(194 days)
No
The description focuses on the RF electrosurgical system's hardware components, power output, and performance testing related to thermal effects. There is no mention of AI, ML, image processing, or data training/testing sets, which are typical indicators of AI/ML integration.
Yes.
The device is used for electrocoagulation and hemostasis in surgical procedures, which are therapeutic interventions.
No
This device is described as an RF electrosurgical system used for electrocoagulation and hemostasis in dermatological and general surgical procedures. It generates RF current for treatment, not for diagnosis.
No
The device description explicitly states it is an RF electrosurgical system consisting of hardware components like an electrosurgical device (ESU), handpieces, a grounding plate, and a foot switch. Performance testing also involves bench testing of hardware components and animal studies.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "For use in dermatological and general surgical procedures for electrocoagulation and hemostasis." This describes a surgical procedure performed on a patient, not a test performed on a sample taken from a patient.
- Device Description: The device is an "RF electrosurgical system" that generates and delivers RF current to tissue for surgical purposes. This is a therapeutic/surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates directly on the patient's tissue during surgery.
N/A
Intended Use / Indications for Use
For use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device 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 through a mono-polar active electrode and returned through the grounding plate (neutral electrode).
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)
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".
- 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.
- The subject device did not show any change in the time reaching basal temperature by all set temperatures compared to the predicate device.
- The 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.
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.
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 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
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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)
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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)
- Diameter: Ø 2.0
- Length: 80mm | V-10-10-18-B-G2
- Diameter: Ø 1.15
- Length: 100mm | Different
(Note. 4) |
| | Physical
Dimensions | AE20-180 (SMART) - Diameter: Ø 2.0
- Length: 180mm
AE40-300 (LIPO) - Diameter: Ø 4.0
- Length: 300mm | V-15-10-18-B-G2
V-20-10-16-B-G2
V-5-5-20-B-G2 - Diameter: Unknown
- 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.
-
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
-
- ISO 10993-10:2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.
-
- ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
- 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.