Sunmed Control Syringes

{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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 10, 2016 Sunny Medical Device (Shenzhen) Co., Ltd. James Qi Zhang General Manager 56 Lehigh Aisle Irvine, California 92612 Re: K160190 Trade/Device Name: Sunmed Control Syringes Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector and Syringe Regulatory Class: Class II Product Code: DXT Dated: September 28, 2016 Received: October 3, 2016 Dear James Qi Zhang: 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 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. {1}------------------------------------------------ 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) K160190 Device Name Sunmed Control Syringes Indications for Use (Describe) The Sunmed Control Syringes is intended to inject contrast media or saline for angiographic procedures. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Submitted by: Sunny Medical Device (Shenzhen) Co., Ltd. Registered Address: 4/F and 5/F, Dongpingxing Creative Science Park, Longgang District, Shenzhen, Guangdong, P.R. China 518172 56 Lehigh Aisle, Irvine, CA 92612 Contact Address: | Telephone: | (949)216-8838 | |------------|--------------------------------| | Fax: | (949)423-0168 | | Contact: | JamesQi Zhang, General Manager | | E-mail: | jamesqizhang@gmail.com | | Date: | November 9, 2016 | ### 2. Proposed Device: | Trade/Proprietary Name: | Sunmed™ Control Syringes | |-------------------------|-----------------------------------| | Common/Usual Name: | Control Syringes | | Classification: | II | | Classification Name: | Angiographic injector and syringe | | Regulation Number: | 870.1650 | | Product Code: | DXT | - 3. Predicate Device: | 510(k)<br>Number | Trade Name | Manufacture | |------------------|------------------------------------------|----------------------------------------------| | K093830 | Medline Angiographic Control<br>Syringes | Medline Industries Inc. | | K072696 | ANT Angiographic Syringes | Shenzhen Ant Hi-Tech<br>Industrial Co., Ltd. | Note: In the case of other characteristics substantially the same, Mediline Angiographic Control Syringes and our company's product are more similar in the specification model and materials. Medline Angiographic Control Syringes is identified as the primary predicate, which manufactured by Medline Industries Inc. {4}------------------------------------------------ ## 4. Device description The Sunmed™ Control Syringes using dynamics principle, by means of the interference fit between the plunger with piston and the barrel, using the aspirating or driving force generated by manual function to draw or inject angiography medicament or saline for clinical disposable use. The Sunmed™ Control Syringes is a single-use device that consists of two different structures: one is the standard type; the other is locking plunger type. The properties of the standard plunger type and locking plunger type are in table below: | Standard plunger Type | Locking Plunger Type | |-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------| | Humanized design, easy and simple operation, can be single hand operation | Humanized design, easy and simple operation, can be single hand operation | | The wall of the tube is clear and transparent, the inner surface is smooth, and the promotion is convenient | The wall of the tube is clear and transparent, the inner surface is smooth, and the promotion is convenient | | Printing scale is clear and accurate | Printing scale is clear and accurate | | Pressure rating: 300 kPa | Locking design improve the security and stability.<br>Pressure rating: 300 kPa | The volume of two type control syringes that to be offered in 10ml, 12ml. The sunmed™ Control Syringes are available with rotating male luer and fixed male luer. The rotating male luer can be rotated. When connected with the other device, they can rotate freely. While the fixed male luer cannot be rotated. The rotating male luer and fixed male luer both are in line with ISO 594-2:1998. The sterilization method of the Sunmed™ Control Syringes is Ethylene Oxide sterilization. - 5. Intended Use The Sunmed™ Control Syringes is intended to inject contrast media or saline for angiographic procedures. {5}------------------------------------------------ - 6. Technological Comparison to Predicate Device The technological characteristics of the subject device, the Sunmed™ Control Syringes, are equivalent in intended use, materials, operating principle, sterility assurance level, and method of sterilization to the Medline Angiographic Control Syringes; and the Sunmed™ Control Syringes is also similar to the ANT Angiographic Syringes in that it consists of the intended use, operating principle, sterility assurance level, and method of sterilization. - Summary of Non-Clinical Testing 7. The following tests were performed; the results of the performance testing demonstrated the substantial equivalence of the Sunmed™ Control Syringes. Biocompatibility Testing: Acute Systemic Toxicity Test (two kinds of solvent) Skin sensitization Test (two kinds of solvent) In Vitro Hemolysis Study Intracutaneous Reactivity Test (two kinds of solvent) In Vitro Cytotoxicity Test Package Penetrate Testing Asepsis Testing Aging Testing EtO and ECH Residue Testing Bench Testing - 8. Clinical Evaluation was not applicable. - 9. Conclusions Based on the information presented in this 510(k) premarket notification, the Sunmed™ Control Syringes is considered substantially equivalent to the Medline Angiographic Control Syringes and ANT Angiographic Syringes.