WTF SECURA SYRINGE AND NEEDLE

{0}------------------------------------------------ # 510(K) Summary # Date: 2013-12-11 ### 1. Sponsor Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, 102200, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961 ### 2. Submission Correspondent Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing,China Tel: 8610-60750950 Fax: 8610-60750961 Email: lightsman@163.com # 3. Summary of technological characteristics of proposed Device: | PRODUCT | SPECIFICATIONS | REF | |---------------------------|----------------|---------------| | Safety Syringe | 1 ml | 110101 | | | 2.5 ml | 110251 | | | 3 ml | 110301 | | | 5 ml | 110501 | | | 10 ml | 111001 | | Retracting Needle | 25G 1" | 212551/222551 | | | 23G 1" | 212351 | | | 22G 1" | 212251 | | | 21G 1 1/8" | 212161 | | | 30G 1" | 223051/213051 | | | 21G 1 1/4" | 212171 | | | 22G 1 1/4" | 212271 | | Filling Needle (Optional) | 18G 1" | 311812 | DEC 12 2013 {1}------------------------------------------------ Niantou Industrial Park, Machikou, Changping District, Belilng, China Tel: 8610-60750950 Fax: 8610-60750961 - Trade Name: WTF Secura Safety Syringe (with Needle) ● - . Common Name: Safety syringe (with needle) - . Classification Name: Piston Syringe - . Review Panel: General Hospital - Product Code: FMF, FMF, FMI, MEG ● - . Regulation Number: 880.5860 - Device Class: II . - Predicate Device Trade name: BD Integra 1ml Syringe K023752 . - Predicate Device manufacturer: BD Medical Surgical 1 Becton Drive MC226 ♥ Franklin Lakes, NJ # 4. Intended use: The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination. # 5. Product Description: # a. Description of each component: The WTF Secura Safety Syringe (with needle) is a sterile, single use, hypodermic syringe with a 6% Luer taper tip and an integrated Sharps Injury Prevention Feature. The syringe is provided in the following syringe sizes: 1ml, 2.5ml, 3m1, 5ml, and 10ml. and needle sizes: 21-30G. All sizes will be available with a Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a isoamyl stopper, a polypropylene plunger rod and a polypropylene sharps injury prevention feature. The sharps injury prevention feature consists of needle retracting performance before or after use, allowing for secure encapsulation of the needle point. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The {2}------------------------------------------------ Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 needle assembly consists of indicidual lubricated retracting stainless steel needle and individual safety syringe. | PRODUCT | SPECIFICATIONS | REF | |-------------------|----------------|---------------| | Safety Syringe | 1 ml | 110101 | | | 2.5 ml | 110251 | | | 3 ml | 110301 | | | 5 ml | 110501 | | | 10 ml | 111001 | | Retracting Needle | 25G 1" | 212551/222551 | | | 23G 1" | 212351 | | | 22G 1" | 212251 | | | 21G 1 1/8" | 212161 | | | 30G 1" | 223051/213051 | | | 21G 1 1/4" | 212171 | | | 22G 1 1/4" | 212271 | | Filling Needle | 18G 1" | 311812 | - b. Main material of WTF Secura Safety Syringe (with needle) are Polypropylene pellets (PP) , Isoamyl rubber piston, retracting needle made of stainless tube, and its main package material are gumming paper and Medical composite membrane. - c. Standards applied: EN ISO 13485:2012/AC 2012, EN ISO 14971:2009, EN ISO 11135-1:2007, EN ISO 11607-1:2009, EN ISO 11607-2:2009, EN ISO 10993-1:2009, EN 556-1, EN1041:2008, EN 980:2008, ISO 9626, ISO 594-1,ISO 594-2, ISO 7886-4:2006, ISO ISO 7886-1:1993. ISO 7864:1993. WTF/JS-H-AZS7-A-01-2010 | Parts | Material of the<br>part | Size | Standards | Component | |-----------------------|-----------------------------------|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | polypropylene | K4818<br>K4912 | 1. The requirements for polyethylene<br>special material for medical use in<br>YY/T0242-2007 shall be met.<br>2. The material meeting YY/T0242-2008<br>standard cannot be found due to<br>procurement cause, and it shall be<br>replaced by other similar materials.<br>Furthermore, the biological performance<br>of the used material shall be evaluated<br>according to the requirements of GB/T<br>16886.1 (BS EN ISO 10993-1), so as to<br>ensure that the requirements for safety of<br>product material are met (the biological<br>assessment and type inspection have<br>been performed for the fabricated small<br>batch of samples). | Sleeve,<br>Outer core bar,<br>Limit sheath,<br>Inner core bar,<br>Needle base<br>connector<br>cover,<br>Needle base,<br>Needle base<br>connector,<br>Protective<br>cover,<br>Protection cap,<br>Luer adapters,<br>Filling needle<br>base | | injection<br>moulding | TPE<br>thermoplastic<br>elastomer | A805-60<br>R62<br>E2000-4<br>5R92 | Shore hardness: 65<br>Elongation rate: 270<br>Biological detection shall be performed<br>for the first batch