(200 days)
The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.
The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864. Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use. The sterile disposable syringes are made with prolypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.
This 510(k) summary describes a submission for Clinicare Sterile Disposable Syringes, Sterile Disposable Syringes With Needles, and Sterile Disposable Needles. It does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.
The document is a regulatory submission intended to demonstrate substantial equivalence to predicate devices, not a study report detailing performance against specific acceptance criteria. It focuses on:
- General Information: Submitter and device names, classification.
- Predicate Devices: Lists Becton, Dickinson & Company products.
- Description of Device: States compliance with relevant ISO standards (ISO 7886, ISO 7864, ISO 594, ISO 9626, ISO 6009) and material composition (polypropylene, SS304 capillary tubes, natural rubber, polydimethyl silicone lubricant).
- Intended Use: General purpose injections.
- Technological Characteristics & Tests for Substantial Equivalence: States "None," implying the device is substantially equivalent to predicates without requiring new technological characteristics or specific performance tests for this particular submission type.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study design, sample sizes, expert involvement, or ground truth, as this information is not present in the provided text.
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11 - 8 1996
H. 12. 13. MIDC Industrial Area Walut Auranganas 43. 13 Telephone 5413 Fax 5518
510(k) Summary Clinicare Sterile Disposable Syringes Sterile Disposable Syringes With Needles Sterile Disposable Needles
- I. General Information on Submitter:
Name: TTK Biomed Limited H-12-13, M1DC, Industrial Area, Waluj, India 431 136 Address: Telephone: 54037 Fax: 22189 Name of Contact Person: Date Summary Prepared:
II. General Information on Device
Name: Clinicare Sterile Disposable Syringe Clinicare Sterile Disposable Syringes and Needles Clinicare Sterile Disposable Hypodermic Needles
Common Name: Sterile Disposable Syringe Sterile Disposable Syringes and Needles Sterile Disposable Hypodermic Needle
Classification Name: Piston Syringes Hypodermic Single Lumen Needle
- III. Predicate Devices: Sterile Disposable Syringe Sterile Disposable Syringes and Needles Sterile Disposable Hypodermic Needle Becton, Dickinson & Company
- IV. Description of Device: The Clinicare Needles and Syringes comply with: ISO 7886, Sterile Hypodermic Syringes for Single Use; ISO 7864. Sterile Hypodermic Needles for Single Use; ISO 594, Conical Fitting with a 6% (Luer) Paper for Syringes, Needles and Certain Other Equipment; ISO 9626 Stainless Steel Needle Tubing for Manufacture of Medical Devices; and, ISO 6009, Hypodermic Needles for Single Use.
Image /page/0/Picture/12 description: The image shows the text "A Group Company" in a bold, sans-serif font. The word "Group" is slightly larger than the other words. There is a logo above the word "Group", but it is difficult to make out the details.
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The sterile disposable syringes are made with prolypropylene. The needles are made from thin walled SS304 capillary tubes. The rubber gaskets are made from natural rubber. The barrels are lubricated with Polydimethyl Silicone.
- V. Intended Use: The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.
- VI. Technological Characteristics of Device Compared to Predicate Device: None.
- VII. Tests for Substantial Equivalence: None.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).