Verifine Safety Type Insulin Pen Needle

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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. April 22, 2021 Promisemed Hangzhou Meditech Co., Ltd. % Wei Hsu Regulatory Manager Vee Care (Asia) Limited 17th Chung Pont Commercial Building, 300 Hennessy Road Hong Kong, Hong Kong China Re: K210065 Trade/Device Name: Verifine Safety Type Insulin Pen Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: March 23, 2021 Received: March 23, 2021 Dear Wei Hsu: 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 Rumi Young Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K210065 Device Name Verifine Safety Type Insulin Pen Needle ### Indications for Use (Describe) Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, after withdrawal of the Verifine Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| Prescription Use (Part 21 CFR 801 Subpart D) X 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}------------------------------------------------ # 510(k) Summary #### Date Prepared ー April 22nd, 2021 #### Submitter's Information 2 # Submission Sponsor: Name: Promisemed Hangzhou Meditech Co., Ltd. Address:No. 1388 Cangxing Street, Canggian Community, Yuhang District, Hangzhou City, 311121 Zhejiang, China Contact Name: Zearou Yang Telephone No.: +86 571 88772985 Fax No.: +86 571 88772985 Email Address: zearou.yang@promisemed.ca # Submission Correspondent: Name: Vee Care (Asia) Limited Address: 17F Chung Pont Commercial Building, 300 Hennessy Road, Hong Kong, China Contact Name: Wei-Shan Hsu E-mail: ws@vee.com.hk #### Trade Name, Common Name, Classification 3 Trade/Product Name: Verifine Safety Type Insulin Pen Needle Common Name: Insulin Pen Needle Classification name: Needle, Hypodermic, Single Lumen Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: FMI #### 4 Identification of Predicate Device(s) K161950: Verifine Safety Type Insulin Pen Needle #### 5 Description of the Device {4}------------------------------------------------ Verifine Safety Type Insulin Pen Needle is manufactured by Promisemed Hangzhou Meditech Co., Ltd, which is designed for use with a pen injector for the subcutaneous injection of insulin. The Verifine Safety Type Insulin Pen Needle consists of needle tube, trigger shield, spring, fixer, needle hub, needle container, UV glue and silicone oil. UV glue is used to glue needle tube and needle hub and the silicone oil is used to needle tube lubrication. The user proceeds with inserting the needle into the skin manually. Verifine Safety Type Insulin Pen Needle is designed to reduce occurrence of accidental needle sticks from patient end of the needle by providing a shield that covers and locks the needle after use. As the user proceeds with inserting the needle into the skin the shield will retract. After the injection is completed and needle is removed from the skin, the shield will automatically extend to cover the needle and lock in place. Once the Safety Type Insulin Pen Needle is in the locked mode, it can no longer be used. Verifine Safety Type Insulin Pen Needle is sterile with a Sterility Assurance Level (SAL) of 10-6, non-pyrogenic and single-use devices. It is supplied with several models. Different models are distinguished by needle gauge and length. #### 6 Indications for Use Verifine Safety Type Insulin Pen Needle is intended for use with pen injector device for subcutaneous injection of insulin. Additionally, after withdrawal of the Verifine Safety Type Insulin Pen Needle from the body, the attached needle safety shield automatically covers the needle to minimize the risk of accidental needlestick. #### 7 Performance Testing Summary The bench testing performed verifies that the performance of the subject device is substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include: - · ISO 9626: Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods {5}------------------------------------------------ - · ISO11608-2: Needle-based injection systems for medical use Requirements and test methods - Part 2: Needles · ISO 7864: Sterile hypodermic needles for single use - Requirements and test methods - · ISO 23908: Sharps injury protection Requirements and test methods Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - · Biocompatibility - a. ISO 10993-1:2009 Biological Evaluation of Medical Devices -- Part 1: Evaluation and testing within a risk management process - b. ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro Cytotoxicity - c. ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization - d. ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test - f. ASTM F756-13 Standard Practice for Assessment of Hemolytic Properties of Materials ### Similarities and Differences of the Proposed Devices to the 8 Predicate Devices The Verifine Safety Type Insulin Pen Needle is substantially equivalent to the predicate device, the Verifine Safety Type Insulin Pen Needle (K161950) in that these devices have identical designs, methods of construction and operation, and indications for use. The differences from the predicate is the sterilization method. The differences above between the subject device and predicate device do not affect the basic design principle, usage of the subject device. | | Subject Device | Predicate Device (K161950) | | |--------------|--------------------------------------------|------------------------------------------|----------| | Trade Name | Verifine Safety Type<br>Insulin Pen Needle | Verifine Safety Type Insulin Pen Needle | Comments | | Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Promisemed Hangzhou<br>Meditech Co., Ltd | | | Device Class | Class II | Class II | | | | | | Same | A detailed comparison to the predicate is provided in Table 1. {6}------------------------------------------------ | Product Code | FMI | FMI | Same | |--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation number | 880.5570 | 880.5570 | Same | | Regulation Name | Needle,<br>Hypodermic,<br>Single Lumen | Needle,<br>Hypodermic,<br>Single<br>Lumen | Same | | Intended<br>Use/<br>Indications for Use | The Safety Type Insulin<br>Pen Needle is intended<br>for use with pen injector<br>device for subcutaneous<br>injection of insulin.