Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 2, 2017 Yangzhou Medline Industry Co., Ltd. c/o Ms. Diana Hong Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai 200120 CHINA Re: K170651 Trade/Device Name: Sterile Disposable Syringe With Safety Needle, Sterile Disposable Syringe With Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: MEG, FMF, FMF, FMI Dated: July 3, 2017 Received: July 5, 2017 Dear Ms. 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Tara A. Ryan -S for Michael Ryan Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Change Control Table, Change History ## Change Control Table | Version | Document Author | Document Approver | Date Approved | |---------|---------------------|---------------------|---------------| | 1.00 | Name, Title, Office | Name, Title, Office | MM/DD/YYYY | Complete Change Control Table (all versions) retained in SWIFT Docs. {3}------------------------------------------------ ## Indications for Use ### 510(k) Number (if known) ## K170651 #### Device Name Sterile Disposable Syringe with Safety Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle #### Indications for Use (Describe) The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration of fluids for medical purpose. The Sterile Disposable Syringe is a sterile luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. The Sterile Disposable Needle is intended to be used with a luer lock syringe for aspiration and injection of fluids for medical purpose. Type of Use (Select one or both, as applicable) | <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |----------------------------------------------------------------------------------------------------------------| | <div> <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 comblete 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." {4}------------------------------------------------ ## 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: K170651 - 1. Date of Preparation: 8/2/2017 - Sponsor Identification 2. # Yangzhou Medline Industry Co., Ltd. No. 108, Jinshan Road, Economic Development Zone Yangzhou, China 225000 Establishment Registration Number: Not yet registered Contact Person: Jianzhong Qi Position: General Manager Tel: +86-514-87525631 Fax: +86-514-87525631 Email: President@cnmedical.net - 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net {5}------------------------------------------------ 4. Identification of Proposed Device Trade Name: Sterile Disposable Syringe with Safety Needle Sterile Disposable Syringe with Needle Sterile Disposable Syringe Sterile Disposable Safety Needle Sterile Disposable Needle Regulatory Information Classification Name: Syringe Antistick Classification: II Product Code: MEG Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital Classification Name: Piston Syringe Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital Additional Product Code: FMI, Hypodermic single lumen needle Indications for Use Statement: The Sterile Disposable Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose. The Sterile Disposable Syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose. The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlesticks. {6}------------------------------------------------ The Sterile Disposable Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. Device Description The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Syringe with Needle is intended for manual and single use only, which consists of a hypodermic needle and a luer slip or luer lock syringe. The proposed device is available in a variety combination of syringe volume and needle size. The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The proposed device is available in a variety syringe volume. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The Sterile Disposable Safety Needle is intended for manual and single use only, which consists of a hypodermic needle with a safety sheath attached to the connector hub. The proposed device is available in variety combination of needle gauge and needle length. The proposed device is compatible for use with a luer slip or luer lock syringe. The safety sheath will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks. The Sterile Disposable Needle is intended for manual and single use only, which is compatible for use with a luer slip or luer lock syringe. The proposed device is available in variety combination of needle gauge and needle length. The syringe barrel sizes and needle gauges/ lengths of the subject device are provided in following table. Table 1 Syringe barrel sizes and needle gauges/ lengths | | Syringe volume | Needle Gauge | Needle Length | |-----------------------------------------------|--------------------------------------------------|---------------------------------------------------------------------|---------------------------------------------| | Sterile Disposable Syringe with Safety Needle | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | 16G,18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G | 5/16", 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | | Sterile Disposable Syringe with Needle | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml | 16G,18G, 19G, 20G, 21G, 22G, 23G, 24G | 5/16", 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | {7}------------------------------------------------ | | | 50ml, 60ml | 25G, 26G, 27G, 28G,<br>29G, 30G | | |---------|-----------------------------|--------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------| | Sterile | Disposable<br>Syringe | 1ml, 2ml, 3ml, 5ml,<br>10ml, 20ml, 30ml,<br>50ml, 60ml | N.A. | N.A. | | Sterile | Disposable<br>Safety Needle | N.A. | 16G,18G, 19G, 20G,<br>21G, 22G, 23G, 24G,<br>25G, 26G, 27G, 28G,<br>29G, 30G | 5/16", 1/2", 5/8", 3/4",<br>1", 1-1/4", 1-1/2" | | Sterile | Disposable<br>Needle | N.A. | 16G,18G, 19G, 20G,<br>21G, 22G, 23G, 24G,<br>25G, 26G, 27G, 28G,<br>29G, 30G | 5/16", 1/2", 5/8", 3/4",<br>1", 1-1/4", 1-1/2" | #### 5. Identification of Predicate Device Predicate Device 1 510(k) Number: K113422 Product Name: TERUMO® SurGuard® 3 Safety Needle TERUMO® SurGuard® 3 Hypodermic Syringe with Safety Needle Predicate Device 2 510(k) Number: K083514 Product Name: TERUMO® Syringe with/without Needle #### б. 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: | Cleanliness | Clause 5 of ISO 7886-1:1993 | |----------------------------------|------------------------------| | Limits for acidity or alkalinity | Clause 6 of ISO 7886-1:1993 | | Limits for extractable metals | Clause 7 of ISO 7886-1:1993 | | Lubricant | Clause 8 of ISO 7886-1:1993 | | Tolerance on graduated capacity | Clause 9 of ISO 7886-1:1993 | | Graduated scale | Clause 10 of ISO 7886-1:1993 | | Barrel | Clause 11 of ISO 7886-1:1993 | | Piston/ plunger assembly | Clause 12 of ISO 7886-1:1993 | | Nozzle | Clause 13 of ISO 7886-1:1993 | | Performance | Clause 14 of ISO 7886-1:1993 | {8}------------------------------------------------ Cleanliness Clause 4 of ISO 7864:1993 Limits for acidity or alkalinity Clause 5 of ISO 7864:1993 Limits for extractable metals Clause 6 of ISO 7864:1993 Size designation Clause 7 of ISO 7864:1993 Colour coding Clause 8 of ISO 7864:1993 Needle hub Clause 9 of ISO 7864:1993 Sheath Clause 10 of ISO 7864:1993 Needle tube Clause 11 of ISO 7864:1993 Needle point Clause 12 of ISO 7864:1993 Performance Clause 13 of ISO 7864:1993 Clause 3 of ISO 9626:1991/AMD-1:2001 Clause 4 of ISO 9626:1991/AMD-1:2001 Clause 5 of ISO 9626:1991/AMD-1:2001 Clause 6 of ISO 9626:1991/AMD-1:2001 Clause 7 of ISO 9626:1991/AMD-1:2001 Clause 8 of ISO 9626:1991/AMD-1:2001 Clause 9 of ISO 9626:1991/AMD-1:2001 Clause 10 of ISO 9626:1991/AMD-1:2001 Clause 11 of ISO 9626:1991/AMD-1:2001 Gauging Liquid leakage Air leakage Separation force Stress cracking Gauging Leakage Separation force Unscrewing torque Ease of assembly Resistance to overriding Stress cracking Materials Surface finish Size designation Resistance to breakage Resistance to corrosion Limits for acidity and alkalinity Cleanliness Dimensions Stiffness Clause 4.1 of ISO 594-1:1986 Clause 4.2 of ISO 594-1:1986 Clause 4.3 of ISO 594-1:1986 Clause 4.4 of ISO 594-1:1986 Clause 4.5 of ISO 594-1:1986 Clause 4.1 of ISO 594-2:1998 Clause 4.2 of ISO 594-2:1998 Clause 4.3 of ISO 594-2:1998 Clause 4.4 of ISO 594-2:1998 Clause 4.5 of ISO 594-2:1998 Clause 4.6 of ISO 594-2:1998 Clause 4.7 of ISO 594-2:1998 Sterile Barrier Packaging Testing performed on the proposed device: | Seal strength | ASTM F88/F88-09 | |-------------------|----------------------| | Internal pressure | ASTM F1140/F1140M-13 | | Dye penetration | ASTM F1929-12 | {9}------------------------------------------------ | Sterilization and Shelf Life Testing performed on the proposed device: | | |------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | EO residue | ISO 10993-7:2008 | | ECH residue | ISO 10993-7:2008 | | Bacteria Endotoxin Limit | USP 38-NF 33 <85> | | Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests<br>were performed on aging samples to verify the<br>claimed shelf life of the device | | Biocompatibility Testing: | | | In Vitro Cytotoxicity | ISO 10993-5:2009 | | Intracutaneous Reactivity | ISO 10993-10:2010 | | Skin Sensitization | ISO 10993-10:2010 | | Acute Systemic Toxicity | ISO 10993-11:2006 | | Hemolysis | ASTM F756-13 | | Pyrogen | USP<151> | | Complement Activation | ISO 10993-4:2002/A12006 | Sterilization and Shelf Life Testing performed on the proposed device: Simulated Clinical Study In Vivo Thrombogenicity A simulated clinical study was performed on proposed device according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 to evaluate the safety mechanism of the proposed device. The results demonstrated that the proposed device met the pre-established criteria. ISO 10993-4:2002/A12006 Safety Feature Test The safety feature test was performed on both proposed device and predicate device to determine its safety feature. The results demonstrated that the proposed device did not show a significant difference from predicate device. - 7. Clinical Test Conclusion No