(26 days)
No
The summary describes electrosurgical electrodes and their associated testing, with no mention of AI or ML capabilities. The device description focuses on the physical components and cooling mechanism.
Yes.
The device is used for "coagulation and ablation of tissue," which directly involves a therapeutic action on the body.
No
The device is indicated for "coagulation and ablation of tissue," which are therapeutic actions, not diagnostic ones. There is no mention of it being used to gather information about a patient's condition or disease for diagnosis.
No
The device description explicitly states that the device consists of physical components: electrode tip, insulation part, and handle. It also describes a cooling system involving saline and tubing, and mentions dispersive electrodes. These are all hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "coagulation and ablation of tissue". This is a therapeutic procedure performed directly on the patient's tissue.
- Device Description: The device is an "electrosurgical electrode" used in conjunction with an RF generator. It works by applying electrical current to tissue for therapeutic purposes.
- Mechanism of Action: The description details how the electrode delivers electrical current to the tissue to cause coagulation and ablation.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
Electrodes Handpieces (VCT, RFTV, BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
Product codes
GEI, JOS
Device Description
Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle.
Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
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
Prescription Use (Rx) - 21 CFR 201.100(b)
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
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility testing:
The patient contact components and materials are tested and validated according to ISO10993-1: 2018. They are identical to the predicate device.
Shelf-Life testing
Electrodes Handpieces (VCT, RFTV, BMDT) are sterilized and tested for packaging seal strength, packaging dye penetration, appearance, conduction, and sterility in accordance with ASTM F 1980 Accelerated Aging method for valid shelf life. All testing results passed the acceptance criteria.
Non Clinical testing:
IEC 60601-1: 2005, AMD 1: 2012 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2: 2014 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2017 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. The requirements of specified standards were fulfilled.
Temperature sensor accuracy test of RF electro-surgical cautery apparatus (VCT, RFTV, BMDT series) was performed to test and verify the accuracy of the temperature sensor of the equipment produced by RF Medical. Temperature accuracy was tested in multiple power mode, three times for each power setting. The test results confirmed that the values measured by temperature sensor of V-1000 and the temp. calibrator were within the acceptance criteria, ±3°.
LAL Validation and Quantitative
LAL test for the electrode material has been conducted according to the United Sates Pharmacopoeia (USP) [3] [4] in the guidance by the Food and Drug Administration and the ANSI/AAMI. (ULMDT Endotoxicological laboratory, Project 12280140 1.1, Orcle No: 4788458245). Bacterial endotoxin concentration was less than 0.050 EU/device and the acceptance criteria for the validity of the test were fulfilled. There were no deviations from the study protocol.
A thermal effect test
Electrodes Handpieces (VCT, RFTV, BMDT series) have been tested for a thermal effect according to the FDA guidance 'Premarket Notification (510K) Submission for Electrosurgical Devices for General Surgery'. The test was conducted on a pig' liver, kidney and muscle tissue, during immediately after treatment to verify the safety and effect it will have on the tissue and surrounding anatomical structures. Parameters of necrosis crosssectional aera show coagulated necrotic cells with markedly collapsed cellular architecture. By comparison, the surrounding liver, thyroid, muscle tissues were normal in appearance.
No clinical studies were considered for this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 4, 2023
RF Medical Co., Ltd % Mr. Dave Kim, MBA President Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K232763
Trade/Device Name: Electrode Handpieces (VCT, RFTV, BMDT)
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: August 22, 2023 Received: September 8, 2023
Dear Mr. Kim:
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/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
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" (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 QS 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.
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).
Sincerely,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is from Mark Trumbore -S. The date of the signature is 2023.10.04. The time of the signature is 08:09:32-04'00'.
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices
2
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232763
Device Name Electrodes Handpieces (VCT, RFTV, BMDT)
Indications for Use (Describe)
Electrodes Handpieces (VCT, RFTV, BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Rx) - 21 CFR 201.100(b) | ☐ Over-The-Counter Use (OTC) - 21 CFR 201.66 |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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4
Special 510(k) Summary K232763
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date of Submission: 10/3/2023
I. SUBMITTER
| Submitter's Name : | RF Medical Co., Ltd. |
|---|---|
| Submitter's HQ Address: | #502, 503, 505, 506, 507,511, 254, Beotkkot-ro, Geumcheon |
| gu, Seoul, KOREA, 08513 | |
| Submitter's Telephone: | +82-2-2108-4200 |
| Contact person: | Kwang S Choi (ra@rfa.co.kr) / RA Manager |
| Official Correspondent: | Dave Kim, MBA |
| President | |
| Address: | Mtech Group LLC |
| 7505 Fannin St. Suite 610 | |
| Houston, TX 77054 | |
| Telephone: | +713-467-2607 |
| Email: | davekim@mtechgroupllc.com |
| DEVICE | |
| Trade/proprietary name: | Electrode Handpieces (VCT, RFTV, BMDT series) |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, JOS |
| Regulatory Class: | Class II |
| Prescription Use |
5
PREDICATE DEVICE (K193355)
| Primary Device Manufacturer: | RF Medical Co. Ltd |
|---|---|
| Trade/proprietary name: | Electrodes Handpieces for Mygen V-1000 RF System |
| Model: | BT, JET |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, JOS |
| Regulatory Class: | Class II |
This predicate has not been subject to a design-related recall.
DEVICE DESCRIPTION II.
Electrodes Handpieces (VCT, RFTV, BMDT) are sterile, single-use electrosurgical electordes intended to be use in conjunction with with compatible radio frequency generator, mainly Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
Electrodes Handpieces (VCT, RFTV, BMDT) consist of electrode tip, insulation part, handle.
