Verifine Mechanical Safety Insulin Syringe

{0}------------------------------------------------ September 8, 2021 Image /page/0/Picture/1 description: The image contains 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. 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: K210712 Trade/Device Name: Verifine Mechanical Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: August 9, 2021 Received: August 9, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (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-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, CAPT Alan Stevens 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) K210712 Device Name Verifine Mechanical Safety Insulin Syringe Indications for Use (Describe) It is intended for subcutaneous injection of U-40 and U-100 insulin in the treatment of diabetes. The safety shield is intended to reduce the risk of sharp injuries. 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}------------------------------------------------ # K210712 510(k) Summary #### Date Prepared 1 Sep 7th, 2021 #### Submitter's Information 2 # Name of Sponsor: 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 #### Trade Name, Common Name, Classification ന Trade/Product Name: Verifine Mechanical Safety Insulin Syringe Classification name: Syringe, Piston Regulation Number: 21 CFR 880.5860 Device Class: Class II Product Code: FMF, FMI (hypodermic needle) #### ldentification of Predicate Device ব K193273: Insulin Syringe Classification name: Syringe, Piston Regulation Number: 21 CFR 880.5860 Device Class: Class II Product Code: FMF {4}------------------------------------------------ #### 5 Description of the Device Verifine Mechanical Safety Insulin Syringe is a sterile device consisting of a calibrated barrel with plunger intended to be used to administer an injection of insulin to a patient subcutaneously. It includes an attached needle with a safety mechanism, i.e, after the injection, the protective shield will permanently be locked in place by pushing forward till click, providing protection against needle sticks and rendering the device unusable. | Gauge | Length | Wall Type | |-------|--------|--------------| | 29G | 6 mm | | | 29G | 8 mm | | | 29G | 10 mm | | | 29G | 13mm | | | 30G | 6 mm | | | 30G | 8 mm | | | 30G | 10 mm | Regular Wall | | 30G | 13mm | Thin Wall | | 31G | 4 mm | | | 31G | 6 mm | | | 31G | 8 mm | | | 31G | 10 mm | | | 31G | 13mm | | | 32G | 4 mm | | It can be used by health care personnel. This is a single-use device. #### Indication for Use 6 | Characteristics | Subject Device | Predicate Device | |-----------------|-------------------------------------------------------|----------------------------| | | Verifine Mechanical Safety<br>Insulin Syringe K210712 | Insulin Syringe<br>K193273 | {5}------------------------------------------------ | Indication for Use | It is intended for | Insulin Syringe is intended | |------------------------------------------|----------------------------|-------------------------------| | | subcutaneous injection of | for subcutaneous injection | | | U-40 and U-100 insulin in | of U-40 and U-100 insulin | | | the treatment of diabetes. | in the treatment of diabetes. | | | The safety shield is | | | | intended to reduce the | | | | risk of sharp injuries. | | | Prescription Only or<br>Over the counter | Prescription Only | Prescription Only | ### 7 Similarities and Differences of the Proposed Devices to the Predicate Devices The Verifine Mechanical Safety Insulin Syringe is substantially equivalent to the predicate device, the Insulin Syringe (K193273) in that these devices have same intended use and technological characteristics. The basic technological and operating principles are the same for both devices. Both the subject and predicate devices are disposable, sterile, single patient use devices. 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<br>(K193273) | | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | Verifine<br>Mechanical<br>Safety Insulin Syringe | Insulin Syringe | Comments | | Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Promisemed Hangzhou<br>Meditech Co., Ltd | | | Device Class | Class II | Class II | Same | | Product Code | FMF | FMF | Same | | Regulation number | 880.5860 | 880.5860 | Same | | Regulation Name | Piston syringe | Piston syringe | Same | | Intended Use/<br>Indications for Use | It is intended for<br>subcutaneous injection<br>of U-40 and U-100<br>insulin in the treatment<br>of diabetes. The safety<br>shield is intended to<br>reduce the risk of sharp<br>injuries. | Insulin Syringe is<br>intended for<br>subcutaneous injection<br>of U-40 and U-100 insulin<br>in the treatment of<br>diabetes. | Similar<br>The subject<br>device has<br>additional safety<br>shield to prevent<br>sharp injury. | | Operating<br>Principle | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated | The insulin is injected to<br>subcutaneous tissue by<br>pushing force generated | Different<br>The subject<br>device has | | | through pushing plunger<br>rod of the insulin<br>syringe. The protective<br>shield will permanently<br>be locked in place by<br>pulling forward till click,<br>providing protection<br>against needle sticks. | through pushing plunger<br>rod of the insulin<br>syringe. | additional safety<br>shield to prevent<br>sharp injury. | | Volume | 0.3ml,0.5ml, 1.0ml | 0.3ml,0.5ml, 1.0ml | Same | | Gauge | 32G, 31G, 30G, 29G | 32G, 31G, 30G, 29G, 28G | Different<br>The gauge range<br>of subject device<br>is within that of<br>predicate device. | | Dead Space | Maximum dead space<br>0.01ml | Maximum dead space<br>0.01ml | Same | | Wall Type | Regular wall, Thin wall | Regular wall, Thin wall | Same | | Needle Length | 4mm, 6mm, 8mm, 10mm,<br>13mm | 6mm, 8mm, 12mm | Different<br>Subject device<br>has wider needle<br>length than<br>predicate<br>device. The<br>specification