Disposable Endoscopic Hemoclip

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue. May 1, 2023 Jiangsu Vedkang Medical Science and Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 2000120 CHINA Re: K222146 Trade/Device Name: Disposable Endoscopic Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal Ligator Regulatory Class: Class II Product Code: PKL Dear Diana Hong: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 28, 2023. Specifically, FDA is updating this SE Letter as an administrative correction to update the company name. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shanil Haugen, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices,. Sincerely, # Shanil P. Haugen -S 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 {1}------------------------------------------------ Image /page/1/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 text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 28, 2023 Jiangsu Horizon Medical Science & Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai. 2000120 CHINA Re: K222146 > Trade/Device Name: Disposable Endoscopic Hemoclip Regulation Number: 21 CFR 876.4400 Regulation Name: Hemorrhoidal ligator Regulatory Class: Class II Product Code: PKL Dated: February 16, 2023 Received: February 23, 2023 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. {2}------------------------------------------------ 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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-devices/medical-device-safety/medicaldevice-reporting-mdr-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/medical-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-devices/device-advicecomprehensive-regulatory-assistance/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). Sincerelv. Sivakami Venkatachalam -S 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K222146 Device Name Disposable Endoscopic Hemoclip ### Indications for Use (Describe) It is indicated for Endoscopic clip placement within the Gastromtestinal 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 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. 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." {4}------------------------------------------------ Page 1 of 6 # 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: K222146 - 1. Date of Preparation: 02/18/2023 - 2. Sponsor Identification ### Jiangsu Vedkang Medical Science & Technology Co., Ltd. No. 52, Guoxiang Road, Wujin Economic Development Zone, Changzhou 213149, Jiangsu, P.R. China Establishment Registration Number: 3013526170 Contact Person: Lin Zhang Position: International Registrar Tel: +86-519-69877755 Fax: +86-519-69877753 Email: rateam@vedkang.com - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Tingting Su (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 {5}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Disposable Endoscopic Hemoclip Common Name: Hemostasis Clipping Device Regulatory Information Classification Name: Hemorrhoidal Ligator; Classification: II; Product Code: PKL; Regulation Number: 21CFR 876.4400 Review Panel: Gastroenterology/Urology; Indications for Use: It 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 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 include: metal cap, spring sheath, pulling wire component, coating layer, protective tube, core rod, and slider. The clip include: clip components and sleeve, and it is deployed from the delivery system during use. The hemoclip can be opened and closed up to five times prior to deployment, aiding in repositioning of the clip at the lesion site. The device is available in four clip opening widths, which are 9mm, 11mm, and the device effective length is available in 1600mm, 1800mm, 2600mm, 2600mm. - ર. Identification of Predicate Device Predicate Device 510(k) Number: K182556 Product Name: SureClip Repositionable Hemostasis Clip {6}------------------------------------------------ #### 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 10993-6:2017 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation - ア 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 delaved-type hypersensitivitv - > 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. - A ASTM F88/F88M-15 standard method for seal strength of flexible barrier materials - > ASTM F1886 / F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - > USP <85> Bacterial Endotoxins Test - > USP 43 <151> Pyrogen Test - A ASTM F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment - > ASTM F2213-17 Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment - > ASTM F2182-19 e2, Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance - A ASTM F2119-07(Reapproved 2013), Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants - > ASTM D4169:2016 Standard Practice for Performance Testing of Shipping Containers and Systems ### Performance testing - The following bench tests were performed on the Disposable Endoscopic Hemoclip:Dimension - Rotation test - . Relocation test - Mechanical integrity test - Tensile strength test - Release force test - Clamping strength test {7}------------------------------------------------ Above