The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.

Device Description

The Disposable Electrosurgical pencils are used for the cutting and coagulation of soft tissue and have a conductive cable which is designed for use with high frequency surgical generator (Electrosurgical unit). The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad). The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available.

AI/ML Overview

The provided text is a 510(k) Summary for the Cathay Manufacturing Corp.'s Disposable Electrosurgical Pencils (CP1001 Series). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner of a clinical trial for a novel AI/software medical device.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size and ground truth establishment for training set) are not applicable or not provided in this regulatory submission for a hardware device.

However, I can extract the acceptance criteria and the reported device performance based on the provided document within the context of a 510(k) submission, which relies heavily on bench testing and comparison to an existing device.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Description	Reported Device Performance and Conformance
Indications for Use: Used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. Disposable for single use, supplied sterile with electrode tip.	Conforms: The subject device has identical Indications for Use as the predicate device.
Classification: 21 CFR 878.4400, Class II, Product Code GEI.	Conforms: The subject device has identical Classification, Class, and Product Code as the predicate device.
Operational Characteristics (e.g., energy source, sterility, sterilization method, electrode type, materials, dimensions, cable, foot control): Consistent with the predicate device.	Conforms: The subject device is largely identical or highly similar to the predicate device in essential components, raw materials, physical features (e.g., RF Energy, Sterile and single use, EO sterilization, Monopolar electrode, Stainless steel electrode material, ABS insulation, standard hex blade electrode 2.36 x 70mm, ABS shaft material, Blue PVC cable, 3m/5m cable length, foot control option). Minor differences in handle length (95mm vs 90mm) and total length (145mm vs 140mm) were noted but not deemed to impact equivalence. The predicate device also had "other shape and dimensions" for electrodes, while the subject device specified "standard hex blade electrode." This was not highlighted as a non-conformance.
Biocompatibility: Conforms to ISO 10993.	Conforms: "Conforms to ISO10993." Biocompatibility performance equivalence evidence of the proposed electrode can be demonstrated.
Labeling: Conforms to 21 CFR Part 801.	Conforms: "confirm to 21 CFR Part 801."
Performance (Electrical Safety & Essential Performance): Conforms to IEC 60601-1 and IEC 60601-2-2, and requirements specified in 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery'.	Conforms: "Performed by Third party, TUV Rheinland, through testing following IEC 60601-1:2005+CORR. 1(2006) + CORR.2(2007) and IEC 60601-2-2:2009." Performance conforms to the requirements.
Thermal Effects on Tissues: Similar/equivalent performance to the predicate device.	Conforms: Evaluation performed using three tissue types (liver, kidney, muscle) by measuring thermal damage zone sizes (length, width, depth). "The comparison tests conclusively prove that the proposed electrode is similar / equivalence in the performance of thermal effects on tissues as the predicate device device."
Stability and Shelf Life: 3 years shelf life, with package integrity and functional performance maintained.	Conforms: "Stability and shelf life: 3 year." Package integrity and functional performance testing completed following aging and real-time stability tests to support the proposed shelf life.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Test Set Sample Size: Not explicitly stated as a number of devices. The "bench testing" involved using "three tissue types, liver, kidney and muscle tissue" for thermal effects evaluation. The number of devices tested for electrical safety, biocompatibility, and shelf-life is not specified.
Data Provenance: The device manufacturer (Cathay Manufacturing Corp.) is located in Shanghai, China. The testing was conducted by a "Third party, TUV Rheinland," which is a German-based certification body with global operations. The location of the specific testing labs is not mentioned. The studies were conducted specifically for this 510(k) submission, implying they were prospective relative to the submission date.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a hardware device. Ground truth, in the context of AI/software, refers to definitively correct outputs for comparison. For this device, ground truth relates to established engineering standards (IEC, ISO) and physical measurements in a lab setting, not expert clinical interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically for resolving discrepancies in expert interpretation, which is not relevant for the type of bench testing performed for this device.

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 a hardware electrosurgical pencil, not an AI/software 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 a hardware electrosurgical pencil, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance evaluation is based on:
- International Electrotechnical Commission (IEC) Standards: IEC 60601-1 (General requirements for basic safety and essential performance) and IEC 60601-2-2 (Particular requirements for high-frequency surgical equipment and accessories).
- International Organization for Standardization (ISO) Standards: ISO 11135 (Sterilization of health-care products), ISO 11607 (Packaging for terminally sterilized medical devices), and ISO 10993 (Biological evaluation of medical devices).
- Regulatory Guidance: 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery.'
- Physical Measurements: Measurements of thermal damage zones in tissue models.
- Predicate Device Comparison: Performance equivalence was established by comparing the subject device's thermal effects to those of the legally marketed predicate device (K092634).

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

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

Not applicable. As above, there is no training set for this hardware device.

Summary

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July 19, 2018

Cathay Manfacturing Corp. % Ren Ren Manager No. 328, Xishe Road Maogang Town, Songjiang Area Shanghai, China 201607

Re: K170369

Trade/Device Name: Disposable Electrosurgical Pencils, CP1001 Series Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: July 3, 2018 Received: July 3, 2018

Dear Ren Ren:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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.

