← Product Code [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF) · K110421 # DISPOSABLE INSULIN SYRINGE (K110421) _Wenzhou Wuzhou Import & Export Co., Ltd. · FMF · Apr 26, 2011 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K110421 ## Device Facts - **Applicant:** Wenzhou Wuzhou Import & Export Co., Ltd. - **Product Code:** [FMF](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF.md) - **Decision Date:** Apr 26, 2011 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5860 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. ## Device Story Disposable insulin syringe consists of a calibrated hollow barrel, movable plunger, fixed needle, needle cover, and end cap. Designed for manual operation by clinicians or patients to aspirate and inject insulin subcutaneously. Available in 0.3ml, 0.5ml, and 1ml volumes. Provided sterile for single use. Device functions as a standard manual piston syringe; no electronic or automated components. ## Clinical Evidence Bench testing only. No clinical data provided. Testing verified compliance with ISO 8537:2007, ISO 9626:1991/Amendment 1:2001, and ISO 7864:1993. ## Technological Characteristics Manual piston syringe; calibrated hollow barrel; fixed needle. Materials comply with ISO 8537 (syringes), ISO 9626 (stainless steel needle tubing), and ISO 7864 (hypodermic needles). Sterilized for single use. No software or electronic components. ## Regulatory Identification A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body. ## Predicate Devices - Sterile Insulin Syringe for single use, with fixed needle ([K072739](/device/K072739.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K110421 page 10 ## Section III 510(k) Summary • Project #:MIDLINK0312010Ab 26 2011 APR ## Section III 510(k) Summary This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number: J - 1. Date of Submission: February 9, 2011 - 2. Sponsor Wenzhou Wuzhou Import & Export Co., Ltd. Room 1703 Fortune Center Chezhan Avenue Wenzhou. Zhejiang Province, 325000. China Establishment Registration Number: 9681901 Contact Person: Bingyi Xiang Position: General Manager Tel: +86-577-88868068 Fax: +86-577-88868065 Email: birrell wetd@yahoo.com - 3. Submission Correspondent Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023, Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net - 4. Proposed Device Identification Proposed Device Name: Disposable Insulin Syringe Proposed Device Model: 0.3ml, 0.5ml, 1ml Classification: II Product Code: FMF Regulation Number: 21 CFR 880.5860 Review Panel: General Hospital Intended Use Statement: Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. III-I {1}------------------------------------------------ - Predicate Device Identification 5. 510(k) Number: K072739 Product Name: Sterile Insulin Syringe for single use, with fixed needle Manufacturer: ShanDong WeiGao Group Medical Polymer Products Co .. LTD - Device Description 6. Disposable insulin syringe is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. The proposed device of Disposable Insulin Syringe is a syringe with needle, consisting of a calibrated hollow barrel, a movable plunger, the needle cover and end cap. The needle is fixed on the syringe. The syringe is designed for manual use. The proposed device of Disposable Insulin Syringe is available in 0.3ml (U-100), 0.5ml (U-40, U-100), 1ml (U-40, U-100) volumes. The proposed device is provided sterilized. - 7. Non-Clinical Test Conclusion Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: ISO 8537:2007, Sterile single-use syringes, with or without needle, for insulin. ISO 9626:1991/Amendment 1:2001, Stainless steel needle tubing for the manufacture of medical devices. ISO 7864:1993, Sterile hypodermic needles for single use. - Substantially Equivalent Conclusion 8. The proposed device. Disposable Insulin Syringe, is determined to be Substantially Equivalent (SE) to the predicate device, Sterile Insulin Syringe for single use, with fixed needle, in respect of safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Wenzhou Wuzhou Import & Export Company, Limited C/O Ms. Diana Hong General Manager Mid-Link Consulting Company, Limited P.O. Box 237-023 Shanghai, China 200237 APR 2 6 2011 Re: K110421 Trade/Device Name: Disposable Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: February 9, 2011 Received: February 14, 2011 Dear Ms. Hong: 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. Hong 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/ucm 115809.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/ResourcesforYou/Industry/default.htm. Sincerely yours, James I. Robertson for D 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}------------------------------------------------ ## Section II Indications for Use 510(k) Number: Device Name: Disposable Insulin Syringe Indications for Use: Disposable insulin syringe is a device intended for medical purpose for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin. 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 ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Rld C. Ch 4/26/4 Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K110421 --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K110421](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/FMF/K110421) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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