Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

Device Description

The Bipolar Coagulation Forceps described in this submission are a sterile, single use devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.
Bipolar Coagulation Forceps consists of Handle part, plug, sheath and forceps part.

AI/ML Overview

The acceptance criteria and study proving device performance are not present in the provided text. The document is a 510(k) summary for the Bipolar Coagulation Forceps, asserting substantial equivalence to a predicate device (Coagrasper™).

The document mentions that "The Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135)." and "The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device." However, concrete acceptance criteria and detailed performance data, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies are not provided.

Specifically, the following information requested in the prompt is not available in the provided text:

Acceptance Criteria Table and Reported Performance: No such table is present. The document generally states compliance with standards but provides no specific metrics or thresholds.
Sample Size for Test Set and Data Provenance: No test set or sample size is mentioned.
Number of Experts and Qualifications for Ground Truth: No experts or ground truth establishment method for a test set are described.
Adjudication Method: Not applicable as no human-read test set is described.
Multi-reader Multi-case (MRMC) Comparative Effectiveness Study: The document explicitly states "No Clinical test is included in this submission," indicating that no human-in-the-loop study was performed.
Standalone Performance: While "non-clinical performance meets the design specification" is stated, no specific standalone performance metrics or the study details are provided.
Type of Ground Truth Used: Not applicable as no clinical test or human-read evaluation is detailed.
Sample Size for Training Set: No training set is mentioned as this is a medical device, not an AI/ML model being trained on data.
How Ground Truth for Training Set was Established: Not applicable.

The document primarily focuses on demonstrating substantial equivalence through a comparison of technological characteristics with a predicate device and adherence to general medical device standards. It lists biocompatibility tests conducted for the proposed device due to differences in materials compared to the predicate, but these are not for establishing a "ground truth" in the context of an AI/ML or diagnostic device clinical study.

In summary, the provided document does not contain the detailed study information or acceptance criteria requested, as it is a 510(k) summary focused on substantial equivalence rather than a detailed performance study report.

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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 5, 2021

Hangzhou AGS MedTech Co., Ltd. Yanping Fu RA Supervisor Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA

Re: K210406

Trade/Device Name: Bipolar Coagulation Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: Class II Product Code: KGE Dated: August 20, 2021 Received: August 26, 2021

Dear Yanping Fu:

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.

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) 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 (OS) 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,

for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) / K210406

Device Name Bipolar Coagulation Forceps

Indications for Use (Describe)

Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

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."

FORM FDA 3881 (6/20)

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K210406 Page 1 of 6

Image /page/3/Picture/1 description: The image shows the logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by the same text in Chinese characters. The logo appears to be for a medical technology company.

Section 5 510(k) Summary Bipolar Coagulation Forceps

510(k) Summary

We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.

5.1 Submitter

Submitted by/Owner:	Hangzhou AGS MedTech Co., Ltd.Building 5, Building 6, No.597 Kangxin Road YuhangDistrict, 311106 Hangzhou, Zhejiang, China
EstablishmentRegistration Number:	3010288205
Registration Status:	Active
Contact Person:	Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671225Email: fuyp@bioags.com
Date Prepared:	Feb. 07, 2021

5.2 Proposed Device

Trade Name:	/
Device Name:	Bipolar Coagulation Forceps
Common Name:	Bipolar Coagulation Forceps
Regulation class:	Class II
Regulation Number:	876.4300
Regulation Description:	Endoscopic electrosurgical unit and accessories.
Review Panel:	Gastroenterology/Urology
Product Code:	KGE
Product Code Name:	Forceps, Biopsy, Electric

5.3 Predicate Device

Trade Name:	Coagrasper™
Device Name:	Single-use Electrosurgical Hemostatic Forceps
Common Name:	Electrosurgical Hemostatic Forceps Series
510(k) Number:	K062517
Regulation class:	Class II
Regulation Number:	876.4300
Regulation Description:	Endoscopic electrosurgical unit and accessories.
Review Panel:	Gastroenterology/Urology
Product Code:	KGE
Product Code Name:	Forceps, Biopsy, Electric

5.4 Device Description

The Bipolar Coagulation Forceps described in this submission are a sterile, single use

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Image /page/4/Picture/0 description: The image shows the text "K210406" on the first line and "Page 2 of 6" on the second line. The text is in a simple, sans-serif font and is likely part of a document or report. The text suggests that this is page 2 of a 6-page document with the identifier K210406.

Image /page/4/Picture/1 description: The image contains the logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the circular design, the text "AGS MEDTECH" is written in a sans-serif font, with the Chinese characters for "Anjie Si Medical" written below.

Section 5 510(k) Summary Bipolar Coagulation Forceps

devices compatible with the working channel of endoscope. The device is used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

5.5 Indication for use statement

Bipolar Coagulation Forceps have been designed to be used with endoscopes to cauterize and coagulate or to perform hemostasis using high-frequency current within the digestive tract.

5.6 Comparison of Technology Characteristics

Our proposed device Bipolar Coagulation Forceps is substantially equivalent to the predicate devices. The differences between the Bipolar Coagulation Forceps and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

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Image /page/5/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a blue and green circular design on the left, with the text "AGS MEDTECH" in black on the right. Below the English text is the same company name in Chinese characters. The logo is simple and professional, and it is likely used to represent the company's brand.

