Search Results
Found 3 results
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 |
Ask a specific question about this device
(141 days)
Nipro Syringe
To inject fluids into or withdraw fluids from the body.
The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-27G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years.
The provided text is a 510(k) summary for a medical device, specifically a Nipro Syringe. It describes a conventional medical device, not an AI/ML-driven device. Therefore, the information requested in the prompt regarding acceptance criteria, study details, expert involvement, and ground truth for an AI/ML device is not present in the provided document.
The document discusses:
- Device Description: A piston syringe with varied sizes, gauges, and tips.
- Indications for Use: To inject or withdraw fluids from the body.
- Technological Characteristics: Materials, design, sterilization, expiry dating, and dimensions.
- Non-Clinical Performance Testing: A comprehensive list of biocompatibility, visual inspection, dimensional, mechanical, chemical, sterilization, transportation, pyrogen, and shelf-life tests performed to demonstrate substantial equivalence to a predicate device.
- Clinical Study Conclusion: Explicitly states "No clinical Study is included in this submission."
Since the prompt is specifically about the acceptance criteria and study that proves the device meets the acceptance criteria (implying an AI/ML device context), and the document describes a physical medical device (syringe), it does not contain the information necessary to answer the questions about AI/ML device performance, ground truth, expert consensus, or MRMC studies.
Ask a specific question about this device
(183 days)
Nipro Syringe
to inject fluids into or withdraw fluids from the body
The NIPRO Syringe is a piston syringe consisting of graduated barrel, plunger rod, and gasket. It is provided in luer slip, luer lock and eccentric luer slip tips, with and without attached hypodermic needles are available in ranges of 20-25G, and 3/8 to 1 ½" in length. Gauges are color coded for easy differentiation. Its function is mechanical. The syringe is sterile, single use only, non-toxic, non-pyrogenic and sterilized by Ebeam radiation. The shelf-life has been determined to be 5 years. This device is not intended for patients less than 2 years of age.
The Nipro Syringe is a medical device and thus the provided document is a 510(k) summary, which outlines its substantial equivalence to a predicate device rather than a study proving unmet acceptance criteria in the context of AI/ML performance. Therefore, most of the requested information regarding AI/ML clinical study specifics (such as expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for training and test sets) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria related to the device's physical and performance characteristics, and how the device's performance was evaluated against these criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical tests performed to ensure the Nipro Syringe meets established standards. The acceptance criteria are implicit in the "specifications of the standards listed," and the reported device performance is that these tests were "performed within the specifications" and that the device "performs equivalent to the predicate device."
Acceptance Criteria (Standards Met) | Reported Device Performance |
---|---|
Visual Inspection (ISO 7886-1, ISO 7864-1) | Performed within specifications of the standards; no significant differences. |
Dimensional Specifications (ISO 7886-1) | Performed within specifications of the standards; slight dimensional changes from predicate, but both devices remain in compliance with all aspects of ISO 7886-1. |
Gauging (ISO 594-1) | Performed within specifications of the standards. |
Mechanical and Performance Characteristic (ISO 7886-1, ISO 7864-1, ISO 594-1, ISO 594-2) | Performed within specifications of the standards; results demonstrate equivalent performance to the predicate device. |
Chemical and Biological Characteristic (ISO 7886-1, ISO 11137-1, and specific biological tests) | Performed within specifications of the standards. Includes: Cytotoxicity, Sensitization, Intracutaneous Irritation, Systemic Toxicity, Pyrogen testing (Material Mediated & LAL), Hemolysis, Particulate Analysis. |
Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO 11137-3) | Performed within specifications of the standards; Ebeam sterilization validated. |
Transportation Tests (ASTM-D4169-09) | Performed within specifications of the standards. |
Biocompatibility (ISO 10993) | Performed within specifications; tests conducted: MEM Elution (Cytotoxicity), Kligman Maximization (Sensitization), Intracutaneous Irritation, ISO Systemic Toxicity Study in Mice, USP Rabbit Pyrogen Study, ASTM Hemolysis Study, USP Limulus Amebocyte Lysate (LAL) testing, Particulate Analysis Device fluid pathway. |
Pyrogen Testing (ISO 10993-11, USP 39-NF34: 2016, ) | Performed within specifications of the standards. |
Shelf-life Testing (ASTM F1980-07) | Performed within specifications of the standards; 5-year shelf-life determined. |
2. Sample Size Used for the Test Set and Data Provenance:
This information is not explicitly provided in the document. The document refers to non-clinical tests performed to specific standards, but it doesn't detail the sample sizes used for each test or the provenance of any data (e.g., country of origin, retrospective/prospective). As this is a physical medical device, not an AI/ML system, "test set" in the context of data for model evaluation is not directly applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. This device is a physical syringe, not an AI/ML system requiring expert consensus for ground truth establishment. The "ground truth" for this device's performance is determined by meeting the specifications of established engineering and biological standards.
4. Adjudication Method for the Test Set:
Not applicable for a physical device. The compliance with standards and their specifications serves as the evaluation basis, not human adjudication of AI output.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic or treatment device, so there is no human-in-the-loop performance improvement with or without AI to measure.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
Not applicable. This is a physical medical device, not an algorithm. Its performance is inherent to its design and manufacturing, evaluated through non-clinical testing against established standards.
7. Type of Ground Truth Used:
The "ground truth" for the Nipro Syringe is compliance with internationally recognized and industry-accepted standards (ISO, ASTM, USP) for medical devices, specifically for piston syringes and needles. This includes performance benchmarks for:
- Physical dimensions and integrity
- Mechanical function
- Sterility
- Biocompatibility
- Chemical characteristics
- Shelf-life
8. Sample Size for the Training Set:
Not applicable. This is a physical device, not an AI/ML model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant in this context.
Ask a specific question about this device
Page 1 of 1