Sterile Auto-Disable Syringes with/without Needle for Single Use

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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. January 27, 2022 Azur Medical Company Inc. Di Zhao General Manager 6710 Everglades Dr. Richmond, Virginia 23838 Re: K211210 Trade/Device Name: Sterile Auto-Disable Syringes with/without Needle for Single Use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI Dated: December 14, 2021 Received: December 21, 2021 Dear Di Zhao: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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, 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) K211210 Device Name Sterile Auto-Disable syringes with/without needle for single use Indications for Use (Describe) The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy. Type of Use (Select one or both, as applicable)X | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ # K211210 # 510(k) summary January 27, 2022 ## I Submitter Device submitter: Azur Medical Company Inc. 6710 Everglades Dr., Richmond, Virginia, VA 23838, USA Contract manufacturer: Zhejiang Kangkang Medical-Devices CO., Ltd. Longwang Industrial District, Chumen Town, Yuhuan, Zhejiang, 317605, China Registration number: 3015042030 Contact person: Di Zhao General Manager Phone: 928-5922380 Email: dzhao@azur-ppe.com ## II Device Trade Name of Device: Sterile Auto-Disable syringes with/without needle for single use Common Name: Piston Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product code: FMF, FMF, FMI Review Panel: General Hospital ## III Predicate Devices | Trade name: | Safety Auto-Disable Syringe with Needle (Auto-Lock) | |-------------------------|-----------------------------------------------------| | Common name: | Piston Syringe | | Classification: | Class II, 21 CFR 880.5860 | | Product Code: | MEG, FMF, FMI | | Premarket Notification: | K143497 | | Manufacturer: | Guangdong Intmed Medical Appliance Co., Ltd. | ## IV Device description The Sterile Auto-Disable syringes with/without needle for single use is a syringe with or without needle, sterile, single use hypodermic syringe with a 6% (Luer) male {4}------------------------------------------------ connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The main principle of the syringe is that after the injection is completed, the device automatically locks the plunger to prevent reuse. | Syringe Size | Needle Gauge | Needle Length | |-------------------------------------------|--------------------------------------------------------------------|---------------------------------------------| | Available in 1ml, 2ml, 3ml, 5ml and 10ml. | Available in 18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 30G | Available in 1/2", 5/8", 1", 1 1/4", 1 1/2" | ## V Indications for use The Sterile Auto-Disable syringes with/without needle for single use is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin except phlebotomy. ## VI Comparison of technological characteristics with the predicate devices The Sterile Auto-Disable syringes with/without needle for single use have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the Sterile Auto-Disable syringes with/without needle for single use and predicate devices do not alter suitability of the proposed device for its intended use. | Device feature | Subject Device | Predicate Device K143497 | Comment | |-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Indications for use | The Sterile Auto-Disable<br>syringes with/without needle<br>for single use is used for<br>aspiration of fluids from vials<br>and ampoules and a variety of<br>fluid injections below the<br>surface of the skin except<br>phlebotomy. | The Safety Auto-Disable<br>Syringe with Needle<br>(Auto-Lock) is used for<br>aspiration of fluids from vials<br>and ampoules and a variety of<br>fluid injections below the<br>surface of the skin except<br>phlebotomy.<br>It has a detachable needle with<br>a dedicated fitting. The Safety<br>Auto-Disabled Syringe with<br>Needle (Auto-Lock) contains an<br>inner mechanism used to allow | Different<br>Comment #1 | | Device feature | Subject Device | Predicate Device K143497 | Comment | | | | the needle to be retracted inside the plunger rod of the syringe after the operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination. | | | Product code | FMF, FMI | MEG, FMF, FMI | Different<br>Comment #2 | | Regulation<br>number | 21 CFR 880.5860 | 21 CFR 880.5860 | Same | | Class | II | II | Same | | Principle of<br>operation | For manual use only | For manual use only | Same | | Safety Features | Active safety feature, manually<br>activated by user | Active safety feature, manually<br>activated by user | Same | | Intended user | Medical professionals and<br>trained care givers | Medical professionals and<br>trained care givers | Same | | Environment of<br>use | Hospitals and clinics | Hospitals and clinics | Same | | Syringe volume | 1 ml, 3 ml, 5 ml, 10 ml | 1ml, 3ml, 5ml, 10ml | Same | | Nozzle type | Luer slip; Luer lock | Needle hub Luer connector | Same | | Lubricant | Silicone oil | PDMS | Same | | Barrel<br>transparency | Transparent and clear | Clear as required by<br>ISO 7886-1 | Same | | Gradations<br>legibility | Legible | Legible according to<br>ISO 7886-1 | Same | | Needle Length | 1/2", 5/8", 1", 1 1/4", 1 1/2" | 12-38mm | Same | | Needle Gauge | 18G, 19G, 20G, 21G, 22G,<br>23G, 24G, 25G, 26G, 27G,<br>30G | 21G, 