Who is the manufacturer of Single Use Hemoclip?

Zhejiang Chuangxiang Medical Technology Co., Ltd. filed the 510(k) submission for Single Use Hemoclip (K212669).

What is the FDA product code for Single Use Hemoclip?

PKL. It is classified under 21 CFR 876.4400 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Single Use Hemoclip?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Single Use Hemoclip?

Single Use Hemoclip (K172762); Lockado™ Repositionable Hemostasis Clip (K202333).

Who can help prepare an FDA 510(k) submission like Single Use Hemoclip?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Single Use Hemoclip

K212669 · Zhejiang Chuangxiang Medical Technology Co., Ltd. · PKL · May 27, 2022 · Gastroenterology, Urology

Device Facts

Record ID	K212669
Device Name	Single Use Hemoclip
Applicant	Zhejiang Chuangxiang Medical Technology Co., Ltd.
Product Code	PKL · Gastroenterology, Urology
Decision Date	May 27, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Single Use Hemoclip is a sterile, single-use endoscopic device consisting of a delivery system and a clip assembly. Used in the GI tract via endoscope; operated by physicians. Device enables endoscopic marking, hemostasis for defects/ulcers/polyps/diverticula, and closure of small perforations. Clip is repositionable up to 8 times before final deployment. Provides mechanical closure of tissue; aids in managing bleeding or defects; benefits patients by facilitating minimally invasive endoscopic repair.

Clinical Evidence

No clinical data. Bench testing only, including dimensional verification, mechanical integrity, clamping strength, release force, tensile strength, and rotation testing. Biocompatibility and sterilization validation performed per ISO 10993 and ISO 11135-1 standards.

Technological Characteristics

Sterile, single-use endoscopic clip assembly and delivery system. Materials comply with ISO 10993. Compatible with 2.8mm minimum working channel endoscopes. Available in various working lengths (1650mm-2700mm) and clip openings (9mm-16mm). Repositionable up to 8 times. MRI compatible per ASTM F2503, F2052, F2119, F2182, F2213. Sterilized via Ethylene Oxide (EO) per ISO 11135-1 and ISO 10993-7.

Indications for Use

Indicated for endoscopic clip placement in the GI tract for patients 18+ years old. Uses include endoscopic marking; hemostasis for mucosal/sub-mucosal defects <3cm, bleeding ulcers, polyps <1.5cm, and colonic diverticula; and supplementary closure of GI tract 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

Single Use Hemoclip (K172762)
Lockado™ Repositionable Hemostasis Clip (K202333)

Related Devices

K172762 — Single Use Hemoclip · Zhejiang Chuangxiang Medical Technology Co., Ltd. · Mar 20, 2018
K152001 — Sterile Repositionable Hemostasis Clipping Device · Micro-Tech (Nanjing) Co., Ltd. · Dec 10, 2015
K182556 — SureClip Repositionable Hemostasis Clip · Micro-Tech (Nanjing) Co., Ltd. · Dec 14, 2018
K180325 — Single Use MultiClip Device · Micro-Tech (Nanjing) Co., Ltd. · Jun 1, 2018
K234124 — Single Use Hemoclips · Promisemed Hangzhou Meditech Co., Ltd. · Jul 12, 2024

Submission Summary (Full Text)

{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 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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. 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/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 2. 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 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. {4}------------------------------------------------ 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). {5}------------------------------------------------ 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 to Predicate Devices | | Device name | Single use hemoclip | Single use hemoclip | Lockado™ Repositionable Hemostasis Clip | Similiar | | 510(k) number | / | K172762 | K202333 | Different 510(k) number | | Manufacturer | Zhejiang Chuangxiang medical technology Co., LTD. | Zhejiang Chuangxiang medical technology 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 clip assembly | Delivery system and clip assembly | Delivery system and clip assembly | Same | | Clip opening | 9mm, 12mm,13mm,15mm,16mm | 9mm, 12mm,13mm,15mm | 8mm, 11mm and 16mm | Similar | | Minimal working channel | 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 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 (4)the age of the intended population for the device is for patients who are 18 and older. | 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 (4)the age of the intended population for the device is for patients who are 18 and older. | Hemostasis Clip is indicated for Endoscopic clip placement within the Gastrointestinal tract in adult patients only via a straight or side viewing flexible endoscope 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, (e) Arteries < 2 mm, (f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection; (3) As a supplementary method, closure of Gl tract luminal perforations <20mm that can be treated 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 pouch with one device per pouch | Single-use EO sterilized pouch with one device per pouch | Single-use EO sterilized pouch with one device 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, ASTM F2213 | Same | {6}------------------------------------------------ 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: {7}------------------------------------------------ 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: {8}------------------------------------------------ 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. 8. 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).