(251 days)
Sterile Blunt for Single Use includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle is used in conjunction with a syringe to penetrate the vial/ampoules stopper intended for injection or aspiration of fluid.
The blunt plastic cannula is used in conjunction with a syringe to access the pre-slit septum covering injection sites on I.V. System intended for injection or aspiration of fluid.
The proposed device, Sterile Blunt for Single Use, includes two models, which are blunt fill needle and blunt plastic cannula.
The blunt fill needle consists of a stainless steel needle tube, a hub and a sheath. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. It is not intended to access the injection site on I.V. System.
The blunt plastic cannula consists of molded plastic blunt tipped cannula, a hub and a sheath. It is used to replace hypodermic needles to prevent from the unintended injury by metal needle.
Both two models are available in either EO sterilized to achieve a Sterilized to achieve a Sterility Assurance Level (SAL) of 106. The proposed device is sealed in a sterility maintenance package to maintain its sterility during its shelf life of three (3) years.
This is a 510(k) premarket notification for a medical device, not a study evaluating a device's performance against specific acceptance criteria in a clinical setting. Therefore, many of the requested categories (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific effect sizes for human readers with and without AI) are not applicable to this type of document.
The document focuses on demonstrating Substantial Equivalence (SE) to a legally marketed predicate device, rather than proving performance against predefined acceptance criteria from a clinical study. The "acceptance criteria" here refer to compliance with recognized consensus standards and general safety/performance attributes.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k), the "acceptance criteria" are compliance with various ISO and ASTM standards, as well as general performance attributes related to safety and effectiveness compared to the predicate device. The device "performance" is reported as meeting these standards and being substantially equivalent.
| Acceptance Criteria (Standards and Attributes) | Reported Device Performance (Compliance/Demonstration) |
|---|---|
| Mechanical/Physical Performance: | |
| ISO 9626:1991/Amendment 1:2001 (Stainless steel needle tubing) | Complies (mentioned under "Bench tests... met all design specifications" and "complied with the referenced standards") |
| ISO 7864:1993 (Sterile hypodermic needles for single use) | Complies |
| ISO 594-1:1986 (Conical Luer fittings) | Complies |
| ASTM F1140-07 (Internal Pressurization Failure Resistance of Unrestrained Packages) | Complies |
| ASTM F88-09 (Seal Strength of Flexible Barrier Materials) | Complies |
| Bevel of the device | Identical to the predicate device |
| Gauge of the device | Different from the predicate device, but physical performance tests demonstrated compliance with referenced standards. |
| Biocompatibility: | |
| ISO 10993-1: 2009 (Biological evaluation - Part 1) | Complies (biocompatibility test demonstrated materials are safe and acceptable) |
| ISO 10993-4:2002/Amd 1:2006 (Biological Evaluation - Part 4: Interactions with Blood) | Complies |
| ISO 10993-5: 2009 (Biological evaluation - Part 5: Cytotoxicity) | Complies |
| ISO 10993-10: 2002/Amd. 1:2006(E) (Biological evaluation - Part 10: Irritation and Hypersensitivity) | Complies |
| ISO 10993-11: 2006 (Biological evaluation - Part 11: Systemic toxicity) | Complies |
| Sterilization: | |
| ISO 11135-1: 2007 (Ethylene oxide sterilization) | Complies (for EO sterilized models); Achieves SAL of 10-6 |
| ISO 10993-7:2008 (Ethylene oxide sterilization residuals) | Complies |
| ISO 11137-2: 2006 (Radiation sterilization) | Complies (for Radiation sterilized models); Achieves SAL of 10-6 |
| USP 34:2011, (Bacterial Endotoxins Test) | Complies |
| Shelf life | Maintains sterility for three (3) years. |
| Leachable substance analysis | Demonstrated materials are safe and acceptable |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. The text refers to "bench tests" and "test results" but does not provide specific sample quantities for these tests.
- Data Provenance: The tests were conducted by the manufacturer, Shanghai Double-Dove Industry Co, Ltd., in China. The data would be considered prospective for the purpose of this 510(k) submission, as it was generated to support the review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For a medical device 510(k) submission focused on mechanical, physical, and biological bench testing, there isn't a "ground truth" derived from expert consensus in the way it's used for diagnostic algorithms. Ground truth here refers to the validated methods and results of the specified international standards.
4. Adjudication method for the test set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers. This submission relies on standardized test methods where the outcome (pass/fail against a standard's criteria) is objectively measured.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This device is a sterile blunt needle/cannula, a physical medical device, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device, not an algorithm, so "standalone performance" in that context is not relevant. The performance evaluated here is the device's compliance with established safety and performance standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical and biological tests: The "ground truth" is defined by the acceptance criteria specified within the referenced ISO and ASTM standards (e.g., specific force limits, chemical concentrations, sterility levels, etc.). Compliance with these standards indicates the device meets established safety and performance benchmarks.
8. The sample size for the training set:
- Not Applicable. This is a physical medical device, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. (See point 8).
§ 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).