The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of:
a .Endoscopic Marking
b. Hemostasis for:

Mucosal/Submucosal defects < 3cm
Bleeding Ulcers
Arteries <2 mm
Polyps < 1.5 cm in diameter
Diverticula in the Colon
c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.

Device Description

The Disposable Hemostatic Closure Clip Device is a sterile, single-use endoscopic clipping device, intended for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The device is indicated for clip placement within the GI tract for the purpose of.
a. endoscopic marking
b. hemostasis for:

mucosal/submucosal defects < 3cm
bleeding ulcers
arteries < 2 mm
polyps < 1.5 cm in diameter
diverticuli in the colon
C. Closure of GI tract luminal perforations < 20mm that can be treated conservatively.
The Disposable Hemostatic Closure Clip Device consists of one pre-loaded clip and delivery device for single patient use only. The clip is made of nickel-titanium alloy with good superelasticity performance. The clip is pre-loaded in the barrel at the end of the delivery system through its deformation.
The proposed device has twenty-four (24) specifications that vary to the outer diameter of the clip: φ14.5 mm, φ17.0 mm; working length: 1650 mm, 1950 mm, 2350 mm, 2700 mm; and whether the outer tube is coated or not.
The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

AI/ML Overview

The provided text describes the acceptance criteria and the studies performed to demonstrate the substantial equivalence of the "Disposable Hemostatic Closure Clip Device" (Proposed Device) to the "OTSC™ (Over-The-Scope-Clip) System Set" (Predicate Device).

Here's an analysis of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" in a separate section with pass/fail results for each criterion. Instead, it states that various performance tests were conducted, and the results demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device.

The table below summarizes the technical characteristics compared, which implicitly serve as acceptance criteria for similarity to the predicate device. The "Remark" column indicates if the characteristic is "Same" or "Similar" to the predicate, implying acceptance if it falls within these categories or if differences do not affect substantial equivalence.

ITEM	Acceptance Criteria (Implicitly based on Predicate)	Reported Device Performance (Proposed Device)	Remark
Product Code	PKL	PKL	Same
Regulation No.	876.4400 Hemorrhoidal ligator	876.4400 Hemorrhoidal ligator	Same
Class	II	II	Same
Intended use	The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating lesions of the wall of gastrointestinal organs. Marking of lesions. The OTSC clip is indicated for clip placement within the gastrointestinal (GI) tract for the purpose of: - Endoscopic marking - Hemostasis for: - Mucosal/submucosal defects < 3 cm - Bleeding ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the colon - Closure of GI tract luminal perforations < 20 mm that can be treated conservatively	The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of: a. Endoscopic Marking b. Hemostasis for: - Mucosal/Submucosal defects < 3cm - Bleeding Ulcers - Arteries < 2 mm - Polyps < 1.5 cm in diameter - Diverticula in the Colon c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively	Same
Single Use	Yes	Yes	Same
Supplied in Sterile	Yes	Yes	Same
Configuration	Clip, Delivery System	Clip, delivery system	Same
Clip (Material)	Niti	Niti	Same
Clip Width (mm)	9, 10, 11 (Rectangular shape)	φ14.5, φ17 (Circular shape)	The clip of proposed device is circular in shape, while the clip of predicate device is rectangular in shape. (Considered not to affect substantial equivalence after testing)
Scope Compatibility (mm)	φ 9.5---φ14	φ 9.5---φ14	Same
Working Length (mm)	1650, 2200	1650, 1950, 2350, 2700	Similar
Principles of Operation	Use negative pressure to attract tissue, operate handle and release clip	Use negative pressure to attract tissue, operate handle and release clip	Same
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1	Same (Demonstrated through specific tests)
Packaging	Single-use EO sterilized pouch with one device per pouch	Single-use EO sterilized pouch with one device per pouch	Same
MRI	Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213	Comply with ASTM F 2503, ASTM F 2052, ASTM F2119, ASTM F2182, ASTM F2213	Same (Demonstrated through testing)
Sterilization	EO Sterilized, SAL: 10-6	EO Sterilized, SAL: 10-6	Same (Validated according to ISO 11135)
Shelf Life	3 years	3 years	Same (Demonstrated through accelerated aging tests)
Labeling	Conforms to 21 CFR part 801	Conforms to 21 CFR part 801	Same
Bench Test Performances (e.g., Release Performance, Closure Force, etc.)	Predetermined acceptance criteria	Met predetermined acceptance criteria	Passed

