Disposable High Pressure Injector Syringe

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a single, continuous line. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 22, 2016 Wuxi Yushou Medical Appliances Co., Ltd % Jun Peng Principal Consultant P&L Scientific Inc. 6840 SW 45th Ln Unit 5 Miami, Florida 33155 Re: K152906 Trade/Device Name: Disposable High Pressure Injector Syringe Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: February 19, 2016 Received: March 2, 2016 Dear Jun Peng: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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" (21 CFR 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 yours, Brian D. Pullin -S for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K152906 Device Name Disposable High Pressure Injector Syringe Indications for Use (Describe) Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors. Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------| | ☐ 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}------------------------------------------------ # 510(k) Summary 510(k) summary of Safety and Effectiveness as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which Substantial Equivalence is based: #### The Assigned 510(k) Number is: k152906 - 1. Submitter Information: - Sponsor/510(K) Owner: . WUXI YUSHOU MEDICAL APPLICANCES CO., LTD. NO. 215 XIGANG ROAD, DONGBEITANG WUXI CITY, JIANGSU, 214191, CHINA Phone: +86-510-83771274 Fax: +86-510-83772037 Dated: May 4, 2016 - Contact Name: . Mr. Jun Peng P&L SCIENTIFIC INC. 6840 SW 45TH LN UNIT 5 MIAMI, FL 33155 Phone: 305-609-4701 Fax: 305-397-0289 Email: jpeng@plscientificinc.com - 2. Device Name | Trade Name: | Disposable High Pressure Injector Syringe | |--------------|-------------------------------------------| | Common Name: | Angiographic Injector and Syringe | ### 3. Classification: | Classification Names | FR Number | Product Code | |------------------------------------|-----------|--------------| | Injector and syringe, angiographic | 870.1650 | DXT | ### 4. Predicate Devices: | Name | K number | Manufacturer information | |-------------------------------------------------------------------------------------------------------------------|----------|-----------------------------------------| | DISPOSABLE ANGIOGRAPHIC SYRINGE MODEL(S) CT-200-NE CT-200-MA CT-200+200-MA CT-200-LF CT -100-NE CT-200NE CT-50+CT | K082439 | SHANDONG WEIGAO MEDICAL POLYMER CO. LTD | | ANT ANGIOGRAPHIC SYRINGES MODEL(S) 100101102103100201202203204100301200101201202 203200301101102202301 | K072696 | SHENZHEN ANT HI-TECH INDUSTRIAL CO. LTD | {4}------------------------------------------------ ## 5. Description of Device The product has two types: one type is composed of one or several syringes and one or several accessories. The accessories include connecting tube and medicine aspirator (punctured medicine aspirator and tubular medicine aspirator); the other type is composed of individual accessory; the syringe is composed of barrel, plunger, piston or plunger cap. The connecting tube has one-way and multi-way. One-way connecting tube is composed of locking connector, tubing, female conical fitting, nozzle cap, protective cap or one-way valve; multi-way connecting tube is composed of multi-way connector, locking connector, tubing, female conical fitting, nozzle cap, protective cap, one-way valve or puncture. Maximum rated pressure for the Disposable High Pressure Injector Syringe is either 300psi (2.07MPa) or 1200psi (8.3MPa). The rated pressure for each models are listed in the following Models and Combinations Table. The aspirator has tubular medicine aspirator and punctured medicine aspirator. Punctured medicine aspirator has plastic pin. Product packaging: Primary package is heat-sealed by Tyvek paper and PS blister. The following configurations of various syringes and accessories are available than are in compatible with market available injectors from Medrad, Liebel-Flarsheim, Acist or Nemoto. | Models | Composition | Compatible with | Maximum<br>Rated<br>Pressure | | | |---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | 10060A/<br>10060A | 2-65ml Syringe<br>1-255cm Multi-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | MEDRAD SOLARIS&<br>SPECTRIS MRI | 300psi | | | | 10060C/<br>10060C | 2-60ml Syringe<br>1-255cm Multi-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | Liebel-Flarsheim Optistar<br>MRI | 300psi | | | | 100100C/<br>10060A | 1-115ml Syringe<br>1-65ml Syringe<br>1-255cm Multi-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | MEDRAD SOLARIS&<br>SPECTRIS MRI | 300psi | | | | 100100C/100100C | 2-115ml Syringe<br>1-255cm Multi-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | MEDRAD SOLARIS&<br>SPECTRIS MRI | 300psi | | | | 100100A | 1-100ml Syringe | MEDRAD MCT PLUS CT | 300psi | | | | | 1-150cmOne-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD VISTRON CT<br>MEDRAD ENVISION CT | | | | | 100100B | 1-100ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MCT PLUS CT<br>MEDRAD VISTRON CT<br>MEDRAD ENVISION CT | 300psi | | | | 100100D | 1-100ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | Liebel-Flarsheim 3000 Series<br>DSA | 1200psi | | | | 100130A | 1-130ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MARK IV &<br>MARK III DSA | 1200psi | | | | 100150A | 1-150ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MARK V DSA<br>MEDRAD MARK V Provis<br>DSA | 1200psi | | | | 100150C | 1-150ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MARK 7 DSA | 1200psi | | | | 100200A | 1-200ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MCT PLUS CT<br>MEDRAD