TM SAFETY NEEDLE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 11, 2015 ThinkMed Medical Technology Co., Ltd. Mr. Garfield Wang No. 4 Building, 322 Hongyang Road Jiangsu 215341 CHINA Re: K142765 Trade/Device Name: TM Safety Needle Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: II Product Code: FMI Dated: September 23, 2014 Received: July 14, 2015 Dear Mr. Wang: 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}------------------------------------------------ Page 2 - Mr. Wang 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/Resourcesfor You/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 vours. # Erin I. Keith -S Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "ThinkMed" in a blue font. The word is written in a sans-serif font, and the letters are slightly shadowed. The word is centered on a white background. The image is simple and clean, and the focus is on the word "ThinkMed". [TM Safety Needle] 510(k) Submission Rev 1.00 05/08/15 # Section 004 Indications for Use 510(k) Number (if known): Device Name: TM Safety Needle Indications for Use The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM 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 needle-stick. ______________________________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "ThinkMed" in a stylized font. The word is written in a dark blue color, with a lighter blue outline that gives it a 3D effect. The letters are bold and slightly rounded, making the word appear modern and professional. 510(k) Submission [TM Safety Needle] 10/08/15 Rev 1.01 #### 510(K) Summary Date Prepared: 10. 08.2015 #### 1. Submitter Name and Address: | Owner Name: | ThinkMed Medical Technology Co., Ltd. | |-----------------|---------------------------------------------------------------------------------------------------------------------| | Address: | No.4 Building, 322 Hongyang Road, Qiandeng Town,Kunshan City, CHINA<br>No 20 South Renhe Road Tianchang city, CHINA | | Contactor Name: | Garfield Wang | | TEL: | +86-13564751751 | | E-mail: | Blackwang@tkmedical.com | | Contract Manufacturer Name: | ANHUI TIANKANG MEDICAL PRODUCTS CO., LTD | |-----------------------------|------------------------------------------------| | Address: | No 20 south renhe road tianchang, CHINA 239300 | | Web: | www.tkmedical.com | #### US Agent: | Name: | CARELIFE (USA) INC. | |------------------|----------------------------------------------| | Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 | | TEL: | 404 6612228 | | Contact person : | Ms. LI QIAN liqian@shanghaicarelife.com | #### 2. Submission Devices Information: Trade/Proprietary Name: TM Safety Needle Common Name: Safety Needle Submission Type: Traditional 510k Regulation Number: 21CFR 880.5570 Requlation Name: Hypodermic single lumen needle Product Code: FMI Class: 2 #### 3. Predicate Devices Information: | Trade Name: | TERUMO® SurGuard®3 Safety Needle | |----------------|----------------------------------| | 510(K) Number: | K113422 | | Trade Name: | U&U Hypodermic Needle | | 510(K) Number: | K132552 | #### 4. Devices Description: #### TM Safety Needle The TM Safety Needle consists of a hypodermic needle with a hinged safety sheath attached to the needle hub. The safety sheath is simultaneously activated when manually pressed over the needle after use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with one-hand operation by pressing the sheath either with the finger or thumb, or by surface activation. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "ThinkMed" in a blue, sans-serif font. The letters are bold and have a slight 3D effect, with a darker blue outline and a lighter blue fill. The word is centered and appears to be on a white background. 510(k) Submission [TM Safety Needle] The locking mechanism is positioned within the center and proximal end of the sheath. The hinge feature allows the medical practitioner the flexibility to adjust the sheath to its desired position for use. | Ref<br>Number | Model<br>Number | Description | Length | Gauge | |---------------|-----------------|--------------------------|-------------|-------| | TMSN001 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 30G | | TMSN002 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 29G | | TMSN003 | TMSN | Safety Hypodermic Needle | 1/2 to 1" | 28G | | TMSN004 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 27G | | TMSN005 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 26G | | TMSN006 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 25G | | TMSN007 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 24G | | TMSN008 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 23G | | TMSN009 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 22G | | TMSN010 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 21G | | TMSN011 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 20G | | TMSN012 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 19G | | TMSN013 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 18G | | TMSN014 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 17G | | TMSN015 | TMSN | Safety Hypodermic Needle | 1 to 1 1/2" | 16G | #### NOTE: The hypodermic needle used is the U&U Hypodermic Needle, the K number is K132552. # 5. Intended Use: The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM 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 needle-stick. # 6. Technological Characteristics: The following table illustrates the similarities between the TM safety needle (subject device) and the two predicate devices. | Element of<br>Comparison | Submission Device | Predicate Device<br>K113422 | Predicate Device<br>K132552 | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The TM Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TM Safety Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after | The TERUMOO SurGuard®3 Safety Needle device is intended for use in the aspiration and injection of fluids for medical purposes. The TERUMO SurGuard®3 Safety Needle is compatible | U&U Sterile Hypodermic Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "ThinkMed" in a blue font. The letters are bold and have a slight shadow effect, giving them a three-dimensional appearance. The word is centered and takes up most of the frame, with a white background. 510(k) Submission | [TM Safety Needle] | | | Rev 1.01<br>10/08/15 | |----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------| | | withdrawal of the<br>needle from the body,<br>the attached needle<br>safety shield can be<br>manually activated to<br>cover the needle<br>immediately after use<br>to minimize risk of<br>accidental needle-<br>stick. | for use with standard<br>luer slip and luer lock<br>syringes.<br>Additionally, after<br>withdrawal of the<br>needle from the body,<br>the attached needle<br>safety shield can be<br>manually activated to<br>cover the needle<br>immediately after use<br>to minimize risk of<br>accidental<br>needlestick. | | | Principle of Operation | Normal | Normal | Normal | | Needle Gauge and<br>Length | Various Sizes | Various Sizes | Various Sizes | | Lubricant for Needle | Silicone Oil | Silicone Oil | Silicone Oil | | Materials<br>Needle Hub<br>Needle<br>Needle Sheath | PP<br>Stainless Steel<br>PP | PP<br>Stainless Steel<br>PP | PP<br>Stainless Steel<br>N.A. | | Sharps Injury<br>Prevention Features | Needle safety shield | Needle safety shield | N.A. | | Performances | Conforms to ISO7864 | Conforms to ISO7864 | Conforms to ISO7864 | | Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 | Conforms to ISO10993 | | Labeling | Meet the requirements<br>of 21 CFR Part 801 | Meet the requirements<br>of 21 CFR Part 801 | Meet the requirements<br>of 21 CFR Part 801 | # 7. Non-Clinical Test Conclusion: Non clinical tests were conducted to verify that the subject device met all design specifications and was substantially equivalent to the predicate devices. The non-clinical test results demonstrated that the subject device complies with the following standards: ISO 7864 Sterile hypodermic needles for single use. ISO 9626 Stainless steel needle tubing for the manufacture of medical devices ISO 23908 Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. #### 8. Conclusion: The intended use, materials, performance, and operational features of the TM safety needle are substantially equivalent to the predicate devices. END