Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers. Arteries < 2mm. Polyps < 1.5cm in diameter, Diverticula in the colon, 3) As a supplementary method, closure of GI tract luminal perforations < 20mm that can be treated conservatively

Device Description

The proposed device is a sterile, single-use endoscopic clipping device. It is consisted of two main components: the delivery system and the clip. The delivery system is available in three different working length. The clip is deployed from the delivery system during use. The hemoclip jaws can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site.

AI/ML Overview

The provided document is an FDA 510(k) premarket notification for a medical device called the "Single Use Rotatable and Repositionable Hemoclip." This type of submission aims to demonstrate that a new device is "substantially equivalent" (SE) to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a Premarket Approval (PMA).

As such, the document does not describe a study that proves the device meets specific acceptance criteria in the manner of a clinical trial for an AI/algorithm-based device. Instead, it focuses on demonstrating equivalence through non-clinical testing and comparison to predicate devices.

Therefore, many of the requested details about acceptance criteria, test set sizes, expert involvement, and ground truth establishment (which are typical for AI/algorithm performance studies) are not applicable to this 510(k) submission.

Here's a breakdown of the information that is available and what is not for this specific product, structured to address your points as much as possible:

Acceptance Criteria and Device Performance (Not applicable in the context of an algorithm or AI performance)

This device is a mechanical medical instrument (hemoclip), not an AI or algorithm-based device. Therefore, the "acceptance criteria" here refer to meeting design specifications and demonstrating performance comparable to predicate devices through bench testing (mechanical and biocompatibility). There are no performance metrics like sensitivity, specificity, or accuracy for an AI.

Table of Acceptance Criteria and Reported Device Performance (as per non-clinical testing for a mechanical device):

Performance Test / Acceptance Criteria Category	Specific Test / Characteristic	Acceptance Criteria (Success Metric)	Reported Device Performance and Conclusion
Biocompatibility	Cytotoxicity	Comply with ISO 10993-5:2009 (No cytotoxicity)	No cytotoxicity
	Skin Sensitization	Comply with ISO 10993-10:2010 (No skin sensitization)	No skin sensitization
	Irritation	Comply with ISO 10993-10:2010 (No irritation)	No irritation
	Acute Systemic Toxicity	Comply with ISO 10993-11: 2017 (No acute toxicity)	No acute toxicity
	Sub-acute Systemic Toxicity	Comply with ISO 10993-11: 2017 (No sub-acute toxicity)	No sub-acute toxicity
	Pyrogen	Comply with USP 42 NF 37 <151> (No pyrogen)	No pyrogen
Sterilization	Method	Ethylene oxide	Ethylene oxide (Matches predicate)
	Sterility Assurance Level (SAL)	10^-6	10^-6 (Matches predicate)
	Endotoxin Limit	20EU	20EU (Matches predicate)
Shelf Life	Shelf life duration	3 years	3 years (Matches predicate)
Packaging Integrity	Seal Leaks (Dye Penetration)	Comply with ASTM F1929-15	Test results demonstrated compliance. (Specific value not provided, but deemed satisfactory)
	Seal Strength	Comply with ASTM F88/F88M-15	Test results demonstrated compliance. (Specific value not provided, but deemed satisfactory)
Dimensional Specifications	Device Dimensions	Meet design specification requirements	Dimension test performed, results demonstrated device meets design specification requirement.
Mechanical Performance	Mechanical Integrity of Clip Assembly	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.
	Clamping Strength Testing	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.
	Tensile Strength Testing	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.
	Release Force Testing	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.
	Rotation Testing	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.
	Repositionability	Not explicitly stated, but implied to be comparable to predicate	Performance test performed, no significant difference found compared to predicate devices.

Study to Prove Device Meets Acceptance Criteria

The "study" refers to the non-clinical testing described, not a clinical trial or AI performance study.

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated numerically for each non-clinical test (e.g., how many clips were tested for clamping strength). However, the general statement "Performance test was performed on both the proposed device and predicate device" implies a sufficient number of samples were tested to robustly compare performance and draw conclusions of no significant difference.
- Data Provenance: The tests were conducted internally by Anrei Medical (Hangzhou) Co., Ltd. in the People's Republic of China, as indicated by the sponsor's identification. This is non-clinical laboratory data.
- Retrospective or Prospective: These are laboratory bench tests conducted prospectively to gather data for the submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a mechanical device. Ground truth, in the context of an AI device, refers to expert labeling of medical images or other data. For a mechanical device, "ground truth" is measured physical properties or biological responses to materials (e.g., measuring clamping force, observing cell growth in cytotoxicity tests, or confirming sterility). These are objective measurements against established standards, not expert consensus on interpretations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used in studies involving human interpretation or subjective assessments, typically for AI/imaging devices. For mechanical performance and biocompatibility tests, results are derived from objective measurements and laboratory protocols, not human adjudication between different interpretations.
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. This is a mechanical device, not an AI or imaging device. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. As a mechanical device, there is no "algorithm only" performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Measurements Against Standards. The "ground truth" for this device's performance is established by objective physical and biological tests according to recognized international and national standards (e.g., ISO, ASTM, USP). For example:
  - Biocompatibility: Established biological reactions (e.g., no cytotoxicity via cell culture tests).
  - Mechanical Properties: Measured physical forces (e.g., tensile strength in Newtons, clamping force).
  - Sterility: Absence of microbial growth, reaching a specific SAL.
  - Shelf Life: Data demonstrating stability of materials/performance over time.
The sample size for the training set:
- Not Applicable. This is a mechanical device, not an AI requiring a "training set."
How the ground truth for the training set was established:
- Not Applicable. There is no training set for this type of device.

