(248 days)
No
The description focuses on the electrosurgical mechanism and basic electrical components, with no mention of AI or ML.
Yes
The device is used to cut and coagulate soft tissue during electrosurgical procedures, which directly treats anatomical sites (soft tissue).
No
Explanation: The device is used to cut and coagulate soft tissue, which are therapeutic functions, not diagnostic ones. It delivers high-frequency electrical current for surgical procedures.
No
The device description clearly outlines hardware components such as a plastic handle, connecting cable and plug, internal PCB, and electrode tip. The performance studies also focus on hardware characteristics like thermal effects on tissue and electrical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The device is a handheld instrument used to deliver electrical energy to tissue for cutting and coagulation. This is a surgical tool.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
- Mechanism of Action: The device works by applying electrical energy to tissue, not by interacting with biological samples for diagnostic purposes.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
Product codes
GEI
Device Description
The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile.
The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU.
The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).
This device is intended to be used as a hand-switching monopolar accessory in conjunction with a compatible electrosurgical generator for tissue cutting and coagulation. The distal end of the pencil has a 3/32" (2.36mm) collet that will accept a variety of electrosurgical electrodes with 3/32" (2.38mm) diameter shafts.
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
Non-Clinical Bench Testing:
Thermal Effects on Tissue: In accordance with the nonbinding FDA guidance on "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", part XI-E, the thermal effects on animal tissue of our device was compared with the predicate device K192542. Ex-vivo kidney, liver, and muscle tissues were used and the thermal damage zone sizes were compared for length, width, and depth. These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device. The non-stick performance of our non-stick electrode was found to be similar to the predicate device but without occurring holes and craters as in the predicate device's non-stick coating.
Third party electrical testing: The device K231405 successfully passed the following electrical tests: Conducted Emmisions (150kHz-30MHz), Radiated Emissions (30MHz-1GHz), Radiated Emissions (1GHz-18GHz), Electrostatic Discharge (ESD), Radio frequency electromagnetic field radiation immunity, Power frequency magnetic field. All other EMC tests are not applicable to our device.
Third party biocompatibility testing was performed.
Subject device package integrity and functional performance tests were performed in-house in our Jiangsu facilities after aging and real-time stability tests to confirm the proposed shelf life.
Conclusion: The device has been shown to be substantially equivalent to the predicate device in terms of performance and physical and technological characteristics. The devices passed all tests both in-house and by third party qualified labs. It has been deemed safe and conforms to the standards discussed above.
Key Metrics
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.
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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
January 18, 2024
Jiangsu Rong Fu Kang Medical Instruments Co., Ltd. Mr. Steve Livneh CEO/President 3rd floor, Building D6, 6 Dongsheng Road West Jiangyin, Jiangsu 214400 China
Re: K231405
Trade/Device Name: Sterile Single Use Electrosurgical Pencil with Non-Coated and Non-Stick Electrode
Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 17, 2023 Received: December 21, 2023
Dear Mr. Livneh:
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
Trumbore -S | Digitally signed by
Mark Trumbore -S
Date: 2024.01.18
10:07:00 -05'00' |
| --------------------- | --------------------------------------------------------------------------------- |
|---|
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) K231405
Device Name
Sterile Single Use Electrosurgical Pencil with Non-coated and Non-stick Electrodes
Indications for Use (Describe)
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
| 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
Image /page/3/Picture/0 description: The image shows a logo with a blue globe on the left and the text "荣孚康 RFK" on the right. The globe is a network of interconnected nodes, suggesting a global network or connection. A horizontal line is placed under the text, emphasizing the brand name.
510(K) SUMMARY- K231405
1. 510(k) Owner:
Name: Jiangsu Rong Fu Kang Medical Instruments Co., Ltd Address: 3rd floor, Building D6, 6 Dongsheng Road West, Jiangyin, Jiangsu, China 214400 Prepared on: January 17, 2024
2. 510(k) Contact Information:
Please Contact: Mr. Steve Livneh, CEO/President (1)-720-277-6060 Email: info@rfkinetics.com Address: 1589 Roseanna Drive, Northglenn Colorado 80234 USA
3. Device:
Trade Name: Sterile Single Use Electrosurgical Pencil with Non-coated and Nonstick Electrodes Common Name: RFK Disposable Electrosurgical Pencil with Standard and Non-Stick Tip Electrodes
Device Models: For the pencil: EP-100-3, EP-100-5 For the electrodes:
-
- Non coated electrode AE-EBD
-
- Non-stick electrode: AE-EBDN
Classification Name: 878.4400: Electrosurgical Cutting and Coagulation Device and Accessories Class: II Product Code: GEI
4. Predicate and Reference Devices:
Predicate Device: K192542 Single Use Electrosurgical pencil with non-coated and non-stick electrode (Nonsterile and sterile) Reference Device: K170369 Disposable Electrosurgical Pencils. CP1001 Series
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Image /page/4/Picture/0 description: The image shows a logo with a blue globe on the left and the text "荣孚康 RFK" on the right. The globe has a network of white lines and dots on it, suggesting a global network or connection. A blue line is underneath the text "荣孚康 RFK".
