1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle

{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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 10, 2020 Jiangsu Caina Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 Cn Re: K192551 Trade/Device Name: 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF. MEG Dated: June 24, 2020 Received: July 13, 2020 Dear Diana Hong: 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, 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) K192551 Device Name 1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle Indications for Use (Describe) 1ml Luer Slip or Luer Lock Syringe 1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. Syringe with permanently attached needle The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. Safety Syringe with permanently attached needle as annlicahle) The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="text-decoration: underline;"></span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="text-decoration: underline;"></span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | 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}------------------------------------------------ # Exhibit #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:____K192551 - 1. Date of Preparation: 08/06/2020 - 2. Sponsor Identification # Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China Establishment Registration Number: 3005670221 Contact Person: Jianwei Pan Position: Management Representative Tel: +86-0510-8686 6666-8027 Fax: +86-0510-8686 6666-8009 Email: jianwei.pan@cainamed.com - Designated Submission Correspondent 3. Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### Identification of Proposed Device 4. Trade Name: 1ml Luer Slip or Luer Lock Syringe Syringe with permanently attached needle Safety Syringe with permanently attached needle Common Name: Piston Syringe and antistick syringe Regulatory Information: Classification Name: Piston Syringe; Classification: II; Product Code: FMF, MEG; Regulation Number: 21CFR 880.5860 Review Panel: General Hospital; ### Indications for Use: 1ml Luer Slip or Luer Lock Syringe 1ml Luer Slip or Luer Lock Syringe is intended to be connected with the luer slip or luer lock needle and intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. ### Syringe with permanently attached needle The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. ### Safety Syringe with permanently attached needle The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse. ### Device Description The proposed Syringes include 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle. Each of the 1ml Luer Slip or Luer Lock Syringe, Safety Syringe with permanently attached needle. have one kind of product configuration, and the Syringe with permanently attached needle has two kinds of product configurations (Type A and Type B). The proposed syringes are available in different combination of syringe volumes and/or needle sizes {5}------------------------------------------------ (refer to Table 1). | Model | Needle length (mm) | Needle gauge | Needle wall type | Needle bevel | Syringe size/volume | |-------------------------------------------------|--------------------|--------------|------------------|----------------|---------------------| | 1ml Luer Slip or Luer Lock Syring | NA | NA | NA | NA | 1ml | | Syringe with permanently attached needle-type B | 20, 25 | 21G | RW, TW | 11°±2°, 15°±2° | 1ml | | | 20, 25 | 23G | RW, TW | 11°±2°, 15°±2° | | | Syringe with permanently attached needle-type A | 8,10,13,16 | 29G | RW, TW | 11°±2°, 15°±2° | 0.3ml | | | 8,10,13,16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8,10,13,16 | 31G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 25G | RW, TW | 11°±2°, 15°±2° | 0.5ml | | | 10, 13, 16 | 26G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 27G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 28G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 29G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 31G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 25G | RW, TW | 11°±2°, 15°±2° | 1ml | | | 10, 13, 16 | 26G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 27G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 28G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 29G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 31G | RW, TW | 11°±2°, 15°±2° | | | Safety Syringe with permanently attached needle | 8,10,13,16 | 29G | RW, TW | 11°±2°, 15°±2° | 0.3ml | | | 8,10,13,16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8,10,13,16 | 31G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 25G | RW, TW | 11°±2°, 15°±2° | 0.5ml | | | 10, 13, 16 | 26G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 27G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 28G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 