Hemoclip

K211787 · Hangzhou AGS MedTech Co., Ltd. · PKL · Mar 3, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K211787
• Device Name: Hemoclip
• Applicant: Hangzhou AGS MedTech Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Mar 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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 · Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel. 4. As a supplementary method, closure of GI tract luminal perforations 20mm that can be treated conservatively.

Device Story

Hemoclip is a single-use endoscopic clipping device consisting of a release mechanism (handle, spring tube) and a clip component. Operated by a physician during endoscopic procedures, the device is inserted through an endoscope into the GI tract. The physician uses a sliding handle to open/close the clip for tissue clamping. The clip features a locking hook mechanism that allows for mechanical suturing. A key feature is the ability to remove a deployed clip if positioning is unsatisfactory; this is achieved by using a snare loop to engage grooves on the frap tube, releasing the lock buckle, and allowing the clip to be withdrawn. The device provides mechanical tissue closure, aiding in hemostasis, marking, or anchoring, and is intended to fall off naturally after 1-2 weeks if not removed.

Clinical Evidence

No clinical data included. Substantial equivalence is supported by non-clinical bench testing, including clip releasing force, open/close functionality, clamping strength, tensile strength, separation force, rotation property, endoscope compatibility, and removability performance. Biocompatibility and sterility (ISO 11135) were verified.

Technological Characteristics

Materials: SUS631, SUS304, SUS303, PE. Principle: Mechanical clip deployment via sliding handle; self-locking mechanism. Dimensions: Opening spans of 9, 11, 13, 16, 18mm; working lengths of 165, 195, 230cm. Sterilization: EO. Biocompatibility: ISO 10993-3, -5, -6, -10, -11.

Indications for Use

Indicated for patients requiring endoscopic clip placement in the GI tract for marking, hemostasis (mucosal/sub-mucosal defects <3cm, bleeding ulcers, arteries <2mm, polyps <1.5cm, colonic diverticula), prophylactic clipping post-resection, anchoring jejunal feeding tubes, or closure of GI luminal perforations <20mm.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Hemoclip (K172727)

Submission Summary (Full Text)

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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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable.

March 3, 2022

Hangzhou AGS MedTech Co., Ltd. Yanping Fu, RA Supervisor Building 5, Building 6, No. 597 Kangxin Road Yuhang District Hangzhou, Zhejiang 311106 CHINA

Re: K211787 Trade/Device Name: Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: January 26, 2022 Received: February 2, 2022

#### Dear Yanping Fu:

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 ([e-mail]) or phone [phone] 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K211787

# 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,
- 2. 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
- 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

4. 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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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

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FORM FDA 3881 (6/20)

Page 1 of 1

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Image /page/3/Picture/0 description: The image contains a logo with a blue and green circular design on the left, and the text "AGS MEDTECH" in English and Chinese on the right. The circular design consists of three blue curved shapes that converge towards the center, with a green triangle in the middle. The text "AGS MEDTECH" is written in a simple, sans-serif font, and the Chinese characters below it are in a traditional style.

# 510(k) Summary

We submit this 510(k) Summary as per 21 CFR 807.92, it meets the content and format regulatory requirements.

## 5.1 Submitter

| Submitted by/Owner: | Hangzhou AGS MedTech Co., Ltd.<br>Building 5, Building 6, NO.597 Kangxin Road Yuhang<br>District, Hangzhou, Zhejiang 311106 China |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 3010288205 |
| Registration Status: | Active |
| Contact Person: | Yanping Fu<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | Jun,1,2021 |

## 5.2 Proposed Device

| Trade Name: | / |
|-------------------------|----------------------------------------|
| Device Name: | Hemoclip |
| Common Name: | Endoscope Clipping Device |
| Regulation class: | Class II |
| Regulation Number: | 876.4400 |
| Regulation Description: | Hemorrhoidal ligator. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | PKL |
| Product Code Name: | Hemostatic Metal Clip For The Gi Tract |

## 5.3 Predicate Device

| Trade Name: | / |
|-------------------------|----------------------------------------|
| Device Name: | Hemoclip |
| Common Name: | Endoscope Clipping Device |
| 510(k) Number: | K172727 |
| Regulation class: | Class II |
| Regulation Number: | 876.4400 |
| Regulation Description: | Hemorrhoidal ligator. |
| Review Panel: | Gastroenterology/Urology |
| Product Code: | PKL |
| Product Code Name: | Hemostatic Metal Clip For The Gi Tract |

# 5.4 Device Description

Hemoclip consists of Release part and Clip part. Clip part consists of Clip and Frap Tube . Release part consists of Spring End, Plastic Coated Spring Tube / Spring Tube

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Image /page/4/Picture/0 description: The image shows the logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the circular design is the text "AGS MEDTECH" in English, followed by the same name in Chinese characters.

K211787 Page 2 of 5

and Handle. EO Sterilization and use for single use only.

For 510 family, the grooves on the frap tube allow the released clip could be removed by snare loops. If the clip has been deployed, but its position is not satisfactory, or it affects the field of vision, we can remove it.

# 5.5 Indication for use statement

The Hemoclip is indicated for endoscopic clip placement within the gastrointestinal 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

● Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection 3. Anchoring to affix jejunal feeding tubes to the wall of the small bowel.

