Verisafe Safety sterile needles

{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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. February 15, 2023 Promisemed Hangzhou Meditech Co., Ltd. Zearou Yang Regulatory Affairs Manager No. 1388 Cangxing Street. Cangqian Community Yuhang District Hangzhou City, Zhejiang 311121 China Re: K222271 Trade/Device Name: Verisafe Safety sterile needles Regulation Number: 21 CFR 880.5570 Regulation Name: Needle, hypodermic, single lumen Regulatory Class: Class II Product Code: FMI Dated: December 14, 2022 Received: December 14, 2022 Dear Zearou Yang: 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, Alan M. Stevens -S3 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 {2}------------------------------------------------ {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K22271 Device Name Verisafe Safety Sterile Needles #### Indications for Use (Describe) It is intended for use in the aspiration of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick. Type of Use (Select one or both, as applicable) | <span style="font-family: sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |----------------------------------------------------------------------------------------------| | <span style="font-family: sans-serif;">☐</span> 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}------------------------------------------------ # K22271 510k Summary #### 1. Date Prepared February 14th, 2023 ## 2. Submitter's Information #### Name of Sponsor: Promisemed Hangzhou Meditech Co., Ltd. #### Address: No. 1388 Cangxing Street, Cangqian 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 ### 3. Trade Name, Common Name, Classification Trade/Product Name: Verisafe Safety sterile needles Common Name: Safety sterile needles Classification name: Needle, hypodermic, single lumen Regulation Number: 880.5570 Device Class: Class II Product Code: FMI ### 4. Identification of Predicate Device K123684: Sol-Care Safety Needle ### 5. Description of the Device The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use. The Verisafe Safety sterile needles are for use with syringes. The device mainly consists of hub, needle cap and safety shield. It is packaged in a {5}------------------------------------------------ sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control. Sterilized by ETO, shelf life 5 years. #### 6. Indication It is intended for use in the aspiration and injection of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick. #### 7. Similarities and Differences of the Proposed Devices to the Predicate Devices Promisemed Safety sterile needles are substantially equivalent to the predicate device, Sol-Care Safety Needle, K123684 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 between the subject device and predicate device do not affect the basic design principle, usage of the subject device. A detailed comparison to the predicate is provided in Table 1. | Items | Subject Device | Predicate Device<br>(K123684) | Comments | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------| | Trade Name | Verisafe Safety sterile<br>needles | Sol-Care Safety Needle; | | | Manufacturer | Promisemed Hangzhou<br>Meditech Co., Ltd | Sol-Millennium. Medical.<br>Inc. | | | Device Class | Class II | Class II | Similar | | Product Code | FMI | FMI | Similar | | Regulation number | 880.5570 | 880.5570 | Similar | | Regulation Name | Needle, hypodermic,<br>single lumen | Needle, hypodermic,<br>single lumen | Similar | | Intended Use/<br>Indications for Use | It is intended for use in the<br>aspiration and injection of<br>fluids for medical purposes.<br>When the safety shield is<br>manually activated, it will<br>cover the needle<br>immediately after use to<br>minimize risk of accidental<br>needle stick. | It is intended for use in the<br>aspiration and injection of<br>fluids for medical purposes.