Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type)

{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. November 12, 2021 Tianjin Huahong Technology Co., Ltd. Yan Li Regulatory Affair A01, Plant B, No. 278, Hangkong Road, Tianiin Pilot Free Trade Zone Tianjin, 300308 China Re: K202319 Trade/Device Name: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: September 30, 2021 Received: October 12, 2021 Dear Yan Li: 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 M. 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) K202319 Device Name Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) Indications for Use (Describe) The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the subcutaneous injection of insulin. | 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 This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92. The assigned 510(k) Number: K202319 #### 1. Applicant information ## Tianjin Huahong Technology Co., Ltd. A01, Plant B, No. 278, Hangkong Road, Tianjin Pilot Free Trade Zone (Air Port Industrial Park) 300308 Tianjin China Contact Person: Yan Li Position: Regulatory Affair Tel: +86-22-58775333 Fax: +86-22-58775353 Email: yan.li@hh-technology.com - 2. Date of Preparation: November 10, 2021 - Identification of Proposed Device 3. Trade Name: Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) Common Name: Insulin Pen Needle Regulatory Information Classification Name: Needle, Hypodermic, Single Lumen; Classification: II; Product Code: FMI; Regulation Number: 21 CFR 880.5570; Review Panel: General Hospital; - Identification of Predicate Device 4. Predicate Device 1 510(k) Number: K181069 Trade Name: Disposable Insulin Pen Needle Predicate Device 2 510(k) Number: K170988 {4}------------------------------------------------ Trade Name: DropSafe Safety Pen Needle #### న్. Device Description The proposed devices, Insulin Pen Needle (Ordinary Type) and Insulin Pen Needle (Safety Type) are single use device, which is designed for used with a pen injector for the subcutaneous injection of insulin. For the safety type, it is designed with a sharp injury prevention feature to minimize the risk from accidental needles sticks. The proposed device is available in 29G, 30G, 31G, 32G and 33G five different specifications with the needle length available in 4mm, 8mm, 10mm and 12mm for Insulin Pen Needle (Ordinary Type) and 4mm, 5mm, and 8mm for Insulin Pen Needle (Safety Type). The product is for single use and provided sterile (Irradiation). The shelf-life of the product is five-years. #### 6. Indications for Use The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the injection of insulin. - 7. Comparison of Technological Characteristics | ITEM | Proposed Device | Predicate Device 1 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | | K202319 | K181069 | | Proprietary/ trade name | Insulin Pen Needle (Ordinary Type) | Disposable Insulin Pen Needle | | Regulation No. | 880.5570 | 880.5570 | | Product Code | FMI | FMI | | Class | II | II | | Intended Use | The Insulin Pen Needle (Ordinary Type) is intended for use with pen injector devices for the subcutaneous injection of insulin. | The Disposable Insulin Pen Needle is intended for use with pen injector devices for the subcutaneous injection of insulin. | | Environment of use | In hospital or in the home environment. | In hospital or in the home environment. | | Type-of-use | Disposable | Disposable | | Configuration and materials of | Needle Tube Stainless Steel | Needle Tube Stainless Steel | | | Needle Hub Polypropylene | Hub Polypropylene | Table 1 General Comparison for Insulin Pen Needle (Ordinary Type) {5}------------------------------------------------ | construction for all<br>components | Outer Sheath | Polypropylene | Cup | Polyethylene | |--------------------------------------------|-----------------------------|---------------|-----------------------------|---------------| | | Inner Sheath | Polypropylene | Inner Sheath | Polypropylene | | | Sealed Paper | Paper | Sealed Paper | Paper | | Operation Mode | For Manual Use Only | | For Manual Use Only | | | Method of<br>attachment to pen<br>injector | Through threaded connection | | Through threaded connection | | ## Table 2 Safety and Performance Comparison for Insulin Pen Needle (Ordinary Type) | ITEM | Proposed