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

# 5.6 Comparison of Technology Characteristics

Our proposed device Hemoclip is substantially equivalent to the predicate devices. The differences between the Hemoclip and the predicate devices do not raise any questions regarding its safety and effectiveness. The differences are listed in the table below:

| Item | | Proposed device<br>Hangzhou AGS MedTech Co., Ltd. | Predicate device<br>(K172727)<br>Hangzhou AGS MedTech Co.,<br>Ltd. | Comparion | | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| | Model number | 510 Family | 510 Family, 543 Family,<br>550 Family | Similar, only<br>510 family in<br>this submission. | | |
| Tech<br>nical | Principl<br>e of<br>operatio<br>n | The clip is opened or closed by<br>operating the sliding handle. After<br>positioning and clamping the related<br>tissues, the sliding handle is operated<br>to separate the clip components from<br>the delivery device components, and<br>the delivery device then exits the<br>human digestive tract. The clip<br>remained in the alimentary tract for<br>about 1-2 weeks, fell off naturally and<br>was discharged through the intestine<br>and anus. | The clip is opened or closed by<br>operating the sliding handle.<br>After positioning and clamping<br>the related tissues, the sliding<br>handle is operated to separate<br>the clip components from the<br>delivery device components,<br>and the delivery device then<br>exits the human digestive tract.<br>The clip remained in the<br>alimentary tract for about 1-2<br>weeks, fell off naturally and | Different.<br>Our proposed<br>device 510<br>family could be<br>removed by<br>specified<br>removal device. | | |
| Item | Proposed device<br>Hangzhou AGS MedTech Co., Ltd. | Predicate device<br>(K172727)<br>Hangzhou AGS MedTech Co.,<br>Ltd. | Comparion | | | |
| | For 510 series, the released clip could<br>be removed by specified instruments.<br>There is a locking hook at the end of<br>the clips, when the clip part released<br>after the closing movement, the<br>locking hook forms a buckle with the<br>groove at the lower end of the frap<br>tube, making the two clips self-<br>locking and closing, so as to achieve<br>mechanical suture of the tissue at the<br>lesion. Intraoperative, when operators<br>find close position is not ideal, need<br>to be adjusted to remove the released<br>and closed clip head, they could take<br>a snare product, since the endoscopic<br>clamp inserts, in the perspective of<br>endoscopic, the snare loop goes into<br>the grooves, gradually tightening the<br>snare loop, apply a pressure to the<br>locked hook, press the hooks in,<br>release the lock buckle, so that the<br>two closed clips open, and the closed<br>clip head leave the original lesion<br>site; The snare loop tightens the<br>opened clip head and exits from the<br>human digestive tract together with<br>the endoscope. Then the endoscope<br>was reintroduced into the human<br>digestive tract and the operation<br>continued. | was discharged through the<br>intestine and anus | | | | |
| Opening<br>span | 9 mm,11 mm,13 mm,16 mm,18mm | 9mm, 11mm, 13mm,16mm | Different.<br>We add 18mm<br>opening span<br>for more<br>options for<br>doctors. | | | |
| Workin<br>g length | 165cm, 195cm, 230cm | 165cm, 195cm, 230cm | Same. | | | |
| Item | | Proposed device<br>Hangzhou AGS MedTech Co., Ltd. | Predicate device<br>(K172727)<br>Hangzhou AGS MedTech Co., Ltd. | Comparion | | |
| | Removable<br>performance | Yes | No such performance | Different, our<br>proposed 510<br>Family add<br>removable<br>performance.<br>Bench tests<br>have been done<br>for proposed<br>device | | |
| | Biological | Metallic<br>materials<br>contacting with<br>human body | Clip part: SUS631, SUS304<br>Spring end: SUS303;<br>Spring Tube: SUS304;<br>Plastic Coated Spring Tube: SUS304, PE | Clip part: SUS631, SUS303<br>Connected end: SUS 303<br>Spring Tube: SUS304;<br>Plastic Coated Spring Tube:<br>SUS304, PE | Similar<br>Different.<br>Biocompatibility tests<br>have been done<br>for the<br>difference.<br>Biological<br>risks are<br>acceptable. | |
| | | | Biocompatibility | ISO 10993-5:2009, ISO 10993-10:2010,<br>ISO 10993-11:2017, ISO 10993-3:2014<br>ISO 10993-6:2016 | ISO 10993-5:2009, ISO<br>10993-10:2010<br>ISO10993-11:2006, ISO<br>10993-3:2014 | Similar<br>Standard update |

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Image /page/5/Picture/1 description: The image shows a logo for AGS Medtech. The logo consists of a circular symbol with three curved shapes in blue and green, arranged in a triangular pattern. To the right of the symbol, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The text is in a simple, sans-serif font and is horizontally aligned.

Section 5 510(k) Summary
Hemoclip

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Image /page/6/Picture/0 description: The image contains a logo for AGS Medtech. The logo consists of a blue circular design with a green triangle in the center. To the right of the logo, the text "AGS MEDTECH" is written in English, followed by the same name written in Chinese characters.

Section 5 510(k) Summary
Hemoclip

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Image /page/7/Picture/0 description: The image shows a logo for AGS Medtech. The logo consists of a circular design with three blue curved shapes forming a triangle, with a green shape in the center. To the right of the circular design, the text "AGS MEDTECH" is written in English, followed by Chinese characters below it. The logo appears to be for a medical technology company.

5.7 Applicable Guidance Document NA

# 5.8 Performance Data

The Hemoclip meets all design specifications and medical device standards for biocompatibility (ISO 10993) and sterility (ISO 11135). The non-clinical performance meets the design specification and shows substantial equivalence to the predicated device.

Following tests was conducted in our non-clinical bench test:

Clip Releasing Force, Open and Close, Clamping Strength, Tensile Strength, Separation Force, Rotation property, Matching with Endoscope, Removability Performance.

# 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 demonstrated that proposed device Hemoclip is substantially equivalent to the predicate devices.