(269 days)
The blunts include 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 blunts include two models, which are blunt fill needle and blunt plastic cannula. The blunt fill needle is an 18G stainless needle tube with a luer slip hub. It is used to penetrate the vial and/or ampoules stopper intended for injection or drawl fluid. The hub is a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe. It is not intended to access the injection site on I.V. System. The blunt plastic cannula is a molded plastic blunt tipped cannula to penetrate pre-slit septum injection site on I.V. Safety Systems, which is designed for penetration with needleless I.V. access device, intended for injection and/or aspiration of fluid. It also has a luer slip female conical fitting, which can be connected to the luer slip male conical fitting on the syringe to be filled. The blunt plastic cannula is used to replace hypodermic needles to prevent from the unintended injury by metal needle. These two products can be sold together in one immediate package or respectively in separate immediate packages.
Here's an analysis of the provided 510(k) summary, aiming to extract the requested information about acceptance criteria and the study that proves the device meets them:
Important Note: The provided document is a 510(k) summary for a medical device (Blunt Fill Needle and Blunt Plastic Cannula), not an AI or software-as-a-medical-device (SaMD). Therefore, many of the requested fields (like "Multi Reader Multi Case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "effect size of how much human readers improve with AI vs without AI assistance," "sample size for the training set," etc.) are not applicable to this type of device and submission. The testing described is for physical characteristics of hardware, not performance of an algorithm.
Acceptance Criteria and Device Performance for Blunt Fill Needle and Blunt Plastic Cannula
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device, the "acceptance criteria" are compliance with established international standards and comparison to a predicate device. The "performance" is demonstrated by passing these tests.
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 594-1:1986 (Female Luer Slip Connector) | Passed - Evaluated for compatibility with standard male luer slip connector of the syringe for both blunt fill needle and blunt plastic cannula. (Implies compliance) |
| ISO 7864:1993 (Blunt Fill Needle) | Passed - Evaluated physical and chemical specifications of the blunt fill needle. (Implies compliance) |
| ISO 9626:1991 (Blunt Fill Needle) | Passed - Evaluated physical and chemical specifications of the blunt fill needle. (Implies compliance) |
| Surface Condition (Blunt Plastic Cannula) | Performed testing - No specific pass/fail criteria or results provided in the summary, but implies acceptable. |
| Comparison to Predicate Device (Blunt Plastic Cannula) | Performed comparison testing - "has similar performance with the predicate device." |
| ISO 10993 Standards (Biocompatibility) | Comply with ISO 10993 Standards. (Implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact sample sizes for each bench test conducted. It states that "Bench tests were conducted."
- Data Provenance: The tests were conducted by the manufacturer, ShanDong WeiGao Group Medical Polymer Co., Ltd, in China, to verify design specifications. This implies internal, prospective bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a hardware medical device. "Ground truth" in the context of expert consensus is not relevant here. The "ground truth" is adherence to engineering standards and functional performance requirements.
4. Adjudication Method for the Test Set
- Not Applicable. As the performance is based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant. The "adjudication" is the objective passing or failing of the specified tests.
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 is not an AI/SaMD device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an AI/SaMD device.
7. The Type of Ground Truth Used
- For the physical tests (e.g., luer slip connector compatibility, physical/chemical specs), the "ground truth" is defined by international engineering standards (ISO standards) and the functional performance requirements of the device (such as the ability to penetrate a vial stopper or connect to a syringe).
- For biocompatibility, the "ground truth" is compliance with ISO 10993 Standards.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/SaMD device. There is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
§ 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).