<br>Additionally, after<br>withdrawal of the Safety<br>Type Insulin Pen Needle<br>from the body, the<br>attached needle safety<br>shield automatically<br>covers the needle to<br>minimize the risk of<br>accidental needlestick. | The Safety Type Insulin Pen<br>Needle is intended for use with<br>pen injector device for<br>subcutaneous injection of<br>insulin.<br>Additionally, after withdrawal<br>of the Safety Type Insulin Pen<br>Needle from the body, the<br>attached needle safety shield<br>automatically covers the<br>needle to minimize the risk of<br>accidental needlestick. | Same | | Operating Principle | As the user proceeds with<br>inserting the needle into<br>the skin the shield will<br>retract. After the<br>injection is completed<br>and needle is removed<br>from the skin, the shield<br>will automatically extend<br>to cover the needle and<br>lock in place. Once the<br>Safety Type Insulin Pen<br>Needle is in the locked<br>mode, it can no longer be<br>used. | As the user proceeds with<br>inserting the needle into the<br>skin the shield will retract.<br>After the injection is<br>completed and needle is<br>removed from the skin, the<br>shield will automatically<br>extend to cover the needle and<br>lock in place. Once the Safety<br>Type Insulin Pen Needle is in<br>the locked mode, it can no<br>longer be used. | Same | | Gauge | G29, G30, G31 | G29, G30, G31 | Same | | Needle Length | 4mm,5mm,6mm,8mm | 4mm,5mm,6mm,8mm | Same | | Sharps<br>Injury<br>Prevention<br>Features | Trigger shield | Trigger shield | Same | | Configuration<br>and<br>Material | Needle Tube: X5CrNi18-<br>10 | Needle Tube: X5CrNi18-10 | Same | | | Needle Hub:<br>Polyformaldehyde (POM) | Needle Hub: Polyformaldehyde<br>(POM) | Same | | | Fixer: Polyformaldehyde<br>(POM) | Fixer: Polyformaldehyde (POM) | Same | | | Spring: 0Cr18Mn8Ni5N | Spring: 0Cr18Mn8Ni5N | Same | | | Needle container: | Needle container: | Same | | | Polypropylene (PP) | Polypropylene (PP) | Same | | | Trigger shield:<br>Acrylonitrile Butadiene<br>Styrene (ABS) | Trigger shield: Acrylonitrile<br>Butadiene Styrene (ABS) | Same | | Performance | Complied with ISO 7864,<br>ISO 9626, ISO 11608-2 and<br>ISO 23908 | Complied with ISO 7864, ISO<br>9626, ISO 11608-2 and ISO 23908 | Same | | Sterilization | EO Sterilization | Gamma Sterilization | Different¹ | | | | | been performed<br>(Appendix 16A).<br>A 5 years shelf-<br>life has been<br>validated<br>supported by<br>accelerated<br>aging testing<br>using EO<br>sterilized<br>product<br>(Appendix 16B). | | | SAL:10-6 | SAL:10-6 | Same | | Shelf Life | 5 years | 5 years | Same | | Single use | Yes | Yes | Same | | Biocompatibility | Complied with ISO10993<br>series standards, and the<br>following tests are<br>performed<br>- Cytotoxicity: No<br>cytotoxicity<br>- Skin Irritation: No<br>evidence of skin irritation<br>- Skin Sensitization: No<br>evidence of sensitization<br>- Acute Systemic<br>Toxicity:No systemic<br>toxicity<br>- Hemolysis: No evidence<br>of hemolysis<br>- Pyrogen: No pyrogenic<br>- Repeated exposure<br>systemic toxicity: No<br>systemic toxicity | Complied with ISO10993 series<br>standards, and the following<br>tests are performed<br>- Cytotoxicity: No cytotoxicity<br>- Skin Irritation: No evidence of<br>skin irritation<br>- Skin Sensitization: No<br>evidence of sensitization<br>- Acute Systemic Toxicity:No<br>systemic toxicity<br>- Hemolysis: No evidence of<br>hemolysis<br>- Pyrogen: No pyrogenic | Different2 | {7}------------------------------------------------ #### Justification for the differences: の ### 1) Different Sterilization The proposed sterilization method for the subect device is Ethylene Oxide sterilization as opposed to the predicate device which is sterilized by Gamma Irradiation. This difference in sterilization does not raise any additional concerns of safety or effectiveness because the proposed device met the necessary biocompatibility and sterility testing requirements per ISO 10993. - 2) Different Biocompatibility In addition to the Biocompatibility testing of the predicate device, the subject device was tested for Repeated Exposure Systemic Toxicity due to the nature {8}------------------------------------------------ of the device and the possibility of inadvertant reuse. This additional testing does not raise any additional concerns of safety or effectiveness. # 10 Conclusion Based on the information provided within this 510(k) submission, proposed Verifine Safety Type Insulin Pen Needle is substantially equivalent to the predicate device (K161950) and is as safe, as effective and performs as well as the legally marketed predicate device.