Single Use Rotatable and Repositionable Hemoclip

K201771 · Anrei Medical (Hangzhou) Co., Ltd. · PKL · Oct 19, 2020 · Gastroenterology, Urology

Device Facts

• Record ID: K201771
• Device Name: Single Use Rotatable and Repositionable Hemoclip
• Applicant: Anrei Medical (Hangzhou) Co., Ltd.
• Product Code: PKL · Gastroenterology, Urology
• Decision Date: Oct 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Sterile, single-use endoscopic clipping device; consists of delivery system and clip. Used by physicians in clinical settings during endoscopic procedures. Device allows clip rotation and repositioning; jaws open/close up to five times prior to final deployment. Physician operates delivery system to place clip at lesion site. Provides mechanical closure of tissue defects, aiding hemostasis or marking. Benefits include reduced bleeding risk and non-surgical closure of small perforations.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via mechanical integrity, clamping strength, tensile strength, release force, rotation, and repositionability tests. Biocompatibility verified per ISO 10993 (cytotoxicity, sensitization, irritation, systemic toxicity) and pyrogen testing (USP <151>).

Technological Characteristics

Single-use endoscopic clip with delivery system. Working lengths: 1650mm, 1950mm, 2300mm, 2700mm. Minimum working channel: 2.8mm. Open widths: 9mm, 11mm, 13mm, 16mm. Sterilization: Ethylene oxide (SAL 10^-6). Biocompatibility: ISO 10993 compliant. Packaging: ASTM F1929-15 (dye penetration), ASTM F88/F88M-15 (seal strength).

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), or closure of GI luminal perforations <20mm treatable conservatively.

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

• SureClip(TM) Repositionable Hemostasis Clip (K161463)
• Sterile Repositionable Hemostasis Clipping Device (K152001)

Submission Summary (Full Text)

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

3) 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
- 2. 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: [phone] Fax: [phone] Email: [e-mail]

- 3. 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: [phone], Fax: [phone] Email: [e-mail]

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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,
- 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.

#### 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

- 7. 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 and<br>Repositionable Hemoclip is indicated<br>for clip placement within the<br>Gastrointestinal (GI) tract for the<br>purpose of:<br>1. Endoscopic marking,<br>2. Hemostasis for:<br>Mucosal/sub-mucosal defects <3cm,<br>Bleeding ulcers,<br>Arteries < 2mm,<br>Polyps < 1.5cm in diameter,<br>Diverticula in the colon,<br>3. As a supplementary method,<br>closure of GI tract luminal perforations<br>< 20mm that can be treated<br>conservatively. | The SureClip(TM) Repositionable<br>Hemostasis Clip is indicated for<br>endoscopic clip placement within the<br>gastrointestinal tract for the purpose of:<br>(1) endoscopic marking,<br>(2) hemostasis for<br>(a) mucosal / sub-mucosal defects <<br>3cm,<br>(b) bleeding ulcers,<br>(c) polyps < 1.5cm in diameter,<br>(d) diverticula in the colon,<br>(3) as a supplementary method, closure<br>of GI tract luminal perforations <20mm<br>that can be treated conservatively | The Sterile Repositionable Hemostasis<br>Clipping Device is indicated for<br>endoscopic clip placement within the<br>gastrointestinal tract for the purpose of:<br>(1) endoscopic marking,<br>(2) hemostasis for<br>(a) mucosal / sub-mucosal defects <<br>3cm,<br>(b) bleeding ulcers,<br>(c) polyps < 1.5cm in diameter,<br>(d) diverticula in the colon,<br>(3) as a supplementary method, closure<br>of GI tract luminal perforations <20mm<br>that 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 and<br>2700mm | 1650mm, 1950mm and 2350mm | 1650mm, 1950mm, 2350mm and<br>2700mm |
|-----------------------------|--------------------------------------|---------------------------------|--------------------------------------|
| 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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- 9. 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.