Safety Insulin Pen Needles

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Zhejiang Kindly Medical Devices Co. Ltd % Alice Huang RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor, No 1399, Jiangyue Road, Minhang District Shanghai, 201114 China Re: K213183 Trade/Device Name: Safety Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 14, 2022 Received: September 15, 2022 Dear Alice Huang: 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 (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 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) K213183 Device Name Safety Insulin Pen Needles Indications for Use (Describe) Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. 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}------------------------------------------------ #### K213183 510(K) Summary #### I. SUBMITTER: Zhejiang Kindly Medical Devices Co. Ltd No.758, 5th Binhai Road, Binhai Industrial Park Longwan District Wenzhou City, Zhejiang Province, China. Tel: +0086 13806556169 Fax: +86-0577- 86374972 Contact Person: Yong Zhang Title:General Manager Phone: +86 13806556169 Email: zhangyong(@kdlchina.com Submission Correspondent: Alice Huang Email: alice.huang@mind-link.net Tel:+86 15618536177 Shanghai Mind-link Business Consulting Co., Ltd. Room 8208, Second Floor , No 1399, Jiangyue Road, Minhang District, Shanghai Summary prepared: 10/14/2022 II. DEVICE Name of Device: Safety Insulin Pen Needles Regulation Number: 21 CFR 880.5570 Common Name: Hypodermic single lumen needle Classification Panel: General Hospital Regulatory Class: II Product Code: FMI III. PREDICATE DEVICE Primary predicate device: K181447 Safety insulin needle for single use {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The proposed device, Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. It consists of needle tube, needle hub, spring, needle hub sheath, safety protective sheath, positioning ring, outer protective cap and sealing paper. The needle hub is clear, and the positioning ring and sealing paper contains colorants for the different gauge sizes. The Safety insulin needle for single use is offered in various gauge sized and length. The proposed device is available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6. | Gauge (G) | Specifications Diameter<br>x Length (mm) | Out Diameter<br>(mm) | Inner Diameter<br>(mm) | Point<br>Type | Wall<br>Type | Color of<br>positioning<br>ring | |-----------|------------------------------------------|----------------------|------------------------|---------------|--------------|---------------------------------| | 28G | 0.36×4 | 0.349-0.370 | ≥0.190 | LB | TW | Blue-green | | 28G | 0.36×5 | 0.349-0.370 | ≥0.190 | LB | TW | Blue-green | | 28G | 0.36×6 | 0.349-0.370 | ≥0.190 | LB | TW | Blue-green | | 28G | 0.36×8 | 0.349-0.370 | ≥0.190 | LB | TW | Blue-green | | 28G | 0.36×12 | 0.349-0.370 | ≥0.190 | LB | TW | Blue-green | | 29G | 0.33×4 | 0.324-0.351 | 0.133-0.189 | LB | RW | Red | | 29G | 0.33×5 | 0.324-0.351 | 0.133-0.189 | LB | RW | Red | | 29G | 0.33×6 | 0.324-0.351 | 0.133-0.189 | LB | RW | Red | | 29G | 0.33×8 | 0.324-0.351 | 0.133-0.189 | LB | RW | Red | | 29G | 0.33×12 | 0.324-0.351 | 0.133-0.189 | LB | RW | Red | | 30G | 0.30×4 | 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow | | 30G | 0.30×5 | 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow | | 30G | 0.30×6 | 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow | | 30G | 0.30×8 | 0.298-0.320 | 0.165-0.189 | LB | TW | Yellow | | 31G | 0.25×4 | 0.254-0.267 | 0.125-0.145 | LB | TW | White | | 31G | 0.25×5 | 0.254-0.267 | 0.125-0.145 | LB | TW | White | | 31G | 0.25×6 | 0.254-0.267 | 0.125-0.145 | LB | TW | White | | 31G | 0.25×8 | 0.254-0.267 | 0.125-0.145 | LB | TW | White | | 32G | 0.23×4 | 0.229-0.241 | 0.105-0.124 | LB | TW | Deep green | | 32G | 0.23×5 | 0.229-0.241 | 0.105-0.124 | LB | TW | Deep green | | 32G | 0.23×6 | 0.229-0.241 | 0.105-0.124 | LB | TW | Deep green | Table 1 Specification of Safety Insulin Pen Needle {5}------------------------------------------------ | 33G | 0.20×4 | 0.203-0.216 | 0.105-0.124 | LB | TW | Black | |-----|--------|-------------|-------------|----|----|--------| | 33G | 0.20×5 | 0.203-0.216 | 0.105-0.124 | LB | TW | Black | | 33G | 0.20×6 | 0.203-0.216 | 0.105-0.124 | LB | TW | Black | | 34G | 0.18×4 | 0.178-0.191 | 0.091-0.104 | LB | TW | Orange | | 34G | 0.18×5 | 0.178-0.191 | 0.091-0.104 | LB | TW | Orange | | 34G | 0.18×6 | 0.178-0.191 | 0.091-0.104 | LB | TW | Orange | ### V. INDICATIONS FOR USE Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE Safety Insulin Pen Needle is intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. Additionally, the Safety Insulin Pen Needle is similar to the Safety Insulin Needle For Single Use (K181447) in regard to insertion, design, size ranges, and material. | Item | Proposed Device<br>Safety Insulin Pen Needle | Predicate Device<br>Safety insulin needle for<br>single use | Remark | |-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | K number | K213183 | K181447 | | | Classification | Class II | Class II | Same | | Product Code | FMI | FMI | Same | | Common name | Hypodermic single lumen<br>needle | Hypodermic single lumen<br>needle | Same | | Intended use | Safety Insulin Pen Needle is<br>intended to be used with<br>Insulin Pen for hypodermic<br>injection of insulin and<br>medicinal fluids. | The Safety insulin needle for<br>single use is intended for use<br>with pen injector devices for<br>the<br>subcutaneous injection of<br>insulin. | Similar<br>Note 1 | | Indications for use | Safety Insulin Pen Needle is<br>intended to be used with<br>Insulin Pen for hypodermic<br>injection of insulin and | The Safety insulin needle for<br>single use is intended for use<br>with pen injector devices for<br>the | Similar<br>Note 1 | | | | | | | | medicinal fluids. | subcutaneous injection of<br>insulin. | | | Configuration | needle tube, needle hub, spring,<br>needle hub sheath, safety<br>protective sheath, positioning<br>ring, outer protective cap and<br>sealing paper | needle tube, hub, safety<br>protective cover,<br>self-destruction seat, spring,<br>hub sheath, safety seat and<br>sealed paper. | Different<br>Note 2 | | Needle Gauge | 28G, 29G, 30G, 31G, 32G,<br>33G, 34G | 29G, 30G, 31G, 32G, 33G,<br>34G | Different<br>Note 3 | | Needle Length | 4mm, 5mm, 6mm, 8mm,12mm | 4mm, 5mm, 6mm, 8mm | Different<br>Note 3 | | Wall type | Regular walled<br>Thin-walled | Thin-walled<br>Extra-thin-walled | Different<br>Note 4 | | Patient-contact<br>Material | Needle tube SUS 304<br>Needle hub PP<br>Safety<br>protective ABS<br>sheath | Needle tube SUS 304<br>Hub PP<br>Safety<br>protective MABS<br>cap | Different<br>Note 5 | | Design | Compared with traditional<br>insulin pen needle, this product<br>is designed with a safety feature<br>that could help avoid accidental<br>needle stick injury between<br>patients and healthcare<br>professionals. | Compared with traditional<br>insulin pen needle, this<br>product is designed with a<br>safety feature that could help<br>avoid accidental needle stick<br>injury between patients and<br>healthcare professionals. | Same | | Single Use | Single use | Single use | Same | | Performance<br>testing | Comply with ISO 7864, ISO<br>9626 and ISO 11608-2 | Comply with ISO 7864, ISO<br>9626 and ISO 11608-2 | Same | | Biocompatibility | Biocompatible | Biocompatible | Same | | Sterility Condition | 10-6 | 10-6 | Same | {6}------------------------------------------------ # Discussion in details: ### Note 1: Intended Use and Indications for use Safety insulin pen needle and safety insulin needle for single use have similar intended use and indications for use, which are intended to be used with Insulin Pen for hypodermic injection of insulin and medicinal fluids. This device is EO sterilized and intended for single use. # Note 2: Configuration {7}------------------------------------------------ The components name of proposed device are different to that of the predicate, however, the components share the same configuration and function. Therefore, this difference in name will not affect the Substantial Equivalence (SE) between the proposed and predicate device. #### Note 3: Needle gauge and Needle length The needle gauge and needle length of proposed device is more than that of predicate devices. This difference in needle size will not affect the performance of the needle. In addition, all the needle size of proposed device has been tested. The test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantially Equivalency (SE) between the proposed and predicate device. ### Note 4: Wall type The wall thickness of the proposed device is different than the predicate device. The needles including both wall thickness (i.e., Regular walled and Thin-walled) of proposed device have been tested and the test results comply with ISO 7864 and ISO 9626 standards requirements. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device. # Note 5: Patient-contact Material Although the material of proposed and the predicate device is different, the patient-contact material of the proposed device material conforms to the ISO 10993 series of standards. Therefore, this difference will not affect the Substantial Equivalence (SE) between the proposed and predicate device. ### VII.PERFORMANCE DATA ### Non-Clinical Performance Data To verify that the Safety Insulin Pen Needle is as safe and effective as the predicate device, representative samples of Safety Insulin Pen Needle were underwent a series of tests including bench testing (needle performance testing), and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogen, subchronic toxicity and Particulate Matter). The test results demonstrated that the proposed device complies with the following standards: - A ISO 7864:2016, Sterile hypodermic needles for single use. {8}------------------------------------------------ - ISO 9626:2016, Stainless steel needle tubing for the manufacture of medical devices. A - ISO 11608-2 Second edition 2012-04-01, Needle-based injection systems for medical A use - Requirements and test methods - Part 2: Needles - A ISO 10993-5: 2009(R), 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 A irritation and skin sensitization - A ISO 10993-7:2008 Biological Evaluation of Medical Devices-Part 7: Ethylene Oxide Sterilization Residuals. - A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials. - A ASTM F1140/F1140M-13 Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages - > USP <85> Bacterial Endotoxins Test - ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for A systemic toxicity - USP <788> Particulate Matter Test A ### Clinical Performance Data No data from human clinical studies have been included to support the substantial equivalence of the proposed device, Safety Insulin Pen Needle, as clinical studies are not required for this medical device. #### VIII. CONCLUSION The same intended use, the similarity in overall technological characteristics, and performance data result in that Safety Insulin Pen Needle are substantially equivalent to legally marketed device, Safety insulin needle for single use.