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
1. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

Device Description

The Hemoclip is a sterile device consisting of a pre-loaded, radiopaque, single-use, endoscopic clipping device consisting of two main components: the delivery system and the clip. The delivery system consists of a handle and delivery catheter. The delivery system is constructed using stainless steel, and polyester materials. The delivery system will allow for the device to rotate at the distal end. The delivery system is offered in 1650mm, 1950mm and 2300mm working lengths. The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories included with this device.

AI/ML Overview

The provided document, a 510(k) Summary for the Hemoclip, does not contain information about acceptance criteria for device performance based on diagnostic metrics (e.g., sensitivity, specificity) derived from a study involving human readers or ground truth established by experts.

Instead, this document focuses on establishing substantial equivalence for a medical device (Hemoclip) through a series of bench tests and comparison to predicate devices, without involving clinical trials or diagnostic performance studies in the way one might expect for AI/Software as a Medical Device (SaMD) clearances.

Therefore, many of the requested categories cannot be answered from the provided text.

Here's what can be extracted:

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

The document lists several bench tests that were performed. The acceptance criteria are implicitly "passing" for each test.

Test Name	Acceptance Criteria (Implicit)	Reported Device Performance
Open and Close	Passing	Passing
Clip releasing force	Passing	Passing
Clamping strength	Passing	Passing
Tensile Strength	Passing	Passing
Separation Force	Passing	Passing
Rotation property	Passing	Passing
Corrosion	Passing	Passing
Appearance	Passing	Passing
Size	Passing	Passing

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

This information is not provided in the document. The tests mentioned are bench tests, not clinical studies involving patient data.

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)

This information is not applicable/provided. Ground truth by medical experts (e.g., radiologists) is typically established for diagnostic performance studies, which were not conducted for this device clearance.

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

This information is not applicable/provided. Adjudication methods are typically used for establishing ground truth in clinical/diagnostic studies.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No Clinical test is included in this submission." This device is a mechanical medical instrument, not an AI/SaMD.

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

No, a standalone performance study was not done. This device is a mechanical medical instrument, not an AI/SaMD.

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

This information is not applicable/provided. The "ground truth" for the bench tests would be defined by engineering specifications and physical test standards (e.g., a force gauge measurement, a caliper measurement), not medical ground truths like pathology or expert consensus.

8. The sample size for the training set

This information is not applicable/provided. There is no mention of a "training set" as this device is not a machine learning or AI product.

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

This information is not applicable/provided. There is no mention of a "training set" or its ground truth establishment.

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). 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

April 16, 2018

Hangzhou AGS MedTech CO., Ltd % Ethan Liu RA Specialist Shanghai Thinkwell Consulting Co., Ltd. Xinling Rd., 211/6F Shanghai, 201100 China

Re: K172727 Trade/Device Name: Hemoclip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: March 5, 2018 Received: March 8, 2018

Dear Ethan Liu:

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 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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).

Sincerely,

Image /page/1/Picture/6 description: The image shows the name "Benjamin R. Fisher -S" in a large, bold font. The text is black and appears to be centered on a white background. The letters are clearly legible, and the overall impression is clean and professional.

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172727

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
1. As a supplementary method, closure for GI tract luminal perforations<20mm that can be treated conservatively.

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

| Y Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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 Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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Image /page/3/Picture/0 description: The image contains a logo with a circular design on the left and text on the right. The circular design features three curved shapes in blue and green, arranged in a triangular pattern. To the right of the logo, the text "AGS MEDTECH" is written in a sans-serif font, with smaller text below it in Chinese characters. The text and logo are aligned horizontally, creating a balanced composition.

K172727 Page 1 of 4

510(k)Summarv

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

5.1 Submitter

Submitted by:	Hangzhou AGS MedTech CO., Ltd.Building 6, Kangxin Road No.597, Qianjiang EconomicDevelopment Area, Hangzhou, Zhejiang, 311106, China
Establishment RegistrationNumber:	Active; Awaiting Assignment Of Registration Number
Owner/Operator Number:	10052959
Contact Person:	Ethan LiuPhone:0086-15216699240Fax: 0086-21-60732022Email:xtdeepwater@126.com
Date Prepared:	Jan 18, 2017

5.2 Proposed Device

Trade Name:	Hemoclip
Common Name:	Endoscope Clipping Device
Classification:	Class II
Regulation Number	876.4400
Classification Name:	Hemorrhoidal ligator
Product Code Description:	Hemostatic Metal Clip For The Gi Tract
Product Code:	PKL

5.3 Predicate Device

K122660 - Resolution™ Hemostasis Clipping Device(Primary) K161463- SureClip(TM) Repositionable Hemostasis Clip(Secondary)

5.4 Device Description

The clip consists of a stainless steel capsule, and clip arms, a Cobalt Chrome Yoke, and a styrene tension breaker. The clip is deployed from the delivery system during use. The hemoclip jaws are engineered such that they can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. Re-opening, closing, and rotation capability may be limited by clinical circumstances and patient anatomy. There are no associated accessories

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Section 5 510(k) Summary Hemoclip

included with this device.

