DropSafeTM SicuraTM

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December 2, 2022 Pikdare SpA % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059 Re: K223353 Trade/Device Name: DropSafe™ Sicura™ Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: FMI Dated: October 30, 2022 Received: November 2, 2022 Dear Dave Yungvirt: 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. {1}------------------------------------------------ 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 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 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. Image /page/1/Picture/5 description: The image shows a digital signature. The signature is by Courtney Evans -S. The date of the signature is 2022.12.02. The time of the signature is 11:41:35 -05'00'. 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) K223353 Device Name DropSafeTM Sicura™ Indications for Use (Describe) The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### 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 - K223353 As required by the Safe Medical Devices Act of 1990 and in accordance with 21 CFR §807.92(a). [807.92 (a)(1,2)] | Date Summary<br>Prepared: | July 20, 2022 | |---------------------------|-----------------------------------------------------------------------------------------------------------------| | Submitted By: | Pikdare S.p.A<br>Via Saldarini Catelli 10<br>22070 Casnate con Bernate – COMO - Italy<br>Phone: +39 031 7297757 | | Primary Contact: | Roberta Zanoni - RA<br>roberta.zanoni@pikdare.com | | Secondary Contact: | Sylvie verdon - RA US<br>Sylvie.Verdon@htl-strefa.com | | Trade Name: | DropSafe™ Sicura™ | ## Models: | Reference number | Description | |------------------|--------------------------| | 02094000180250 | DropSafe™ Sicura™ G18X25 | | 02094000210250 | DropSafe™ Sicura™ G21X25 | | 02094000220250 | DropSafe™ Sicura™ G22X25 | | 02094000230250 | DropSafe™ Sicura™ G23X25 | | 02094000250160 | DropSafe™ Sicura™ G25X16 | | 02094000250250 | DropSafe™ Sicura™ G25X25 | | 02094000270130 | DropSafe™ Sicura™ G27X13 | | 02094000300130 | DropSafe™ Sicura™ G30X13 | | Common Name: | Passive Safety Injection Needle | |------------------------|---------------------------------| | Regulation Number: | 21 CFR § 880.5570 | | Product Code: | FMI | | Device Classification: | II | | Review Panel: | 80 General Hospital | Section 8 Page 1 of 10 {4}------------------------------------------------ #### Predicate Device [807.92(a)(3)] #### The legally marketed devices to which substantial equivalence is claimed are: | Manufacturer | Trade Name | 510(k) Number | |------------------|--------------------|---------------| | Terumo Europe NV | K-pack SurshieldTM | K111797 | #### Description of Device: [807.92(a)(4)] #### Device description DropSafe™ Sicura™ are Sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection. DropSafe™ Sicura™ are single patient and used by HCP (Healthcare professionals: nurses, pharmacist and physician). DropSafe™ Sicura™ passive safety injection needles, are hypodermic needles intended for subcutaneous and intramuscular injection of fluids using syringes with male luer slip or luer lock fitting. Passive safety injection needles are equipped with passive sharps prevention feature. They are sterilized with ETO. Non-toxic single use, single patient devices. The device is designed to minimize the risk from accidental needle sticks with an already used needle by application of a sharps injury prevention feature. Following use, the slider of the needle is automatically locked out preventing reuse. The needle is protected by an external cover, the cover must be in place during the connection between the needle and the syringe. After removing the external cover the needle is still protected by a transparent slider, the slider will protect the needle and the user during the injection activity (sharp prevention feature). The slider is transparent for allowing the user to have a clear view of the cannula during the injection. During the injection the slider progressively uncovers the cannula; this action is possible thanks to the presence of two components (spring and sleeve) which let the slider moves up and down. Once the injection is done and the needle removed from the slider automatically covers the cannula and remain blocked, guaranteeing the sharp prevention feature. The confirmation about the blocking is done thanks to the appearing of red marks visible through the housing. DropSafe™ Sicura™ is not intended to be used for the drawing up of drugs from vials and/or ampule, for which it's indicated to use blunt needles. Each DropSafe™ Sicura™ is individually packaged in a sealed container. The DropSafe™ Sicura™ is used by opening the blister and applying the needle on a syringe filled with drug. While inserting the needle into the skin at a 90° or 45° angle (with or without skin fold), the Section 8 Page 2 of 10 {5}------------------------------------------------ slider glides into the housing. While the slider glides into the housing, the safety feature is activated. Following injection, the slider glides back into its initial position, completely covering the needle where it remains locked. The red safety lock indicator tells the user that the safety lock has been activated. Once the