made by Cathay Manufacturing Corp.
5. Product Description:
The Jiangsu Rong Fu Kang Medical Instruments Co. Ltd (here and after RFK) Electrosurgical Pencils and Electrodes are handheld instruments that are used for cutting and coagulation of soft tissue. They consist of a plastic handle, a connecting cable and plug, control buttons, internal PCB, and either a stainless steel uncoated or non-stick electrode tip. The Electrosurgical Pencils and electrodes are disposable and are supplied sterile.
The connecting cable is plugged into an Electro-Surgical Generator Unit (ESU) which provides the high-frequency energy to be deployed in the surgical procedure. The plastic handle has two buttons: cutting and coagulation. The cutting button activates the CUT mode of the ESU and the coagulation button activates the COAG mode of the ESU.
The electrode tip makes contact with the target tissue and delivers high frequency energy from the ESU to the target organs for the purposes of cutting and coagulation. This energy then passes through the body tissues and returns to the ESU via a return electrode (ground pad).
6. Indications for Use:
The devices are used to cut and coagulate soft tissue by means of high frequency electrical current during an electrosurgical procedure.
7. Technological Characteristics:
The proposed devices have substantially equivalent construction and performance as the predicate devices.
8. Substantial Equivalence:
The technological characteristics and performance testing of the subject and predicate devices are substantially equivalent. The following table shows the comparisons in more detail information among the subject device and the predicate devices.
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Image /page/5/Picture/0 description: The image shows a logo with a blue globe on the left and the text "荣孚康 RFK" on the right. The globe is a sphere with white dots connected by lines, creating a network-like appearance. The text is in blue and is accompanied by a horizontal blue line underneath.
FIGURE 5-1: SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE TESTING
| Subject Device: K231405 | Predicate Device: K192542 | |
|---|---|---|
| Intended Use | The devices are used to cut and | |
| coagulate soft tissue by means | ||
| of high frequency electrical | ||
| current during an electrosurgical | ||
| procedure. | The devices are used to cut and | |
| coagulate soft tissue by means | ||
| of high frequency electrical | ||
| current during an electrosurgical | ||
| procedure. | ||
| Device Description | This device is intended to be | |
| used as a hand-switching | ||
| monopolar accessory in | ||
| conjunction with a compatible | ||
| electrosurgical generator for | ||
| tissue cutting and coagulation. | ||
| The distal end of the pencil has | ||
| a 3/32" (2.36mm) collet that will | ||
| accept a variety of | ||
| electrosurgical electrodes with | ||
| 3/32" (2.38mm) diameter shafts. | This device is intended to be | |
| used as a hand-switching | ||
| monopolar accessory in | ||
| conjunction with a compatible | ||
| electrosurgical generator for | ||
| tissue cutting and coagulation. | ||
| The distal end of the pencil has | ||
| a 3/32" (2.36mm) collet that will | ||
| accept a variety of | ||
| electrosurgical electrodes with | ||
| 3/32" (2.38mm) diameter shafts. | ||
| Classification | 878.4400 | 878.4400 |
| Product Code | GEI | GEI |
| OTC or Prescription | Prescription | Prescription |
| Energy Type | High-Frequency Monopolar | High-Frequency Monopolar |
| Sterile? | Yes | Yes |
| Sterilization Type | EO Sterilization | EO Sterilization |
| Single Use? | Yes | Yes |
| Electrode Type | Monopolar | Monopolar |
| Electrode Material | Stainless Steel | Stainless Steel |
| Electrode non-stick coating | Silicon oxide | Teflon |
| Electrode Insulation Material | ABS | ABS |
| Electrode Dimensions | Standard Blade Electrode 2.38 | |
| mm x 70 mm | Standard Blade Electrode 2.38 | |
| mm x 70 mm | ||
| Insulating collar Materials | ABS | ABS |
| Handle Length | 145 mm | 165 mm |
| Effective Electrode Length | 45 mm | 45 mm |
| Total Device Length | 190 mm | 210 mm |
| Cable Material | Blue PVC Cable | Blue PVC Cable |
