Who is the manufacturer of Retraction, CWM-910T, APOLEX Tite?

Chungwoo Co., Ltd. filed the 510(k) submission for Retraction, CWM-910T, APOLEX Tite (K222709).

What is the FDA product code for Retraction, CWM-910T, APOLEX Tite?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Retraction, CWM-910T, APOLEX Tite?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Retraction, CWM-910T, APOLEX Tite?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Retraction, CWM-910T, APOLEX Tite

K222709 · Chungwoo Co., Ltd. · GEI · Mar 21, 2023 · General, Plastic Surgery

Device Facts

Record ID	K222709
Device Name	Retraction, CWM-910T, APOLEX Tite
Applicant	Chungwoo Co., Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Mar 21, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

For use in dermatological and general surgical procedures for electrocoagulation and hemostasis.

Device Story

RF electrosurgical system (ESU) delivers 480KHz RF current to heat tissue via intracellular oscillation of ionized molecules; induces elevation of intracellular temperature for coagulation/hemostasis. System comprises ESU console, foot switch, grounding plate, and detachable monopolar handpieces. Operated by physicians in clinical settings. Input: user-selected power settings; Output: RF energy delivered through active electrode to patient tissue, returning via grounding plate. Output monitored via impedance and continuity sensors. Benefits include controlled thermal tissue effect for surgical hemostasis.

Clinical Evidence

Bench testing only; no human clinical data. Performance verified per IEC 60601-2-2 and FDA guidance. Animal study (9 mini-pigs) compared thermal effects (skin, liver, kidney, muscle) between subject and predicate. Subject device showed decreased maximum temperature and smaller thermal imaging area compared to predicate; time to reach basal temperature was equivalent.

Technological Characteristics

RF electrosurgical system; 480kHz output frequency; 50W max power. Materials: SUS304 electrodes with TEFLON-PFA insulation. Components: ESU console, monopolar handpieces, grounding plate, foot switch. Connectivity: Standalone. Sterilization: Steam sterilization for reusable handpieces. Electrical safety: IEC 60601-1, IEC 60601-2-2. EMC: IEC 60601-1-2.

Indications for Use

Indicated for dermatological and general surgical procedures requiring electrocoagulation and hemostasis.

Regulatory Classification

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.

Predicate Devices

ThermiX Temperature Controlled Radiofrequency (RF) System (K173582)