of supplied material (or<br>entrust the third party to perform the<br>biological detection). The haemolytic<br>activity shall not exceed 5%; it shall have<br>no acute systemic toxicity; in vitro<br>cytotoxic response level shall be no<br>larger than level 1, and there shall be no<br>sensitization response. | Stop dog | | | Color<br>concentrate | Green,<br>orange,<br>blue,<br>black | tinctorial strength 95-105%:<br>Chromatic aberration≤0.3 | The<br>different<br>colors<br>correspond to<br>different<br>specifications<br>needle base<br>and needle<br>base connector | {3}------------------------------------------------ Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 {4}------------------------------------------------ Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 | Needle<br>tube | Filling needle<br>( bare<br>needle ) | 0.4(27G)<br>,0.5(25G<br>),<br>0.6(23G<br>),0.7(22<br>G),0.8(2<br>1G),0.9(<br>20G) | Meet standards of ISO 8764 Sterile<br>Hypodermic Needle for Single Use and<br>ISO 9626 Stainless steel needle tubing<br>for the manufacture of medical devices | Integrated<br>needle、Filling<br>needle、Filling<br>needle tube | |-------------------------------|--------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | spring | Stainless tube | $¢$ 0.1, $¢$<br>0.3 | tensile strength≥110kg/mm | | | O ring | Ø5.0×1.0<br>5<br>Ø3.9×1.0<br>5 | | silicon rubber<br>Hardness 55~60 | | | | | | | | | silica gel or Isoprene rubber | 2.5ml;3m<br>1; 5ml;<br>10ml | | 1、Meet YY/T0243-2003 Plunger of<br>sterile controllable safety syringe for<br>single use (with detachable needle)<br>2、Meet WTF/JS-A-AZS3-2-06-2005 | Plunger | | | | | | | # 6. Product Performance Test Summary I. Product test report information | Property | ltem | Conclusion | |------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | | Sterile | sterile growth | | | Pyrogen | Non-pyrogen | | Biological<br>property | Hemolysis | Hemolysis ratio: 1%<br>Compliance with technical<br>requirements <5% | | | Acute systemic<br>toxicity | No acute systemic toxicity<br>reaction | | Chemical<br>property | Readily oxidizable<br>substance ml | 0.1-<br>Meet the requirement of<br>potassium permanganate<br>consumption <0.5 | | | pH value | 0.04-<br>Meet the requirement of pH<br>difference <1.0 | | | Heavy metal u g/ml | 0.05-<br>Meet the following requirement:<br>namely total quantity of lead, zinc, tin<br>and iron is ≤5, cadmium content is<br>≤0.1 | {5}------------------------------------------------ Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 | | | Residual quantity of<br>ethylene oxide μ g/g | Not detected-<br>Meet the requirement that<br>residual quantity of ethylene oxide is<br>equal to or less than 10 | |----------------------|-----------------------------------|----------------------------------------------|------------------------------------------------------------------------------------------------------------------| | | Controllable core pin | | Qualified | | | Self-destruction<br>performance | | Qualified | | | Body adaptation | | Qualified | | | Volume tolerance | | Qualified | | | Piercing force of<br>sword | | Qualified | | | | Rigidity | Qualified | | | Needl<br>e | Toughne<br>ss | Qualified | | Physical<br>property | | Corrosio<br>n resistance | Qualified | | | | Surface | Qualified | | | | Cleanlin<br>ess inside<br>the tube | Qualified | | | | Appearance | | | | | Scale length | | | | | Scale volume line | | | | | Zero line position | | | | Metering number | | Qualified | | | Scale printing | | Qualified | | | Jacket length | | Qualified | | | Jacket hemming | | Qualified | | | Handle interval | | Qualified | | | Piston | | Qualified | | | Sliding property | | Qualified | | | Residual capacity | | Qualified | | | | retrac<br>ting<br>needle | Appeara<br>nce | | | Dimensi<br>on | | Qualified | | | Upright<br>connection | | Qualified | | | Smooth<br>pinhole | | Qualified | | | Color | | Qualified | | Cone<br>cover | Separati<br>ng force of<br>sheath | | Qualified | | | | | | | | Single packing mark | | Qualified | III. Conclusion Based on the test report analysis, main indexes of products meet the product standard requirements. . 7 The Simulated Clinical Study Summary {6}------------------------------------------------ ### Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou, Changping District, Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 According to the chapter 10 of "Guidance for Industry and FDA Staff-- Medical Devices with Sharps Injury Prevention Features on Aug.9. 