Cooling of the electrode is provided by saline which is pumped (using the peristaltic pump) through the inflow tubing, the electrode and out through the outflow tubing. This is an enclosed system within the electrode and saline does not contact the patient. For the electrodes (VCT, RFTV, BMDT), dispersive electrodes are provided so that electrical current flows through the tip of the electrodes, through the target tissue and to the dispersive electrodes.
INDICATIONS FOR USE: III.
Electrodes Handpieces (VCT. RFTV. BMDT) are indicated for coagulation and ablation of tissue when used in conjunction with compatible radio frequency generators. Mygen V-1000 RF generator (K193355) and M-3004 RF generator (K221277).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS IV.
| Proposed device | Primary Predicate Device | Remark | |
|---|---|---|---|
| Model name | Electrodes Handpieces (VCT, | ||
| RFTV, BMDT), K232763 | Electrodes handpieces (BT, | ||
| JET), K193355 | |||
| Manufacturer | RF Medical Co., Ltd | RF Medical Co., Ltd | |
| Electrodes Handpieces (VCT, | |||
| RFTV, BMDT) are indicated | Electrodes Handpieces (BT, | ||
| JET) are indicated for | SE |
6
| Proposed device | Primary Predicate Device | Remark | |
|---|---|---|---|
| for coagulation and ablation of | |||
| tissue | |||
| when used | |||
| in | |||
| conjunction with Mygen V- | |||
| 1000 RF generator (K193355) | |||
| and M-3004 RF generator | |||
| (K221277). | coagulation and ablation of soft | ||
| tissue | |||
| when used | |||
| in | |||
| conjunction with Mygen V- | |||
| 1000 radio frequency generator | |||
| Type of Use | Prescription Use | Prescription Use | |
| Components | Electrosurgical unit, active | ||
| electrode, grounding pad, | |||
| peristaltic pump and foot pedal | Electrosurgical unit, active | ||
| electrode, grounding pad, | |||
| peristaltic pump and foot pedal | Same | ||
| Electrosurgical | |||
| RF applicator | Monopolar | Monopolar | Same |
| Output energy | |||
| type | Radio frequency | Radio frequency | Same |
| Electrode Length | |||
| (mm) | 60 ~ 300 mm | 60 ~ 300 mm | SE |
| Exposure Tip | |||
| Length(mm): | 5, 10, 15, 20, 25, 30 mm | 5, 10, 15, 20, 25, 30 mm | SE |
| Patient contacting | |||
| materials | SUS 304, Polymer, Polyester, | ||
| Polyimide | SUS 304, Polymer, Polyester, | ||
| Polyimide | SE | ||
| Sterile | EO Sterilization | EO Sterilization | Same |
| Single Use | Single Use | Single Use | Same |
SUMMARY OF TECHNOLOGICAL COMPARISON BETWEEN THE SUBJECT V. AND PREDICATE DEVICE
The indications for use, operating principle, technical specifications of the subject device described in this 510k are identical to those of the predicate device, BT, JET electrode for V-1000 and M-3004 RF generator system.
The differences include the length of the tip of the electrodes and the size of the handpieces.
PERFORMANCE DATA VI.
The following performance data was provided in support of the substantial equivalence determination.
Biocompatibility testing:
The patient contact components and materials are tested and validated according to ISO10993-1: 2018. They are identical to the predicate device.
7
Shelf-Life testing
Electrodes Handpieces (VCT, RFTV, BMDT) are sterilized and tested for packaging seal strength, packaging dye penetration, appearance, conduction, and sterility in accordance with ASTM F 1980 Accelerated Aging method for valid shelf life. All testing results passed the acceptance criteria.
Non Clinical testing:
IEC 60601-1: 2005, AMD 1: 2012 Test for Medical Electrical Equipment was performed for General
Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2: 2014 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2017 Medical electrical equipment
Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.
The requirements of specified standards were fulfilled.
Temperature sensor accuracy test of RF electro-surgical cautery apparatus (VCT, RFTV, BMDT series) was performed to test and verify the accuracy of the temperature sensor of the equipment produced by RF Medical . Temperature accuracy was tested in multiple power mode, three times for each power setting. The test results confirmed that the values measured by temperature sensor of V-1000 and the temp. calibrator were within the acceptance criteria, ±3°
LAL Validation and Quantitative
LAL test for the electrode material has been conducted according to the United Sates Pharmacopoeia (USP) [3] [4] in the guidance by the Food and Drug Administration and the ANSI/AAMI. (ULMDT Endotoxicological laboratory, Project 12280140 1.1, Orcle No: 4788458245). Bacterial endotoxin concentration was less than 0.050 EU/device and the acceptance criteria for the validity of the test were fulfilled. There were no deviations from the study protocol.
8
A thermal effect test
Electrodes Handpieces (VCT, RFTV, BMDT series) have been tested for a thermal effect according to the FDA guidance 'Premarket Notification (510K) Submission for Electrosurgical Devices for General Surgery'. The test was conducted on a pig' liver, kidney and muscle tissue, during immediately after treatment to verify the safety and effect it will have on the tissue and surrounding anatomical structures. Parameters of necrosis crosssectional aera show coagulated necrotic cells with markedly collapsed cellular architecture. By comparison, the surrounding liver, thyroid, muscle tissues were normal in appearance.
No clinical studies were considered for this submission.
VII. CONCLUSIONS
Electrodes Handpieces (VCT, RFTV, BMDT series) have the same indication of use as the predicate devices and it shares the same technological characteristics as the predicate devices. There is no new concern for safety and effectiveness.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of RF Medical Co, Ltd. that Electrodes Handpieces (VCT, RFTV, BMDT series) are substantially equivalent in comparison with BT, JET electrode, the predicate device as described herein.