1. Endoscopic marking,
1. Hemostasis for:
Mucosal/sub-mucosal defects <3cm
Bleeding ulcers
Arteries<2mm
Polyps<1.5cm in diameter
Diverticula in the colon
Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

As a supplementary method, closure of digestive tract luminal perforations<20mm that can be treated conservatively.

Device Description

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube. Release part consists of Spring End, Spring hose near clip end, Connect end, Plastic Coated Spring Tube / Spring Tube and Handle part. EO Sterilization and use for single use only. For our proposed Hemoclip, the release part could connect and release the clips repeatedly.

We include 5 series for this submission, 55501series, 55502 series, 55504 series and 55505 series. 55501 series and 55502 series are models consist of release part and clip part, and the release part and clip part are already combined, no additional separate clips include, 55501series and 55502 series are reloadable, the release part could connect and release clips repeatedly. 55503 series are models only consist of separate clip part, and the release part of 55501, 55502, 55503 and 55504 series can connect with the separate clip (55503 series) repeatedly. 55504 and 55505 series are models consist of one preloaded Hemoclip (consist of release part and clip part, and the release part and clip part are already combined) and additional separate clips, 55504 series and 55505 series are reloadable, the release part can connect separate clips and release clips repeatedly.

AI/ML Overview

The provided text describes a 510(k) summary for a medical device called Hemoclip. This document does not pertain to an AI/ML device, therefore, the requested information regarding acceptance criteria and study details for such a device is not applicable. The Hemoclip is a medical device for endoscopic clip placement and its clearance is based on substantial equivalence to a predicate device, not on AI/ML performance metrics.

Specifically, the document states:

No Clinical test is included in this submission. (Section 5.9)
The performance data provided relates to non-clinical performance (shelf life validation, packaging validation, biocompatibility, and sterility) to meet design specifications and show substantial equivalence to the predicate device (Section 5.8).

As such, I cannot extract the acceptance criteria, study details, human reader performance, standalone algorithm performance, or ground truth information relevant to an AI/ML device from this document.

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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

July 12, 2022

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

Re: K213143

Trade/Device Name: Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: May 27, 2022 Received: June 6, 2022

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,

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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Indications for Use

510(k) Number (if known) K213143

Device Name Hemoclip

Indications for Use (Describe)

The Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:

1. Endoscopic marking,
1. Hemostasis for:
· Mucosal/sub-mucosal defects <3cm
· Bleeding ulcers
· Arteries<2mm
· Polyps<1.5cm in diameter
· Diverticula in the colon
1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
1. As a supplementary method, closure of digestive tract luminal perforations <20mm that can be treated conservatively

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/1 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 circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The Chinese characters are likely the translation of the company name.

510(k) Summary Hemoclip

510(k) Summary (K213143)

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
Establishment Registration Number:	3010288205
Registration Status:	Active
Contact Person:	Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671225Email: fuyp@bioags.com
Date Prepared:	July. 21, 2021

5.2 Proposed Device

Trade Name:	Hemoclip
Device Name:	Hemoclip
Common Name:	Hemoclip
Regulation class:	Class II
Regulation Number:	876.4400
Regulation Description:	Hemorrhoidal ligator
Review Panel:	Gastroenterology/Urology
Product Code:	PKL
Product Code Name:	Hemostatic Metal Clip For The Gi Tract

5.3 Predicate Device and Reference Device

5.3.1Predicate Device

Trade Name:	Hemoclip
Device Name:	Hemoclip
Common Name:	Hemoclip
510(k) Number:	K172727
Regulation class:	Class II
Regulation Number:	876.4400
Regulation Description:	Hemorrhoidal ligator
Review Panel:	Gastroenterology/Urology
Product Code:	PKL
Product Code Name:	Hemostatic Metal Clip For The Gi Tract
5.3.2 Reference Device
Trade Name:	Single Use Reloadable Clip Applicator,

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Image /page/4/Picture/1 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes intertwined, forming a triangular space in the center filled with green. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it.

