3S Safety Insulin 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 circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other, creating a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 19, 2015 Sincere Medical Device Co., Ltd. Mr. Garfield Wang RA Manager Rm. 218, 2F., No. 183, Zhouzi St. Taipei City, Taipei City 114 TAIWAN (R.O.C.) Re: K142436 Trade/Device Name: 3S Safety Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: MEG Dated: August 15, 2014 Received: January 23, 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}------------------------------------------------ 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/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 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. Sincerely yours, Tina Kiang -S for 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}------------------------------------------------ [3S Safety Insulin Syringe] Rev 0.00 15/08/14 # Section 004 Indications for Use K142436 510(k) Number (if known): Device Name: 3S SAFETY INSULIN SYRINGE Indications for Use The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. Prescription Use V 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 logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular design with the letter 'S' in the center. The company name, 'Sincere Medical Device Co., Ltd.,' is written in gray text to the right of the logo. Rev 0.02 05/02/15 [3S Safety Insulin Syringe] # Section_005 510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 Date Prepared: 15. 01.2015 ## 1. Submitter Name and Address: | Owner Name: | Sincere Medical Device Co., Ltd. | |-----------------|-----------------------------------------------------------------------------------| | Address: | Rm. 218, 2F., No. 183, Zhouzi St., Neihu Dist., Taipei City 114.<br>Taiwan(R.O.C) | | Contactor Name: | Garfield Wang, Vivian Lu | | TEL: | +86-13564751751 | | E-mail: | Wangxuebo_11@hotmail.com | | Web: | http://sincere-med.com | | Fax: | +886-2-2659-8698 | #### US Agent: | US Agent: | Benjamin Lee. | |-----------|------------------------------------------------------| | Address: | 8692 9th Street, unit 42, Rancho Cucamonga, ca 91730 | | TEL: | 1909-985-0648 | # 2. Submission Devices Information: Trade/Proprietary Name: 3S Safety Insulin Syringe Common Name: Syringe, Antistick Piston Syringe Classification name: Piston Syringe.. Class: 2. Panel: 80. Product codes: MEG Submission Type: 510(k) Requlation Number: 880.5860 #### 3. Predicate Devices Information: | Trade Name: | InsoSAFE BakSNAP Retractable Insulin Safety Syringe | |----------------|-----------------------------------------------------| | 510(K) Number: | K050131 | | Company: | M.K. Meditech Co., Ltd | #### 4. Devices Description: The 3S Safety Insulin Syringe is an integrated needle and piston syringe with an innovative antineedle-stick mechanism. The design incorporates the ideal features desired in a safety syringe. No special techniques are required to use the safety mechanism. The mechanism allows clear visualization of the injection site at all times. The mechanism clearly shows the needle is contained within the syringe barrel. After standard techniques for injection, the plunger is withdrawn, snapped off and used syringe is discarded into a sharps container per regulatory provision. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular graphic on the left, with the company name written in gray text to the right of the graphic. The graphic appears to be a stylized representation of a medical symbol, possibly incorporating the letter 'S'. [3S Safety Insulin Syringe] Rev 0.02 05/02/15 The 3S safety syringe with/without Needle will be available in numerous sizes and combinations between the smallest (0.3cc/ml + 31G) and the largest (1cc/ml + 27G ) # 5. Intended Use: The 3S Safety Insulin Syringe a sterile, single-use, disposable and non-reusable, manual retractable safety insulin syringe intended for injection of insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. 1 ## 6. Technological Characteristics: Through comparisons between the submitted devices with the predicate devices as follows tables. We believe the applicant devices are substantially equivalent with the predicate devices. # Safety Syringe Comparison Table | Element of Comparison | Submission Device | Predicate Device<br>K040545 | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The 3S Safety Insulin Syringe<br>a sterile, single-use,<br>disposable and non-reusable,<br>manual retractable safety<br>insulin syringe intended for<br>injection of insulin into the<br>body, while reducing the risk of<br>sharps injuries and the potential<br>for insulin syringe reuse. | The InsoSAFE BakSNAP<br>Retractable Insulin Safety<br>Syringe a sterile, single-use,<br>disposable and non-reusable,<br>manual retractable safety<br>insulin syringe intended for<br>injection of insulin into the<br>body, while reducing the risk<br>of sharps injuries and the<br>potential for insulin syringe<br>reuse. | | Principle of Operation | Normal | Normal | | Syringe Capacity | Various Sizes | Various Sizes | | Nozzle Type | N.A | N.A | | Lubricant for Barrel | Silicone Oil | Silicone Oil | | Barrel Transparency | Transparent and Clear | Transparent and Clear | | Gradations Legibility | Legible | Legible | | Materials | | | | Barrel | PP | PP | | Plunger | PP | PP | | Piston | TPE | TPE | | Needle Hub | PP | PP | | Needle | Stainless Steel | Stainless Steel | | Needle Sheath | PP | PP | | Needle Gauge and Length | Various Sizes | Various Sizes | | Lubricant for Needle | Silicone Oil | Silicone Oil | | Sharps Injury Prevention | Manual Retractable | Manual Retractable | | Features | | | | Performances | Conforms to ISO7864 ISO8537 | Conforms to ISO7864 ISO8537 | | Biocompatibility | Conforms to ISO10993 | Conforms to ISO10993 | | Labeling | Meet the requirements of 21 CFR | Meet the requirements of 21 | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Sincere Medical Device Co., Ltd. The logo consists of a green circular emblem with the letter 'S' inside, along with the words 'SINCERE MEDICAL' arranged around the circle. To the right of the emblem, the company name 'Sincere Medical Device Co., Ltd.' is written in a clear, sans-serif font. | [3S Safety Insulin Syringe] | | | Rev 0.02 | 05/02/15 | |-----------------------------|----------|--------------|----------|----------| | | Part 801 | CFR Part 801 | | | # 7. Conclusion: The materials, performance, and operational features of both the submitted device and the predicate device are substantially equivalent. END