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).

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for a medical device: a Sterile Single Use Electrosurgical Pencil with Non-Coated and Non-Stick Electrode. While it describes the device, its intended use, and substantial equivalence to a predicate device, it does not contain the level of detail typically found in a clinical study report or a submission for an AI/ML-based medical device that would include specific acceptance criteria for algorithm performance, sample sizes for test sets, expert ground truth establishment, or MRMC studies.

The document focuses on "Non-Clinical Bench Testing" to demonstrate substantial equivalence, primarily comparing physical characteristics, energy type, sterilization, and material properties, as well as thermal effects on tissue and electrical safety (EMC).

Therefore, based on the provided text, I cannot extract the information required to answer your prompt about acceptance criteria and a study proving the device meets those criteria, as it would be relevant for an AI/ML-based device. The device in question is a physical instrument, and its performance evaluation relies on different types of testing.

However, I can interpret the available information to frame a response in the context of what is provided for this electrosurgical pencil.

Interpretation Based on Provided Document (Electrosurgical Pencil - Not an AI/ML Device):

This document describes the regulatory submission for a physical medical device, an electrosurgical pencil. The "acceptance criteria" in this context are not for an algorithm's performance (e.g., accuracy, sensitivity, specificity) but rather for the device's physical and functional characteristics demonstrating substantial equivalence to a legally marketed predicate device. The "study" proving acceptance is the non-clinical bench testing performed.

Here's how the information can be mapped:

1. A table of acceptance criteria and the reported device performance:

Since this is not an AI/ML device with performance metrics like accuracy or AUC, the "acceptance criteria" are implicitly the functional and safety equivalence to the predicate device. The "reported device performance" are the results of the bench tests confirming this equivalence.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate K192542)	Reported Device Performance (Summary from Non-Clinical Bench Testing)
Intended Use Equivalence: Devices for cutting and coagulating soft tissue via high-frequency electrical current.	Subject device has the same intended use as the predicate.
Technological Characteristics Equivalence: - Energy Type: High-Frequency Monopolar - Sterilization Type: EO Sterilization - Single Use - Electrode Type: Monopolar - Electrode Material: Stainless Steel - Standards Applied: IEC 60601-1, IEC 60601-2-2, ISO 11135, ISO 11607 - Biocompatibility: Conforms to ISO 10993 - Labeling: Conforms to 21 CFR Part 801 - Stability and Shelf Life: 3 Years	All characteristics are identical or demonstrably equivalent. - Electrode non-stick coating: Subject device uses Silicon oxide; predicate uses Teflon. Demonstrated to be "similar" in performance without craters. - Handle Length: Subject: 145mm; Predicate: 165mm. (Difference noted, but not deemed critical enough to prevent equivalence). - Total Device Length: Subject: 190mm; Predicate: 210mm. (Difference noted, but not deemed critical enough to prevent equivalence).
Thermal Effects Equivalence: Similar thermal damage zone sizes on ex-vivo tissues (kidney, liver, muscle).	"These tests showed that the thermal effects of our electrode are virtually identical to those shown in the predicate device."
Non-Stick Performance Equivalence: Similar non-stick performance to predicate.	"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."
Electrical Safety (EMC) Compliance: Pass specified electrical tests.	"The device K231405 successfully passed the following electrical tests: Conducted Emissions, Radiated Emissions (30MHz-1GHz, 1GHz-18GHz), Electrostatic Discharge (ESD), Radio frequency electromagnetic field radiation immunity, Power frequency magnetic field."
Package Integrity & Functional Performance for Shelf Life: Maintain integrity and function after aging.	"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."

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a numerical count of units tested. For the "Thermal Effects on Tissue", it mentions "Ex-vivo kidney, liver, and muscle tissues were used." The quantity of each tissue type or the number of device samples tested is not provided. For electrical testing, it's typically a set number of units for compliance, but not specified here.
Data Provenance: The thermal effects and package integrity/functional performance tests were conducted "in-house in our Jiangsu facilities." Electrical (EMC) testing was conducted by "Suzhou Yipin Quality Technical Service Co., Ltd." in Suzhou, China. Biocompatibility testing was performed by "Sanitation & Environment Technology Institute, Soochow University" in Suzhou, China. This indicates retrospective testing performed specifically for the 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This concept is not applicable here as the device is a physical instrument, not an AI/ML algorithm requiring expert annotations for ground truth on images or data. The "ground truth" for this device's performance is established by direct physical measurements, electrical tests, and tissue studies.

4. Adjudication method for the test set:

Not applicable for this type of device testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI/ML device that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" for this medical device's performance relies on:

Direct measurements and physical properties: Comparing specifications like dimensions, materials, and sterile status to the predicate device.
Ex-vivo tissue studies: For thermal effects, the "ground truth" is the empirically measured thermal damage zone size on animal tissues, compared to the predicate device's effects.
Standardized electrical test results: Compliance with international electrical safety standards.
Material properties and biocompatibility studies: Compliance with ISO standards for materials and biological safety.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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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.

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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.

MarkTrumbore -S	Digitally signed byMark Trumbore -SDate: 2024.01.1810:07:00 -05'00'
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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) 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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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:

1. Non coated electrode AE-EBD
1. 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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made by Cathay Manufacturing Corp.

5. Product Description:

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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FIGURE 5-1: SUMMARY OF TECHNOLOGICAL CHARACTERISTICS AND PERFORMANCE TESTING

	Subject Device: K231405	Predicate Device: K192542
Intended Use	The devices are used to cut andcoagulate soft tissue by meansof high frequency electricalcurrent during an electrosurgicalprocedure.	The devices are used to cut andcoagulate soft tissue by meansof high frequency electricalcurrent during an electrosurgicalprocedure.
Device Description	This device is intended to beused as a hand-switchingmonopolar accessory inconjunction with a compatibleelectrosurgical generator fortissue cutting and coagulation.The distal end of the pencil hasa 3/32" (2.36mm) collet that willaccept a variety ofelectrosurgical electrodes with3/32" (2.38mm) diameter shafts.	This device is intended to beused as a hand-switchingmonopolar accessory inconjunction with a compatibleelectrosurgical generator fortissue cutting and coagulation.The distal end of the pencil hasa 3/32" (2.36mm) collet that willaccept a variety ofelectrosurgical electrodes with3/32" (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 2.38mm x 70 mm	Standard Blade Electrode 2.38mm 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, andIEC 60601-2-10, Part 2particular requirements for thebasic safety and essentialperformance of high frequencysurgical equipment and highfrequency surgical accessories.Performance conforms to therequirements specified in"Premarket Notification(510(k)) Submissions forElectrosurgical Devices forGeneral Surgery	Conforms to IEC 60601-1, andIEC 60601-2-10, Part 2particular requirements for thebasic safety and essentialperformance of high frequencysurgical equipment and highfrequency surgical accessories.Performance conforms to therequirements specified in"Premarket Notification(510(k)) Submissions forElectrosurgical Devices forGeneral 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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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.

Regulation Number and Section

§ 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.