| Standards Applied | IEC 60601-1, IEC 60601-2-2, | |
| ISO 11135, ISO 11607 | IEC 60601-1, IEC 60601-2-2, | |
| ISO 11135, ISO 11607 | ||
| Biocompatibility | Conforms to ISO 10993 | Conforms to ISO 10993 |
| Labeling | Conforms to 21 CFR Part 801 | Conforms to 21 CFR Part 801 |
| Performance | Conforms to IEC 60601-1, and | |
| IEC 60601-2-10, Part 2 | ||
| particular requirements for the | ||
| basic safety and essential | ||
| performance of high frequency | ||
| surgical equipment and high | ||
| frequency surgical accessories. | ||
| Performance conforms to the | ||
| requirements specified in | ||
| "Premarket Notification | ||
| (510(k)) Submissions for | ||
| Electrosurgical Devices for | ||
| General Surgery | Conforms to IEC 60601-1, and | |
| IEC 60601-2-10, Part 2 | ||
| particular requirements for the | ||
| basic safety and essential | ||
| performance of high frequency | ||
| surgical equipment and high | ||
| frequency surgical accessories. | ||
| Performance conforms to the | ||
| requirements specified in | ||
| "Premarket Notification | ||
| (510(k)) Submissions for | ||
| Electrosurgical Devices for | ||
| General Surgery | ||
| Stability and Shelf Life | 3 Years | 3 Years |
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Image /page/6/Picture/0 description: The image shows a logo with a blue globe on the left and the text "荣孚康 RFK" on the right. The globe is a network of interconnected nodes, suggesting a global network or connection. The text is in Chinese and English, with a horizontal line underneath it.
9. Non-Clinical Bench Testing:
Thermal Effects on Tissue
In accordance with the nonbinding FDA guidance on "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery", part XI-E, the thermal effects on animal tissue of our device was compared with the predicate device K192542
Ex-vivo kidney, liver, and muscle tissues were used and the thermal damage zone sizes were compared for length, width, and depth.
These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device.
The non-stick performance of our non-stick electrode was found to be similar to the predicate device but without occurring holes and craters as in the predicate device's non-stick coating.
Third party electrical testing:
The device K231405 successfully passed the following electrical tests:
- Conducted Emmisions (150kHz-30MHz)
- Radiated Emissions (30MHz-1GHz)
- Radiated Emissions (1GHz-18GHz)
- Electrostatic Discharge (ESD)
- Radio frequency electromagnetic field radiation immunity
- Power frequency magnetic field
All other EMC tests are not applicable to our device.
The testing was conducted by:
Organization Name: Suzhou Yipin Quality Technical Service Co., Ltd. Institutional Address: No. 558, Fenhu Avenue, Lili Town, Wujiang District,
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Image /page/7/Picture/0 description: The image shows a logo with a blue globe on the left and the text "荣孚康 RFK" on the right. The globe is surrounded by a network of lines and dots, suggesting a global connection. The text is in Chinese and English, with a blue line underneath. The logo appears to represent a company or organization with a global reach.
Suzhou City, Jiangsu Province Test Location Name: Suzhou Yipin Quality Technical Service Co., Ltd. Industrial Park Branch Test Location Address: South side of Building B, No. 5 Minsheng Road, Suzhou Industrial Park 215028 www.epintek.com Tel: 0512-67997780
Third party biocompatibility testing was performed by:
Sanitation & Environment Technology Institute, Soochow University No.199 Ren'ai Road, Suzhou Industrial Park, China Postcode 215123, www.sudatest.com. Tel: Direct: +86 512 65880038, Free: 4001078828, Email: med(@sudatest.com
Subject device package integrity and functional performance tests were performed in-house in our Jiangsu facilities after aging and real-time stability tests to confirm the proposed shelf life.
10.Conclusion:
The device has been shown to be substantially equivalent to the predicate device in terms of performance and physical and technological characteristics. The devices passed all tests both in-house and by third party qualified labs. It has been deemed safe and conforms to the standards discussed above.