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

The document does not specify sample sizes for the test sets of the described performance data. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective nature) for any of the tests. The tests conducted are primarily bench tests and material safety tests, not clinical studies involving human patients or a specific geographic origin of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in the document because the submission does not involve an AI/ML-based device that requires expert-established ground truth for a test set. The validation involves engineering, material science, and microbiology testing against international standards and comparison to a predicate device's characteristics.

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

This information is not applicable and not provided as there is no mention of a human expert adjudication process for establishing ground truth, given that this is not an AI/ML device submission.

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

This information is not applicable and not provided as this is not an AI/ML device submission. No MRMC study was performed.

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

This information is not applicable and not provided as this is not an AI/ML device submission.

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

The concept of "ground truth" as typically used in AI/ML validation (e.g., expert consensus, pathology) is not directly applicable here. The "ground truth" for the device's performance is established by:

Adherence to recognized international standards (e.g., ISO 10993-1 for biocompatibility, ISO 11135 for sterilization, ASTM standards for MRI compatibility, ASTM F1980-16 and ISO 11607 for shelf-life).
Demonstrating that the device's functional performance (e.g., release performance, closure force, endoscope adaptability, deployment, clip persistence) meets predetermined engineering specifications (acceptance criteria), which are implicitly based on the predicate device's established safety and effectiveness.
Direct comparison of technical characteristics to a legally marketed predicate device (K101428).

8. The sample size for the training set

This information is not applicable and not provided as this is not an AI/ML device submission that involves a training set.

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

This information is not applicable and not provided as this is not an AI/ML device submission.

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). 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.

June 13, 2022

Micro-Tech (Nanjing) Co., Ltd. Sally He, RA Engineer No. 10 Gaoke Third Road. Naniing National Hi-Tech Industrial Development Zone Nanjing, Jiangsu 210032 CHINA

Re: K220157

Trade/Device Name: Disposable Hemostatic Closure Clip Device Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: May 11, 2022 Received: May 13, 2022

Dear Sally He:

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

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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 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-safetyreporting-combination-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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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).

Sincerelv.

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) K220157

Device Name

Disposable Hemostatic Closure Clip Device

Indications for Use (Describe)

a .Endoscopic Marking
b. Hemostasis for:
Mucosal/Submucosal defects < 3cm
Bleeding Ulcers
Arteries <2 mm
Polyps < 1.5 cm in diameter
Diverticula in the Colon

c. 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)

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Image /page/3/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, blocky font. The letters are interconnected and have a three-dimensional appearance, with shading suggesting depth. A registered trademark symbol '®' is positioned in the upper right corner of the logo.

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: K220157

Date of Preparation: 2022-05-10 1.

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: Sally He Position: RA Engineer Tel: +86-25-58646395 Fax: +86-25-58350006 Email: RA.Micro-Tech@outlook.com

Identification of Proposed Device 3.

Product Name: Disposable Hemostatic Closure Clip Device Trade Name: / Common Name: Hemostasis Clip Regulatory Information Classification Name: Hemorrhoidal ligator Classification: 2 Product Code: PKL Regulation Number: 876.4400 Review Panel: Gastroenterology/Urology

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K220157 Page 2 of 7

Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be made of solid blocks. A registered trademark symbol (®) is located in the upper right corner of the logo. The logo has a clean and modern design.

Identification of Predicate Device 4.