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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K170369

Device Name

Disposable Electrosurgical Pencils (CP1001 Series)

Indications for Use (Describe)

The Disposable Electrosurgical Pencil is used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter:	CATHAY MANUFACTURING CORP.No. 328, Xishe Road, Maogang Town, Songjiang AreaShanghai, CN 201607
Contact:	Ms. Ren, RenPhone: (86)021-57878328Email: rubyfantasy@qq.com
Date Prepared:	July. 6, 2018
Device Trade Name:	Disposable Electrosurgical Pencils
Model:	CP1001 Series
Device Common Name:	Disposable Electrosurgical Pencils
Classification Name:accessories	Electrosurgical cutting and coagulation device and
Class:	II
Classification Name:	21 CFR 878.4400
Product Code:	GEI

Predicate Device:

Device	Company	Product Code	510(k) Number
OBS DisposableElectrosurgical Pencils	Jiangmen City XinhuiBaisheng MedicalEquipment Co., Ltd	GEI	K092634

1. Indication for Use:

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2. Product Description:

The connector or plug fits into electrosurgical unit. The hand-pieces are made of plastic with two buttons (cutting and coagulation buttons) in the case of the handcontrolled pencils, while the foot controlled pencils is activated by a monopolar footswitch connected to the generator. One button or switch is to control the cutting mode, CUT, of the ESU while the other controls the coagulation mode, COAG. The applied electrosurgery, monopolar, is the emittance of the high frequency alternating current, HFAC, from the diathermy via an active electrode through the patient's body tissues and then returned back to the diathermy machine via a dispersive electrode (patient return pad).

The proposed device mainly consists of electrode tip, hand piece handle, cable, and plug. For all applied device models, only one kind of dimension of electrode tip, standard hex blade electrode is available. However, two kind of cable length, 3m or 5m, and three kind of available hand-piece color, white/blue/green color, are available

ELEMENT OFCOMPARISON	SUBJECT DEVICE	Predicate Device
		K092634OBS Disposable Electrosurgical Pencils
Indications for Use	used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.	used for cutting and coagulation to remove tissue and control bleeding by using high frequency during electrosurgical surgery with a specified Electrosurgery Unit (ESU) generator. The device is disposable for single use and supplied as sterile with an electrode tip.
Classification	878.4400	878.4400
Product Code	GEI	GEI
OTC orPrescription	For Prescription Use	For Prescription use
Energy sourcetype	RF Energy	RF Energy
Sterility and forsingle use	Yes, Sterile and for single use	Yes, Sterile and for single use
Sterilizationmethod	EO Sterilization	EO Sterilization
Monopolar orBipolar electrode	Monopolar electrode	Monopolar electrode
Electrodematerials	Stainless steel	Stainless steel
Electrodeinsulation material	ABS	ABS
Electrode coating	N/A	N/A
Electrode shapeand dimensions	standard hex blade electrode, 2.36 x 70mm	standard hex blade electrode, 2.36 x 70mm;other shape and dimensions
Shaft materials	ABS	ABS
Handle length	95 mm	90 mm

4. Summary of Technology Characteristics and Performance Testing (Comparison to the Predicate Device)

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K170369

CATHAY MANUFACTURING CORP.

Shaft length	50mm	50 mm
Total length	145mm	140mm
Shaft diameter	2.36 mm	2.36 mm
Cable materials	Blue PVC cable	Blue PVC cable
Cable length	3m or 5m	3m or 5m
Foot control model	Yes, has foot control mode	Yes, has foot control mode
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 ISO10993	Conforms to ISO10993
Labeling	confirm to 21 CFR Part 801	confirm to 21 CFR Part 801
Performance	Conforms to IEC 60601-1 andIEC 60601-2-10:2012,Part 2 particular requirements for the basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories.Performance conforms the requirementsspecified in 'Premarket Notification (510(k))Submissions for Electrosurgical Devices forGeneral Surgery'	Conforms to IEC 60601-1 andIEC 60601-2-10:2012,Part 2 particular requirements for the basicsafety and essential performance of highfrequency surgical equipment and highfrequency surgical accessories Performanceconforms the requirements specified in'Premarket Notification (510(k)) Submissionsfor Electrosurgical Devices for GeneralSurgery'
	Stability and shelflife	3 year	3 year

5. Bench Testing (non-clinical):

Compare to predicate product specified in K092634, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.

And also following the 'Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery, the proposed Disposable Electrosurgical Pencils had evaluated the Performance of Thermal effects on tissues, comparing with reference device specified in K092634. Three tissue types, liver, kidney and muscle tissue, were used for this evaluation by measuring the thermal damage zone sizes (length, width, and depth).

The comparison tests conclusively prove that the proposed electrode is similar / equivalence in the performance of thermal effects on tissues as the predicate device device.

The safety performances of subject device are demonstrated by the Third party, TUV Rheiland, through testing following IEC 60601-1:2005+CORR. 1(2006) + CORR.2(2007), Part 1General requirements for basic safety and essential performance, and IEC 60601-2-2:2009, Medical electrical equipment -Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.

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CATHAY MANUFACTURING CORP.

The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.

Package integrity and functional performance testing were completed on the subject device following aging and real time stability tests to support the proposed shelf life.

6. Conclusion:

Based on the indication for use, technology characteristics, and performance testing, the proposed product, Disposable Electrosurgical Pencils, has been shown to be appropriate for its indication for use and is considered to be substantially equivalent to the predicate device.

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.