BD Insulin Syringe (0.3mL)

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March 9, 2022 Becton, Dickinson and Company Mark William Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K212499 Trade/Device Name: BD Insulin Syringe (0.3mL) Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 16, 2022 Received: February 17, 2022 Dear Mark William: 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) K212499 Device Name BD Insulin Syringe (0.3mL) | Indications for Use (Describe) | Becton Dickinson Insulin Syringes are intended for subcutaneous injection of U-100 insulins | |--------------------------------|---------------------------------------------------------------------------------------------| |--------------------------------|---------------------------------------------------------------------------------------------| | 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}------------------------------------------------ # K212499 510(k) SUMMARY Becton, Dickinson and Company BD Insulin Syringe (0.3mL) | Submitted By: | Mark William<br>Regulatory Affairs Specialist<br>1 Becton Drive<br>Franklin Lakes, NJ 07417<br>Tel: 732-527-5008 | | |----------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Date Prepared: | March 9, 2022 | | | Device Name: | Trade Name:<br>Common Name:<br>Classification:<br>Product Code: | BD Insulin Syringe (0.3mL)<br>BD Insulin Syringes<br>Class II device; 21 CFR 880.5860, (Piston<br>Syringe)<br>FMF | #### Legally marketed predicate devices to which substantial equivalence is being claimed: - BD Insulin Syringe (K190054). ● ### Device Description: The BD Insulin Syringe, 0.3mL size, is a plastic syringe designed for subcutaneous injection of a desired dose of U-100 insulins. The product is a single use, sterile, non-toxic, non-pyrogenic, disposable syringe that consists of a needle, barrel, cannula shield, stopper, plunger, and plunger cap. The needle is a single ended lubricated stainless-steel cannula, which is permanently attached to the barrel nozzle with an adhesive. The needle is covered by a polyethylene cannula shield which is placed on the barrel. The barrel is molded from polypropylene with the exterior permanently marked with the proper scale markings. The stopper is attached to the plunger and a polyethylene cap is placed over the plunger rod. All products are gamma sterilized. The BD Insulin Syringe, 0.3mL size, are packaged in polybags as self-contained syringes. The subject device operates on the principle of a piston syringe and has a shelf life of 5 years. Table 1 below shows the different cannula configurations for BD Insulin Syringe (0.3mL). {4}------------------------------------------------ | Gauge | Length | Bevel Size | Wall Type | |-------|--------|------------|--------------| | 29G | 12.7mm | | Regular Wall | | 30G | 8mm | | Thin Wall | | 30G | 12.7mm | 3 | Thin Wall | | 31G | 6mm | | Thin Wall | | 31G | 8mm | | Thin Wall | Table 1: Summary of BD Insulin Syringe (0.3mL) Cannula Configurations The subject device includes the following main differences from the predicate device: - . Design changes: - New flared end design of the cannula shield o - New integrated barrel tip design o - Material changes: ● - 0 New cannula adhesive - New UV-bonded scale marking ink formulation O - Labeling changes: ● - Updates to include new ISO revisions and recommendations O - Added cannula shield icon O ### Intended Use / Indications for Use | Characteristics | Subject Device<br>BD Insulin Syringe (0.3mL)<br>K212499 | Predicate Device<br>BD Insulin Syringes<br>K190054 | |------------------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | Indication for Use | BD Insulin Syringes are<br>intended for subcutaneous<br>injection of U-100 insulins. | BD Insulin Syringes are<br>intended for subcutaneous<br>injection of U-100 insulins. | | Prescription Only or<br>Over the counter | Over the counter | Over the counter | The indications for use statement for the subject device is identical to the predicate device. {5}------------------------------------------------ # Technological Characteristics The technological characteristics of the BD Insulin Syringe (0.3mL) are similar to those of the predicate devices. A summary of the differences between BD Insulin Syringe (0.3mL) subject device and BD Insulin Syringes (0.3mL and 1mL) cleared under K190054 are outlined in Table 2 below. | General<br>Information<br>Feature | Subject Device:<br>BD Insulin Syringe (0.3mL) | Predicate Device:<br>BD Insulin Syringes | Comparison | |-----------------------------------|------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------| | Specific Drug<br>Use | U-100 Insulins | U-100 Insulins | Same | | Single Use Only | YES | YES | Same | | Non-pyrogenic | YES | YES | Same | | Sterilization<br>method | Gamma irradiation | Gamma irradiation | Same | | SAL 10-6 | YES | YES | Same | | Capacity | 0.3mL | 0.3mL and 1mL | Different see<br>Comment # 1 | | Cannula Gauge<br>Size(s) | 29G, 30G, and 31G | 27G, 28G, 29G, 30G, and<br>31G | Same | | Cannula Length<br>Size(s) | 6mm, 8mm, and 12.7mm | 6mm, 8mm, 12.7mm, and<br>16mm | Same | | Scale Markings | 1 unit increments and ½ unit<br>increments (0.3mL) | 1 unit increments and ½ unit<br>increments (0.3mL)<br>2 units increments (1mL) | Same | | Barrel Nozzle<br>Tip | Unique integral barrel for<br>permanently attached needles | Snap fit needle hub for<br>permanently attached needles<br>(0.3mL) | Different see<br>Comment # 2 | # Table 2: Comparison of Subject and predicate devices {6}------------------------------------------------ | General | Subject Device: | Predicate Device: | Comparison | | | |--------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------|------------------------------|--|--| | Information<br>Feature | BD Insulin Syringe (0.3mL) | BD Insulin Syringes | | | | | | | Integral barrel for<br>permanently attached needles<br>(1mL) | | | | | Cannula Shield<br>Design | Flared cannula shield | Ribbed cannula shield<br>(0.3mL)<br>Flat head cannula shield<br>(1mL) | Different see<br>Comment # 3 | | | | Barrel Collar<br>Inner Profile | Inner profile has added ribs | Inner profile has no ribs<br>(0.3mL)<br>Inner profile has ribs (1mL) | Different see<br>Comment # 4 | | | | Materials | | | | | | | Cannula | Stainless Steel 304 | Stainless Steel 304 | Same | | | | Cannula Shield | Polyethylene | Polyethylene | Same | | | | Cannula Shield<br>Color | Orange | Orange | Same | | | | Cannula<br>Lubrication | Medical Grade Silicone | Medical Grade Silicone | Same | | | | Cannula Bonding<br>Adhesive | UV Cured Adhesive | UV Cured Adhesive | Different see<br>Comment # 5 | | | | Cannula Hub | Integrated barrel design<br>made with Polypropylene | Hub design made with<br>Polypropylene (0.3mL)<br>Integrated barrel design<br>(1mL) | Different see<br>Comment # 6 | | | | Scale Marking<br>Ink | Black: UV-bonded ink | Black: Solvent based<br>Markem | Different see<br>Comment # 7 | | | {7}------------------------------------------------ | General<br>Information<br>Feature | Subject Device: | Predicate Device: | Comparison | |----------------------------------------|-----------------------------------------------------------------------------|-------------------------------------------------------------------------------|-------------------------------| | Plunger | BD Insulin Syringe (0.3mL) | BD Insulin Syringes | | | Plunger | Polystyrene | Polystyrene | Same | | Plunger Stopper | Rubber stopper | Rubber stopper | Same | | Plunger Stopper<br>Lubricant | Medical Grade Silicone | Medical Grade Silicone | Same | | Plunger Cap | Polyethylene | Polyethylene | Same | | Plunger Cap<br>Color | Natural or Orange | Natural or Orange | Same | | Barrel | Polypropylene | Polypropylene | Same | | Barrel Lubricant | Medical grade Silicone | Medical grade Silicone | Same | | Labeling | | | | | Editorial<br>Changes | Copyright statement and<br>website updated | Prior copyright statement and<br>website | Different see<br>Comment # 8 | | Updates as<br>required by<br>standards | ISO symbols updated | Prior ISO symbols | Different see<br>Comment # 9 | | | Added Gauge size in<br>millimeters in addition to<br>inches | Gauge size displayed in<br>inches | Different see<br>Comment # 10 | | Image of<br>proposed device | Cannula shield icon with the<br>statement "Now with Wider<br>Shield" added | No product/component icon<br>on the labels | Different see<br>Comment # 11 | | Content Change | IFU updated recommending<br>straight in injection while<br>pinching up skin | IFU recommended 45<br>degrees injection for longer<br>needles with a pinch up | Different see<br>Comment # 12 | | General<br>Information<br>Feature | Subject Device:<br>BD Insulin Syringe (0.3mL) | Predicate Device:<br>BD Insulin Syringes | Comparison | | | Never re-shield and<br>satisfaction guaranteed<br>statements updated | Prior Never re-shield and<br>satisfaction guaranteed<br>statements | Different see<br>Comment # 13 | | | Promotional insert removed<br>and a new claim added to the<br>shelf carton | Promotional insert | Different see<br>Comment # 14 | {8}------------------------------------------------ - Comment 1: Minor dimensional changes to the barrel for the 0.3mL design with the same volumetric capacity per ISO 8537:2016. - Comment 2: Modification to introduce a new integral barrel tip design for manufacturing efficiency of the BD Insulin Syringe (0.3mL). - Comment 3: Wider cannula shield than the current BD Insulin Syringe designs for manufacturing efficiency. - Comment 4: Added ribs, for ease of manufacturing, no impact to the performance of the BD Insulin Syringe (0.3mL). - Comment 5: A new adhesive is introduced to mechanically hold the cannula in the barrel rather than adhere the cannula to the barrel. - Comment 6: Integrated barrel design replaces the hub design of the predicate. The barrel design is made with the same material as the predicate. Polypropylene. - Comment 7: The new UV-bonded ink formulation supports the new scale mark printing technology for ease of manufacturing. Comment 8: Updated to current year. - Comment 9: Updated in accordance with ISO 8537and ISO 15223-1. - Comment 10: Updated in accordance with ISO 8537. - Comment 11: Added to highlight the modified subject device. - Comment 12: Updated to align with recent recommendations in published literature. - Comment 13: Updated for further clarity and simplification. Comment 14: Claim substantiated by the American Diabetes Association Recommendations. The modifications to the design, material, and labeling of the subject device met the requirements of the standards. The modifications between the predicate (K190054) and the subject device do not raise any new or different questions of safety or effectiveness. {9}------------------------------------------------ ## Performance Testing: The sterile single-use insulin syringes described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards: - ISO 9626 Second edition: Stainless steel needle tubing for the manufacture of medical . devices - Requirements and test methods - ISO 8537 Third edition: Sterile single-use syringes, with or without needle, for insulin . # Biocompatibility testing In accordance with ISO 10993-1, the insulin syringe is classified as: Externally communicating medical device, direct contact with tissue; prolonged (>24 hours to 30 days) contact duration. The following testing was conducted: - . Cytotoxicity - Sensitization ● - . Irritation - . Acute Systemic & Pyrogenicity - Subacute/Subchronic Toxicity ● - . Genotoxicity Particulate testing was conducted in accordance with USP <787> Subvisible Particulate Matter in Therapeutic Protein Injections and USP<790> Visible Particles in Injections and met the USP acceptance criteria. # Sterility, Shipping and Shelf-life - The BD Insulin Syringe (0.3mL)'s sterilization method is gamma irradiation by Cobalt 60 with sterilization dose minimum of 20kGy. - The subject device complies with the limits as stated in ISO 11137-2: Sterilization of health . care products - Radiation - Part 2: Establishing the sterilization dose and ANSI/AAMI/ISO TIR13004:2013/(R)2016 for gamma irradiation sterilization. Residuals are not applicable for the gamma irradiation sterilization method. - Limulus Amebocyte Lysate (LAL) assay was used to measure endotoxin limit the . requirement was met. The product is non-Pyrogenic. - Minimum Sterility Assurance Level of 10-6. . {10}------------------------------------------------ - Sterile barrier testing performed on the subject device: ● - Microbial Ingress per analytical test procedures O - Syringe Air Bubble Leak per analytical test procedures O - Packaging Integrity Testing under simulated shipping conditions were conducted to satisfy ● the requirements in ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems. All packaging deemed acceptable for protection of product and sterility maintenance. - Accelerated stability testing has been conducted to validate the sterility and performance . of the BD Insulin Syringe (0.3mL) device to support the shelf-life of 5 years. ### Clinical Test Summary Not Applicable. ### Conclusions The modifications to the design, material, and labeling of the subject device met the requirements of the standards. The modifications between the predicate (K190054) and the subject device do not raise any new or different questions of safety or effectiveness. The BD Insulin Syringe (0.3mL) is substantially equivalent to the predicate BD Insulin Syringes (K190054) with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.