← Product Code [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL) · K152001 # Sterile Repositionable Hemostasis Clipping Device (K152001) _Micro-Tech (Nanjing) Co., Ltd. · PKL · Dec 10, 2015 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K152001 ## Device Facts - **Applicant:** Micro-Tech (Nanjing) Co., Ltd. - **Product Code:** [PKL](/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL.md) - **Decision Date:** Dec 10, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.4400 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use 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 Gl tract luminal perforations <20mm that can be treated conservatively. ## Device Story Sterile, single-use endoscopic clipping device; consists of delivery system and clip assembly. Used by physicians during endoscopic procedures to place clips within the gastrointestinal tract. Enables endoscopic marking, hemostasis for defects/ulcers/polyps/diverticula, and closure of small luminal perforations. Device is repositionable prior to final deployment. Provides mechanical closure of tissue to stop bleeding or seal perforations; benefits patient by facilitating minimally invasive management of GI lesions and defects. ## Clinical Evidence No clinical data. Bench testing only: dimensional verification, mechanical integrity, clamping strength, tensile strength, release force, and rotation testing. Compliance with ISO 10993 (biocompatibility) and ISO 11135-1/10993-7 (EO sterilization) demonstrated. ## Technological Characteristics Single-use endoscopic clipping device; delivery system and clip assembly. Working lengths: 1650mm, 1950mm, 2350mm, 2700mm. Compatible with minimum 2.8mm working channel. Open width: 11mm. Sterilization: Ethylene Oxide (EO). ## 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 - Resolution™ Hemostasis Clipping Device ([K122660](/device/K122660.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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a cascading manner. The profiles are connected and appear to be emerging from a single form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 10, 2015 Micro-Tech (Nanjing) CO., Ltd. Becky Li Manager of Quality Department No. 10 Gaoke Third Road Nanjing, 210032 China Re: K152001 > Trade/Device Name: Sterile Repositionable Hemostasis Clipping Device Regulation Number: 21 CFR §876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: II Product Code: PKL Dated: November 10, 2015 Received: November 12, 2015 Dear Becky Li, 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. 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. {1}------------------------------------------------ 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely vours. Image /page/1/Picture/8 description: The image shows the name "Herbert P. Lerner -S" in a large, bold font. The text is black and is set against a white background. The letters are evenly spaced and easy to read. The image is simple and straightforward, with the focus on the name. Benjamin R. Fisher, Ph.D. for Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152001 #### Device Name Sterile Repositionable Hemostasis Clipping Device Indications for Use (Describe) 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 Gl 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. 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." {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional font on the left side. To the right of the letters is the text "MICRO-TECH" in a sans-serif font, with a line underneath. Below the line are two Chinese characters. ## 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: K152001 ## 1. Date of Preparation: 12/08/2015 ## 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: Becky Li Position: Manager of Quality Department Tel: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn ## 3. Identification of Proposed Device Trade Name: Sterile Repositionable Hemostasis Clipping Device Common Name: Hemostasis Clipping Device ## Regulatory Information Classification Name: Hemostatic Metal Clip for the GI Tract Classification: 2 Product Code: PKL Regulation Number: 876.4400 Review Panel: Gastroenterology/Urology ## Intended Use Statement: {4}------------------------------------------------ Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional blue font. To the right of the letters, the words "MICRO-TECH" are written in a simple, sans-serif font. Below the words "MICRO-TECH", there are two Chinese characters. This device is intended to be used for endoscopic marking, hemostasis for mucosal/submucosal defects in digestive tract. #### 4. Identification of Predicate Device 510(k) Number: K122660 Product Name: Resolution™ Hemomstasis Clipping Device #### 5. Indications for Use 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 #### 6. Device Description The proposed device Sterile Repositionable Hemostasis Clipping Device 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. #### 7. Comparison of Technological Characteristics The Sterile Repositionable Hemostasis Clipping Device incorporates {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "510K Summary". The text is in a simple, sans-serif font and is left-aligned. The background is plain white, which makes the text stand out. Image /page/5/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the words "MICRO-TECH" in a smaller, sans-serif font to the right. Below the words "MICRO-TECH" are two Chinese characters. substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific predicate devices. ## Comparison to predicate Devices: | Item | Proposed Device
Sterile Repositionable Hemostasis
Clipping Device | Comparison to
Predicate
Devices | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------| | Product Code | PKL | Similar | | Regulation No. | 876.4400 | Same | | Class | 2 | Same | | Supplied Sterile | Yes | Same | | Configuration | Delivery system and clip assembly | Same | | Open width | 11mm | Same | | Minimal working
channel | 2.8mm | Same | | Working Length | 1650mm, 1950mm, 2350mm, 2700mm | Similar | | Indications for Use | 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 | Similar | | Single Use | Yes | Same | | Packaging | Single-use EO sterilized pouch with one device
per pouch | Similar | | Shelf Life | Three years | Same | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of a blue 3D block letter "MT" on the left, followed by the text "MICRO-TECH" in blue on the right. Below the text "MICRO-TECH" are two Chinese characters, also in blue. #### 8. Performance Data The proposed device the Sterile Repositionable Hemostasis Clipping Device 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 Sterile Repositionable ## Hemostasis Clipping Device: | 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. ## 9. Clinical Test Conclusion No clinical study is included in this submission. #### 10. Substantially Equivalent (SE) Conclusion Based on the indications for use, technological characteristics, and safety and performance testing, the Sterile Repositionable Hemostasis Clipping Device has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Resolution™ Hemostasis Clipping Device (K122660) . --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K152001](https://fda.innolitics.com/submissions/GU/subpart-e%E2%80%94surgical-devices/PKL/K152001) **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