MYSAFETY SYRINGE

{0}------------------------------------------------ K113673 # Section 5. 510(k) Summary 3 2012 AUG This 510(k) Summary has been submitted in accordance with the requirements of SMDA and 21 CFR §807.92 ( c ). - 5.1. Submitter's Name : Address : Tel : Fax : Contact Person : 510 (k) Owner : Date Prepared : - Device Name : 5.2. Trade Name : (Proprietary Name) Common Name : Classification Name : Classification : Regulatory Number : Product Code : No. 413, Ming-Hsouie Rd., Taipei, Taiwan 886-2-25322825 886-2-25636489 Ms. Lin Lee, Lee / President MedicalChain International Corp. Oct. 25, 2011 MedicalChain International Corp. MySafety® Syringe for Insulin MySafety® Syringe Insulin Syringe (with attached needle ) Piston Syringe / Anti-Stick Syringe Class II 21 CFR 880.5860 FMF / MEG - Predicate Device : 5.3. MySafety Syringe K111734 Disposable Insulin Syringe K110421 Product information of the predicate devices are provided in Appendix B1~B2. ## 5.4. Device Description : The MySafety Syringe for Insulin is a sterile, single-use, disposable, non-reusable, needle-retractable, piston syringe, provided with attached needle, which is intended for the injection of U-100 insulin into a diabetic patient, while minimizing the potential for accidental injury and preventing syringe reuse. {1}------------------------------------------------ The MySafety Syringes for Insulin will be available in different combinations of syringe capacities, needle gauges, and needle lengths. # 5.5. Intended Use : The MySafety Syringe for Insulin is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of insulin into the body. ### 5.6. Technological Characteristics The MySafety Syringe for Insulin has the same technological characteristics as the predicate devices. ## 5.7. Substantial Equivalence : MedicalChain International Corp. makes a Substantial Equivalence claim of the MySafety Syringe for insulin to the predicate device # K110421, based on the similar needle / volume, specifications and same intended use. MedicalChain International Corp. also makes a Substantial Equivalence claim of the MySafety Syringe for Insulin to the predicate device K111734 based on the same design, technological characteristics, operational principles, materials and intended use as K111734. The only difference is the medication which the proposed device is intended to inject is insulin specifically, instead of the non-specified medical fluids of the predicate device K111734 . ## 5.8. Performance Summary : The MuSafety Syringe for Insulin have been designed and successfully tested to meet the applicable requirements outlined in the FDA Recognized Consensus Standards, including ISO 6009, ISO 7864, ISO 7886-1, ISO 8537, ISO 9626, ISO 10993 series, ISO 11135-1, ISO 11607-1 and USP 33 : 2010 <151 > Pyrogen Test as listed in FORM FDA 3514 SECTION I - UTILIZATION OF STANDARDS on pages 2-5 ~ 2-6 of this submission. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity and support. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 > 3 2012 AUG MedicalChain International Corporation C/O Ms. Robin Hwang Consultant ICP Consulting Corporation 1808 Seabreeze Court Thousand Oaks, California 91320 Re: K113673 Trade/Device Name: MySafety® Syringe for Insulin Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF,MEG Dated: July 26, 2012 Received: July 31, 2012 #### Dear Ms. Hwang: 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. {3}------------------------------------------------ #### Page 2- Ms. Hwang 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucmi115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm. Sincerely yours, F. Sester Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Statement of Indications for Use Section 4. 510(K) Number ( if known ): Device Name : MySafety Syringe for Insulin Indications For Use: The MySafety Syringe for Insulin is designed as an anti-stick syringe to reduce the risk of sharps injuries and the potential for syringe re-use and is a single use, disposable and retractable safety syringe which is intended for injection of insulin into the body. Prescription Use (Per 21 CFR 801 Subpart D) AND / OR Over-The-Counter Use _ × (Per 21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE) Sijd H. for RZC Aug 2, 2012 on Sian-O Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K113673 MedicalChain International Corp. Traditional 510(k) Syringe for Insulin CONFIDENTIAL 4-1 .Hy Sufety