DR Safety Syringe, Sterile Hypodermic needle for Single use

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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. September 29, 2021 Zhuhai DR Medical Instruments Co., Ltd % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114 Re: K212226 Trade/Device Name: DR Safety Syringe, Sterile Hypodermic needle for Single use Regulation Number: 21 CFR 880.5860 Regulation Name: Piston syringe Regulatory Class: Class II Product Code: MEG, FMI Dated: July 15, 2021 Received: July 16, 2021 Dear Prithul Bom: 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 {1}------------------------------------------------ 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 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, 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) Device Name DR Safety Syringe; Sterile Hypodermic needle for Single use ### Indications for Use (Describe) The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;">☐</span> 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}------------------------------------------------ # Section 3- 510(k) Summary This 510(k) Summary is being submitted in accordance with the requirements of the guidance The 510(k) Program, 21 CFR 880.5860 and 21 CFR 880.5570. 510(k) Number: K212226 - 1. Date of Submission: August, 06, 2021 #### 2. Submitter Zhuhai DR Medical Instruments Co., Ltd. Room 502, 5th Floor, Building C, No. 288, Airport East Road, Sanzao Town, Jinwan District,Zhuhai,519000,China Establishment Registration Number: Contact Person: Xu Jianhai Position: Management Representative Tel.:086-0756-7770668 Email: xujianhai@kdlchina.com #### 3. Proposed Device 510(k) Number: K212226 Trade Name: DR Safety Syringe Review Panel: General Hospital Regulation Number: 21 CFR 880.5860 Classification name: Piston Syringe with Safety Syringe Regulation Class: Class II Product Code: Safety Syringe: MEG Trade Name: Sterile Hypodermic needle for Single use Review Panel: General Hospital Regulation Number: 21 CFR 880.5570 Classification name: Syringe, Piston Regulation Class: Class II Product Code: Safety Syringe: FMI #### 4. Predicate device ### a. Predicate device 510(k) Number: K092430 Product Name: InviroSnap Safety Syringe {4}------------------------------------------------ Review Panel: General Hospital Regulation Number: 21 CFR 880.5860 Classification name: Piston Syringe with Safety Syringe Regulation Class: Class II Product Code: MEG ### b. The Secondary Predicate Device 510(k) Number: K190002 Trade Name: Sterile Hypodermic needle for Single use Review Panel: General Hospital Regulation Number: 21 CFR 880.5570 Classification name: Syringe, Piston Regulation Class: Class II Product Code: FMF and FMI #### 5. Device description The DR Safety Syringe is a retractable type piston syringe, designed to aid in the prevention of needle stick injuries. This single-use, disposable syringe provided sterile and consists of the following components for 3ml and 5ml safety syringe: Barrel, Plunger, Stopper, Luer Assembly, hypodermic needle, Locking Ring and O-Ring. 0.5ml and 1ml safety syringe: Barrel, Plunger, Stopper, needle hub, needle tube, protective cap, Locking Ring and O-Ring The DR Safety Syringe functions in a manner similar to standard syringes for fluid injection/withdrawal. After use, the health care professional fully depresses the plunger to engage the luer assembly/needle hub. Once the luer assembly/needle hub is engaged, pulling back the plunger causes the adapter and the attached needle to be withdrawn into the safety of the barrel. This retraction into the barrel of the syringe can be visually confirmed. Once this safety mechanism has been activated, the syringe is permanently disabled and the needle is completely secured within the barrel. Both the syringe and plunger are discarded in a Sharp's container. The DR Safety Syringes are available for 0.5mL, 1mL, 3mL, 5mL. The 0.5ml and 1ml DR Safety Syringes with fixed needle and 3ml, 5ml DR Safety Syringes 皿-2 Version 1 {5}------------------------------------------------ with exchangeable needle are used to inject fluids into or withdraw fluids from the body. The DR Safety Syringes are designed to aid in the prevention of needle stick injuries #### 6. Indications for Use DR Safety Syringe: