The SureClip Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope 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,
(e) Arteries < 2 mm
(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;
(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively.

Device Description

The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile, single-use endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

AI/ML Overview

The provided text is a 510(k) summary for the Micro-Tech (Nanjing) Co., Ltd. SureClip™ Repositionable Hemostasis Clip (K182556). This document is a premarket notification to the FDA for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than extensive clinical studies or AI algorithm performance.

Therefore, many of the requested sections regarding AI device performance metrics, expert consensus, and specific clinical study details are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the format requested for an AI device. Instead, it lists various bench tests performed to demonstrate substantial equivalence to the predicate device. The general acceptance criterion implied is that the proposed device performs comparably to the predicate device, thereby meeting safety and effectiveness requirements.

Bench Test Performed	Reported Device Performance
Dimension	Demonstrated equivalence
Release Force	Demonstrated equivalence
Clamping Strength	Demonstrated equivalence
Mechanical Integrity of Clip Assembly	Demonstrated equivalence
Tensile Strength	Demonstrated equivalence
Clip Assembly Repeated Open/Close	Demonstrated equivalence
Clip Open and Close Force	Demonstrated equivalence
Rotation	Demonstrated equivalence
Scope Compatibility/Usability	Demonstrated equivalence
Endoscope Damage	Demonstrated equivalence
Torque	Demonstrated equivalence
Biopsy Valve Compatibility	Demonstrated equivalence
Clip Approach	Demonstrated equivalence
Coil to Handle Tensile	Demonstrated equivalence
Biocompatibility	Meets ISO 10993-1, ISO 10993-7
Sterilization	Meets ISO 11135

Note: The document states that "The testing performed demonstrated that the proposed device and predicate device are equivalent." Specific quantitative performance values for each test are not provided in this summary.

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

Not applicable. This device is a physical medical device (hemostasis clip), not an AI algorithm evaluated on a data set. The "test set" would refer to the physical devices subjected to bench testing. The document does not specify the number of devices tested for each bench test.

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

Not applicable. This is not an AI device, and no ground truth established by experts on a test set is discussed.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI device, and no adjudication method for an AI test set is mentioned.

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

Not applicable. This is not an AI device.

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

Not applicable. This is not an AI device.

7. The Type of Ground Truth Used

Not applicable. For a physical device, performance is evaluated against engineering specifications and regulatory standards rather than a "ground truth" derived from expert consensus or pathology on medical images/data. The "ground truth" here is the expected performance based on the predicate device and established safety/effectiveness standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI device, so there is no training set.

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

Not applicable. This is not an AI device, so there is no training set or associated ground truth.

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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2018

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K182556

Trade/Device Name: SureClip Repositionable Hemostasis Clip Regulation Number: 21 CFR§ 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: II Product Code: PKL Dated: September 13, 2018 Received: September 17, 2018

Dear Becky Li:

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 mav, 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 avare 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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,

Daniel G. Walter Jr -S

for

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K182556

Device Name

SureClip Repositionable Hemostasis Clip

Indications for Use (Describe)

(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,

(e) Arteries < 2 mm

(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;

(3) 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.

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510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K182556

1. Date of Preparation: 2018-12-05

2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone,

Nanjing, Jiangsu Province, PRC

Establishment Registration Number: 3004837686

Contact Person: Becky Li

Position: Quality and Regulatory Affairs Director

Tel: +86-25-58646378

Fax: +86-25-58744269

Email: Beckyli mt@outlook.com

3. Identification of Proposed Device

Trade Name: SureClip™ Repositionable Hemostasis Clip

Common Name: Hemostasis Clipping Device

Regulatory Information

Classification Name: Hemorrhoidal Ligator Classification: II Product Code: PKL Requlation Number: 876.4400 Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH (Nanjing) Co., Ltd. The logo consists of the company name in English, followed by the company name in Chinese characters. The English name is in a blue sans-serif font, and the Chinese name is in a similar font and color. There is a blue graphic to the left of the company name.

510K Summary

4. Identification of Predicate Device

Predicate Device

510(k) Number: K151802

Product Name: Resolution 360™ Clip

Manufacturer: Boston Scientific Corporation

Reference Device

510(k) Number: K152001

Product Name: Sterile Repositionable Hemostasis Clipping Device

Manufacturer: Micro-Tech (Nanjing) Co., Ltd.

