(71 days)
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.
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.
The provided document describes a 510(k) premarket notification for a Disposable Insulin Syringe (K110421). This is a medical device and not an AI/ML software device, therefore, many of the requested criteria (like ground truth, expert adjudication, MRMC studies, standalone performance, training sets, etc.) are not applicable.
The acceptance criteria and the study that proves the device meets them are based on bench tests against established international standards for such devices.
Here's a breakdown of the requested information, adapted for a medical device rather than an AI/ML product:
Acceptance Criteria and Device Performance for Disposable Insulin Syringe (K110421)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reference Standard | Reported Device Performance |
|---|---|---|
| Syringe for Insulin | ISO 8537:2007 (Sterile single-use syringes, with or without needle, for insulin) | "The test results demonstrated that the proposed device complies with... ISO 8537:2007" |
| Needle Tubing Material | ISO 9626:1991/Amendment 1:2001 (Stainless steel needle tubing for the manufacture of medical devices) | "The test results demonstrated that the proposed device complies with... ISO 9626:1991/Amendment 1:2001" |
| Sterile Hypodermic Needles | ISO 7864:1993 (Sterile hypodermic needles for single use) | "The test results demonstrated that the proposed device complies with... ISO 7864:1993" |
| Overall Design Specifications | N/A (Internal Design Specifications) | "Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the bench tests. It refers generally to "Bench tests." As this is a physical medical device, not an AI model, "data provenance" in the typical AI sense (country of origin, retrospective/prospective) is not directly applicable. The "tests" are likely physical tests conducted on a sufficient number of manufactured units to ensure compliance with the specified ISO standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This is Not Applicable (N/A). For medical devices like insulin syringes, "ground truth" is established through adherence to internationally recognized performance and safety standards (e.g., ISO standards) and regulatory requirements, not through expert consensus on medical images or patient outcomes. The "experts" involved are typically engineers, quality assurance personnel, and regulatory specialists who interpret and apply these standards.
4. Adjudication Method for the Test Set:
This is Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation or subjective assessments, typically for AI/ML performance evaluation. For bench testing of a physical medical device, the results are objective measurements against defined criteria in the standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was Not Applicable (N/A). This type of study is relevant for evaluating the impact of an AI diagnostic aid on human reader performance, which is not the nature of this physical medical device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone study was Not Applicable (N/A). This concept applies to AI algorithms. The "standalone performance" of this device is its ability to meet the physical and functional requirements of the ISO standards when tested in a laboratory setting.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is defined by the specifications within the cited ISO international standards (ISO 8537:2007, ISO 9626:1991/Amendment 1:2001, ISO 7864:1993). These standards define physical properties, dimensional tolerances, material requirements, sterility, and functional performance (e.g., fluid delivery accuracy, needle sharpness, leak-proof integrity). Compliance with these standards serves as the "ground truth" for device safety and effectiveness.
8. The Sample Size for the Training Set:
This is Not Applicable (N/A). This device is a physical product, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
This is Not Applicable (N/A). As there is no training set for a physical medical device like this, no ground truth needed to be established for it.
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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
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- Date of Submission: February 9, 2011
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- 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
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- 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
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- 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
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- 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.
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- 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:
- Non-Clinical Test Conclusion
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.
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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.
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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
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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
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(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110421
§ 880.5860 Piston syringe.
(a)
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.(b)
Classification. Class II (performance standards).