510(k) Number: K101428 Product Name: OTSC™ (over-the scope-clip) system set Manufacturer: Ovesco Endoscopy AG

5. Indications for Use

The device for flexible endoscopy and for compression of tissue in the gastrointestinal (GI) tract, for hemostasis or for treating gastrointestinal organ wall lesions, and for making of lesions. The Device is indicated for clip placement within the GI tract for the purpose of:

a .Endoscopic Marking
b. Hemostasis for:
Mucosal/Submucosal defects < 3cm
Bleeding Ulcers
Arteries < 2 mm
Polyps < 1.5 cm in diameter
Diverticula in the Colon
c. Closure of GI tract luminal perforations < 20mm that can be treated conservatively

Device Description 6.

endoscopic marking a.
hemostasis for: b.
mucosal/submucosal defects < 3cm -
bleeding ulcers
arteries < 2 mm -
polyps < 1.5 cm in diameter -
diverticuli in the colon
Closure of GI tract luminal perforations < 20mm that can be treated conservatively. C.

The Disposable Hemostatic Closure Clip Device consists of one pre-loaded clip and delivery device for single patient use only. The clip is made of nickel-titanium alloy with good superelasticity performance. The clip is pre-loaded in the barrel at the end of the delivery system through its deformation.

The proposed device has twenty-four (24) specifications that vary to the outer diameter of

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a unified design. A registered trademark symbol is located in the upper right corner of the logo.

the clip: φ14.5 mm, φ17.0 mm; working length: 1650 mm, 1950 mm, 2350 mm, 2700 mm; and whether the outer tube is coated or not.

The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 3 years.

7. Comparison of Technological Characteristics

The Disposable Hemostatic Closure Clip Device incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, sterilization process and intended use as those featured in the Predicate Device OTSC™ (Over-The-Scope-Clip) System Set (K101428).

ITEM	Proposed DeviceDisposable HemostaticClosure Clip Device	Predicate Device (K101428)OTSCTM(Over-The-Scope-Clip) SystemSet	Remark
Product Code	PKL	PKL	Same
Regulation No.	876.4400 Hemorrhoidalligator	876.4400 Hemorrhoidal ligator	Same
Class	II	II	Same
Intended use	The device for flexibleendoscopy and forcompression of tissue in thegastrointestinal (GI) tract, forhemostasis or for treatinggastrointestinal organ walllesions, and for making oflesions. The Device isindicated for clip placementwithin the GI tract for thepurpose of:a .Endoscopic Markingb. Hemostasis for:- Mucosal/Submucosal defects< 3cm- Bleeding Ulcers- Arteries < 2 mm- Polyps < 1.5 cm in diameter- Diverticula in the Colonc. Closure of GI tract luminal	The OTSC system set isindicated for use in flexibleendoscopy and for thecompression of tissue in thegastrointestinal tract, forhaemostasis or for treatinglesions of the wall ofgastrointestinal organs.Marking of lesions.The OTSC clip is indicated forclip placement within thegastrointestinal (GI) tract forthe purpose of:- Endoscopic marking -Hemostasis for:- Mucosal/submucosal defects< 3 cm- Bleeding ulcers- Arteries < 2 mm- Polyps < 1.5 cm in diameter	Same
ITEM	Proposed DeviceDisposable HemostaticClosure Clip Deviceperforations < 20mm that canbe treated conservatively	Predicate Device (K101428)OTSCTM(Over-The-Scope-Clip) SystemSet- Diverticula in the colon- Closure of GI tract luminalperforations < 20 mm that canbe treated conservatively	Remark
Single Use	Yes	Yes	Same
Supplied inSterile	Yes	Yes	Same
Configuration	Clip, delivery system	Clip, Delivery System	Same
Clip (Material)	Niti	Niti	Same
Clip Width (mm)	φ14.5, φ17	9, 10, 11	The clip ofproposeddevice iscircular inshape, whilethe clip ofpredicatedevice isrectangularin shape
ScopeCompatibility(mm)	φ 9.5---φ14	φ 9.5---φ14	Same
Working Length(mm)	1650, 1950, 2350, 2700	1650, 2200	Similar
Principles ofOperation	Use negative pressure toattract tissue, operate handleand release clip	Use negative pressure to attracttissue, operate handle andrelease clip	Same
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1	Same
Packaging	Single-use EO sterilizedpouch with one device perpouch	Single-use EO sterilized pouchwith one device per pouch	Same
MRI	Comply with ASTM F 2503,ASTM F 2052, ASTM F2119,ASTM F2182, ASTM F2213	Comply with ASTM F 2503,ASTM F 2052, ASTM F2119,ASTM F2182, ASTM F2213	Same
Sterilization	EO Sterilized, SAL: 10-6	EO Sterilized, SAL: 10-6	Same
Shelf Life	3 years	3 years	Same
ITEM	Proposed DeviceDisposable HemostaticClosure Clip Device	Predicate Device (K101428)OTSCTM(Over-The-Scope-Clip) SystemSet	Remark
Labeling	Conforms to 21 CFR part 801	Conforms to 21 CFR part 801	Same

