(243 days)
No
The summary describes a standard electrosurgical device and its accessories, focusing on electrical and thermal performance, biocompatibility, and shelf-life. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes.
Explanation: The device is indicated for "coagulation and ablation of soft tissue," which describes a therapeutic action intended to treat or manage a condition.
No
The device is an electrosurgical tool indicated for "coagulation and ablation of soft tissue," which are treatment functions, not diagnostic ones.
No
The device description clearly states it is a sterile, single-use electrosurgical electrode consisting of physical components (electrode tip, insulation part, handle) and is used in conjunction with a hardware RF generator.
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 soft tissue." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is an "electrosurgical electrode" used in conjunction with an RF generator. It delivers electrical current to tissue for therapeutic purposes.
- Mechanism of Action: The device works by applying radiofrequency energy to tissue, causing heating and destruction (coagulation and ablation). This is a physical interaction with the tissue, not an analysis of a sample taken from the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information about a patient's condition.
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
Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI, JOS
Device Description
Electrodes Handpieces (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).
Electrodes Handpieces (BT, JET) 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 (BT, JET), 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
Soft tissue
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)
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;2009. They are identical to the predicate device.
Shelf-Life testing
Electrodes Handpieces (BT, JET) 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 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 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2009 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 (V-1000) 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 degrees.
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 (BT, JET) 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 cross-sectional 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): 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). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around a symbol. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
August 3, 2020
RF Medical Co., Ltd % Dave Kim Medical Device Regulatory Affairs MTech Group 7707 Fannin St. Ste 200, V111 Houston, Texas 77054
Re: K193355/S002
Trade/Device Name: Electrode Handpieces (BT, JET) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI, JOS Dated: July 13, 2020 Received: July 16, 2020
Dear Dave 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 (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 and Part 809); 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 medical devices and radiation-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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193355
Device Name Electrodes Handpieces (BT, JET)
Indications for Use (Describe)
Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
| 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
Special 510(k) Summary K193355
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared: 7/30/2020
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, | ||
| Submitter's Telephone: | +82-2-2108-4200 | |
| Contact person: | Kwang S Choi ( ra@rfa.co.kr ) / RA Manager | |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) | |
| Address: | 7707 Fannin St. Ste 200, V111 | |
| Houston, TX 77054 | ||
| Telephone: | +713-467-2607 | |
| DEVICE | ||
| Trade/proprietary name: | Electrode Handpieces (BT, JET) | |
| Common Name: | Electrosurgical Cutting and Coagulation Accessories | |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories | |
| Regulation Number: | 21 CFR 878.4400 | |
| Product Code: | GEI, JOS | |
| Regulatory Class: | Class II | |
| Prescription Use. |
4
PREDICATE DEVICE (K180999)
| Primary Device Manufacturer: | RF Medical Co. Ltd |
|---|---|
| Trade/proprietary name: | Electrodes Handpieces for Mygen V-1000 RF System |
| Model: | RFT |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessories |
| Regulation Number: | 21 CFR 878.4400 |
| Product Code: | GEI, JOS |
| Regulatory Class: | Class II |
REFERENCE DEVICE (K181249)
| Device Manufacturer: | STARmed Co., Ltd |
|---|---|
| Device Name: | EUSRA RF Electrode |
| Regulation Name: | Electrosurgical, cutting & coagulation device & accessorie |
| 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 (BT, JET) are sterile, single-use electrosurgical electordes intended to be use in conjunction with Mygen V-1000 RF generator (K180999).
Electrodes Handpieces (BT, JET) 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 (BT, JET), 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 (BT, JET) are indicated for coagulation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE IV. DEVICE
| Proposed device | Predicate device | Remark | |
|---|---|---|---|
| Model name | Mygen V-1000 RF System | ||
| Electrodes Handpieces (BT, | |||
| JET) | Mygen V-1000 RF System | ||
| Electrodes Handpieces (RFT) | |||
| Manufacturer | RF Medical Co., Ltd | RF Medical Co., Ltd | |
| Electrodes Handpieces (BT, | |||
| JET) are indicated for | |||
| coagulation and ablation of soft | |||
| tissue when used in conjunction | |||
| with Mygen V-1000 | |||
| radio frequency generator. | The Mygen V-1000 RF system is | ||
| intended for use in percutaneous | |||
| and intraoperative coagulation | |||
| and ablation of tissue. | SE | ||
| 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) | 100 - 200 mm | 70mm, 100 mm | SE |
| Exposure Tip | |||
| Length (mm) | 5, 10, 15, 20, 25, 30 mm | 5, 10, 15, 20 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 |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. REFERENCE DEVICE
| Proposed device | Reference device | Remark | |
|---|---|---|---|
| Model name | Electrodes Handpieces (BT, JET) | EUSRA RF Electrode K181249 | |
| Manufacturer | RF Medical Co., Ltd | STARmed Co., Ltd | |
| Electrodes Handpieces (BT, JET) are indicated for coagulation and ablation of soft tissue when used in conjunction with Mygen V-1000 radio frequency generator. | The EUSRA RF Electrode is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator. | SE | |
| Type of Use | Prescription Use | Prescription Use | |
| Components | Electrosurgical unit, active electrode, grounding pad, | Electrosurgical unit, active electrode, grounding pad, | Same |
6
| Proposed device | Reference device | Remark | |
|---|---|---|---|
| peristaltic pump and foot pedal | peristaltic pump and foot pedal | ||
| Electrosurgical RF applicator | Monopolar | Monopolar | Same |
| Output energy type | Radio frequency | Radio Frequency | Same |
| Operation mode | Manual mode / Auto mode | Manual mode/ Automatic impedance control | Same |
| Electrode Length (mm) | 100 ~ 200 mm | 70mm, 200 mm | SE |
| Exposure Tip Length (mm) | 5, 10, 15, 20, 25, 30 | 5, 7, 10, 15, 20 mm | SE |
| Patient contacting materials | SUS 304, Polymer, Polyester, Polyimide | Stainless Steel 304, Polyimide, Polyether Block Polyamide Copolymer, Stainless Steel 304 and PTFE | SE |
| Sterile | EO Sterilization | EO Sterilization | Same |
| Single Use | Single Use | Single Use | Same |
SUMMARY OF TECHNOLOGICAL COMPARISON BETWEEN THE SUBJECT VI. 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, RFT electrode for Mygen V-1000 RF System.
The differences include the length of the tip of the electrodes and the size of the handpieces.
VII. PERFORMANCE DATA
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;2009. They are identical to the predicate device.
Shelf-Life testing
Electrodes Handpieces (BT, JET) 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
7
acceptance criteria.
Non Clinical testing:
IEC 60601-1 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 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility.
IEC 60601-2-2: 2009 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 (V-1000) 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 (BT, JET) 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 cross-sectional aera show
8
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.
VIII. CONCLUSIONS
Electrodes Handpieces (BT, JET) 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 (BT, JET) are substantially equivalent in comparison with RFT electrode for Mygen V-1000 RF System, the predicate device as described herein.