29G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 31G | RW, TW | 11°±2°, 15°±2° | | | 10, 13, 16 | 25G | RW, TW | 11°±2°, 15°±2° | 1ml | | | 10, 13, 16 | 26G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 27G | RW, TW | 11°±2°, 15°±2° | | | | 10, 13, 16 | 28G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 29G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 30G | RW, TW | 11°±2°, 15°±2° | | | | 8, 10, 13, 16 | 31G | RW, TW | 11°±2°, 15°±2° | | | Table 1 specification of proposed device {6}------------------------------------------------ The proposed Syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 ° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years. #### ડ. Identification of Predicate Devices - 5.1 Predicate device 1 510(k) Number: K170651 Product Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe (used as predicate device) Sterile Disposable Safety Needle Sterile Disposable Needle Manufacturer: Yangzhou Medline Industry Co., Ltd. - 5.2 Predicate device 2 510(k) Number: K132681 Product Name: Sol-Guard Insulin Safety Syringe and Tuberculin Safety Syringe Manufacturer: Sol-Millennium Medical, Inc. #### Identification of Reference Devices 6. 510(k) Number: K150758 Product Name: Safelock Disposable Insulin Syringe Manufacturer: Jiangsu Caina Medical Co., Ltd. Indication for Use: Safelock disposable insulin syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries. The safety shield of the proposed syringes is the same as that of the legally marketed device, Safety Insulin Syringe (Safelock Disposable Insulin Syringe), as cleared in K150758, which is also {7}------------------------------------------------ manufactured by Jiangsu Caina Medical Co., Ltd #### 7. Non-Clinical Test Conclusion Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - A ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications. - A ISO 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods. - > ISO 7886-1:2017 Sterile hypodermic syringes for single use- Part 1: Syringes for manual use. - > ISO 9626:2016, Stainless Steel Needle Tubing for the Manufacture of Medical Devices. - > ISO 7864:2016 Sterile hypodermic needles for single use - Requirements and test methods - > ISO 10993-7:2008 Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals. - > USP 41-NF36:2018<85> Bacterial Endotoxin Limit - > ASTM F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials. (Sterility) - > ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration - > ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection - > 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. - > Medical Devices with Sharps Injury Prevention Features - Guidance for Industry and FDA Staff # Biocompatibility testing The contact level of the proposed device is blood path, indirect, and the contact duration is limited contact (<24 hours). The patient-contact components and materials of the 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle, are identical to the patient-materials of product components of Safety Insulin Syringe (Safelock Disposable Insulin Syringe), as cleared in K150758, which is also manufactured by Jiangsu Caina Medical Co., Ltd. Therefore, the proposed syringes' biocompatibility can be demonstrated by the reference device (K150758). {8}------------------------------------------------ #### Clinical Test Conclusion 8. No clinical study is included in this submission. #### Substantially Equivalent (SE) Comparison 9. # Table 2 Comparison of differences for 1ml Luer Slip or Luer Lock Syringe | ITEM | Proposed Device | Predicate Device 1<br>K170651 | Reference device<br>K150758 | Remark | |-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | Product | 1ml Luer Slip or Luer<br>Lock Syringe | Sterile Disposable<br>Syringe | Safeflock Disposable<br>Insulin Syringe | / | | Product code | FMF | FMF | FMF<br>MEG | Same | | Regulation<br>No. | 21CFR 880.5860 | 21CFR 880.5860 | 21CFR 880.5860 | Same | | Class | II | II | II | Same | | Indications<br>for Use | 1ml Luer Slip or Luer<br>Lock Syringe is intended<br>to be connected with the<br>luer slip or luer lock<br>needle and intended for<br>use by health care<br>professionals for general<br>purpose aspiration of<br>fluid from vials,<br>ampoules and liquid<br>injection below the<br>surface of the skin. | The Sterile Disposable<br>Syringe is a sterile luer<br>lock or luer slip syringe<br>which is intended to be<br>used with a hypodermic<br>needle for the aspiration<br>and injection of fluids<br>for medical purpose. | Safeflock disposable<br>insulin syringe is<br>intended to inject U-100<br>insulin into the human<br>body and aid in the<br>prevention of accidental<br>needle stick injuries. | Difference<br>1 | | Configuration<br>and material | (1) barrel (PP)<br>(2) plunger (PP)<br>(3) piston (Polysoprene) | (1) barrel (PP)<br>(2) plunger (PP)<br>(3) piston (Polysoprene) | (1) Protective end cap<br>(PE)<br>(2) Plunger (PP)<br>(3) Piston (Polysoprene)<br>(4) barrel (PP)<br>(5) needle cap (PE)<br>(6) needle (Stainless<br>steel 304)<br>(7) Protective shield(PE) | Same | | Syringe<br>Volume | 1ml | 1ml, 2ml, 2.5ml, 3ml,<br>5ml, 10ml, 20ml, 30ml,<br>50ml, 60ml | 0.3ml, 0.5ml, 1ml | Difference<br>2 | {9}------------------------------------------------ | Connector<br>Type | Luer Lock/ Luer slip | Luer Lock/ Luer slip | NA | Same | |------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|------| | Syringe<br>performance | ISO 7886-1 | ISO 7886-1 | ISO 7886-1 | Same | | Biocompatibil<br>ity | Conforms to the<br>requirements of ISO<br>10993 series standards. | Conforms to the<br>requirements of ISO<br>10993 series standards. | Conforms to the<br>requirements of ISO<br>10993 series standards. | Same | | Method | EO Sterilized | EO Sterilized | EO Sterilized | Same | | SAL | 10-6 | 10-6 | 10-6 | Same | | Endotoxin<br>Limit | 20 EU per device | 20 EU per device | 20 EU per device | Same | | Operation<br>Principle | For Manual Use Only,<br>For Single Use Only | For Manual Use Only,<br>For Single Use Only | For Manual Use Only,<br>For Single Use Only | Same | | Label/Labelin<br>g | Complied with 21 CFR<br>part 801 | Complied with 21 CFR<br>part 801 | Complied with 21 CFR<br>part 801 | Same | Difference 1- Indication for use The proposed devices have the same operation principle as that of the predicate device. The description of the indication for use of the proposed device and the predicate devices and reference device are different, but they are all used by health care professionals for fluid aspiration and injection. The essential use of the syringe is the same. Therefore, this item is considered substantially equivalent. # Difference 2- Syringe volume The Syringe volume for proposed devices are different from the predicate devices 1. However, this difference is just in dimension. Different volume devices will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences in syringe volume between the predicate and subject device were addressed through ISO 7886-1:2017 performance testing. Therefore, this difference does not affect substantially equivalence on safety and effectiveness. {10}------------------------------------------------ | ITEM | Proposed Device | Predicate Device 2 | Reference device | Remark | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | | | K132681 | K150758 | | | Product | Syringe with permanently<br>attached needle | Sol-Guard Insulin Safety<br>Syringe and Tuberculin<br>Safety Syringe | Safelock Disposable<br>Insulin Syringe | / | | Product<br>code | FMF | MEG | FMF<br>MEG | Difference<br>3 | | Regulation<br>No. | 21CFR 880.5860 | 21CFR 880.5860 | 21CFR 880.5860 | Same | | Class | II | II | II | Same | | Indications<br>for Use | The Syringe with<br>permanently attached<br>needle is intended for use<br>by health care professionals<br>for general purpose<br>aspiration of fluid from<br>vials, ampoules and liquid<br>injection below the surface<br>of the skin. | For TB Use<br>The Sol-Guard<br>Tuberculin (TB) Safety<br>Syringe is intended for<br>the delivery of<br>Tuberculin.<br>The Sol-Guard TB<br>Safety Syringe Safety<br>Sleeve covers the needle<br>when activated. In the<br>activated position, the<br>Safety Shield guards<br>against accidental needle<br>stick.<br><br>For Insulin Use<br>The Sol-Guard Insulin<br>Safety Syringe is<br>intended for the delivery<br>of U-1 00 insulin.<br>The Sal-Guard Insulin<br>Safety Syringe Safety<br>Sleeve covens the needle<br>when activated. In the<br>activated position, the<br>Safety Shield guards<br>against accidental needle<br>stick. | Safelock disposable<br>insulin syringe is<br>intended to inject U-100<br>insulin into the human<br>body and aid in the<br>prevention of accidental<br>needle stick injuries. | Difference<br>4 | | Configuratio | Syringe with permanently | (1) needle cap | 1) Protective end cap | Difference | | n<br>and<br>material | attached needle-type A | | | | | | (1) needle cap (PP or PE) | (2) needle | (PE) | 5 | | | (2) needle (Stainless Steel<br>304) | (3) piston | (2) Plunger (PP) | | | | (3) piston (Polysoprene) | (4) plunger | (3) Piston (Polysoprene) | | | | (4) plunger (PP) | (5) barrel | (4) barrel (PP) | | | | (5) barrel (PP) | (6) end cap | (5) needle cap (PE) | | | | (6) end cap (PP or PE) | (7) safety mechanism | (6) needle (Stainless<br>steel 304) | | | | Syringe with permanently<br>attached needle-type B | The material of predicate<br>device is not exposured<br>in the predicate device's<br>510(k) summary, so the<br>materials of predicate<br>device is unknown | (7) Protective shield<br>(PE) | | | | (1) needle cap (PP or PE) | | | | | | (2) needle (Stainless Steel<br>304) | | | | | | (3) piston (Polysoprene) | | | | | | (4) plunger (PP or ABS) | | | | | | (5) barrel (PP) | | | | | Syringe<br>Volume | 0.3ml, 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | 0.3ml, 0.5ml, 1ml | Same | | Needle<br>Gauge | 21G, 23G, 25G, 26G, 27G,<br>28G, 29G, 30G, 31G | 25G, 27G, 28G, 29G,<br>30G, 31G | 28G, 29G, 30G | Difference<br>6 | | Needle<br>Length | 8mm, 10mm, 13mm, 16mm,<br>20mm, 25mm | 8mm, 13mm, 16mm,<br>25mm | 8mm, 10mm, 13mm,<br>16mm | | | Needle wall<br>type | RW, TW | Unknown | RW | | | Needle<br>bevel | 11°±2°, 15°±2° | 15 degree regular point | 12°±2° | | | Needle<br>performance | ISO 9626<br>ISO 7864 | ISO 9626<br>ISO 7864 | ISO 9626<br>ISO 7864 | Same | | Syringe<br>performance | ISO 7886-1 | ISO 7886-1 | ISO 7886-1 | Same | | Biocompati<br>bility | Conforms to the<br>requirements of ISO 10993<br>series standards. | Conforms to the<br>requirements of ISO<br>10993 series standards. | Conforms to the<br>requirements of ISO<br>10993 series standards. | Same | | Method | EO Sterilized | EO Sterilized | EO Sterilized | Same | | SAL | 10-6 | 10-6 | 10-6 | Same | | Endotoxin<br>Limit | 20 EU per device | 20 EU per device | 20 EU per device | Same | | Operation | For Manual Use Only, For | For Manual Use Only, | For Manual Use Only, | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | ng | | | | | Table 3 Comparison of differences for Syringe with permanently attached needle {11}------------------------------------------------ {12}------------------------------------------------ ## Difference 3- Product code The proposed devices are a syringe with permanently attached needle, so the corresponding product codes is FMF. The predicate devices 2 are a safety syringe with needle and its product code is MEG. Both proposed device and predicate device are all used by health care professionals for fluid aspiration and injection. The syringe without safety feature is widely used in the clinical. Therefore, the difference on product code and regulation number will not raise new questions on safety and effectiveness of the proposed device. ## Difference 4-Indication for use The proposed devices have the same operation principle as that of the predicate device 2. The description of the indication for use of the proposed device and the predicate devices and reference device are different, but they are all used by health care professionals for fluid aspiration and injection. The syringe without safety feature is widely used in the clinical. Therefore, this item is considered substantially equivalent. # Difference 5- Configuration and materials The configurations of Syringe with permanently attached needle is similar as the configuration of predicate device 2, the difference is that Syringe with permanently attached has no safety mechanism, but the syringe without safety feature is widely used in the clinical. Whether there is a safety mechanism or not will not affect the indication for use of the equipment itself. This difference does not raise new questions about safety and effectiveness. Although the materials of predicate devices 2 are unknown. The proposed syringes' biocompatibility can be demonstrated by the reference device (K150758). Therefore, the differences on configuration and materials do not raise new questions about safety and effectiveness. ### Difference 6- Needle gauge, length, wall type and bevel The needle gauge and length for proposed devices is different from the predicate devices 2. However, this difference is just in dimension. Different size and length device will be selected by physician per patient's condition. This difference does not affect intended use, differences in needle length and gauge between the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. The needle wall type for predicate device is unknown. However, the performance test for proposed device has been conducted and the test result conform with requirements of ISO 7864:2016 and ISO 9626:2016 standards. The needle bevel for proposed devices are different from the predicate device 2. However, this difference is just in dimension. Different needle bevel will be selected by physician per patient's condition. This difference does not affect intended use. In addition, differences in needle bevel between {13}------------------------------------------------ the predicate and subject device were addressed through ISO 7864:2016 and ISO 9626:2016 performance testing. Therefore, the differences on needle length, gauge, wall type and bevel does not affect substantially equivalence on safety and effectiveness. {14}------------------------------------------------ | ITEM | Proposed Device | Predicate Device 2<br>K132681 | Reference device<br>K150758 | Remark | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------| | Product | Safety Syringe with<br>permanently attached<br>needle | Sol-Guard Insulin<br>Safety Syringe and<br>Tuberculin Safety<br>Syringe | Safelock Disposable<br>Insulin Syringe | / | | Product code | MEG | MEG | FMF<br>MEG | Same | | Regulation No. | 21CFR 880.5860 | 21CFR 880.5860 | 21CFR 880.5860 | Same | | Class | II | II…