K210406
Page 3 of 6

Section 5 510(k) Summary
Bipolar Coagulation Forceps

Table 5.6 Comparison of technical characteristics
	Item	Proposed device	Predicate device	Comparison
	Common name	Bipolar Coagulation Forceps	Single-use electrosurgical hemostatic forceps	/
	Trade name	/	Coagrasper™	/
	Model number	5461, 5462, 5463, 5464	KD-410LR	/
	510(k) submitter	Hangzhou AGS MedTechCo., Ltd.	Olympus Medical SystemsCorporation	/
	510(k) number	/	K062517	/
Technical	Principles ofoperation	Bipolar Coagulation Forcepsis an applied part ofelectrosurgical generator,using bipolar high-frequencycurrent delivered by theelectrosurgical generator tocauterize and coagulate or toperform hemostasis within thedigestive tract. We designedtwo electrodes (two forcepscup) of opposite polarityattached to the tip of itssheath. The high-frequencyelectricity flows from oneforceps cup to another forcepscup. No neutral electrode isneeded.	Monopolar Single-use electrosurgical hemostatic forceps is an applied part of electrosurgical generator, using monopolar high-frequency current delivered by the electrosurgical generator to cauterize and coagulate or to perform hemostasis within the digestive tract. The high-frequency electricity flows from the active electrode (forceps) to the neutral electrode placed on patient skin.	Similar.Both Bipolar Coagulation Forceps and Monopolar Single-use Electrosurgical Hemostatic Forceps are applied part of electrosurgical generator.Bipolar Coagulation Forceps has two electrodes (two forceps cup) of opposite polarity attached to the tip of its sheath.Thermal effect study and animal study had been conducted to demonstrate substantial
Bipolar Coagulation Forceps
	Item	Proposed device	Predicate device	Comparison
				equivalence,please refer toSection 18.2Thermal Effectstudy and 19Animal study ofthis submission.
	Structure	Bipolar Coagulation Forcepsconsists of Handle part, plug,sheath and forceps part.	Electrosurgicalhemostaticforceps consists of handlepart, plug, sheath, forcepspart, and A cord.	Similar.Electrosurgicalhemostaticforceps has a Acord whileBipolarcoagulationforceps don'thave.
	Energy Use	Bipolar Radio FrequencyCurrent	Monopolar RadioFrequency Current	Different.Thermal effectstudy andanimal studyhad beenconducted todemonstratesubstantialequivalence,please refer toSection 18.2Thermal Effectstudy and 19Animal study ofthis submission.
	Sheath tube	2.5mm	2.75mm	Similar.
	Span length	4.0mm, 5.0mm, 6.5mm,7.0mm	5.0mm	Similar.The differencewill not raiseany question ofsafety andeffectiveness.Our proposeddevice has morechoice on span
Item	Proposed device	Predicate device	Bipolar Coagulation ForcepsComparison
			length foroperators,operators couldchoose based ontheir clinicalneeds.
MinimumWorkingChannel:	3.2mm	2.8mm	Similar.
	Working length	1650mm, 1950mm, 2300mm	1650mm;	Similar.The differencewill not raiseany question ofsafety andeffectiveness.Our proposeddevice has morechoice onworking lengthfor operators,operators couldchoose based ontheir clinicalneeds.
Biological	Materials orsubstances incontact with thesame humantissue or bodyfluids	Plastic PTFE, StainlessSteel 304, Stainless SteelN, PEEK450-GL30,Ceramic, Stainless Steel630.	No exact information.	Different.Biocompatibilitytests have beendone for thedifference.Biological risksare acceptable.
	Biocompatibility	In Vitro Cytotoxicity Test:ISO 10993-5: 2009;Skin sensitization Test: ISO10993-10: 2010;Intracutaneous ReactivityTest: ISO 10993-10: 2010;Acute Systemic Toxicity Test:ISO 10993-11:2017;Pyrogenicity: ISO10993-11:2017;	No exact information.

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Image /page/6/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three curved shapes in blue and green. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The logo appears to represent a company in the medical technology field.

K210406
Page 4 of 6

Section 5 510(k) Summary
Bipolar Coagulation Forceps

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K210406
Page 5 of 6

Image /page/7/Picture/1 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters that translate to "Anjie Si Medical".

Section 5 510(k) Summary
Bipolar Coagulation Forceps

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Image /page/8/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular symbol with three curved shapes in blue and green. To the right of the symbol, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters. The logo appears to be for a medical technology company.

K210406 Page 6 of 6

Section 5 510(k) Summary Bipolar Coagulation Forceps

5.7 Applicable Guidance Document NA

5.8 Performance Data

The Bipolar Coagulation Forceps meets all design specifications and medical device standards for electrosurgical safety (IEC 60601), biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.

5.9 Clinical Test

No Clinical test is included in this submission.

5.10 Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, Based on the information provided in this premarket notification, Hangzhou AGS MedTech Co., Ltd has demonstrated that proposed device Bipolar Coagulation Forceps is substantially equivalent to the predicate devices.

Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).