Comparison to Predicate Devices:

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Image /page/6/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are bold and appear to be interconnected, creating a sense of unity and strength. A small registered trademark symbol is visible in the upper right corner of the logo.

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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 font. The letters are connected and appear to be angled slightly, giving them a dynamic look. A registered trademark symbol '®' is positioned in the upper right corner of the logo.

The proposed device is similar in design to Predicate Device OTSC™ (Over-The-Scope-Clip) System Set (K101428), the dimensions of proposed device are different to the predicate device. All comparative non-clinical performance testings have been tested and have met the requirements of substantial equivalence to the predicate device.

Therefore, the difference between proposed device and predicated device is considered not to affect the substantially equivalency between the proposed and predicate devices concerning the safety and effectiveness.

Performance Data 8.

The biocompatibility evaluation for the Disposable Hemostatic Closure Clip Device was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020. The following tests were conducted for the clip of Disposable Hemostatic Closure Clip Device:

Cytotoxicity Study 1)
ISO Guinea Pig Maximization Sensitization Test 2)
1. ISO Intracutaneous Study in Rabbits
1. Acute Systemic Toxicity
1. Material Mediated Pyrogenicity in Rabbits
Hemolysis 6)
1. ISO Muscle Implantation Study, 1 Weeks
ISO Muscle Implantation Study, 4 Weeks 8)
1. ISO Muscle Implantation Study, 13 Weeks

The following tests were conducted for the delivery system of Disposable Hemostatic Closure Clip Device:

Cytotoxicity Study 1)
1. ISO Guinea Pig Maximization Sensitization Test
ISO Intracutaneous Study in Rabbits 3)
ISO Acute Systemic Toxicity Study 4)
ર) USP Rabbit Pyrogen Study

Sterilization validation of Disposable Hemostatic Closure Clip Device was carried out in

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'M' and 'T' stacked on top of each other. The 'M' is on the left and the 'T' is on the right, and they are both in a bold, sans-serif font. The logo has a 3D effect, with the letters appearing to be slightly raised. There is a registered trademark symbol in the upper right corner of the image.

accordance with ISO 11135 Second edition 2014-07-15 Sterilization of health-care products -Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]

Shelf-life testing and packaging integrity testing of Disposable Hemostatic Closure Clip Device was conducted based on an accelerated aging test in accordance with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices and ISO 11607-1:2019: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems and ISO 11607-2:2019: Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Three-year accelerated aging test have been performed to demonstrate the stability during the shelf life.

MR compatibility was evaluated in accordance with ASTM F 2503. ASTM F 2052. ASTM F2119, ASTM F2182, ASTM F2213 and FDA guidance "Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment," issued on May 20, 2021.

During design verification, the following bench tests were performed on Disposable Hemostatic Closure Clip Device:

A Dimension
A Release Performance
Clip Recovery Performance
Closure Force of Clip
Connection Force between Cable and Handle
Connection Force between Barrel and Soft Boot
Endoscope Adaptability
Deployment and Clip Persistence

The results of all the performance testings demonstrated that the proposed device met the predetermined acceptance criteria and is substantial equivalence to the predicate device.

Animal Test Conclusion 9.

No animal study is included in this submission.

10. Clinical Test Conclusion

No clinical study is included in this submission.

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Image /page/9/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be leaning slightly to the right. A circled "R" symbol, indicating a registered trademark, is positioned in the upper right corner of the logo.

11. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Disposable Hemostatic Closure Clip Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device OTSC™ (Over-The-Scope-Clip) System Set (K101428).

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.