all tests were passed and demonstrated the result can meet the product requirements. ### Biocompatibility testing The biocompatibility evaluation for the proposed device was conducted in accordance with FDA Guidance, Use of International Standard ISO-10993-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on September 4, 2020. The following tests were conducted for the clip component of Disposable Endoscopic Hemoclip: - Cytotoxicity . - Irritation . - . Skin Sensitization - Acute Systemic Toxicity - Pyrogenicity - . Implantation Test - . Chemical Characterization Study The following tests were conducted for the delivery component of Disposable Endoscopic Hemoclip: - Cytotoxicity - . Irritation - . Skin Sensitization - . Acute Systemic Toxicity - . Pyrogenicity ### Sterility, Shipping, and Shelf -life The proposed device sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135:2014 to achieve a sterility assurance level (SAL) of 10-6. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below the level of 20 EU/device in accordance with USP <85>. Both baseline and accelerated shelf life testing were conducted demonstrating the device will perform as intended to support the proposed 5 year shelf-life. . Package integrity test - after environmental conditioning, simulated transportation testing in accordance to ASTM D4169-16 on final, packaged, and sterile device. - . Sterile Barrier Packaging performed on the proposed device: - Seal Strength ASTM F88/F88-15 O - Dye penetration ASTM F1929-15 O - Visual Inspection ASTM F1886/F1886M-16 o . Shelf-life of 3-years is validated using FDA recognized standard ASTM F1980 -16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. - 7. Clinical Test Conclusion {8}------------------------------------------------ No clinical study is included in this submission. - 8. Substantially Equivalent (SE) Comparison | Item | Proposed Device | Predicate Device K182556 | Remark | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product Code | PKL | PKL | Same | | Regulation Number | 21CFR 876.4400 | 21CFR 876.4400 | Same | | Indications for Use | It is indicated for Endoscopic clip placement within the Gastrointestinal tract only via a straight or side viewing flexible endoscope for the purpose of:<br>(1) Endoscopic marking:<br>(2) Hemostasis for<br>(a) Mucosal/ sub-mucosal defects < 3cm,<br>(b)Bleeding ulcers.<br>(c)Polyps<1.5cm in diameter,<br>(d)Diverticula in the colon<br>(e)Arteries <2 mm<br>(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;<br>(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively. | The SureClip Repositionable 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:<br>(1) Endoscopic marking,<br>(2) Hemostasis for<br>(a)Mucosal / sub-mucosal defects < 3cm,<br>(b) Bleeding ulcers,<br>(c) Polyps < 1.5cm in diameter,<br>(d) Diverticula in the colon,<br>(e) Arteries < 2 mm<br>(f) Prophylactic clipping to reduce the risk of delayed bleeding post lesion resection;<br>(3) As a supplementary method, closure of GI tract luminal perforations <20mm that can be treated conservatively | Same | | Configuration | Delivery system and clip assembly | Delivery system and clip assembly | Same | | Rotation function | Rotatable | Rotatable | Same | | Open width | 9mm, 11mm, 13mm and 16mm | 8mm, 11mm and 16mm | Different | | Minimal working channel | 2.8mm | 2.8mm | Same | | Working length | 1600mm, 1800mm, 2300mm and 2600mm | 1650mm and 2350mm | Different | | Single Use | Single Use | Single Use | Same | | Labeling | Comply with 21 CFR Part 801 | Comply with 21 CFR Part 801 | Same | | | | | | Table 1 Comparison of Technology Characteristics | |--|--|--|--|--------------------------------------------------| |--|--|--|--|--------------------------------------------------| {9}------------------------------------------------ | Material | | | | |-----------------------------|-------------------------------------------------------------------------|---------------------------------|-----------| | Clip components | SUS631 Stainless steel | Unknown | Different | | Sleeve | SUS316F | Unknown | | | Metal cap | SUS303 Stainless steel | Unknown | | | Spring sheath | SUS304 | Unknown | | | Pulling wire component | SUS304 | Unknown | | | Coating layer | Polyethylene (PE), Ethylene-vinyl Acetate (EVA) and Purple Pigment | Unknown | | | Protective tube | SUS304 | Unknown | | | Core rod | Acrylonitrile Butadiene Styrene (ABS) and Thermoplastic Elastomer (TPE) | Unknown | | | Slider | Acrylonitrile Butadiene Styrene (ABS) and Thermoplastic Elastomer (TPE) | Unknown | | | Biocompatibility | | | | | Cytotoxicity | No cytotoxicity | Comply with ISO 10993 standards | Same | | Skin Sensitization | No skin sensitization | | | | Irritation | No irritation | | | | Acute Systemic Toxicity | No acute toxicity | | | | Sub-acute Systemic Toxicity | No sub-acute toxicity | | | | Sterilization | | | | | Method | Ethylene oxide | Ethylene oxide | Same | | SAL | 10-6 | 10-6 | Same | | Endotoxin Limit | 20EU | 20EU | Same | #### Conclusion 9. The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission, Disposable Endoscopic Hemoclip, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182556.