Device<br>K202319 | Predicate Device 1<br>K181069 | |--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Needle Gauge | 29G, 30G, 31G, 32G, 33G | 28G, 29G, 30G,<br>31G, 32G, 33G | | Needle Length | 4mm, 5mm, 6mm, 8mm, 10mm, 12mm | 4mm, 6mm, 8mm,<br>12mm | | Patient-contact materials | | | | Needle Tube | Stainless Steel (SUS304) | Stainless Steel | | Lubricant | MDX4-4159 | Unknown | | adhesive | UV glue | Unknown | | Bond between hub and needle tube | Clause 4.4 of ISO 11608-2:2012;<br>Clause 4.12 of ISO 7864:2016 | Clause 4.4 of ISO<br>11608-2:2012;<br>Clause 4.12 of ISO<br>7864:2016 | | Design specification of the inner<br>sheath (dimensions, color,<br>materials and strength) | 14.3*5.8*5.8mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>20MPa; Flexural<br>modulus: >800MPa; Charpy Notched Impact<br>Strength (23°C) >2.8kJ/m². | Unknown | | Design specification of the outer<br>sheath (dimensions, color,<br>materials and strength) | 30.3*13.4*13.4mm;<br>Transparent color; Polypropylene;<br>Tensile stress at yield>20MPa; Flexural<br>modulus: >800MPa; Charpy Notched Impact<br>Strength (23°C) >2.8kJ/m². | Unknown | | Needle tip configuration | Conform with ISO 7864 standards | Conform with ISO<br>7864 standards | | Cytotoxicity | No Cytoxicity | | | Intracutaneous reactivity | No Irritation to Skin | | | Skin Sensitization | No skin sensitization | Conform with ISO<br>10993 standards | | Acute Systemic Toxicity | No Systemic Toxicity | | | Pyrogen | No pyrogen | | {6}------------------------------------------------ | Hemolysis | No hemolysis | | |----------------------------|-------------------------------|-------------------------------| | Subacute Systemic Toxicity | No Subacute Systemic Toxicity | Unknown | | Method | Irradiation Sterilized | EO Sterilized | | SAL | 10-6 | 10-6 | | Endotoxin Limit | 20 EU per device | 20 EU per device | | Shelf life | 5 years | Unknown | | Label/ Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | | ITEM | Proposed Device | Predicate Device 2 | |----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K202319 | K170988 | | Regulation No. | 880.5570 | 880.5570 | | Product Code | FMI | FMI | | Class | II | II | | Intended Use | The Insulin Pen Needle (Safety Type) is sterile, single-use safety needle intended for use with pen injector devices for the injection of insulin. | The DropSafe Safety Pen Needles are sterile, single-use safety needles intended for use with pen injector devices for the injection of drugs. | | Environment of use | In hospital or in the home environment. | In hospital or in the home environment. | | Proprietary/ trade name | Insulin Pen Needle (Safety Type) | DropSafe Safety Pen Needles | | Type-of-use | Disposable | Disposable | | Configuration and materials of construction for all components | Needle Tube Stainless Steel (SUS304)<br>Needle Hub Polypropylene<br>Outer Sheath Polypropylene<br>Inner Sheath Polypropylene<br>Sealed Paper Paper<br>Spring Stainless Steel (SUS304)<br>Upper Cover Polypropylene | Cannula Medical grade stainless steel<br>Hub Plastic resin<br>Primary container Plastic resin<br>Slider Unknown<br>Seal Unknown<br>Spring-operated Stainless steel wire<br>Needle shield Plastic resin | | Operation Mode | For Manual Use Only | For Manual Use Only | | Method of attachment to pen | Threaded connection method. | Threaded connection method. | Table 3 General Comparison for Insulin Pen Needle (Safety Type) {7}------------------------------------------------ | injector | | | |-------------------------|--------------------------|--------------------------| | Safety Feature | Prevent from needlestick | Prevent from needlestick | | Method of<br>activation | Trigger shield | Trigger shield | Table 4 Safety and Performance Comparison for Insulin Pen Needle (Safety Type) | | Proposed Device | Predicate Device 2 | |--------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | ITEM | K202319 | K170988 | | Needle Gauge | 29G, 30G, 31G, 32G, 33G | 31G | | Needle Length | 4mm, 5mm, 6mm, 8mm | 6mm and 8mm | | Patient-contact material | | | | Needle Tube | Stainless Steel (SUS304) | Medical grade stainless steel | | Lubricant | MDX4-4159 | Unknown | | adhesive | UV glue | Unknown | | Bond between hub and needle tube | Drawing force ≥ 22N (29G);<br>Drawing force ≥ 11N (30G-33G);Clause 4.4 of ISO 11608-2:2012;<br>Clause 4.12 of ISO 7864:2016 | Clause 4.4 of ISO 11608-2:2012;<br>Clause 4.12 of ISO 7864:2016 | | Design specification of the inner<br>sheath (dimensions, color,<br>materials and strength) | 21.5*10.7*9.8mm;<br>Transparent color; Polypropylene.