and biological indicator (BI) overkill method used, implying the SAL of 10^-6 was met.
Shelf-life Validation	Device maintains functionality and safety for its proposed shelf life, using accelerated aging method in accordance with ASTM F1980-07 (2011) and referenced standards ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USP-NF <71>.	Tests conducted using specified methods, implying the proposed shelf life was validated.
Biocompatibility	Patient-contacting components (Consumable Tip) must be biocompatible, in accordance with ISO 10993-4, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, and USP 39<151>.	Tests conducted according to specified standards, implying the device met biocompatibility requirements.
Software Validation	Software (firmware) functions as intended for a moderate level of concern, compliant with relevant validation practices.	Software validation tests were performed.
EMC & Electrical Safety	Compliance with IEC 60601-1:2005, IEC 6061-1-6:2010, IEC 60601-2-2:2009, EN 60601-1-2:2007, EN 6100-3-2:2006, and EN 6100-3-3:2008.	All tests met the pre-set criteria.
Max Output Energy	Max energy per electrode should meet pre-set criteria/specifications for CELFIRM™.	Test results met the pre-set criteria and validated the device performance specifications for max energy.
Preclinical (Animal) Test	Safety and effectiveness comparable to predicate devices, with acceptable tissue response (e.g., transient and resolving erythema, minimal/mild necrosis within expected stages of healing, dermal fibrosis as expected for healing).	Application resulted in transient very slight to well-defined erythema (3-4h post-application, resolved by Day 3). Minimal to mild necrosis noted (Days 1 and 5). Dermal fibrosis at applied sites on Day 22. No other application-related findings. Histology data demonstrated substantial equivalence to predicate devices for intended use.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document explicitly mentions "Yucatan Mini-pigs" for the preclinical (animal) test. However, it does not specify the number of mini-pigs used as the sample size. It refers to "Animal were euthanized 3 h after application on Day 1, Day 4, and Day 22," implying multiple animals or multiple applications on different animals over time points, but no precise count is given. For other tests (sterilization, shelf-life, biocompatibility, software, EMC/electrical safety, max output energy), the sample sizes of the components or units tested are not specified.
Data Provenance: The preclinical animal study was conducted as part of the device's development by VIOL Co., Ltd., based in South Korea. Therefore, the data provenance is likely prospective (generated specifically for this submission) and from South Korea (or the location where the animal study was conducted under the company's purview).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide any information regarding the number or qualifications of experts used to establish a "ground truth" for the test set. The evaluation of test results (e.g., histology data from the animal study) would implicitly involve experts (e.g., veterinary pathologists), but these details are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The results appear to be based on direct measurements and observations from the non-clinical tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical evaluation of the device's safety and performance characteristics, primarily against standards and a predicate device. It does not involve human readers interpreting cases with or without AI assistance.

6. Standalone Performance Study

Yes, the studies described are essentially standalone evaluations of the algorithm/device (CELFIRM™) without a human-in-the-loop performance component in the context of diagnostic interpretation. The tests assess the device's physical, electrical, and biological effects independently.

7. Type of Ground Truth Used

For the preclinical animal test, the ground truth was established through:

Direct observation of tissue responses (erythema, necrosis).
Histology data (microscopic examination of tissue samples).

For other tests (sterilization, shelf-life, biocompatibility, EMC/electrical safety, max output energy), the ground truth is based on established scientific and engineering standards and specifications (e.g., ISO, ASTM, IEC, EN standards).

8. Sample Size for the Training Set

The document does not mention any training set or machine learning model. The CELFIRM™ is an electrosurgical device, not an AI or imaging device that would typically involve a "training set" in the context of machine learning. The studies described are hardware and bio-compatibility related.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set or machine learning in the provided document, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 13, 2017 VIOL Co., Ltd. % Priscilla Chung Regulatory Affairs Specialist LK Consulting Group USA, Inc. 690 Roosevelt. Irvine, California 92620

Re: K172023

Trade/Device Name: CELFIRM Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: June 29, 2017 Received: July 5, 2017

Dear Priscilla Chung:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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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 (DICE) 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. 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 Industry and Consumer Education (DICE) 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, Jennifer R. Stevenson -S For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K172023

Device Name

CELFIRM™

Indications for Use (Describe)

The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

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)

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510(k) Summary

(K172023)

This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: October 12, 2017

1. 510K Applicant / Submitter:

VIOL Co., Ltd. C-808, 809, Bundang Technopark C, 744, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggi-do (13510), South Korea

Phone : +82-31-8017-7893 Fax : +82-31-8016-7894

2. Submission Contact Person

LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary Name: CELFIRM™ .
Common Name: Radiofrequency System ●
Classification: 21 CFR 878.4400 .

