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

Anchoring to affix jejunal feeding tubes to the wall of the small bowel.
As a supplementary method, closure of GI 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, Plastic Coated Spring Tube / Spring Tube and Handle. EO Sterilization and use for single use only.
For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Hemoclip." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device submission might.

Therefore, many of the requested elements for an AI/ML device study (like sample size for test/training, number of experts, adjudication methods, MRMC studies, and detailed ground truth establishment) are not applicable or not present in this document. This document describes a traditional medical device clearance, not an AI/ML product.

However, I can extract information related to the acceptance criteria and performance data that is provided for this traditional device.

Here's an attempt to answer your request based on the provided text, while noting where information is not available due to the nature of the submission (traditional medical device vs. AI/ML):

Device: Hemoclip (Endoscope Clipping Device)
Type of Device: Traditional Medical Device (Class II)

1. Table of Acceptance Criteria and the Reported Device Performance

The submission states, "The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device."

While specific numeric acceptance criteria values are not provided in this summary, the document does list the performance tests conducted, implying these tests were used to demonstrate adherence to design specifications and substantial equivalence.

Acceptance Criterion (Implied)	Reported Device Performance (Summary)
Biocompatibility	Meets ISO 10993 standards (e.g., ISO 10993-5, -10, -11, -3, -6)
Sterility	Meets ISO 11135 standards
Mechanical Performance	Meets design specifications and shows substantial equivalence to predicate device. Specific tests performed:
- Clip Releasing Force	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Open and Close	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Clamping Strength	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Tensile Strength	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Separation Force	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Rotation property	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Matching with Endoscope	Performance not detailed, but results were acceptable to demonstrate substantial equivalence.
- Removability Performance	Demonstrated for the new "removable" feature (510 Family). Bench tests were done.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size: Not specified in the provided summary. Performance testing was "non-clinical bench test."
Data Provenance: Bench test data. No country of origin or retrospective/prospective distinction is relevant for these types of bench tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Not Applicable. For mechanical and biocompatibility testing of a physical medical device, "experts" in the sense of medical professionals establishing ground truth for diagnostic purposes are not relevant. Testing is primarily objective and based on engineering and material science standards.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication is typically for resolving discrepancies in human expert labeling or diagnosis in AI studies. For physical device performance testing, adjudication methods are not typically used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not Applicable. This is a traditional medical device, not an AI-assisted diagnostic device. No human-in-the-loop study involving medical image readers was conducted or is relevant for this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not Applicable. This is a physical medical device (a Hemoclip), not a software algorithm.

7. The Type of Ground Truth Used

For the performance data, the "ground truth" is defined by the design specifications and international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterility, and implied engineering specifications for mechanical properties). There is no "true positive/negative" ground truth as would be established for a diagnostic device.

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not Applicable. As there is no training set, there's no ground truth to establish for it.

Summary for the Hemoclip K211787 Submission:

This 510(k) submission for the Hemoclip is for a traditional physical medical device used for endoscopic clip placement. The "acceptance criteria" revolve around established engineering design specifications, biocompatibility standards (ISO 10993), and sterility standards (ISO 11135). The "study" proving it meets these criteria consisted of non-clinical bench testing. The data presented demonstrates substantial equivalence to a legally marketed predicate device (K172727) by showing that differences do not raise new questions of safety or effectiveness. The concept of "ground truth" as applied to AI/ML diagnostics (expert consensus, pathology, outcomes) does not apply here; rather, the device's performance is objectively measured against predetermined engineering and material standards.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

March 3, 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: K211787 Trade/Device Name: Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: January 26, 2022 Received: February 2, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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,

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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Indications for Use

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

510(k) Number (if known) K211787

Device Name

Hemoclip

Indications for Use (Describe)

The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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
· 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 GI 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)

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)

Page 1 of 1

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Image /page/3/Picture/0 description: The image contains a logo with a blue and green circular design on the left, and the text "AGS MEDTECH" in English and Chinese on the right. The circular design consists of three blue curved shapes that converge towards the center, with a green triangle in the middle. The text "AGS MEDTECH" is written in a simple, sans-serif font, and the Chinese characters below it are in a traditional style.

