Non Absorbable Surgical Nylon Suture

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 22, 2021 Shandong Haidike Medical Product Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China Re: K212603 Trade/Device Name: Non Absorbable Surgical Nylon Suture Regulation Number: 21 CFR 878.5020 Regulation Name: Nonabsorbable Polyamide Surgical Suture Regulatory Class: Class II Product Code: GAR Dated: November 17, 2021 Received: November 18, 2021 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, Deborah Fellhauer, RN, BSN Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K212603 Device Name Non Absorbable Surgical Nylon Suture Indications for Use (Describe) Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| 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}------------------------------------------------ # 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: K212603 - 1. Date of Preparation: 12/17/2021 - 2. Sponsor Identification ## Shandong Haidike Medical Product Co., Ltd. Tianfu Road, Dongcheng District, Shan County, 274300 Heze City, Shandong Province, China. Establishment Registration Number: 3016426842 Contact Person: Lili Xu Position: Registration Manager Tel: +86-530-4660062 Fax: +86-530-4660055 Email: registration@suturescn.com - 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}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Non Absorbable Surgical Nylon Suture Common Name: Nonabsorbable Polyamide Surgical Suture ### Regulatory Information Classification Name: Suture, Nonabsorbable, Synthetic, Polyamide; Classification: II; Product Code: GAR; Regulation Number: 21CFR 878.5020 Review Panel: General & Plastic Surgery; Indication for Use: Non Absorbable Surgical Nylon Suture is indicated for use in general soft tissue approximation and/or ligation, the device can be left in place for a maximum of 7 days. Device Description The proposed device is a nonabsorbable monofilament surgical suture which is supplied sterile. The proposed device will be offered in diameters ranging from USP size 6-0 through 2 and available in length varying from 45cm to 150cm with or without needles attached. The proposed device is dyed blue. The color additive is FD&C BLUE NO. 2, the weight percentage for color additive is less than 0.1%. #### న. Identification of Predicate Device 510(k) Number: K151165 Regulation Number: 21 CFR 878.5020 Classification: II Product Code: GAR Review Panel: General & Plastic Surgery Product Name: Dafilon Nonabsorbable Polyamide Surgical Suture #### 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: - > ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials - ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging A by Dye Penetration - > ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials {5}------------------------------------------------ - > ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity - > ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - > ISO 10993-6:2016 Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation - > ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - > ISO 10993-10 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization - > ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity - > USP 43-NF38:2020 <151> Pyrogen Test (USP Rabbit Test) - > USP 43-NF38:2020 <85> Bacterial Endotoxins Test - > USP 43-NF38:2020 <881> Tensile Strength - > USP 43-NF38:2020 <861> Sutures - Diameter - > USP 43-NF38:2020 <871> Sutures - Needle Attachment - Clinical Test Conclusion 7. No clinical study is included in this submission. {6}------------------------------------------------ #### Summary of Technological Characteristics 8. | ITEM | Proposed Device | Predicate Device<br>K151165 | Remark | |--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product Code | GAR | GAR | Same | | Regulation Number | 21CFR 878.5020 | 21CFR 878.5020 | Same | | Class | II | II | Same | | Indication for Use | Non Absorbable Surgical Nylon<br>Suture is indicated for use in<br>general soft tissue approximation<br>and/or ligation, the device can be<br>left in place for a maximum of 7<br>days. | Dafilon Nonabsorbable Polyamide<br>Surgical Sutures are indicated for<br>use in all types of general soft<br>tissue approximation and/or<br>ligation, including use in<br>cardiovascular, ophthalmic,<br>microsurgery and neurological<br>procedures | Similar | | Structure | Monofilament | Monofilament | Same | | Length | 45cm to 150cm | 3cm to 250cm | Different | | Diameter | 6-0 through 2 | 11-0 through 5 | Different | | Needle | With or without needles attached | With or without needles attached | Same | | Duration of use | Up to 7 days | Permanent | Different | | Performance Test | | | | | Diameter | Comply with USP <861> | All characteristics meet USP | Same | | Needle Attachment | Comply with USP <871> | Requirement | | | Tensile Strength | Comply with USP <881> | | | | Length | Not less than 95.0% of the length<br>stated on the label | Unknown | Different | | Material | Polyamide (PA 6/66)<br>Stainless Steel Wires | Polyamide 6 and/or polyamide 6,6<br>300 or 400 series stainless steel | Same | | Dyed, Un-dyed | Dyed | Dyed and Un-dyed | Different | | Colorant | Blue<br>FD&C BLUE NO. 2<br>Weight percentage less than 0.1% | [Phthalocyaninato(2-)] copper or<br>logwood extract | | | Sterile | Ethylene Oxide (EO) | Gamma Irradiation or Ethylene<br>Oxide (EO) | Different | | Biocompatibility | | | | | Cytotoxicity | The viability is not reduced to less<br>than 70% | | Same | | Sensitization | The Magnusson and Kligman<br>grades is less than 1. | Comply with the requirement of<br>ISO 10993 | Same | | Irritation | The erythema and edema grades is<br>less than 1.0 | Implantation (4 week) | Same | | Implantation | No lesion at the implantation site | | Same | ## Table 1 Comparison of Technology Characteristics {7}------------------------------------------------ | The irritation score is less than 1.0 | | |---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Systemic Toxicity | No animal died or abnormal behavior occurred. The weight loss not exceed 10% | | Pyrogen | Temperature raise less than 0.5°C | | Subacute Systemic Toxicity | No behavioral change or sign of toxicity was observed.<br>Clinical pathology parameter within the reference range.<br>No macroscopic changes in the viscera at necropsy.<br>Histopathology within normal histomorphological limits | | Bacterial Reverse Mutation | No statistical significance for the number of revertant colonies between the test group and control group.<br>No statistically significant dose-effect relationship was observed | | Gene Mutation | No concentration-related increase of mutant frequency. | | Chromosome Aberration | No significant difference in the percentage of cells with structural aberrations between the test group and control group. | | Hemolysis | Hemolytic index is less than 2% | ### Similar-Indication for Use The indication for use for proposed device is not exactly same as the predicate device. The proposed device is just indicated for general tissue approximation and this indication can be covered by the predicate device. In addition, the longest duration of use for the proposed device is up to 7 days, while it the predicate device is permanent contact device per the contact duration. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have an adverse effect when used for up to 7 days. ### Different - Length & Diameter The length and diameter of the proposed device is different from the predicate device. However, the length and diameter of the proposed device is within the range of that of the predicate device. In addition, the performance test about the length and diameter has been conducted on the proposed device and test result shows that the length and diameter of the proposed device met the acceptance criteria. {8}------------------------------------------------ ### Different-Duration of Use The duration of use for the proposed device is different from predicate device. The proposed device is a prolonged contact device, while the predicate device is permanent contact device. Although the duration of use is not same, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have adverse effect. ### Different - Material & Colorant The material and colorant of the proposed device is different from the predicate device. However, the biocompatibility test has been conducted on the proposed device and the test result showed that the material and colorant of the proposed device will not have adverse effect. ### Different - Sterile The sterilization method of the proposed device is different from the predicate device. However, the EO sterilization method is also used by the predicate device. #### 9. Substantially Equivalent (SE) Conclusion The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device K151165.