The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal 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, closure of GI tract luminal perforations <20mm that can be treated conservatively (4)the age of the intended population for the device is for patients who are 18 and older.

Device Description

The proposed device Single Use Hemoclip is a sterile, single-use endoscopic clipping device, 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 describes a 510(k) premarket notification for a medical device (Single Use Hemoclip) and demonstrates its substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered medical device, which the provided prompt seems to be specifically asking for.

The acceptance criteria typically outlined in AI/ML medical device submissions (as per the prompt's structure) would include metrics like sensitivity, specificity, AUC, and performance targets against "ground truth" established by experts. The provided document instead focuses on equivalence testing for a physical medical device (a hemoclip), detailing mechanical and biological testing to ensure its safety and performance.

Therefore, I cannot fulfill the request to provide:

A table of acceptance criteria and reported device performance: Because the document does not define such criteria or report AI/ML performance metrics.
Sample size and data provenance for the test set: Not applicable for a physical device.
Number of experts and qualifications for ground truth: Not applicable for a physical device.
Adjudication method for the test set: Not applicable for a physical device.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable for a physical device.
Standalone (algorithm-only) performance: Not applicable as there is no algorithm.
Type of ground truth used: Not applicable.
Training set sample size: Not applicable.
How ground truth for training set was established: Not applicable.

The "Performance data" section in the document (Page 8, Item 7) lists bench tests conducted on the Single Use Hemoclip, which are relevant for a physical device, but not for an AI/ML driven one:

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

The conclusion states that "The testing performed demonstrated that the proposed and predicate delivery systems are equivalent." This is the "proof" for this specific device, based on physical and material properties, not AI/ML performance.

In summary, the provided document relates to the 510(k) clearance of a physical medical device and thus does not contain the information requested about AI/ML device acceptance criteria and performance studies.

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). 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.

May 27, 2022

Zhejiang Chuangxiang Medical Technology Co., LTD. Lucius Long, RA Manager 301B, No.22, XinYan Road Yuhang District, Hangzhou, Zhejiang 311100 CHINA

Re: K212669

Trade/Device Name: Single Use Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: April 21, 2022 Received: April 28, 2022

Dear Lucius Long:

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

510(k) Number (if known) K212669

Device Name Single Use Hemoclip

Indications for Use (Describe)

The Single Use Hemoclip Device is indicated for endoscopic clip placement within the gastrointestinal 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, closure of GI tract luminal perforations <20mm that can be treated conservatively (4)the age of the intended population for the device is for patients who are 18 and older.

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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Image /page/3/Picture/0 description: The image shows the logo for Zhejiang Chuangxiang Medical Technology Co., LTD. The logo includes a stylized hexagon shape with green and blue gradients. To the right of the shape is the company name in both Chinese characters and the English word "MEDNOVA".

K212669

Page:

Section 5 510(k) Summary( 21CFR 807.92)

1. Submitter's information

Name: Zhejiang Chuangxiang Medical Technology Co., LTD.

Address: Room 101,201,301,401,501, Building 50, No.650 Hongfeng Road Donghu Street, Yuhang District, Hangzhou City, Zhejiang Province,311100,P.R. China

Contact person: Lucius.Long Telephone: 86-571-89167088-8680 Fax: 86-571-89167086

Date of Submission

09-Aug- 2021

3. Device

Name of the device: Single Use Hemoclip Classification name: Hemorrhoidal ligator Regulation class: 2 Regulation number:876.4400 Panel: Gastroenterology/Urology Product code: PKL

4. Predicate device

510(k) Number: K172762, Product Name: Single Use Hemoclip

510(k) Number: K202333 Product Name: Lockado™ Repositionable Hemostasis Clip 5. Device description

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Image /page/4/Picture/0 description: The image contains the logo for MEDNOVA. The logo consists of a hexagon shape on the left, with a gradient from blue to green. To the right of the hexagon is the text "MEDNOVA" in a combination of blue and green colors. Above the text "MEDNOVA" are four Chinese characters in blue.

dical Technology Co.,LTD. K212669 Zheiia

Page:

6.Indication for use

The Single Use Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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, closure of GI tract luminal perforations <20mm that can be treated conservatively

(4) the age of the intended population for the device is for patients who are 18 and older.

6. Summary of comparison of technological characteristics with the predicate device

The Single Use Hemoclip incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Zhejiang Chuangxiang Medical Technology Co., LTD. (K172762) and Micro-Tech predicate devices (K202333).

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Image /page/5/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a gradient fill, transitioning from green at the bottom to blue at the top. Inside the hexagon, there are white lines forming an abstract design. To the right of the shape, there is Chinese text in blue, followed by the word "MEDNOVA" in a smaller font size, with the "MED" part in blue and the "NOVA" part in green.