VISTRON CT<br>MEDRAD ENVISION CT | 300psi | | | | 100200B | 1-200ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-10cm Straight Tube<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD STELLANT Single<br>CT | 300psi | | | | 100200B/<br>100200B | 2-200ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator<br>1-150cm Multi-way Connecting<br>Tube<br>2-10cm Straight Tube<br>2-Punctured Medicine Aspirator | MEDRAD STELLANT<br>Double CT | 300psi | | | | 100200D | 1-200ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | MEDRAD MARK V DSA<br>MEDRAD MARK V Provis<br>DSA | 1200psi | | | | 101100A/<br>101100A | 2-100ml Syringe<br>1-255cm Multi-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | ACIST-MR<br>EZEM INC-CT | 300psi | | | | 101200A | 1-200ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine | ACIST-CT<br>EZEM INC-CT | 300psi | | | | | Aspirator | | | | | | 101200A/<br>101200A | 2-200ml Syringe<br>1-255cmMulti-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | ACIST-CT<br>EZEM INC-CT | 300psi | | | | | 200150A | 1-150ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | Liebel-Flarsheim Angionmat<br>Illumena DSA | 1200psi | | | | | 200150B | 1-150ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | Liebel-Flarsheim Angionmat<br>6000 DSA | 1200psi | | | | | 200200A | 1-200ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | Liebel-Flarsheim CT9000<br>Single | | 200200A/<br>200200A | 2-200ml Syringe<br>1-150cm Multi-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator<br>1-Punctured Medicine Aspirator | | | Liebel-Flarsheim CT9000<br>Double | 300psi | | | 300130A | 1-130ml Syringe<br>1-J-type Tubular Medicine<br>Aspirator | | NEMOTO 120S DSA | 1200psi | | | | 300100B | 1-100ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | NEMOTO A-25, A-60, Dual Shot CT | 300psi | | | | | 300100B/<br>300100B | 2-100ml Syringe<br>1-150cm Multi-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator<br>1-Punctured Medicine Aspirator | NEMOTO A-25, A-60, Dual Shot CT | | 300200B | 1-200ml Syringe<br>1-150cm One-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator | | | NEMOTO A-25, A-60, Dual Shot CT | 300psi | | | 300200B/<br>100060B | 1-200ml Syringe<br>1-60ml Syringe<br>1-150cm Multi-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator<br>1-Punctured Medicine Aspirator | | NEMOTO Dual Shot, Dual Shot Alpha CT | 300psi | | | | 300200B/<br>300100B | | 1-200ml Syringe<br>1-100ml Syringe | NEMOTO Dual Shot, Dual Shot Alpha CT | | | | 1-150cm Multi-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator<br>1-Punctured Medicine Aspirator | | 300psi | | | | | 2-200ml Syringe | | | | | | 300200B/<br>300200B | 1-150cm Multi-way Connecting<br>Tube<br>1-J-type Tubular Medicine<br>Aspirator<br>1-Punctured Medicine Aspirator | NEMOTO Dual Shot, Dual<br>Shot Alpha CT | | | | | | 2-60ml Syringe | | | | | | | 1-255cmMulti-way Connecting<br>Tube<br>2-Punctured Medicine Aspirator | NEMOTO Sonic Shot 50 MRI | | | | 100060B/<br>100060B | | | | | | Models and combinations {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## 6. Intended Use Disposable High Pressure Injector Syringe is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors. ## 7. Summary of Comparison in Technological Characteristics to Predicate Device The Disposable High Pressure Injector Syringe is substantially equivalent to the predicate device ANT Angiographic Syringes (K072696) and DISPOSABLE ANGIOGRAPHIC SYRINGE MODEL(S) CT-200-NE CT-200-MA CT-200+200-MA CT-200-LF CT -100-NE CT-200NE CT-50+CT (k082439). The subject device and the predicate device are both of the - same intended use. ● - the method of use, ● - device construction, ● - . materials used. - packaging, ● - biological characteristics, - and performance ● # 8. Discussion of major difference vs. predicate device Difference between subject device and predicate devices: - Combination of syringes of volumes is different; - Connection nozzles are different. . # 9. Assessment of Non-Clinical Testing: The performance shows the subject device and predicate devices have the substantial equivalent performance. Therefore, the Disposable High Pressure Injector Syringe is {8}------------------------------------------------ substantially equivalent to the predicate devices, there are no safety issues raised, and the device meets the requirements for FDA 510(k) clearance. Performance testing: 1) Maximum Rated Pressure Testing - 2) Connection Strength Test - 3) Compatibility Testing between the Injector and Syringes - 4) Aged Verification - 5) Biocompatibility Tests - ISO 10993-1:2009 Biological Evaluation of Medical Devices Part 1: . Evaluation and Testing - ISO 10993-5:1999 Biological evaluation of medical devices -- Part 5: Tests ● for In Vitro cytotoxicity - ISO 10993-10:2002 Biological evaluation of medical devices Part 10: Tests ● for irritation and delayed-type hypersensitivity - ISO 10993-7: 2008 Biological evaluation of medical devices Part 7: ● Ethylene oxide sterilization residuals - 6) Transportation Validation - ASTM D4169 14 Standard Practice for Performance Testing of Shipping . Containers and Systems ### 10. Assessment of Clinical Testing: The clinical testing is used to evaluate the performance of the high pressure syringe and injectors, the following are evaluated: - 1) Appearance - 2) Sliding Performance - 3) Sealing - 4) Fitting The Disposable High Pressure Injector Syringe was found to have a substantial equivalent profile that is similar to the predicate device. ### 11. Conclusion After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantial equivalent as the predicate devices.