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, Hangzhou, Zhejiang 311106 China
EstablishmentRegistration Number:	3010288205
Registration Status:	Active
Contact Person:	Yanping FuPhone: 0086-15958493282Fax: 0086-0571-87671225Email: fuyp@bioags.com
Date Prepared:	Jun,1,2021

5.2 Proposed Device

Trade Name:	/
Device Name:	Hemoclip
Common Name:	Endoscope Clipping Device
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

Trade Name:	/
Device Name:	Hemoclip
Common Name:	Endoscope Clipping Device
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

5.4 Device Description

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube . Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube

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Image /page/4/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the circular design is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters.

K211787 Page 2 of 5

and Handle. EO Sterilization and use for single use only.

For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

5.5 Indication for use statement

The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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

● Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

As a supplementary method, closure of GI 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 devices. The differences between the Hemoclip and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

Item		Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device(K172727)Hangzhou AGS MedTech Co.,Ltd.	Comparion
	Model number	510 Family	510 Family, 543 Family,550 Family	Similar, only510 family inthis submission.
Technical	Principle ofoperation	The clip is opened or closed byoperating the sliding handle. Afterpositioning and clamping the relatedtissues, the sliding handle is operatedto separate the clip components fromthe delivery device components, andthe delivery device then exits thehuman digestive tract. The clipremained in the alimentary tract forabout 1-2 weeks, fell off naturally andwas discharged through the intestineand anus.	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 thedelivery device components,and the delivery device thenexits the human digestive tract.The clip remained in thealimentary tract for about 1-2weeks, fell off naturally and	Different.Our proposeddevice 510family could beremoved byspecifiedremoval device.
Item	Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device(K172727)Hangzhou AGS MedTech Co.,Ltd.	Comparion
	For 510 series, the released clip couldbe removed by specified instruments.There is a locking hook at the end ofthe clips, when the clip part releasedafter the closing movement, thelocking hook forms a buckle with thegroove at the lower end of the fraptube, making the two clips self-locking and closing, so as to achievemechanical suture of the tissue at thelesion. Intraoperative, when operatorsfind close position is not ideal, needto be adjusted to remove the releasedand closed clip head, they could takea snare product, since the endoscopicclamp inserts, in the perspective ofendoscopic, the snare loop goes intothe grooves, gradually tightening thesnare loop, apply a pressure to thelocked hook, press the hooks in,release the lock buckle, so that thetwo closed clips open, and the closedclip head leave the original lesionsite; The snare loop tightens theopened clip head and exits from thehuman digestive tract together withthe endoscope. Then the endoscopewas reintroduced into the humandigestive tract and the operationcontinued.	was discharged through theintestine and anus
Openingspan	9 mm,11 mm,13 mm,16 mm,18mm	9mm, 11mm, 13mm,16mm	Different.We add 18mmopening spanfor moreoptions fordoctors.
Working length	165cm, 195cm, 230cm	165cm, 195cm, 230cm	Same.
Item		Proposed deviceHangzhou AGS MedTech Co., Ltd.	Predicate device(K172727)Hangzhou AGS MedTech Co., Ltd.	Comparion
	Removableperformance	Yes	No such performance	Different, ourproposed 510Family addremovableperformance.Bench testshave been donefor proposeddevice
	Biological	Metallicmaterialscontacting withhuman body	Clip part: SUS631, SUS304Spring end: SUS303;Spring Tube: SUS304;Plastic Coated Spring Tube: SUS304, PE	Clip part: SUS631, SUS303Connected end: SUS 303Spring Tube: SUS304;Plastic Coated Spring Tube:SUS304, PE	SimilarDifferent.Biocompatibility testshave been donefor thedifference.Biologicalrisks areacceptable.
			Biocompatibility	ISO 10993-5:2009, ISO 10993-10:2010,ISO 10993-11:2017, ISO 10993-3:2014ISO 10993-6:2016	ISO 10993-5:2009, ISO10993-10:2010ISO10993-11:2006, ISO10993-3:2014	SimilarStandard update

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Image /page/5/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular symbol with three curved shapes in blue and green, arranged in a triangular pattern. To the right of the symbol, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The text is in a simple, sans-serif font and is horizontally aligned.

Section 5 510(k) Summary
Hemoclip

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Image /page/6/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters.

Section 5 510(k) Summary
Hemoclip

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Image /page/7/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company.

5.7 Applicable Guidance Document NA

5.8 Performance Data

The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.

Following tests was conducted in our non-clinical bench test:

Clip Releasing Force, Open and Close, Clamping Strength, Tensile Strength, Separation Force, Rotation property, Matching with Endoscope, Removability Performance.

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 devices.

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.