Electrosurgical, Cutting & Coagulation & Accessories

Product Code: GEI

4. Predicate Device

INFINI Radiofrequency System by Lutronic Corporation (K121481)

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5. Description:

6. Indications for Use

The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

7. Substantial Equivalence Discussion:

	Proposed Device	Predicate Device
Manufacturer	VIOL Co., Ltd.	Lutronic Corporation
Device Name	CELFIRM™	INFINI Radiofrequency System
510(K) No.	K172023	K121481
Indications for Use	The CELFIRMTM is intended for use indermatologic and general surgicalprocedures for electrocoagulation andhemostasis.	The INFINI Radiofrequency System isintended for use in dermatologic andgeneral surgical procedures forelectrocoagulation and hemostasis, andthe percutaneous treatment of facialwrinkles.
Electrical Safety/EMC	IEC 60601-1:2005,IEC 6061-1-6:2010,IEC 60601-2-2:2009,EN 60601-1-2:2007,EN 6100-3-2:2006EN 6100-3-3:2008	IEC 60601-1,IEC 60601-2-2,IEC 60601-1-2
Input Voltage	AC100-240V, 50/60 Hz	AC100-240V, 50/60 Hz
Operation Type	Coagulation	Coagulation
Foot Switch	Yes	Yes
Tip Sterilization Method	EO Gas	EO Gas
Number of Usage	Single use	Single use
Dimensions	550 mm(W) x 350 mm(L) x 1220 mm(H)	362 mm(W) x 409 mm(L) x 1713 mm(H)

The CELFIRM™ has similar intended uses and technical characteristics to the INFINI Radiofrequency System made by Lutronic Corporation. The similarities and differences between the systems are described in the table shown above. In summary, CELFIRM™ does not induce any new potential safety risks nor efficacy. We conclude that the CELFIRM™ is substantially equivalent to the predicate device.

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8. Performance Tests (Non-clinical)

Sterilization Validation, Shelf life Validation, Biocompatibility, Software Validation, EMC & Electrical Safety Test, Max Output Energy, and Animal Test were conducted on the subject device.

Sterilization Validation Test

To verify the sterility assurance level (106) for EtO sterilization, the validation and biological indicator (BI) overkill method was used in accordance to ISO 11135-1, ISO 10993-1, ISO 10993-7, ISO 11138-1, ISO 11138-2, ISO 11737-1, ISO 11737-2, AAMI TIR 15, and ISO 13485:2012.

Shelf life Validation Test

The tests to validate the shelf life of the device through the proposed shelf life were conducted using the accelerated aging method in accordance to ASTM F1980-07 (2011) Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The referenced standards for the testing are ISO 11607-1, ISO 11607-2, ISO 11737-2, ASTM F1929, ASTM F 88, and USP-NF <71>.

Biocompatibility Test

The patient contacting component of the subject device is the Consumable Tip and the biocompatibility tests were in accordance with ISO 10993-4. ISO 10993-5, ISO 10993-7. ISO 10993-10, ISO 10993-11, and USP 39<151>.

Software Validation Test

The level of concern of the software (firmware) of the CELFIRM™ is moderate and the software validation tests were performed.

EMC & Electrical Safety Test

The CELFIRM™ has been evaluated for electromagnetic compatibility and electrical safety testing per applicable standards of IEC 60601-1:2005. IEC 6061-1-6:2010. IEC 60601-2-2:2009. EN 60601-1-2:2007, EN 6100-3-2:2006, and EN 6100-3-3:2008, and all the tests met the pre-set criteria.

Max Output Energy

The test on Max Output Energy per Electrode was performed on the subject device to evaluate the max energy per electrode. The test results were compared and evaluated with the standard values of maximum output energy per Electrode of CELFIRM™. The test results met the pre-set criteria and validated the device performance specifications for max energy.

Preclinical Test

This study was designed to evaluate the safety and effectiveness of CELFIRM™ using Yucatan Mini-pigs. Animal were euthanized 3 h after application on Day 1, Day 4, and Day 22. Application with the CELFIRM™ device resulted in transient very slight to well-defined erythema noted within 3-4 h of application but fully resolved by the next Draize evaluation on Day 3. In addition, minimal to mild necrosis was noted in animals euthanized on Days 1 and 5

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with the animal euthanized on Day 22 showing dermal fibrosis at the applied sites. There were no other application-related findings.

Test results including histology data demonstrated that the subject device is substantially equivalent to the predicate devices in the market for its intended use.

9. Conclusions:

Based on the test results provided in this submission including Sterilization Validation, Shelf life Validation, Biocompatibility, Software Validation, EMC & Electrical Safety Test, Max Output Energy, and Animal Test, VIOL Co., Ltd. concludes that the CELFIRM™ is substantially equivalent to the predicate device as described herein in.

Regulation Number and Section

§ 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.