510(k) Summary Hemoclip

	Clip, Long Clip, Short Clip, Super Short Clip
Device Name:	Single Use Reloadable Clip Applicator,Clip, Long Clip, Short Clip, Super Short Clip
Common Name:	Endoscopic Clipping Device
510(k) Number:	K183590
Regulation class:	Class II
Regulation Number:	876.4400
Regulation Description:	Hemorrhoidal ligator
Review Panel:	Gastroenterology/Urology
Product Code:	PKL
Product Code Name:	Hemostatic Metal Clip For The Gi Tract

Trade Name:	Lockado™ Repositionable Hemostasis Clip
Device Name:	Lockado™ Repositionable Hemostasis Clip
Common Name:	Endoscopic Clipping Device
510(k) Number:	K202333
Regulation class:	Class II
Regulation Number:	876.4400
Regulation Description:	Hemorrhoidal ligator
Review Panel:	Gastroenterology/Urology
Product Code:	PKL
Product Code Name:	Hemostatic Metal Clip For The Gi Tract

5.4 Device Description

5.5 Indication for use statement

The Hemoclip is indicated for endoscopic clip placement within the digestive tract for the purpose of:

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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" and "安杰思医学" to the right of the design. The circular design appears to be made up of three curved shapes, with the blue shapes on the outside and the green shape in the center.

510(k) Summary Hemoclip

1. Endoscopic marking,
1. Hemostasis for:
Mucosal/sub-mucosal defects <3cm
Bleeding ulcers
Arteries<2mm
Polyps<1.5cm in diameter
Diverticula in the colon
Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection
1. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

As a supplementary method, closure of digestive tract luminal perforations<20mm that can be treated conservatively.

5.6 Comparison of Technology Characteristics

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

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Image /page/6/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle around a green center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The overall design is clean and professional, suggesting a company in the medical technology field.

K213143
Page 4 of 5

Section 5 510(k) Summary Hemoclip

Table 5.6 Comparison of technical characteristics
	Item	Proposed deviceHangzhou AGS MedTech Co.,Ltd.	Predicate device (K172727)Hangzhou AGS MedTech Co.,Ltd.	Comparion
Technical	Principle of operation	The clip is opened or closed byoperating the sliding handle.After positioning and clampingthe related tissues, the slidinghandle is operated to separatethe clip components from therelease part, and the releasepart then exits the humandigestive tract. The clipremained in the alimentarytract for about 1-2 weeks, felloff naturally and wasdischarged through theintestine and anus.And the release part couldconnect with additionalseparate clip part repeatedly, tobe a new whole Hemoclip, andrealize the intended use.	The clip is opened or closed byoperating the sliding handle.After positioning and clampingthe related tissues, the slidinghandle is operated to separatethe clip components from therelease part, and the releasepart then exits the humandigestive tract. The clipremained in the alimentarytract for about 1-2 weeks, felloff naturally and wasdischarged through theintestine and anus.	Different.Ourproposeddevice 555family couldrepeatedlyconnect andrelease clip.
	Configuration	For 55501 and 55502 series,consists of release part and clippart;For 55504 and 55505 series,there's additional clips forchange; For 55503 series, it'sthe separate clip part.	Consists of release part andclip part;	Different.Ourproposeddevice'srelease partcouldconnect andrelease theclipsrepeatedly.
	Opening span	9 mm,11 mm,13 mm,16mm,18mm	9mm, 11mm, 13mm,16mm	Different.We add18mmopening spanfor moreoptions fordoctors.
	WorkingLength	1650mm, 1950mm, 2150mm,2300mm	1650mm, 1950mm, 2300mm	Similar. Ourproposeddevice
	Item	Proposed deviceHangzhou AGS MedTech Co.,Ltd.	Predicate device (K172727)Hangzhou AGS MedTech Co.,Ltd.	Comparion
	Connect andrelease the cliprepeatedlyperformance	Yes	No	Hemocliphave moreworkinglength.Different.Ourproposeddevice haveconnect andrelease thecliprepeatedlyperformance.

Тэы teristic fr al ch 560 -ic hnic

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Image /page/7/Picture/1 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, there is Chinese text in black. The logo appears to be for a medical technology company.

Section 5 510(k) Summary Hemoclip

5.7 Applicable Guidance Document

5.8 Performance Data

The Hemoclip meets all design specifications and medical device standards for shelf life validation (ISO 11607-1/2 and ASTM F 1980-16), packaging validation (ISO 11607-1/2), 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 Hemoclip is substantially equivalent to the predicate device.

Regulation Number and Section

§ 876.4400 Hemorrhoidal ligator.

(a)
Identification. A hemorrhoidal ligator is a device used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or band placed around the hemorrhoid.(b)
Classification. Class II (special controls). Except for a hemostatic metal clip intended for use in the gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.