DropSafe™ Sicura™ is in the locked mode, it cannot be reused. The DropSafe™ Sicura™ is detached from the syringe and disposed of into a sharps container according to local requirements. The DropSafe™ Sicura™ assembly consists of a cannula that is assembled into an injection molded hub using an UV glue. The hub has been designed in order to guarantee a proper connection with luer lock and luer slip nozzle of syringes. The c a n n u l a i s lubricated using a silicone-based lubricant for ease of injection and thus reduce friction during the injection. The other components that are assembled onto hub/cannula components are stain less steel spring, injection molded housing, sleeve with red coloured stripes and slider. The coupling of spring, sleeve and slider let have the safety prevention feature of the device, avoiding accidental needle-sticks. This needle assembly is inserted into a protective injection molded cover and blistered with a peel away medical grade paper which provides a sterility barrier. {6}------------------------------------------------ # Indications for Use: ## [807.92(a)(5)] The DropSafe™ Sicura™ are sterile, single-use passive safety injection needles to be used in combination with a (pre-)filled syringe for subcutaneous and intramuscular injection. ## Technological Characteristics: #### [807.92(a)(6)] A comparison of characteristics of DropSafe™ Sicura™ and the predicate d e v i c e s is shown in the table below: | Device Name | New Device | Predicate Device | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer | Pikdare SPA | Terumo Europe NV | | 510(k) Number | K223353 | K111797 | | Intended use | Sterile, single-use passive safety<br>injection needle to be used in<br>combination with a (pre-)filled<br>syringe for subcutaneous and<br>intramuscular injection | A single use injection needle with an<br>integrated passive sharps protection<br>feature designed to reduce needle stick<br>injury and to be used in combination<br>with a (pre-)filled syringe for<br>subcutaneous and intramuscular<br>injection | | Indication for<br>use | Sterile, single-use passive safety<br>injection needle to be used in<br>combination with a (pre-)filled<br>syringe for subcutaneous and<br>intramuscular injection | The K-Pack Surshield™ Needle is a<br>sterile hypodermic needle for single use<br>with a passive sharps protection feature<br>that covers the cannula immediately and<br>permanently after use; and is intended for<br>use in combination with hypodermic<br>syringes for subcutaneous and<br>intramuscular injection. | | Operation<br>principle | Manual | Manual | {7}------------------------------------------------ | Design | Injection moulded Hub<br>Cannula<br>Glue<br>Spring<br>Injection moulded Sleeve<br>Injection moulded Slider<br>Injection moulded Housing<br>Injection moulded Cover<br>Blister | Injection moulded hub<br>Cannula<br>Glue<br>Injection moulded tube<br>Spring<br>Injection moulded grip<br>Injection moulded sleeve<br>Injection moulded slider<br>Injection moulded housing<br>Injection moulded case<br>Injection moulded cap<br>Paper seal | |--------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FMI | FMI | {8}------------------------------------------------ | Device Name | Subject Device | Predicate<br>Device | | |------------------|--------------------------------------------|-------------------------------------|----------------------| | Length | 25 mm - 16 mm - 13mm | 1/2" (12mm) | | | Gauges | G18 - G21 - G22 - G23 - G25 -<br>G27 - G30 | 27G | | | Materials | Cannula | Stainless Steel | Stainless Steel | | | Hub | Polypropylene<br>Medical Grade | Polypropylene | | | Housing | Polypropylene<br>Medical Grade | Plastic moulded part | | | Cover | Polypropylene<br>Medical Grade | Plastic moulded part | | | Slider | Polycarbonate<br>Medical Grade (PC) | Plastic moulded part | | | Sleeve | ABS (Food grade) | Plastic moulded part | | | Spring | Stainless steel wire | Stainless steel wire | | | Glue | UV Glue | UV Glue | | Lubricant | Silicone Medial Grade | Silicone Medical Grade | | | Blister | Medical Paper and Plastic Film | | | | Biocompatibility | Conforms toISO<br>10993-1 | Conforms to<br>ISO 10993-1 | | | Sterilization | Ethylene Oxide | Ethylene Oxide | | The new device and the predicate device are classified under 21 CFR 880.5570, which states: "A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin." The intended use of the devices is identical (intended for use with pre-filled syringes). Based upon the above comparisons to the predicate device, DropSafe™ passive safety injection needles do not raise any new issues of safety of effectiveness {9}------------------------------------------------ ## Reference Device | Manufacturer Name | Trade Name | 510(k) Number | |-------------------|-------------------|---------------| | Terumo Corp | SurGuard 2 Safety | K051865 | | | Needle | | The reference device has been included in this submission to cover the gage and lengths of the New Device. The difference between the New Device and the Reference Device is the sharps prevention feature: the new device includes a sharp prevention feature based on an active sharp prevention system and Reference Device includes a Sharp prevention feature based on a passive sharp prevention system. The Reference device has been considered taking into account the offered lengths and gauges of the hypodermic needle included in a safety needle. {10}------------------------------------------------ # Non-Clinical Performance Data: # [(807.92(b)(1)] Verification/Validation testing was conducted in compliance with the requirements of ISO 7864:2016, ISO 9626:2016, ISO 23908:2011 and ISO 80369-7:2021 as summarized below. All testing met the applicable requirements. | Test parameter | Requirement | Result | |-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | Cannula Materials | The needle shall be made of tubing materials<br>specified in ISO 9626:2016 and<br>ISO 15510:2014. | Meets standard | | Dimensions | The needles diameters are in compliance<br>with clause 4.10.1 of ISO 7864:2016 and<br>requirements of ISO 9626:2016.