2005". The WTF Secura Safety Syringe (with needle) had been evaluated by simulated clinical study. For this simulated test, there was only one failure among 1000 devices tested. This result is acceptable for confidence and statistical theory. Generally, the WTF Secura Safety Syringe (with needle) which is designed and manufactured by Beijing WanTeFu Medical Apparatus Co., Ltd is easily to be handled and safe for clinical uses. ### 8. Indications for use: The WTF Secura Syringe (with needle) is used for aspiration of fluids from vials and ampoules and a variety of fluid injections below the surface of the skin. The WTF Secura Syringe (with needle) has a manually attached WTF Secura Retracting Needle. The WTF Secura Syringe (with needle) contains an inner mechanism used to allow the WTF Secura Retracting Needle to be retracted inside the plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination. ### 9. Substantial Equivalence Discussion Summary: The WTF Secura Syringe (with needle) was compared to the predicate devices (BD Integra Syringe) using the followingcriteria: syringe type, intended use(s), principle of operation, specific drug use, Length, Diameter, tip type, Volume, needle length, needle gauge, needle tip configuration, nozzle type, barrel marking specs, gradations legibility, needle cover dimensions, needle cover color, lubricant composition, lubricant amount/cm2, barrel transparency, delivery accuracy, reuse durability, needle cover strength, hub/needle bond strength, Biocompatibility, Materials, Labeling, Re-use prevention feature. Performance after shipping. The testing to applied standards provides additional evidence that the WTF Secura {7}------------------------------------------------ ### Beijing WanTeFu Medical Apparatus Co., Ltd. Niantou Industrial Park, Machikou. Changping District. Beijing, China Tel: 8610-60750950 Fax: 8610-60750961 Syringe (with needle) is substantially equivalent to the predicate devices in terms of safety, efficacy and performance. The WTF Secura Syringe (with needle) performed in a similar manner to the predicate devices(BD Integra Syringe). The WTF Secura Syringe (with needle) performed equivalently to the BD Integra Syringe with respect to the following characteristics: Overall performance: - Ease of maintaining standard injection technique . - Ability to maintain aseptic technique ● - Ability to aspirate medication from a vial 방 - Ability to read the syringe scale on the barrel # - Ability to passively re-shield and transport r - Ability to easily and safely dispose of the used device in a sharps container s - Perceived safety of the device r The differences between the WTF Secura Syringe (with needle) and the predicate devices do not raise new issues of safety or effectiveness. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white. Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the symbol. The image is in black and white. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 December 12, 2013 Beijing WanTeFu Medical Apparatus Company, Limited Mr. Raymond Sun Niantou Industrial Park, Machikou Changping District Beijing, China 102200 Re: K132120 Trade/Device Name: WTF Secura Safety Syringe (with Needle) Regulation Number: 21 CFR 880.5860 Regulation Name: Safety Syringe (with Needle) Regulatory Class: II Product Code: FMF, FMF, FMI & MEG Dated: September 5, 2013 Received: September 16, 2013 ### Dear Mr. Sun: 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. {9}------------------------------------------------ Page 2 - Mr. Sun . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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. Te Cli DA Sincerely vours. Tejashri Purchit-Sheth, M.D. Clinical Deputy Director DAGRID FOR Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use 510(k) Number (if known) K132120 .. . . . . . . . ### Device Name : ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ WTF Secura Safety Syringe (with needle) ### Indications for Use (Describe) The WTF Secura Syringe (with need for aspiration of fluids from vials and a variety of fluid injections below the surface of the skin. The WTF Secure Syringe (with needle) has a manually attacting Needle. The WTF Secure Syringe (with needle) contains an inner mechanism used to allow the WTF Secure Retracting Needle to be plunger rod of the syringe when operator's thumb force released. After activation the needle is fully contained inside the syringe guarding against accidental needle sticks during normal handling and disposal of the used needle/syringe combination. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. | | FOR FDA USE ONLY | |--|------------------| |--|------------------| | Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | | |------------------------------------------------------------------------------|--|--| |------------------------------------------------------------------------------|--|--| | | Digitally signed by Richard C. | |--|----------------------------------------------| | | Chapman<br>Date: 2013.12.12 10:02:46 -05'00' | Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page. FORM FDA 3881 (8/13)