Summary

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October 19, 2020

Anrei Medical (Hangzhou) Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 CHINA

Re: K201771

Trade/Device Name: Single Use Rotatable and Repositionable Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 16, 2020 Received: September 17, 2020

Dear Diana Hong:

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

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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 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 medical devices and radiation-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

Shani 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) K201771

Device Name

Single Use Rotatable and Repositionable Hemoclip

Indications for Use (Describe) Single Use Rotatable and Repositionable Hemocip is indicated for clip placement within the Gastrointestinal (GI) tract for the purpose of: 1) Endoscopic marking 2) Hemostasis for: Mucosal/sub-mucosal defects < 3cm, Bleeding ulcers. Arteries < 2mm. Polyps < 1.5cm in diameter, Diverticula in the colon,

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

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

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

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Exhibit #8 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: K201771

1. Date of Preparation: 09/07/2020
1. Sponsor Identification

Anrei Medical (Hangzhou) Co., Ltd

No.3 Ave. 8, Hangzhou Economic Development Area, Hangzhou, People's Republic of China

Establishment Registration Number: 3006621103

Contact Person: Huibing Yang Position: RA Director Tel: +86-571-86913333 Fax: +86-571-87603502 Email: huibing.yang@aanrui.com.cn

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

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Identification of Proposed Device 4.

510(k) Summary

Trade Name: Single Use Rotatable and Repositionable Hemoclip Common Name: Hemorrhoidal ligator

Regulatory Information

Classification Name: Hemorrhoidal ligator Classification: II; Product Code: PKL; Regulation Number: 21CFR 876.4400 Review Panel: Gastroenterology/Urology;

Indication for Use Statement:

Single Use Rotatable and Repositionable Hemoclip is indicated for clip placement within the Gastrointestinal (GI) 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,

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

Device Description

ર. Identification of Predicate Devices

Predicate Device 1 510(k) Number: K161463 Product Name: SureClip(TM) Repositionable Hemostasis Clip

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Predicate Device 2 510(k) Number: K152001 Product Name: Sterile Repositionable Hemostasis Clipping Device

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Test for in vitro cytotoxicity >
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene Oxide Sterilization Residuals
ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Test for irritation and delayed-type hypersensitivity
ISO 10993-11: 2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ASTM F1929-15 Standard test method for detecting seal leaks in porous medical packaging by dye penetration.
ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials
USP 42 NF 37 <151> Pyrogen Test

Dimension test was performed on the proposed device and the test result demonstrated that the device can meet its design specification requirement.

Performance test was performed on both the proposed device and predicate device and the test result demonstrated that there was no significant difference between them, the test include following items

Mechanical Integrity of Clip Assembly Clamping Strength Testing Tensile Strength Testing Release Force Testing Rotation Testing Repositionability

1. Clinical Test Conclusion
  No clinical study is included in this submission.

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8. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device 1 K161463	Predicate Device 2 K152001
Product Code	PKL	PKL	PKL
Regulation Number	21CFR 876.4400	21CFR 876.4400	21CFR 876.4400
Indication for Use	Single Use Rotatable andRepositionable Hemoclip is indicatedfor clip placement within theGastrointestinal (GI) tract for thepurpose of:1. Endoscopic marking,2. Hemostasis for:Mucosal/sub-mucosal defects <3cm,Bleeding ulcers,Arteries < 2mm,Polyps < 1.5cm in diameter,Diverticula in the colon,3. As a supplementary method,closure of GI tract luminal perforations< 20mm that can be treatedconservatively.	The SureClip(TM) RepositionableHemostasis Clip is indicated forendoscopic clip placement within thegastrointestinal tract for the purpose of:(1) endoscopic marking,(2) hemostasis for(a) mucosal / sub-mucosal defects <3cm,(b) bleeding ulcers,(c) polyps < 1.5cm in diameter,(d) diverticula in the colon,(3) as a supplementary method, closureof GI tract luminal perforations <20mmthat can be treated conservatively	The Sterile Repositionable HemostasisClipping Device is indicated forendoscopic clip placement within thegastrointestinal tract for the purpose of:(1) endoscopic marking,(2) hemostasis for(a) mucosal / sub-mucosal defects <3cm,(b) bleeding ulcers,(c) polyps < 1.5cm in diameter,(d) diverticula in the colon,(3) as a supplementary method, closureof GI tract luminal perforations <20mmthat can be treated conservatively.
Configuration	Delivery system and jaw	Delivery system and jaw	Delivery system and jaw
Rotation function	rotatable	rotatable	rotatable
Open width	9mm, 11mm, 13mm and 16mm	8mm, 11mm and 16mm	11mm
Minimal working channel	2.8mm	2.8mm	2.8mm

Table 1 Comparison of Technology Characteristics

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Working length	1650mm, 1950mm, 2300mm and2700mm	1650mm, 1950mm and 2350mm	1650mm, 1950mm, 2350mm and2700mm
Single Use	Single Use	Single Use	Single Use
Labeling	Comply with 21 CFR Part 801	Comply with 21 CFR Part 801	Comply with 21 CFR Part 801
Biocompatibility
Cytotoxicity	No cytotoxicity	Comply with ISO 10993 standards	Comply with ISO 10993 standards
Skin Sensitization	No skin sensitization
Irritation	No irritation
Acute Systemic Toxicity	No acute toxicity
Sub-acute Systemic Toxicity	No sub-acute toxicity
Pyrogen	No pyrogen
Sterilization
Method	Ethylene oxide	Ethylene oxide	Ethylene oxide
SAL	10-6	10-6	10-6
Endotoxin Limit	20EU	20EU	20EU
Shelf life	3 years	3 years	3 years

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1. Substantially Equivalent (SE) Conclusion
  The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device 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.