<br>Tolerances on lengths shall be in<br>accordance to ISO 7864:2016(clause<br>4.10.2) | Meets standard | | Bond between hub and<br>needle tube | The union of the hub and needle tube shall not break<br>when tested in accordance to ISO 7864 (Clause<br>4.12). | Meets standard | | Freedom from defects | The needle tube shall fulfill the requirements of ISO<br>7864 (clause 4.10.3) | Meets standard | | Lubrication | The needle tube should be lubricated. The lubricant<br>shall not, under normal or corrected- to-normal<br>vision, bevisible as droplets of fluid on the outer or<br>inner surfaces of the needle tube. The quantity of<br>lubricant used should not exceed 0.25 mg/cm² of the<br>lubricated surface area of the needle tube | Meets standard | | Cleanliness | When inspected by normal or corrected-to-normal<br>vision without magnification under an illuminance<br>of 300 lx to 700 lx, the surface of the hypodermic<br>needle tube shall appear free from particles and<br>extraneous matter. When examined under 2,5×<br>magnification, the hub socket (fluid path surface)<br>shall appear free from particles and extraneous<br>matter. | Meets standard | | Limits for Acidity or<br>Alkalinity | When determined with a laboratory pH meter and<br>using a general purpose electrode, the pH value of<br>an extract prepared in accordance with Annex A<br>shall be within one unit of pH of that of the control<br>fluid. | Meets standard | | Limits for extractable<br>metals | When tested by a recognized microanalytical<br>method, for example by an atomic absorption<br>method, an extract prepared in accordance with<br>Annex A shall, when corrected for the metals<br>content of the control fluid, contain not greater than<br>a combined total of 5 mg/l of lead, tin, zinc and<br>iron. The cadmium content of the extract shall,<br>when corrected for the cadmium content of the<br>control fluid, be lower than 0,1 mg/l | Meets standard | | Color of hub | The hub shall be made either of pigmented or of<br>unpigmented material. If pigmented, the color shall<br>be in accordance with ISO 6009. | Meets standard | | Needle point | When examined under 2.5× magnification the<br>needle point shall appear sharp and free from<br>feather edges, burrs and hooks. | Meets standard | | | The needle point should be designed so as to<br>minimize coring and fragmentation when<br>penetrating vial closures | | | | Penetration testing can provide an indication of the<br>needle point sharpness and lubrication | | | Patency of lumen | the flow rate of water through the needle shall not<br>be less than 80 % of an unprocessed needle tube of<br>equivalent outer diameter and length having a<br>minimum inner diameter in accordance with ISO<br>9626 when tested under the same pressure. | Meets standard | | Sharp injury<br>protection | The needle shall meet the requirements of ISO<br>23908, the conformity to this standard has been<br>verified also through usability and Sharps injury<br>prevention studies | Meets standard | | Hub conical fitting | The conical socket of the hypodermic needle hub<br>shall meet the requirements of ISO 80369-7 | Meets standard | | Sterility and<br>Biocompatibility | The needle in its unit packaging shall have been<br>subjected to a validated sterilization process<br>resulting in a Sterility Assurance Level of at least<br>10-6 in accordance with recognized ISO standards. | Meets standard | | | The needle shall be free from biological hazard in<br>accordance with the requirements of ISO 10993-1. | | Section 8 Page 8 of 10 {11}------------------------------------------------ {12}------------------------------------------------ # Clinical Performance Data: [(807.92(b)(2)] #### FDA GUIDANCE Medical Devices with Sharps Injury Prevention Features (issued on August 9, 2005). Testing was performed to evaluate the function of the safety feature in a simulated clinical environment with the participation of clinical users. The Simulated Use Study was performed to validate the Instructions For Use (IFU) with the participation of clinical users. As evidenced in the study, the use of this device does not affect the injection technique or the functionality of the hypodermic needle coupled with a hypodermic syringe and is safe and effective when used as per the Instructions for Use. #### Conclusion: [(807.92(b)(3)] DropSafe™ Sicura™ is substantially equivalent in the intended use, technology/principle of operation and performance to the predicate devices and do not raise any new questions of safety and effectiveness.