clinical study is included in this submission. {10}------------------------------------------------ #### Substantially Equivalent (SE) Comparison 8. | Table 2 Comparison of Technology Characteristics of Proposed device & Predicate Devices | | | | |-----------------------------------------------------------------------------------------|--|--|--| | | | | | | ITEM | Proposed Device | Predicate Device 1 | Predicate Device 2 | |----------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K170651 | K113422 | K083514 | | Product Code | MEG, FMF, FMI | MEG, FMF | FMF, FMI | | Regulation No. | 21 CFR 880.5860, 21 CFR880.5570 | 21 CFR 880.5860, 21 CFR 880.5570 | 21 CFR 880.5860 | | Class | CLASS II | CLASS II | CLASS II | | Intended Use | The Sterile Disposable Syringe with Safety Needle is intended<br>for use in the aspiration and injection of fluids for medical<br>purpose. After withdrawal of the needle from the body, the<br>attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.<br>The Sterile Disposable Syringe with Needle is intended for use in the aspiration and injection of fluids for medical purpose.<br>The Sterile Disposable Syringe is a sterile luer lock or luer slip syringe which is intended to be used with a hypodermic needle for the aspiration and injection of fluids for medical purpose.<br>The Sterile Disposable Safety Needle is intended to be used with a luer slip or luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick.<br>The Sterile Disposable Needle is intended to be used with a luer | The TERUMO® SurGuard® 3<br>Hypodermic Syringe with Safety Needle is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO® SurGuard® 3 Hypodermic Syringe with Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needlestick. | The Terumo Syringe with<br>without needle is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. | {11}------------------------------------------------ | slip or luer lock syringe for aspiration and injection of fluids for medical purpose. | | | | | | | | |---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------|--|----------------------------------|---------|--------------------------------|---------| | Configuration and material | Barrel | Polypropylene (PP) | | Barrel | | Barrel | | | | Plunger | Polypropylene (PP) | | Plunger | | Plunger | | | | Piston | Polyisoprene | | Piston | | Piston | | | | Needle hub | Polypropylene (PP) | | Needle hub | Unknown | Needle hub | Unknown | | | Protective cap | Polypropylene (PP) | | Protective cap | | Protective cap | | | | Needle tube | Stainless Steel (SUS304) | | Needle tube | | Needle tube | | | | Safety sheath | Polypropylene (PP) | | Safety sheath | | | | | | | | | | | | | | Operation Mode | For manual use only | | | Same | | Same | | | Label/Labeling | Complied with 21 CFR part 801 | | | Complied with 21 CFR part 801 | | Complied with 21 CFR part 801 | | | Syringe Volume | 1ml, 2ml, 3ml, 5ml, 10ml, 20ml, 30ml, 50ml, 60ml | | | 3ml, 5ml, 10ml | | 1ml, 2ml, 5ml, 10ml, 50ml | | | Connector Type | Luer Lock/ Luer slip | | | Luer Lock/ Luer slip | | Luer Lock/ Luer slip | | | Syringe performance | Complied with ISO 7886-1: 1993 | | | Complied with ISO 7886-1: 1993 | | Complied with ISO 7886-1: 1993 | | | Needle Gauge and length | 16G,18G, 19G, 20G, 21G, 22G, 23G, 24G, 25G, 26G, 27G, 28G, 29G, 30G<br>Available in 5/16", 1/2", 5/8", 3/4", 1", 1-1/4", 1-1/2" | | | 18G~25G<br>Available in 1" to 2" | | 20G~26G | | | | Biocompatibility | In Vitro Cytotoxicity | | No cytotoxicity | Same | | Same | | Intracutaneous Reactivity | | No intracutaneous reactivity | | | | | | | Skin Sensitization | | No skin sensitization | | | | | | | Acute Systemic Toxicity | | No systemic toxicity | | | | | | | Hemolysis | | No Hemolysis | | | | | | {12}------------------------------------------------ | | Pyrogen | No Pyrogen | | | |----------------|-------------------------------|----------------------------------------------------|------|------| | | Complement Acitivation | Not show potentials to activate<br>complete system | | | | | In Vivo Thrombogenicity | No thrombogenicity | | | | Sterilization | EO Sterilization | | Same | Same | | SAL | $10^{-6}$ | | Same | Same | | Single Use | Yes | | Same | Same | | Label/Labeling | Complied with 21 CFR part 801 | | Same | Same | The Sterile Disposable Syringe with Safety Needle, Sterile Disposable Needle are similar to the predicate device K113422 in device design, Indications for use, materials, sterlization, method of operation and technological characteristics. The proposed device Sterile Disposable Syringe with Needle, Syringe are similar to the predicate device K083514 in device design, Indications for use, materials, sterilization, method of operation and technological characteristics. The differences and barrel sizes. Through performance testing comparison the subject device and predicate device have demonstrated substantial equivalence. #### Substantially Equivalent (SE) Conclusion 9. Based on the Based on the bench performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.