The DR Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. Sterile Hypodermic needle for Single use: The Sterile Hypodermic Needle for single use is intended for use with syringes and injection devices for general purpose fluid injection/aspiration. #### Substantially Equivalent comparison 7. {6}------------------------------------------------ | Item | Proposed Device | Predicate Device | Remark | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K212226(Traditional 510K) | K092430 (Traditional 510K) | | | Manufacturer | Zhuhai DR Medical Instruments Co., Ltd. | INVIRO MEDICAL DEVICES, INC. | / | | Product code | MEG | MEG | Same | | DeviceClassification: | Class II, 21 CFR 880.5860 | Class II, 21 CFR 880.5860 | Same | | Indications forUse | The DR Safety Syringe is used to inject fluids into or withdraw fluids from the body. In addition, the DR Safety Syringe is designed to aid in the prevention of needle stick injuries. | The InviroSnap Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the Inviro Snap Safety Syringe is designed to aid in the prevention of needle stick injuries. | Same | | Principle ofOperation | After use, the plunger is fully retracted into the barrel providing protection against needle sticks, rendering the device unusable. | After use, the plunger is fully retracted into the barrel providing protection against needle sticks, rendering the device unusable. | Same | | Environment ofuse | Hospital | Hospital | Same | | Syringe Volume | 0.5ml, 1ml, 3ml, 5ml | 1ml, 3ml, 5ml, 10 ml, 20 ml | See comment 1 | | Needle Gauge | 18G-30G | 20-23G, 25G, 28-30G | See comment 2 | | Needle Wall | Regular Wall | Unknown | See comment 2 | | DeviceConfiguration | Barrel, Plunger, Stopper, Luer Assembly; Hypodermic Needle/needle tube, needle hub, cap: Locking Ring and O-Ring | Barrel, Plunger, Stopper, Luer Assembly, Cannula, cap, Locking Ring and O-Ring | Similar | | Tip type | Fixed needle and Luer Lock | Fixed needle and Luer Lock | Same | | Material | Barrel, lunger, Locking Ring, Luer<br>Assembly(luer lock), Cap: PP<br>O-Ring: Silicone<br>Stopper: Polyisoprene rubber<br>Needle: Stainless steel:<br>Luer Assembly(Snap Ring): PE<br>Scale line: Ink, Quick-drying water:<br>Lubricant: Silicone oil, Thinning agent | Plunger, Barrel, Cap -Polypropylene<br>Stopper – Santoprene, Thermoplastic<br>Elastomer<br>Needle- Stainless steel | Comment 3 | | Biocompatibility | • Cytotoxicity<br>• Sensitization Study<br>• Irritation Test/Intracutaneous Reactivity<br>• Systemic Toxicity Studies<br>• Haemolysis test<br>• Pyrogenicity<br>• Complement activity (C3a,SC5b-9) test<br>• In Vivo Thrombogenicity Test | • Cytotoxicity<br>• Sensitization Study<br>• Irritation Test/Intracutaneous Reactivity<br>• Systemic Toxicity Studies<br>• Haemolysis test | Similar, we conduct<br>more test than<br>predicate device,<br>and this difference<br>doesn't raise<br>different questions<br>of safety and<br>effectiveness. | | Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Method of<br>supply | Sterile and single use | Sterile and single use | Same | | Sterilization<br>Method | EO | EO | Same | | Sterility<br>Assurance Level | 10-6 | 10-6 | Same | # Table 1 Comparison of Technology Characteristics of Sterile Safety Syringe for Single Use {7}------------------------------------------------ Discussion of Technological characteristics The following differences do not raise different questions of safety and effectiveness, {8}------------------------------------------------ ### Comment 1 Differences in syringe volume between the predicate and subject device were addressed through ISO 7886-4 syringe performance testing. ### Comment 2 Differences in needle gauge, wall between the predicate and subject device were addressed through ISO 7864 and ISO 9626 needle performance testing. Comment 3 Differences in materials between the predicate and subject device were addressed through ISO 10993-1 biocompatibility testing. | Item | Proposed Device | The Secondary Predicate Device | Remark | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | | K212226(Traditional 510K) | K190002 (Traditional 510K) | | | Manufacturer | Zhuhai DR Medical Instruments Co., Ltd. | Shanghai Kohope Medical Devices Co., Ltd | / | | Product name | Sterile Hypodermic needle for Single use | Sterile Hypodermic needle for Single use | Same | | Product code | FMI | FMI | Same | | Device<br>Classification | Class II, 21 CFR 880.5570 | Class II, 21 CFR 880.5570 | Same | | Indications for<br>Use | The Sterile Hypodermic Needle for single use<br>is intended for use with syringes and injection<br>devices for general purpose fluid<br>injection/aspiration. | The Sterile Hypodermic Needle for single use<br>is intended for use with syringes and injection<br>devices for general purpose fluid<br>injection/aspiration. | Same | | Environment of<br>use | Hospital | Hospital | Same | | Intended users | Medical professionals and trained care givers | Medical professionals and trained care givers | Same | | Operation mode | For Manual Use Only, For<br>Single Use only | For Manual Use Only, For<br>Single Use only | Same | | Configuration | Protective cap; Needle tube; Adhesives; Needle hub | Protective cap; Needle tube; Adhesives; Needle hub | Same | | Material | Protective cap: PP<br>Needle tube: Stainless steel (SUS304)<br>Adhesives: Epoxy resin<br>Needle hub: PP | Protective cap: PP<br>Needle tube: Stainless steel (SUS304)<br>Adhesives: Epoxy resin<br>Needle hub: PP | Same | | Needle Gauge | 18G,19G,20G,21G,22G,23G,24G,25G,<br>26G,27G,28G,29G,30G | 18G,19G,20G,21G,22G,23G,24G,25G,<br>26G,27G,28G,29G,30G | Same | | Needle lengths | 16mm, 25mm, 38mm | 4 – 38 mm | See comment 1 | | Needle Wall | Regular Wall | Regular wall, thin wall and extra thin wall | Similar | | Needle Bevel | $17^{\circ}\pm 2^{\circ}$ | Long bevel, short bevel, ultra-treatment bevel | See comment 2 | | Lubrication<br>Amount/cm2 | <0.25mg/cm2 | <0.25mg/cm2 | Same | | Lubricant<br>composition | Silicone Oil | Silicone Oil | Same | | Tip Configuration | Angle $27^{\circ}\pm 3^{\circ}$ | Unknown | See comment 2 | | Needle Cover<br>Dimensions | L: 43±0.5mm, 54.5±0.5mm<br>OD: 8.3±0.1mm/5.8±0.1mm | Unknown | See comment 2 | | Needle Cover<br>Color | Colorless | Unknown | See comment 3 | | Delivery Accuracy | Complied with ISO 7864 | Complied with ISO 7864 | Same | | Needle Cover<br>Strength | <15N | Complied with ISO 7864 | similar | | Hub/Needle Bond<br>Strength | Min 11-69N | Min 11-69N | Same | | Color-coded hub | Confirms to ISO6009 | Confirms to ISO6009 | Same | | Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Method of supply | Sterile and single use | Sterile and single use | Same | | Sterilization<br>Method | EO | EO | Same | | Sterility<br>Assurance Level | 10-6 | 10-6 | Same | ### Table 2 Comparison of Technology Characteristics of Sterile Hypodermic Needle for Single Use {9}------------------------------------------------ {10}------------------------------------------------ Discussion of Technological characteristics The following differences do not raise different questions of safety and effectiveness, Comment 1: The predicate device includes additional needle length compared to the needles are tested in accordance with ISO 7864 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864. Comment 2: As to Needle Bevel, Tip Configuration, Needle Cover Dimensions, we can't get the information about predicate device. The needles are tested in accordance with ISO 7864 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864. Comment 3: Needle Cover for the proposed device is unpigmented, the colorless, we can't get the specific color of the predicate device' needle covers are tested in accordance with ISO 7864 and released in accordance with the standards compliance. This was verified by performance testing according to ISO 7864. {11}------------------------------------------------ ### 8. The results of the comparison DR Safety Syringe is substantially equivalent in indication for use, design, raw material, sterilization method to the predicate devices, InviroSnap Safety Syringe. The sterile hypodermic needle for the proposed device is substantially equivalent in indication for use, design, raw material, sterilization method to the predicate devices. The differences in raw material and needle between the devices do not raise new issues of safety and effectiveness. ### 9. Sterilization and Shelf Life Sterilization and Shelf Life Testing were performed on the proposed device: | Microbiological Performance qualification (MPQ) | |-------------------------------------------------| | Physical