5.5 Indication for Use:

The hemoclip is indicated for endoscopic clip placement within the gastrointestinal tract for the purpose of:

Endoscopic marking 1.
Hemostasis for 2.
- Mucosal/sub-mucosal defects <3cm
- Bleeding ulcers ●
- . Arteries<2mm
- Polyps<1.5cm in diameter ●
- Diverticula in the colon ●
Anchoring to affix jejunal feeding tubes to the wall of the small bowel 3.
As a supplementary method, closure for GI tract luminal perforations<20mm that can be 4. treated conservatively.

5.6 Comparison of Technology Characteristics

The Hemoclip has substantially equivalent device material, design, configuration, packaging fundamental technology, manufacturing process, sterilization process and intended use as those featured in the predicate device Resolution™ Hemostasis Clipping Device, Boston Scientific Corporation, K122660. And the Hemoclip has similar characteristics in Clip Opening Width, Working Length, and Rotation with SureClip™ Repositionable Hemostasis Clip, Micro-Tech(Nanjing) Co., Ltd, K161463.

Below is a table describing the differences and similarities of the Hemoclip in comparison to the Resolution™ Hemostasis Clipping Device and the SureClip™ Repositionable Hemostasis Clip.

Device &PredicateDevices	K172727	K122660	K161463
Indications foruse	The hemoclip is indicated foruse endoscopic clip placementwithin the gastrointestinal tractfor the purpose of:1. Endoscopic marking2. Hemostasis for;- mucosal/sub-mucosal defects<3 cm- bleeding ulcers- arteries < 2cm- polyps <1.5cm in diameter- diverticula in the colon3. Anchoring to affix jejunalfeeding tubes to the wall of thesmall bowel4. As a supplemental closuremethod of luminal perforations<20mm that can be treatedconservatively.	The resolution(tm)hemostasis clipping deviceis indicated for useendoscopic clip placementwithin the gastrointestinaltract for the purpose of:1. Endoscopic marking2. Hemostasis for;- mucosal/sub-mucosaldefects <3 cm- bleeding ulcers- arteries < 2cm- polyps <1.5cm indiameter- diverticula in the colon3. Anchoring to affixjejunal feeding tubes to thewall of the small bowel4. As a supplementalmethod of luminol	The SureClip(TM)Repositionable HemostasisClip is indicated forendoscopic clip placementwithin the gastrointestinaltract for the purpose of:(1) endoscopic marking,(2) hemostasis for(a) mucosal / sub-mucosaldefects < 3cm,(b) bleeding ulcers,(c) polyps < 1.5cm indiameter,(d) diverticula in the colon,(3) as a supplementarymethod, closure of GI tractluminal perforations <20mmthat can be treatedconservatively

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Image /page/5/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 Chinese characters below it. The text is in a simple, sans-serif font.

Section 5 510(k) Summary

		perforations <20mm thatcan be treatedconservatively	Hemocli
Principle ofOperation	Endoscopic accessory used todeliver metal clips to the GItract.	Endoscopic accessory usedto deliver metal clips to theGI tract.	Endoscopic accessory usedto deliver metal clips to theGI tract.
RepositionableClip?	Yes and No (depending onmodel)	Yes	Yes
MinimumEndoscopicWorkingChannel	2.8 mm	2.8 mm	2.8 mm
Working Length	1650 mm, 1950 mm, 2350mm	1550 mm and 2350 mm	1650mm, 1950mm,2350mm,2700mm
Outer TubeDiameter	2.6 mm	2.6 mm	2.6 mm
Clip OpeningWidth	9 mm, 11 mm, 13 mm	11 mm	8mm, 11mm, 16mm
Sterilizationmethod	EO	EO	EO
Clip Materials	Stainless Steel (SUS631)	304 Stainless Steel	SUS 631, SUS316, andSUS304 (Stainless steels)

5.7 Applicable Guidance Document

5.8 Performance Data

The proposed device meets the requirements of ISO 10993 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing", ISO 11135-1 "Sterilization of Health Care products Ethylene Oxide - Part 1: Requirements for Development, Validation, and Routine Control of Sterilization processes for Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices - Part 7: ethylene oxide sterilization residuals"

The following bench tests were performed on Hemoclip: Open and Close, Clip releasing force, Clamping strength, Tensile Strength, Seperation Force, Rotation property, Corrosion, Appearance, Size. The results of all testing were passing.

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

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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 circular design, 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.

Section 5 510(k) Summary Hemoclip

demonstrated that proposed device Hemoclip is substantially equivalent to Boston Scientific Corporation's currently marketed Resolution™ Hemostasis Clipping Device, K122660 and SureClip(TM) Repositionable Hemostasis Clip, Micro-Tech(Nanjing) Co., Ltd, K161463.

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.