Reference Devices

PROPLATE Electrosurgical Grounding Plate (K092761)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other. March 21, 2023 Chungwoo CO., LTD. % Milly (RA Consultant/KMC,Inc. DongHa Lee (RA Consultant / KMC, Inc. KMC, Inc. (G-Plus Tower, # 1709) 123, Digital-ro 26-gil, Guro-gu Seoul. 08390 Korea, South Re: K222709 Trade/Device Name: Retraction, CWM-910T, APOLEX Tite Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 7, 2022 Received: September 8, 2022 Dear Milly (RA Consultant/KMC, Inc.): 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. {1}------------------------------------------------ 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) 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 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). Sincerely. | Mark | Digitally signed by Mark Trumbore -S | |------|-----------------------------------------| | | Date: 2023.03.21 13:21:10 -04'00' | Mark Trumbore, 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) K222709 Device Name Retraction, CWM-910T, APOLEX Tite Indications for Use (Describe) For use in dermatological and general surgical procedures for electrocoagulation and hemostasis. 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) #### 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." {3}------------------------------------------------ # 510(k) Summary (K222709) This summary of 510(K) – safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: September 7, 2022 # 1. Applicant / Submitter CHUNGWOO CO., LTD Address: (Gasan-dong, Woolim Lionsvally-2), 614, 2, Gasandigital 1-ro, Geumcheon-gu, Seoul, 08591, South Korea Tel : +82-2-2027-2200 Fax : +82-2027-2207 ## 2. Official Correspondent (RA Consultant) Milly (RA Consultant / KMC, Inc.) DongHa Lee (RA Consultant / KMC, Inc.) Address: (G-Plus Tower, # 1709) 123, Digital-ro 26-gil, Guro-gu, Seoul, 08390, South Korea Tel : +82-70-8965-5554 Fax : +82-2-2672-0579 Email: dhlee@kmcerti.com #### 3. Device Information - । Trade Name: Retraction, CWM-910T, APOLEX Tite - Common Name: RF Electrosurgical System । - Classification Name: Electrosurgical cutting and coagulation device and accessories - - Classification Product Code and Regulation: GEI, 21CFR 878.4400 । - Device Class: 2 - #### 4. Predicate Device - K Number: K173582 । - Manufacturer: ThermiGen, L.L.C. - Trade Name: ThermiX Temperature Controlled Radiofrequency (RF) System - ## 5. General Description Retraction, CWM-910T and APOLEX Tite are RF electrosurgical system. These are identical except for model designation. The RF electrosurgical system consists of an electrosurgical device (ESU), 3 types of detachable handpieces (mono-polar active electrode), a grounding plate (neutral electrode) and a foot switch. The hand piece consists of a hand grip and an electrode. There are 3types of mono-polar electrode depend on diameter and length. The electrosurgical device generates 480KHz RF current. RF output energy (Max. 50W) is delivered {4}------------------------------------------------ through a mono-polar active electrode and returned through the grounding plate (neutral electrode). # 6. Indication for use For use in dermatological and general surgical procedures for electrocoagulation and hemostasis. # 7. Comparison of the modified device to the cleared device The following comparison table is presented to demonstrate substantial equivalence. | Descriptive Information | Subject Device | Predicate Device | Comparison | | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Manufacturer | CHUNGWOO CO., LTD. | ThermiGen, L.L.C. | - | | | Device Name | RF electrosurgical System (Models: Retraction, CWM-910T, APOLEX Tite) | ThermiX Temperature Controlled Radiofrequency (RF) System | - | | | 510(k) number | - | K173582 | - | | | Regulatory Number | 21CFR 878.4400 | 21CFR 878.4400 | Same | | | Classification Product Code | GEI | GEI | Same | | | Regulatory Class | 2 | 2 | Same | | | Indications for Use | For use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | - for use in dermatological and general surgical procedures for electrocoagulation and hemostasis - to create lesions in nervous tissue | Same (Note. 1) | | | Prescription or OTC | Prescription | Prescription | Same | | | Operation | Radio frequency (RF) alternating current to heat the tissue by RF induced intracellular oscillation of ionized molecules that result in an elevation of intracellular temperature. | Radio frequency (RF) alternating current to heat the tissue by RF induced intracellular oscillation of ionized molecules that result in an elevation of intracellular temperature. | Same | | | Electrosurgical Unit (ESU) | Monopolar or Bipolar | Monopolar | Monopolar | Same | | | Temperature sensors | Yes | Yes | Same | | | Impedance monitor | Yes | Yes | Same | | | Continuity monitor | Yes | Yes | Same | | | Output frequency | 480kHz | 460kHz | Similar (Note. 2) | | | Waveform | Sine curve | Sine curve | Same | | | Max. Output Power | 50W | 50W | Same | | | Voltage output | 140Vrms | 140Vrms | Same | | | Power Input | AC 100-240V, 50/60Hz, 190-200VA | AC 100-240V, 50/60Hz, 190VA | Similar (Note. 3) | | Active accessory (RF Electrode) | Monopolar or Bipolar | Monopolar | Monopolar | Same | | | | AE20-80 (LIFT) 1) Diameter: Ø 2.0 2) Length: 80mm | V-10-10-18-B-G2 1) Diameter: Ø 1.15 2) Length: 100mm | Different (Note. 4) | | | Physical Dimensions | AE20-180 (SMART) 1) Diameter: Ø 2.0 2) Length: 180mm AE40-300 (LIPO) 1) Diameter: Ø 4.0 2) Length: 300mm | V-15-10-18-B-G2 V-20-10-16-B-G2 V-5-5-20-B-G2 1) Diameter: Unknown 2) Length: Unknown | | | | Raw Materials | SUS304 (Insulation coating: TEFLON-PFA) | Unknown | Different (Note. 5) | | | Single Use or Reusable | Reusable | Reusable | Same | | | Sterilization | User Sterilization (Steam sterilization) | Unknown | Different (Note. 6) | | Grounding Plate - Neutral electrode pad | FDA Approval | K092761 (PROPLATE Electrosurgical Grounding Plate) | Unknown | Different (Note. 7) | | | Single Use or Reusable | Single Use | Single Use | Same | | | Specifications | Plug the grounding pad cord into the connection port of ESU. Attach the grounding pad on the patient during the procedure. | Plug the grounding