← Product Code [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL) · K201771 # Single Use Rotatable and Repositionable Hemoclip (K201771) _Anrei Medical (Hangzhou) Co., Ltd. · PKL · Oct 19, 2020 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K201771 ## Device Facts - **Applicant:** Anrei Medical (Hangzhou) Co., Ltd. - **Product Code:** [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL.md) - **Decision Date:** Oct 19, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4400 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **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). ## Regulatory 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](/device/K161463.md)) - Sterile Repositionable Hemostasis Clipping Device ([K152001](/device/K152001.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ## 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) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ ## 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: +86-571-86913333 Fax: +86-571-87603502 Email: huibing.yang@aanrui.com.cn - 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: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 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 {5}------------------------------------------------ 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. {6}------------------------------------------------ #### 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
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. | The SureClip(TM) Repositionable
Hemostasis Clip 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 | The Sterile Repositionable Hemostasis
Clipping 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. | | 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 {7}------------------------------------------------ | Working length | 1650mm, 1950mm, 2300mm and
2700mm | 1650mm, 1950mm and 2350mm | 1650mm, 1950mm, 2350mm and
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 | {8}------------------------------------------------ - 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. --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K201771](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K201771) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com