<br>When the safety shield is<br>manually activated, it will<br>cover the needle<br>immediately after use to<br>minimize risk of accidental<br>needle stick. | Similar | | Operating<br>Principle | When the safety shield is<br>manually activated, it will<br>cover the needle immediately<br>after use to minimize risk of<br>accidental needle stick. | The Sol-Care Safety Needle has<br>a shield that covers the needle<br>point after use. In the<br>activated position, the needle<br>shield guards against<br>accidental needle stick during<br>normal handling and disposal<br>of the used needle/syringe<br>combination. | Similar | | Needle Gauge | 18G, 19G, 20G, 21G, 22G, 23G,<br>24G, 25G, 26G, 27G, 28G, 29G,<br>30G | 18G, 19G, 20G, 21G, 22G, 23G,<br>24G, 25G, 26G, 27G, 28G, 29G,<br>30G | Similar | {6}------------------------------------------------ | Needle Length | 1/2in, 3/4in, 5/8in, 1in, 1 1/4in,<br>1 1/2in, 2 in | 3/8 in to 1 1/2 in | Different, Subject<br>devices have more<br>needle lengths than<br>predicate device. | |-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Needle hub<br>color | Per ISO 6009:<br>Pink/18G, Cream/19G,<br>Yellow/20G, Light green/21G,<br>Black/22G, Light blue/23G,<br>Medium purple /24G,<br>Orange /25G, Brown /26G,<br>Medium grey /27G,<br>Blue - green /28G, Red /29G,<br>Yellow /30G. | Per ISO 6009:<br>Pink/18G, Cream/19G,<br>Yellow/20G, Light green/21G,<br>Black/22G, Light blue/23G,<br>Medium purple /24G,<br>Orange /25G, Brown /26G,<br>Medium grey /27G,<br>Blue - green /28G, Red /29G,<br>Yellow /30G. | Each color is in<br>accordance with ISO<br>6009. | | Reuse durability | Single Use | Single Use | Similar | | Biocompatibility | Complied with ISO10993 series<br>standards, and the following<br>tests are performed<br>- Cytotoxicity: No cytotoxicity<br>- Intracutaneous Reactivity<br>No evidence of irritation<br>- Skin Sensitization: No<br>evidence of sensitization<br>- Acute Systemic Toxicity: No<br>systemic toxicity<br>- Pyrogen: Non pyrogenic<br>- Platelet Count: No effect<br>- Hemolysis: No effect | Per ISO 10993-1 | Similar | | Materials | - Needle: Stainless Steel<br>(06Cr19Ni10)<br>- Hub: Polypropylene (PP)<br>- Need Cap: Polypropylene<br>(PP) | - Needle: Stainless Steel<br>(06Cr19Ni10)<br>- Hub: Polypropylene (PP)<br>- Need Cap: Polypropylene<br>(PP) | Similar | | Performance | Complied with ISO 7864, ISO<br>9626, ISO 80369-7 | Complied with ISO 7864, ISO<br>9626, ISO 80369-7 | Similar | | Sterilization<br>method | EO Sterilization | EO Sterilization | Similar | #### Performance Testing Summary 8. 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 and standard are provided in Table 2 and Table 3. ### • Table 2 Performances | No. | Test item | Reference recognized standards | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | 1.1 Appearance | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | | 1.2 Cleanliness | | | 2. | Color code | EN ISO 6009:2016, Hypodermic needles for single use - Colour<br>coding for identification | | 3. | 3.1 Dimensions | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | | | EN ISO 9626:2016, Stainless steel needle tubing for the<br>manufacture of medical devices — Requirements and test methods | | | 3.2 Length of the<br>needle | EN ISO 7864:2016, Sterile hypodermic syringes for single use –<br>Requirements and test methods | | 4. | Lubricant | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | 5. | Needle point | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | 6. | Penetration force | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | 7. | Bond between<br>needle and hub | EN ISO 7864:2016, Sterile hypodermic syringes for single use -<br>Requirements and test methods | | 8. | Patency of lumen | EN ISO 7864:2016, Sterile hypodermic syringes for single use –<br>Requirements and test methods | | 9. | Needle cap | / | | 10. | 10.1 Stiffness | EN ISO 9626:2016, Stainless steel needle tubing for the<br>manufacture of medical devices - Requirements and test methods | | | 10.2 Resistance to<br>breakage | EN ISO 9626:2016, Stainless steel needle tubing for the<br>manufacture of medical devices - Requirements and test methods | | | 10.3 Resistance to<br>corrosion | EN ISO 9626:2016, Stainless steel needle tubing for the<br>manufacture of medical devices — Requirements and test methods | | 11. | 11.1<br>Safety feature<br>(Activate force) | EN ISO 23908:2013, Sharps injury protection- Requirements and<br>test methods — Sharps protection features for single-use<br>hypodermic needles, introducers for catheters and