The CELLINEW generates radiofrequency(RF) energy by means of high RF at 6.78Mhz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction with is capable of coagulation the tissue. In detail, the main body uses the "reverse thermal gradient" principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers.
The CELLINEW Device is a non-invasive device for coagulation using high frequency current. The device consists of a main body, handpiece, two disposable electrodes, a neutral electrode, neutral electrode cable, foot switch(optional) and power cord, and is controlled by software.

AI/ML Overview

The provided text describes the 510(k) summary for the CELLINEW device, but it lacks the specific details required to fully address your request regarding acceptance criteria and a detailed study report. The document states that "No clinical studies were conducted as part of this submission," and the performance testing described focuses on technical aspects and an ex-vivo thermal test.

However, I can extract the available information and highlight what is missing based on your request.

Missing Information:
The document does not provide:

A formal table of acceptance criteria and reported device performance against those criteria beyond what is inferred from the technical specifications comparison.
Details on sample size, data provenance, number or qualifications of experts, or adjudication methods for any test set, as no clinical studies were performed.
Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
Details on standalone algorithm performance, as this is a physical medical device, not an AI algorithm.
The type of ground truth used for any clinical performance evaluation.
Sample size for a training set or how ground truth was established for a training set, as no AI/machine learning component or related training data is mentioned.

Based on the available text, here is the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

A formal table of acceptance criteria and the device's performance against them is not explicitly provided in the document. However, implied acceptance is based on the comparison to a predicate device and technical performance tests.

Here is a summary of the technical specifications and their comparison to the predicate, which serves as an informal set of performance criteria for equivalence:

Specification	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (CELLINEW)	Comparison / Outcome
Output energy type	Radiofrequency	Radiofrequency	Same
User Interface	Color touch panel	Color touch panel	Same
Operating Frequency	6.78MHz	6.78MHz	Same
Max power	400W	Up to 400W	Same
Electrode Tips	0.25cm², 4cm², 16cm²	0.25cm², 4cm²	Different (Cellinew does not include the 16cm² tip), but deemed not to impact safety/effectiveness.
Coolant Solution	Cryogen	Cryogen	Same
Temperature Range	65~75°C	65~75°C	Same
RF Time	50 ~ 800 ms	0-1050ms	Different. Marginally higher for CELLINEW, but deemed not to impact safety or effectiveness.
Impedance	75 - 400 Ω	75 - 400 Ω	Same
Style of Electrode Tip	Monopolar, Bipolar	Monopolar only	Different (only monopolar for Cellinew), but deemed not to impact safety or effectiveness (implied by substantial equivalence).

2. Sample size used for the test set and the data provenance

For the performance testing mentioned:

Sample Size: Not specified for the "thermal testing" on porcine skin.
Data Provenance: The thermal testing was performed on "porcine skin," indicating an ex-vivo (animal tissue) study, not human data. The country of origin for this data is not specified.

For clinical evidence:

"No clinical studies were conducted as part of this submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no clinical studies were performed and no "ground truth" for diagnostic or treatment outcome accuracy was established in the provided documentation based on human assessment. The "thermal testing" involved demonstrating the device's ability to coagulate tissue, likely measured by technical means rather than expert interpretation of images.

4. Adjudication method for the test set

Not applicable, as no clinical studies or human-interpreted test sets were reported.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The CELLINEW device is an electrosurgical device, not an AI diagnostic or assistance system. No MRMC studies were conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical electrosurgical device; it does not operate as a standalone algorithm in the context of diagnostic or interpretive performance. The software controls the device, and its performance was evaluated via software verification and validation, but not as an "algorithm only" performance study.

7. The type of ground truth used

For the "thermal testing" on porcine skin, the "ground truth" was the observed ability of the device to "coagulate tissue," which is a direct physical effect. This is not comparable to expert consensus, pathology, or outcomes data typically used in diagnostic or screening device evaluations.

8. The sample size for the training set

Not applicable. The device is not an AI/machine learning system that requires a "training set" in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. There is no mention of a training set for an AI/machine learning component.

Summary

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November 26, 2024

Viol Co. Ltd Sugun Lee CEO C-609 Bundang Technopark C, 744 Pangyo-ro, Bundang-gu, Seongnam-si. Gyeonggi-do Seoul, Korea, South

Re: K240897

Trade/Device Name: CELLINEW Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 30, 2024 Received: October 31, 2024

Dear Sugun 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/cdrb/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.

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"

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(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 OS 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 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.

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-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).