5. Indications for Use

The SureClip™ Repositionable Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope 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,
(e) Arteries < 2 mm,

(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion

resection;

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

6. Device Description

The proposed device SureClip™ Repositionable Hemostasis Clip is a sterile,

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Image /page/5/Picture/1 description: The image shows a blue and white logo with the letters "MT" stacked on top of each other. The letters are in a bold, sans-serif font and have a 3D effect. The "M" is on top and the "T" is on the bottom. The logo is simple and modern.

510K Summary

single-use endoscopic clipping device in adult patients only via a straight or side viewing flexible endoscope, intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. It consists of two main components, delivery system and clip assembly. And it is offered in different dimensions.

7. Comparison of Technological Characteristics

The SureClip™ Repositionable Hemostasis Clip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device Resolution 360™ Clip.

Comparison to predicate Devices:

Item	Proposed DeviceSureClip™ RepositionableHemostasis Clip	Predicate DeviceResolution 360™ Clip	SubstantialEquivalence
Product Code	PKL	PKL	Same
Regulation No.	876.4400	876.4400	Same
Class	II	II	Same
Supplied inSterile	Yes	Yes	Same
Configuration	Delivery system and clipassembly	Delivery system and clip assembly	Same
Open width	8mm, 11mm and 16mm	11mm	Similar
Minimalworkingchannel	2.8mm	2.8mm	Same
WorkingLength	1650mm, 2350mm	2350mm	Similar
Indications forUse	The SureClip™ RepositionableHemostasis Clip is indicatedfor Endoscopic clip placementwithin the Gastrointestinal tractin adult patients only via astraight or side viewing flexible	The Resolution 360™ Clip is indicated forclip placement within the gastrointestinal(GI) tract for the purpose of:1. Endoscopic marking2. Hemostasis for● Mucosal/sub-mucosal defects < 3	Similar

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Image /page/6/Picture/1 description: The image shows a blue logo with the letters 'M' and 'T' stacked on top of each other. The letters are in a bold, sans-serif font and have a 3D effect, with the left and top sides of the letters appearing to be slightly raised. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

Item	Proposed DeviceSureClip™ RepositionableHemostasis Clip	510K SummaryPredicate DeviceResolution 360™ Clip	SubstantialEquivalence
	endoscope for the purpose of :(1) Endoscopic marking;(2) Hemostasis for(a) mucosal / sub-mucosaldefects < 3cm,(b) bleeding ulcers,(c) polyps < 1.5cm in diameter,(d) diverticula in the colon,(e) Arteries < 2 mm,(f) Prophylactic clipping toreduce the risk of delayedbleeding post lesion resection;(3) As a supplementarymethod, closure of GI tractluminal perforations <20mmthat can be treatedconservatively.	cm● Bleeding ulcers● Arteries < 2 mm`● Polyps < 1.5 cm in diameter● Diverticula in the colon● Prophylactic clipping to reduce therisk of delayed bleeding postlesion resection3. Anchoring to affix jejunal feeding tubesto the wall of the small bowel; andAnchoring to affix fully coveredesophageal self-expanding metalstents to the wall of the esophagus4. As a supplemental closure method ofluminal perforations < 20 mm that canbe treated conservatively
Single Use	Yes	Yes	Same
Packaging	Single-use EO sterilizedpouch with one device perpouch	Single-use EO sterilized pouch with onedevice per pouch	Same
Shelf Life	Three years	Three years	Same

8. Performance Data

The proposed device the SureClip™ Repositionable Hemostasis Clip meets the

requirements of ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1:

Evaluation and Testing Within A Risk Management Process", ISO 11135

"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 the SureClip™ Repositionable

Hemostasis Clip

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional design. The 'M' is formed by two angled lines that meet at the top, and the 'T' is a simple vertical line. The logo has a blocky, geometric appearance, and the blue color is consistent throughout the design.

Dimension;
Release Force; >
Clamping Strength;
Mechanical integrity Of Clip Assembly;
Tensile Strength;
Clip Assembly Repeated Open/Close; >
Clip Open And Close Force
Rotation;
Scope Compatibility/Usability;
Endoscope Damage;
Torque;
Biopsy Valve Compatibility;
Clip Approach;
Coil to Handle Tensile

The testing performed demonstrated that the proposed device and predicate device are equivalent.

9. Clinical Test Conclusion

No clinical study is included in this submission.

10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the SureClip™ Repositionable Hemostasis Clip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device Resolution 360™ Clip (K151802).

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.