Zhejiang Chuangxiang Medical Technology Co.,LTD.

K212669

Page:

Comparison to Predicate Devices:
Item	Proposed device	Predicate device	Additional predicate device	Comparison toPredicateDevices
Device name	Single use hemoclip	Single use hemoclip	Lockado™ Repositionable HemostasisClip	Similiar
510(k) number	/	K172762	K202333	Different 510(k)number
Manufacturer	Zhejiang Chuangxiang medicaltechnology Co., LTD.	Zhejiang Chuangxiang medicaltechnology Co., LTD.	Micro-Tech(Nanjing) Co., Ltd.	Same
Product Code	PKL	PKL	PKL	Same
Regulation No.	876.4400	876.4400	876.4400	Same
Class	2	2	2	Same
Supplied Sterile	Yes	Yes	Yes	Same
Configuration	Delivery system and clipassembly	Delivery system and clipassembly	Delivery system and clip assembly	Same
Clip opening	9mm,12mm,13mm,15mm,16mm	9mm, 12mm,13mm,15mm	8mm, 11mm and 16mm	Similar
Minimal workingchannel	2.8mm	2.8mm	2.8mm	Same
Working Length	1650mm, 1950mm, 2300mm,2700mm	1650mm, 1950mm, 2300mm,2700mm	1650mm, 1950mm, 2350mm, 2700mm	Same
Indications for	The single use hemoclip is	The single use hemoclip is	The Lockado™ Repositionable	Same
Use
	indicated for endoscopic clipplacement within thegastrointestinal tract forthe 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,(3) as a supplementarymethod, closure of Gl tractluminal perforations <20mmthat can be treatedconservatively(4)the age of the intendedpopulation for the device is forpatients who are 18 and older.	indicated for endoscopic clipplacement within thegastrointestinal tract forthe 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,(3) as a supplementarymethod, closure of Gl tractluminal perforations <20mmthat can be treatedconservatively(4)the age of the intendedpopulation for the device is forpatients who are 18 and older.	Hemostasis Clip is indicated forEndoscopic clip placement within theGastrointestinal tract in adult patients onlyvia a straight or side viewing flexibleendoscope for the purposeof :(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 therisk of delayed bleeding post lesionresection;(3) As a supplementary method,closure of Gl tract luminalperforations <20mm that can betreated conservatively.(4) Anchoring to affix jejunal feeding(2) tubes to the wall of the small bowel.
Repositionability	Clip reopened and	Clip reopened and	Clip reopened and repositioned up to 5	Same
	repositioned up to 8 times	repositioned up to 8 times	times
Single Use	Yes	Yes	Yes	Same
Packaging	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilized pouchwith one device per pouch	Single-use EO sterilized pouch with onedevice per pouch	Same
Shelf Life	Three years	Three years	Three years	Same
MRI information	Comply with ASTM F 2503,ASTMF 2052, ASTM F2119,ASTM F2182, ASTM F2213	/	Comply with ASTM F 2503, ASTMF 2052,ASTM F2119, ASTM F2182, ASTMF2213	Same

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Image /page/6/Picture/0 description: The image shows a logo for MEDNOVA. The logo consists of a green and blue hexagon shape on the left, with the text "MEDNOVA" in blue below it. To the right of the hexagon shape is some Chinese text in blue.

Zhejiang Chuangxiang Medical Technology Co.,LTD.

K212669

Page:

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Image /page/7/Picture/0 description: The image contains a logo with a geometric shape on the left and text on the right. The geometric shape is a hexagon with a gradient fill, transitioning from green at the bottom to blue at the top. Inside the hexagon, there is a stylized letter "M". To the right of the logo, there is Chinese text at the top and the word "MEDNOVA" in English below it. The word "MEDNOVA" is in a sans-serif font, with "MED" in blue and "NOVA" in green.

Zhejiang Chuangxiang Medical Technology Co.,LTD.

K212669

Page:

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Image /page/8/Picture/0 description: The image shows a logo with a hexagon shape on the left side that transitions from green to blue. To the right of the hexagon is the text "MEDNOVA" in green and blue. Above the text are Chinese characters in blue. The logo appears to represent a medical or healthcare-related organization.

lical Technology Co.,LTD.

K212669

6 / 6 Page: Page

7. Performance data

The proposed device the Single Use Hemoclip 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 the Single Use Hemoclip:

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

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

Clinical Test Conclusion

No clinical study is included in this submission.

9. Conclusions

Based on the indications for use, technological characteristics, and safety and performance testing, Single Use Hemoclip has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Single Use Hemoclip (K172762) and Lockado™ Repositionable Hemostasis Clip (K202333).

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.