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510(k) Data Aggregation
(246 days)
Nipro SafeTouch Needle; Nipro Syringe with SafeTouch Needle
The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.
The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.
The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.
The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.
The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.
The provided text describes specific acceptance criteria and study details for the Nipro SafeTouch Needle and Nipro Syringe with SafeTouch Needle, but it does not describe a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it outlines a 510(k) premarket notification for a traditional medical device, comparing it to a predicate device.
The document discusses non-clinical tests and a simulated clinical study, but these are for a physical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, I cannot provide information on items such as multi-reader multi-case studies, standalone algorithm performance, ground truth establishment for AI training sets, or sample sizes for AI training sets, as these concepts are not relevant to the provided text.
However, I can extract the acceptance criteria and performance related to the physical medical device and the simulated clinical study.
Here's the information based on the provided text, focusing on the device's physical and functional properties:
Table of Acceptance Criteria and Reported Device Performance
| Item for Comparison | Acceptance Criteria (Predicate Device K162081 BD Luer-Lok™ Hypodermic Syringe with BD Eclipse™ Hypodermic Needle performance or recognized standards) | Reported Device Performance (Subject device: K222852 SafeTouch Needle / Syringe with SafeTouch Needle) | Conclusion |
|---|---|---|---|
| 1. Device Description | |||
| 1.1. Indications for Use | General purpose injection and aspiration of fluid; mechanism to cover needlepoint after use to prevent accidental needle sticks. | General purpose injection and aspiration of fluid; needle shield to prevent accidental needlestick injuries. | Similar - no new issues of safety and effectiveness |
| 1.2. Mechanism of Action | Mechanical/Manual | Mechanical/Manual | Same |
| 1.3. Technology Overview | Graduated disposable piston syringe with safety hypodermic needle (Stainless-Steel cannula, plastic hub, needle shield). | Graduated disposable piston syringe with safety hypodermic needle (Stainless-Steel cannula, plastic hub, needle shield). | Same |
| 1.4. Anatomical Location | Intramuscular, intravascular, or subcutaneous injection | Intramuscular, intravascular, or subcutaneous injection | Same |
| 2. Material Components | |||
| 2.1. Syringe barrel | Styrene acrylic copolymer | Polypropylene | Similar - no new issues of safety and effectiveness |
| 2.2. Lubricant | Silicone | Silicone | Same |
| 2.3. Plunger | Polypropylene | Polypropylene | Same |
| 2.4. Stopper | Polyisoprene Rubber | Polyisoprene Rubber | Same |
| 2.5. Needle Cannula | Stainless Steel | Stainless Steel | Same |
| 2.6. Needle Hub with integrated safety mechanism (needle shield) | Polypropylene | Polypropylene | Same |
| 3. Physical Characteristics | |||
| 3.1. Needle Gauge | 20 - 30 | 18 - 30 | Nipro provides a larger gauge needle. Testing results demonstrate no new issues of safety and effectiveness |
| 3.2. Needle hub Color | Color-coded to the appropriate gauge needle per ISO 6009 | Color-coded to the appropriate gauge needle per ISO 6009 | Same |
| 3.3. Needle Length | 1/2" - 1" | 1/2" - 1 1/2" | Nipro provides a longer length needle. Testing results demonstrate no new issues of safety and effectiveness |
| 3.4. Syringe Volume | 1 - 10 mL | 1 - 10 mL | Same |
| 4. Sterility | |||
| 4.1. Method | Gamma | EO (Ethylene Oxide) | Both methods are recognized as Category A. |
| 4.2. Single-Use | Yes | Yes | Same |
| 4.3. SAL (Sterility Assurance Level) | 10^-6 | 10^-6 | Same |
| 4.4. Shelf Life | 5 years | 5 years | Same |
| 5. Biological Specifications | |||
| 5.1. Systemic Injection | No abnormalities or mice death | No abnormalities or mice death | Within Criteria; Same |
| 5.2. Intracutaneous reaction test | No erythema, edema, or necrosis | No erythema, edema, or necrosis | Within Criteria; Same |
| 5.3. Hemolysis test | Hemolytic index shall not exceed 2% | Hemolytic index shall not exceed 2% | Within Criteria; Same |
| 5.4. Bacterial Endotoxin |
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