(200 days)
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No
The device description and intended use are for standard, non-electronic, disposable syringes and needles. There is no mention of any software, data processing, or AI/ML related terms.
No
The device is described as syringes and needles for general purpose injections and does not provide therapy itself.
No
Explanation: The device is described as "general-purpose injections" and consists of syringes and needles. There is no mention of it being used to identify or analyze a condition, disease, or its predisposition.
No
The device description clearly states it is comprised of physical components like syringes, needles, and rubber gaskets, which are hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose injections." This describes a device used to administer substances into the body or withdraw substances from the body, which is a direct interaction with the patient's body.
- IVD Definition: In vitro diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details the materials and standards for syringes and needles, which are tools for injection, not for analyzing samples in a lab setting.
The information provided clearly indicates a device for direct patient use (injection), not for laboratory testing of patient samples.
N/A
Intended Use / Indications for Use
The Clinicare Sterile Disposable Syringes and Needles are intended to be used for general purpose injections.
Product codes
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Becton, Dickinson & Company
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
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.
1
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.