Performance qualification (PPQ) | | EO residue | | ECH residue | | Bacteria Endotoxin Limit | | Microbial barrier test | | Seal Strength test | | Seal leak test | | Shelf Life Evaluation | | | ISO11135:2014 ISO11135:2014 ISO 10993-7:2008 ISO 10993-7:2008 USP <85> ASTM F1608 ASTM F 88 ASTM F 1929 Physical, Mechanical, Chemical, Package Tests were performed on aging samples to verify the claimed shelf life of the device. ### 10. Clinical Test No clinical study is included in this submission. ### 11. Performance data All necessary bench and non-clinical testing were conducted on DR Safety Syringe to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench testing are conducted according to ISO 7886-1 and ISO 7886-4, USP 788, ISO 23908 and FDA guidance titled: "Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff," included: - 1 Appearance - 2 Tolerance on graduated capacity - 3 Graduated scale - 4 Barrel - 5 Plunger stopper/plunge - 6 Syringe needle - 7 Liquid leakage - 8 Air leakage {12}------------------------------------------------ - 9 Syringe with Luer nozzle - 10 Dead space - 11 Re-use prevention feature test - 12 Limits for acidity or alkalinity - 13 Limits for extractable metals - 14 EO residual - 15 Sterility - 16 Bacterial Endotoxin (LAL test) - 17 Testing activation of a sharps injury protection feature - 18 Particulate test, - 19 ECH residual All necessary bench and non-clinical testing were conducted on Fixed needle to support the performance of the needle in safety syringe. The non-clinical, bench testing are conducted according to ISO 9626 included: - 1 Appearance - 2 Dimensions of tubing - 3 Stiffness - 4 Bond between hub and needle tube - 5 Resistance to breakage - 6 Limits for acidity or alkalinity - 7 Corrosion resistance All necessary bench and non-clinical testing were conducted on proposed sterile hypodermic needle to support a determination of substantial equivalence to the predicate devices. The non-clinical, bench testing are conducted according to ISO 7864 included: - 1 Appearance - 2 Colour coding - 3 Tolerances on length - 4 Bond between hub and needle tube - 5 Patency of lumen - 6 The penetration force and drag force for needles - 7 Limits for acidity or alkalinity - 8 Limits for extractable metals ### 12. Biocompatibility Testing Summary Biocompatibility testing was conducted in compliance with ISO 10993-1, for externally communicating devices with limited exposure (<24 hours) to blood path, direct, and included below test items. {13}------------------------------------------------ | Items | Standards | Conclusion | |------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | In Vitro Cytotoxicity | ISO 10993-5:2009 | Under the conditions of this study, the test<br>article Micro catheter extract did not show<br>potential toxicity to L-929 cells. | | Intracutaneous reactivity | ISO 10993-10:2010 | The test results showed that the polar and<br>non-polar test article extracts did not induce<br>intracutaneous reactivity in rabbit under the<br>test condition. | | Skin Sensitization | ISO 10993-10:2010 | No evidence of causing skin sensitization | | Acute System Toxicity | ISO 10993-11:2017 | Under the conditions of this study, there was<br>no evidence of systemic toxicity from the<br>extracts, the test article extract met the<br>requirements of this study. | | Pyrogenicity | ISO 10993-11:2017 | No rabbit an individual rise in temperature of<br>0.5℃ or more. | | In Vitro hemolytic | ASTM F756-17 | The test result showed the Micro catheter had<br>no influence on hemolytic properties. | | Complement activity<br>(C3a,SC5b-9) test | ISO 10993-4:2017 | Under the conditions of this study, the test<br>article safety syringe had no effect on<br>complement activity. | | In Vivo Thrombogenicity<br>Test | ISO 10993-4:2017 | Under the conditions of this study, the test<br>article safety syringe meets the requirement<br>of thrombogenicity test. | Table 1 Biocompatibility tests The subject device, DR Safety Syringe is subject to biocompatibility test in accordance with ISO 10993-1, the test result demonstrate that DR Safety Syringe is safe. ## 13. Conclusion The nonclinical tests demonstrated that the device is as safe, as effective, and performs as well as or better than the predicate device.