(239 days)
Not Found
No
The description focuses on the physical principles of RF energy delivery and tissue coagulation, with no mention of AI or ML algorithms for control, analysis, or decision-making. The software mentioned likely controls basic device functions like power and time.
Yes
The device is used in dermatologic and general surgical procedures for electrocoagulation and hemostasis, which are therapeutic medical procedures.
No
The device description clearly states its purpose is for electrocoagulation and hemostasis, which are surgical therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including a main body, handpiece, electrodes, cables, and a power cord, indicating it is a hardware device controlled by software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "electrocoagulation and hemostasis" in dermatologic and general surgical procedures. This describes a therapeutic or surgical intervention performed directly on the patient's tissue, not a test performed on a sample taken from the patient.
- Device Description: The device generates RF energy and delivers it through the skin to coagulate tissue. This is a physical interaction with the body, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
Cellinew is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
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.
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
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.
Key Metrics
Not Found
Predicate Device(s)
Density (K230663)
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.
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: on the left, there is a seal with an eagle and text around it, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other products.
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"
1
(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)
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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4
510(K) Summary CELLINEW K240897
| Applicant | Viol Co., Ltd. |
|---|---|
| Address | C-609 Bundang Technopark C, 744 Pangyo-ro, Bundang-gu, |
| Seongnam-si, Gyeonggi-do | |
| Seoul, South Korea | |
| Contact Person | Oskar (Sugun) Lee |
| Contact Information | Telephone : 070-7954-1388 |
| Cellphone : +82-10-2388-7739 | |
| ceo@skingrab.co.kr | |
| Preparation Date | October 31, 2024 |
| Device Trade Name | CELLINEW |
| Classification Name | |
| Common Name | |
| Regulation Number | Electrosurgical cutting and coagulation |
| RF Electrosurgical Device | |
| 878.4400 | |
| Product Code | |
| Regulatory Class | GEI |
| II | |
| Legally Marketed Predicate | |
| Device | Density (K230663) |
| Jeisys Medical Incorporated |
Device Description:
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.
Indications for use:
Cellinew is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
5
510(K) Summary CELLINEW K240897
Device Comparison—Indications for Use:
| Subject Device (CELLINEW) | Predicate Device (Density K230663) | Comparison |
|---|---|---|
| CELLINEW is indicated for use in dermatological | ||
| and general surgical procedures for | ||
| electrocoagulation and hemostasis. | Density is indicated for use in | |
| dermatological and general surgical | ||
| procedures for electrocoagulation | ||
| and 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
6
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.