22G, 23G, 24G, 25G,<br>26G, 27G, 28G | Different<br>Comment #3 | | Configuration of<br>the tip | Short bevel, long bevel. | 15 °C regular point | Different<br>Comment #4 | | Needle hub | Color-coded per ISO 6009 | Colorless according to ISO<br>7864 | Same | | Device feature | Subject Device | Predicate Device K143497 | Comment | | Single use | Yes | Yes | Same | | Performance<br>specifications | Complies with ISO 7864, ISO<br>7886-1, ISO 7886-4 | Conforms to ISO 7864, ISO<br>7886-1, ISO 7886-4 | Same | | Sterilization | EO | EO | Same | | SAL | 10-6 | 10-6 | Same | | Materials | Barrel: PP | Barrel: Polypropylene | Different<br>Comment #5 | | | Plunger: PP | Plunger: Polypropylene | | | | Piston: Silicone Rubber | Piston: Isoprene rubber | | | | Needle: Stainless steel | Needle Hub: Polypropylene | | | | Needle hub: PP | Needle: Stainless Steel<br>Needle Sheath: Stainless Steel<br>O Ring: Silicone rubber | | | | | | | | Pyrogen | Non-pyrogenic | Non-pyrogenic | Same | | Biocompatibility | Conforms to ISO 10993 See<br>below | Conforms to ISO10993 | Same | | | | | | | Labeling | Meet the requirements of 21<br>CFR Part 801 | Meet the requirements of 21<br>CFR Part 801 | Same | | | | | | Table 5-1 Substantial equivalence discussion – Sterile Auto-Disable syringes with/without needle for single use {5}------------------------------------------------ {6}------------------------------------------------ ## Comment #1 The subject device and the predicate device have the same intended use, to aspirate and inject fluids into a patient. The predicate device has a needle safety feature which after use allows the needle to be encapsulated into the plunger rod of the syringe to prevent needle sticks, thus preventing re-use of the syringe. The subject device does not have a needle safety feature but has a disc on the plunger which could be stuck by the buckle of the syringe to prevent re-use of the syringe. The subject device and the predicate device both have the same intended use, this difference does not affect the clinical safety of the subject device. # Comment #2 The subject device and the predicate device are both syringes that render the syringe unusable after injection, the predicate device also has a needle safety feature. # Comment #3 The subject device is available in gauges 18g-30g and the predicate device is available in Performance testing was done per ISO 9626 and ISO 7864 done to 21g-28g. demonstrate that the differences in needle gauges do not affect the clinical safety or effectiveness of the devices. ## Comment #4 {7}------------------------------------------------ The bevel of subject device is different from the predicate device. However, this difference does not affect intended use. The difference was addressed through ISO 9626 and ISO 7864. Therefore, the differences on bevel do not raise different question of safety and effectiveness. ## Comment #5 The material of subject device is different from the predicate device. The piston of subject device is silicone rubber while the predicate device is isoprene rubber. The configurations of subject device do not include Needle Sheath compared with predicate device, which was not affect intended use and did not introduce new materials. However, the materials of subject device were demonstrated to be equivalently biocompatible by the biocompatibility tests done. Therefore, the differences on materials do not raise new questions about safety and effectiveness. ## VII Performance Testing The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility testing In accordance with ISO 10993-1, the device is classified as Externally Communicating Device, Blood Path Indirect, Limited Contac (<24 hours). The following tests were conducted: - Cytotoxicity - Skin Sensitization ● - Intracutaneous Reactivity (Irritation) ● - Acute Systemic Toxicity - Material-Mediated Pyrogens - Hemolysis - Particulate Matter per USP <788> ● ## Sterilization, Shipping and shelf-life - . EO sterilization validation per ISO11135:2014 - . Pyrogen testing per USP <85> Bacterial Endotoxin Test - EO residuals per ISO 10993-7 ● - . Simulated shipping per ASTM D4169 - Sterile Barrier Package testing performed on the proposed device: . - o Seal Strength ASTM F88/F88M-2015 - o Bubble leak testing ASTM D3078-02(2013) - o Dye Penetration ASTM F1929-2015 - . Shelf life of 5 years validated using FDA recognized standards ASTM F1980-16 Standard Guide for Accelerated Aging of sterile barrier Systems for Medical {8}------------------------------------------------ #### Devices ## Performance testing Performance testing is performed according to the following standards: - ISO 7864:2016 Sterile hypodermic needles for single use Requirements and test A methods - A ISO 9626:2016, Stainless Steel Needle Tubing For The Manufacture of Medical Devices - > ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications - > ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use. - A ISO 7886-4:2018 sterile hypodermic syringes for single use — part 4: syringes with re-use prevention feature. # VIII Conclusion The differences between the predicate and subject device do not raise any new or different questions of safety or effectiveness. The Sterile Auto-Disable syringes with/without needle for single use are substantially equivalent to The Safety Auto-Disable Syringe with Needle (Auto-Lock) with respect to indications for use, target population, and technological characteristics.