of<br>4mm and 13mm<br>meets the<br>requirement of<br>ISO9626, ISO7864<br>and ISO8537. | | Needle tip<br>configuration | 3 bevels | 3 bevels | Same | | Nozzle type | Not applicable | Not applicable | Same | | Numbering of scale | At every five units for<br>the 0.3mL and 0.5mL<br>syringes, and at every 5<br>or 10units for 1.0mL<br>syringe | At every five units for<br>the 0.3mL and 0.5mL<br>syringes, and at every<br>10units for 1.0mL<br>syringe | Same | | Gradations<br>legibility | Legible | Legible | Same | | Needle cover color | Red (U-40) and orange<br>(U-100) | Red (U-40) and orange<br>(U-100) | Same | | Lubricant | Silicone oil | Silicone oil | Same | | Lubricant<br>amount/cm² | The lubricant is not form<br>pools of fluid on the<br>interior surface of the<br>syringe or outside<br>surfaces of the needle<br>tube | The lubricant is not form<br>pools of fluid on the<br>interior surface of the<br>syringe or outside<br>surfaces of the needle<br>tube | Same | | Barrel<br>transparency | Transparent | Transparent | Same | | Reuse durability | Single Use | Single Use | Same | | Hub/needle<br>bond<br>strength | Bond between hub and<br>needle tube should be | Bond between hub and<br>needle tube should be | Same | A detailed comparison to the predicate is provided in Table 1. {6}------------------------------------------------ {7}------------------------------------------------ | | Nominal<br>outside<br>diameter<br>of needle<br>(mm) | Minimum<br>shearing<br>strength | Nominal<br>outside<br>diameter<br>of needle<br>(mm) | Minimum<br>shearing<br>strength | | |--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-----------------------------------------------------|---------------------------------|------| | | ≥0.33 | 22N | ≥0.33 | 22N | | | | <0.33 | 11N | <0.33 | 11N | | | 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<br>irritation<br>- Skin Sensitization: No<br>evidence of sensitization<br>-Acute and Subacute<br>Systemic Toxicity: No<br>systemic toxicity<br>-Hemolysis: No evidence<br>of hemolysis<br>-Pyrogen: Non pyrogenic | | | | Same | | Configuration and<br>Materials | Needle: Stainless Steel<br>(SUS304)<br>Barrel: Polypropylene<br>Plunger: Polypropylene<br>Push-bottom:<br>Polypropylene<br>Needle cap:<br>Polyethylene<br>Piston: Polyisoprene<br>rubber<br>Sliding Sleeve, Cover:<br>Polypropylene<br>Plug, Supporting bar:<br>Acrylonitrile Butadiene<br>Styrene | | | | Same | | Label | Device name, indication,<br>instruction for use,<br>precaution, warning,<br>shelf life, manufacturer | | | | Same | | Sterilization | EO Sterilization | | | | Same | #### 8 Discussion of differences in technological characteristics - . Considering the skin thickness of different populations, additional length is added for patients to choose from. The additional length does not affect the effectiveness and safety of the device. {8}------------------------------------------------ - . The gauge range of subject device is within that of predicate device. The different gauge range does not impact the effectiveness and safety of the device. - . The operating procedure for insulin injection process is the same as predicate device. The subject device has additional safety shield to protect against sharps injury. #### Performance Testing Summary の 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 9626:2016, Stainless steel needle tubing for the manufacture of . medical devices - Requirements and test methods - . ISO 7864:2016, Sterile hypodermic needles for single use -Requirements and test methods - ISO 8537:2016, Sterile single-use syringes, with or without needle, for ● insulin - ISO 23908:2011, Sharps injury protection Requirements and test . methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling - Simulated clinical use testing was conducted as recommended in FDA . guidance, Medical Devices with Sharps Injury Prevention Features. ### Biocompatibility In accordance with ISO 10993-1 the device is classified as External communicating device, Blood path, indirect, with prolonged contact duration (> 24h to 30d). It is leverage for the predicate the following testing; - ISO 10993-5:2009 Biological Evaluation of Medical Devices -- Part 5: . Tests for in Vitro Cytotoxicity - ISO 10993-10:2010 Biological Evaluation of Medical Devices -- Part 10: Tests for Irritation and Skin Sensitization {9}------------------------------------------------ - ISO 10993-11:2006, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Acute systemic toxicity and pyrogen test - ISO 10993-11:2017, Biological evaluation of medical devices Part 11: Tests for systemic toxicity-Subacute systemic toxicity - ISO 10993-4:2017, Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood, Hemocompatibility - USP42-NF37<151> Pyrogen Test - Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and met the USP acceptance criteria. ### Sterility, Shipping, and Shelf-Life - ISO 11135:2014, Sterilization of health-care products Ethylene . oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices - Package integrity testing, after environmental conditioning and . simulated transportation in accordance with ASTM D4169-16, was conducted on the final, packaged, and sterile devices. All packaging deemed acceptable for protection of product and sterility maintenance. - Sterile Barrier Packaging Testing performed on the proposed device: . - Seal strength ASTM F88/F88-15 - Dye penetration ASTM F1929-15 - Sterility test USP38-NF33 C71 - Shelf life of 5 years is validated using the FDA recognized standard . ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices # 10 Conclusion The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Verifine Mechanical Safety Insulin Syringe is substantially equivalent to the Insulin Syringe with respect to the indications for use, target populations, treatment method, and technological characteristic.