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Sincerely,

Digitally signed by Long H. Chen Long H. Chen -S Date: 2024.11.26 16:29:49 -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

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Indications for Use

Submission Number (if known)

K240897

Device Name

Cellinew

Indications for Use (Describe)

Cellinew is indicated 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 CELLINEW K240897

Applicant	Viol Co., Ltd.
Address	C-609 Bundang Technopark C, 744 Pangyo-ro, Bundang-gu,Seongnam-si, Gyeonggi-doSeoul, South Korea
Contact Person	Oskar (Sugun) Lee
Contact Information	Telephone : 070-7954-1388Cellphone : +82-10-2388-7739ceo@skingrab.co.kr
Preparation Date	October 31, 2024
Device Trade Name	CELLINEW
Classification NameCommon NameRegulation Number	Electrosurgical cutting and coagulationRF Electrosurgical Device878.4400
Product CodeRegulatory Class	GEIII
Legally Marketed PredicateDevice	Density (K230663)Jeisys Medical Incorporated

Device Description:

The CELLINEW Device is a non-invasive device for coagulation using high frequency current. The device consists of a main body, handpiece, two disposable electrodes, a neutral electrode, neutral electrode cable, foot switch(optional) and power cord, and is controlled by software.

Indications for use:

Cellinew is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

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510(K) Summary CELLINEW K240897

Device Comparison—Indications for Use:

Subject Device (CELLINEW)	Predicate Device (Density K230663)	Comparison
CELLINEW is indicated for use in dermatologicaland general surgical procedures forelectrocoagulation and hemostasis.	Density is indicated for use indermatological and general surgicalprocedures for electrocoagulationand hemostasis.	Same

Device Comparison - Technical Specifications:

Specification	CELLINEW (Subject Device)	Jeisys Density (K230663)	Comparison
Output energy type	Radiofrequency	Radiofrequency	Same
User Interface	Color touch panel	Color touch panel	Same
Operating Frequency	6.78MHz	6.78MHz	Same
Max power	Up to 400W	400W	Same
Electrode Tips	0.25cm2, 4cm2	0.25cm2, 4cm2, 16cm2	Same (the Cellinew does not include the 16cm2 tip that the Density has.)
Coolant Solution	Cryogen	Cryogen	Same
Temperature Range	65~75°C	65~75°C	Same
RF Time	0-1050ms	50 ~ 800 ms	Different. The RF time of the subject device is marginally higher than the predicate, but it does not impact the safety or effectiveness of the device.
Impedance	75 - 400 Ω	75 - 400 Ω	Same
Style of Electrode Tip	Monopolar only	Monopolar, Bipolar	Different. The Cellinew only operates in monopolar.

Electrical Safety and Electromagnetic Compatibility

The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.

. IEC 60601-1: 2005, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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510(K) Summary CELLINEW K240897

. IEC 60601-2-2: 2017/AMD2:2020 Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of Radio frequency surgical equipment and Radio frequency.
. IEC 60601-1-2: 2014/AMD1:2020, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

Biocompatibility

ISO 10993-1: 2018, Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process
ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
. ISO 10993-10: 2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ISO 10993-23:2021, Biological evaluation of medical devices – Part 23:Test for Intracutaneous Reactivity
. ISO 10993-11:2017, Biological evaluation of medical devices – Part 11:Test for Acute Systemic toxicity
ISO 10993-11:2017, Biological evaluation of medical devices – Part 11:Test for Material Mediated Pyrogenicity

Biocompatibility Tests were performed in accordance with FDA standards and all patient contacting materials were determined to be biocompatible.

Software and Risk Management

IEC 62304:2006+A1:2015; Medical Device Software Life Cycle Processes . Software verification and validation testing was conducted, and documentation provided in accordance with FDA's Guidance or the Content of Premarket Submissions for Software Contained in Medical Devices.
. EN ISO 14971:2019+A11:2021; Medical Devices – Application of Risk Management To Medical Devices

Performance Testing – Performance testing was conducted to demonstrate the accuracy of RF frequency and output power, RF time, and impedance measuring. Thermal testing was performed on porcine skin to demonstrate the device's ability to coagulate tissue. Tests were performed with both tips at all power levels and demonstrated a desired clinical effect.

Clinical Evidence – No clinical studies were conducted as part of this submission.

Conclusion

CELLINEW 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 CELLINEW has two. The predicate functions in both monopolar and bipolar modes while the CELLINEW has only a monopolar function. There are slight differences in the RF duration but they are not large enough to impact the performance of the device. The CELLINEW and the predicate device can therefore be considered substantially equivalent.

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.