needles used for<br>blood sampling | | | 11.2<br>Safety feature<br>(Reuse<br>Prevention) | EN ISO 23908:2013, Sharps injury protection- Requirements and<br>test methods — Sharps protection features for single-use<br>hypodermic needles, introducers for catheters and needles used for<br>blood sampling | | | 11.3<br>Safety feature<br>(Safety<br>Performance) | EN ISO 23908:2013, Sharps injury protection- Requirements and<br>test methods — Sharps protection features for single-use<br>hypodermic needles, introducers for catheters and needles used for<br>blood sampling | | 12. | 12.1 Dimension | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | 12.2 Positive<br>pressure liquid<br>leakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 12.3 Sub<br>atmospheric<br>pressure air leakage | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 12.4 Stress cracking | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 12.5 Resistance to<br>separation from<br>axial load | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 12.6 Resistance to<br>separation from<br>unscrewing | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 12.7 Resistance to<br>overriding | ISO 80369-7:2021, Small-bore connectors for liquids and gases in<br>healthcare applications - Part 7: Connectors for intravascular or<br>hypodermic applications | | | 13. | Particulate<br>contamination | USP 39 $<788>$ Particulate matter in injections | | 14. | Acidity and<br>alkalinity | EN ISO 7864:2016, Sterile hypodermic syringes for single use –<br>Requirements and test methods | | 15. | Extractable metals | EN ISO 7864:2016, Sterile hypodermic syringes for single use –<br>Requirements and test methods | | 16. | Package<br>appearance | ASTM F1886/F1886M – 16 Standard Test Method for Determining<br>Integrity of Seals for Flexible Packaging by Visual Inspection | | 17. | Seal strength | EN 868-5:2018 Packaging for terminally sterilized medical devices<br>Part 5: Sealable pouches and reels of porous materials and plastic<br>film construction - Requirements and test methods | | 18. | Dye penetration | ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in<br>Porous Medical Packaging by Dye Penetration | | 19. | Sterility | USP 39 $<71>$ Sterility tests | | 20. | Bacterial endotoxin | USP 40 $<85>$ Bacterial endotoxins test | {7}------------------------------------------------ {8}------------------------------------------------ # ・ Table 3 Biocompatibility | No. | Test item | Reference recognized standards | |-----|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | 1. | In Vitro Cytotoxicity - MTT Method,<br>MEM with 10% FBS extract | ISO 10993-5:2009 – Biological Evaluation of<br>Medical Devices -- Part 5: Tests for in Vitro<br>Cytotoxicity | | 2. | Skin Sensitization – Guinea Pig<br>Maximization, 0.9% sodium chloride<br>extract and sesame oil extract | ISO 10993-10:2021, Biological Evaluation of<br>Medical Devices -- Part 10: Tests for Irritation and<br>Skin Sensitization | {9}------------------------------------------------ | 3. | Intradermal reaction test,<br>0.9% sodium chloride extract and<br>sesame oil extract | ISO 10993-23:2021, Biological evaluation of<br>medical devices - Part 23: Tests for irritation | |----|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 4. | Acute systemic toxicity<br>0.9% sodium chloride extract and<br>sesame oil extract | ISO 10993-11:2017, Biological evaluation of<br>medical devices - Part 11: Tests for systemic<br>toxicity- Acute systemic toxicity and pyrogen test | | 5. | Pyrogen study in rabbits<br>0.9% sodium chloride injection | ISO 10993-11:2017, Biological evaluation of<br>medical devices - Part 11: Tests for systemic<br>toxicity- Acute systemic toxicity and pyrogen test<br>USP43-NF37<151> Pyrogen Test | | 6. | In Vitro Hemolytic Properties Test | ASTM F756-17 Standard Practice for Assessment<br>of Materials | | 7. | Ethylene Oxide residues EO ECH Test | ISO 10993-7:2008, Biological evaluation of<br>medical devices — Part 7: Ethylene oxide<br>sterilization residuals | #### Conclusion 9. The comparison of intended use, technological characteristics, and performance data of the subject device has demonstrated substantial equivalence to the predicate device.