pad cord into the connection port of ESU. Attach the grounding pad on the patient during the procedure. | Same | | Miscellaneous accessory (Foot switch) | Functions | Start or stop RF power delivery | Start or stop RF power delivery | Same | | | Performance Specifications | Press and release the footswitch | Press and release the footswitch | Same | | | Specification | IP68 | Unknown | Different (Note. 8) | {5}------------------------------------------------ Note 1. The indications for use of the subject device is included within The indications for use of the predicate device. # Note 2. {6}------------------------------------------------ RF output power and waveform of the subject device is the same as the predicate device. Output frequency of the subject device is 480 kHz which is similar to the predicate device (460kHz). The RF output was tested and verified according to IEC 60601-2-2 and performance bench testing (comparison test). #### Note 3. Power input of the subject device is similar to the predicate device. The electrical safety was tested and verified according to IEC 60601-1 and IEC 60601-1-2. EMC also was tested and verified according to IEC 60601-1-2. #### Note 4. The shape of the RF electrode of the subject device is similar to the predicate device but dimension (diameter and length) is little bit different. The difference was tested and verified according to IEC 60601-2-2 and performance bench testing (comparison test). #### Note 5. Raw material of the patient contact part (RF electrode) is different from the predicate device. The patient contact part (RF electrode) of the subject device was evaluated about bio-compatibility according to ISO 10993-1. Bio-compatibility was tested and verified according to ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-23. #### Note 6. The reprocessing method of the reusable handpiece (hand grip and electrode) of the subject device is different from the predicate device. The reprocessing method was tested and validated according to FDA reprocessing guidance. #### Note 7. The grounding plate (neutral electrode pad) of the subject device is different from the predicate device. The grounding plate (neutral electrode pad) of the subject device is FDA cleared product (K092761). The compatibility with the subject device was tested and verified according to IEC 60601-2-2. #### Note 8. The footswitch of the subject device is different from the predicate device. The footswitch was tested and verified according to IEC 60601-1 with the subject device. #### 8. Reprocessing The reusable hand piece (hand grip and electrode) should be conducted reprocessing after use to prevent contamination and cross-infection. The reprocessing method was tested and validated according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff". {7}------------------------------------------------ ## 9. Biocompatibility The RF electrode can be touched with a patient. Biocompatibility tests were conducted to ensure that no risks arise from biological hazards associated with materials of manufacture and the final device. - 1) ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity - 2) ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization. - 3) ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity - 4) ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation # 10. Software The firmware is intended to control the RF electrosurgical system. It is installed in a microprocessor of the device. The firmware was verified and validated according to FDA Guidance "Content of Premarket Submission for Software Contained in Medical Devices" and IEC 62304: 2006 + A1:2015, Medical device software - Software life cycle processes. ## 11.Electrical Safety and Electromagnetic compatibility Electrical hazard and high temperature hazard are included within the device. The risks are controlled by design, protection method and information according to the FDA recognized standards, IEC 60601-1:2005+A1:2012 (AAMI/ANSI ES 60601-1: 2005+A1: 2012) and IEC 60601-2-2:2017 Electromagnetic compatibility was tested and verified according to the FDA recognized standard, IEC 60601-1-2:2020 # 12.Performance Testing - Bench The RF output power was tested and verified according to with the FDA recognized standard, IEC 60601- 2-2:2017. Comparison Test with the predicate device was conducted about graphical display of the output waveform at the rated load, identifying the associated mode, amplitude, frequency, duty cycle, load used, and crest factor. This test also considered a graph displaying the power output at maximum and half-of-maximum intensity over the range of expected loads (100/200/500/1000/2000 Ω). These tests are according to FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery: Guidance for Industry and Food and Drug Administration Staff". In addition, as part of comparison test, animal (mini pig) test was conducted to assess the safety assessment (thermal effect) between subject device and predicate device. The skin, liver, kidney, and femoral muscles dissected from 9 mini pigs were used in the thermal tissue spread experiments. Thermal imaging area analysis, maximum temperature and time to reach basal temperature were evaluated. the subject device showed a tendency to decrease in maximum temperature by all set temperatures compared to the predicate device. And the subject device did not show any change in the time reaching basal temperature by all set temperatures compared to the predicate device. The {8}------------------------------------------------ results of thermal imaging area analysis using the correction factor, considering that it is two - four folds larger than the predicate device, the thermal image area of the subject device showed a tendency to decrease in thermal image area compared to the predicate device. # 13.Conclusion The major consideration such as intended use and principle of operation is the same as the predicate device. Although there are some differences, the safety and performance test reports are supported to the safety and effectiveness of the subject device. In this regard, we conclude that the subject device is substantially equivalent to the predicate devices.