<br>Tensile stress at yield>20MPa;<br>Flexural modulus: >800MPa;<br>Charpy Notched Impact Strength<br>(23 °C) >2.8kJ/m². | Unknown | | Design specification of the outer<br>sheath (dimensions, color,<br>materials and strength) | 43.8*18.6*18.6mm; Transparent<br>color; Polypropylene.<br>Tensile stress at yield>20MPa;<br>Flexural modulus: >800MPa;<br>Charpy Notched Impact Strength<br>(23 °C) >2.8kJ/m². | Unknown | | Design specification of the upper<br>cover (dimensions, color,<br>materials and strength) | 30.2*14.6*14.6mm;<br>White;<br>Polypropylene.<br>Tensile stress at yield>20MPa;<br>Flexural modulus: >800MPa;<br>Charpy Notched Impact Strength<br>(23 °C) >2.8kJ/m². | Unknown | | Needle tip configuration | Conform with ISO 7864<br>standards | Conform with ISO 7864<br>standards | | Biocompatibility | | | | Cytotoxicity | No Cytoxicity | | | Intracutaneous reactivity | No Irritation to Skin | | | Skin Sensitization | No skin sensitization | Conform with ISO 10993<br>standards | | Acute Systemic Toxicity | No Systemic Toxicity | | | Pyrogen | No pyrogen | | | Hemolysis | No hemolysis | | | Subacute Systemic Toxicity | No Subacute Systemic Toxicity | Unknown | | Sterilization | | | | Method | Irradiation Sterilized | Irradiation Sterilized | | SAL | 10-6 | 10-6 | | Endotoxin Limit | 20 EU per device | 20 EU per device | | Shelf life | 5 years | Unknown | | Label/ Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | {8}------------------------------------------------ #### 8. Compatible injectors The Insulin Pen Needle was tested for use with the following pen injectors: Autopen® K983974 Owen Mumford, Inc. Novopen Echo® K162602 Novo Nordisk Inc. Humapen and Humapen Ergo K982842 Eli Lilly and Company Humapen Luxura K142518 Eli Lilly and Company Humapen Memoir K053563 Eli Lilly and Company #### 9. Summary of Non-clinical Performance Testing Non clinical tests were conducted to verify that the proposed device met all design specifications and that the subject device is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: Performance Testing: - > ISO 7864: 2016 Sterile hypodemic needles for single use - ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices A - > ISO 11608-2: 2012 Needle-based injection systems for medical use- Requirements and test methods- Part 2: Needles - > 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 ### Biocompatibility Testing: In accordance with ISO 10993-1, the Insulin Pen Needles are classified as: Externally communicating, indirect blood path with prolonged contact duration (>24 h to 30 d). The following testing was {9}------------------------------------------------ conducted: - Cytotoxicity ● - . Sensitization - Irritation - Acute Systemic Toxicity - . Material-Mediated Pyrogenicity - . Subacute Toxicity - . Hemocompatibility 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: The Insulin Pen Needles were sterilized by irradiation to achieve a SAL of 10th. The radiation source was CO60, and the radiation dose was 25kGy, which was established according to VDmax method per ISO11137-2, Sterilization of healthcare products. Radiation. Establishing the sterilization dose. The sterilization was validated according to ISO 11137-2. The Insulin Pen Needles were evaluated for bacterial endotoxin utilizing the USP <85> Limulus Amebocyte Lysate (LAL) method. - · Package integrity testing, after environmental conditioning and simulated transportation 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: - 0 Seal strength ASTM F88/F88-15 - o Dye penetration ASTM F1929-15 - · 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. Simulated clinical use testing A simulated clinical use study was performed on 600 device samples for the Insulin Pen Needle (Safety Type) according to FDA Guidance (Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature) and ISO 23908:2011 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria. - 11. Conclusion The clinical and non-clinical tests demonstrate that the subject device is substantially equivalent to the predicate device.