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510(k) Data Aggregation
(28 days)
0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle
The 0.5ml Sol-Care™ Retractable Safety Syringe is used to inject fluids into, or withdraw fluids from, the body. In addition, the 0.5ml Sol-Care™ Retractable Safety Syringes is designed to aid in the prevention of needle stick injuries.
The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is a sterile, single use, safety syringe with a fixed needle that is used to inject fluids into, or withdraw fluids from, the body. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle is also designed to aid in the prevention of needle stick injuries. The retractable piston syringe is a plastic disposable syringe made of the following components: Barrel, Plunger, Stopper, Cannula, Locking Ring, Needle Cap, O-Ring, Protective Cap. After use, the health care professional firmly pushes the plunger past the zero line to engage the safety mechanism. Once the safety mechanism is engaged, pulling back the plunger causes the needle to be retracted into the barrel. In this position against the flange, lateral pressure on the plunger results in a controlled fracture of the plunger. Both the syringe and the plunger are discarded into a sharps container. The 0.5ml Sol-Care™ Retractable Safety Syringe with Fixed Needle are sterilized by Ethylene Oxide and supplied sterile in a blister pack or tray pack.
The provided document is for a medical device called "0.5ml Sol-Care™ Ret retractable Safety Syringes" and primarily focuses on its substantial equivalence to a predicate device for FDA clearance. Therefore, the information requested about acceptance criteria and study details related to performance metrics like sensitivity, specificity, or AI assistance is not typically found in this type of submission for a physical medical device.
However, I can extract information regarding performance in terms of meeting established standards for the device. The document explicitly states that the device met the requirements of several ISO standards.
Here's the closest representation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|
| ISO 7886:1993, Sterile Hypodermic Syringes for Single Use | Met the appropriate requirements (implies compliance with all specifications within the standard, e.g., sterility, fluid tightness, material properties, plunger operation, scale markings, etc. specific to single-use hypodermic syringes). |
| ISO 7886-4:2006, Sterile Hypodermic Syringes for Single Use Syringes with re-use prevention feature | Met the appropriate requirements (implies compliance with additional specifications for safety features preventing re-use, likely related to the retraction mechanism and its function). |
| ISO 11607-1,-1:2006, Packaging for terminally sterilized medical devices | Met the appropriate requirements (implies compliance with standards for maintaining sterility of the packaged device, integrity, and labeling). |
| ISO 11135:2007, Medical Apparatus Epoxy Ethane Sterilization Confirmation and Routine Control | Met the appropriate requirements (implies successful sterilization using Ethylene Oxide and confirmation of its effectiveness). |
| ISO 10993-1:2006, Biological evaluation of medical devices Part 1: Evaluation and testing | Met the appropriate requirements (implies successful completion of biocompatibility tests such as Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and Hemolysis tests without adverse reactions). |
| ISO 9626:1991, Stainless Steel needle tubing for the manufacture of medical devices | Met the appropriate requirements (implies the needle tubing conforms to the specified properties for stainless steel medical device needles). |
| All product specifications and requirements | The device has been tested and found to meet all product specifications and requirements. |
Regarding the other points, the document states or implies the following limitations:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document does not specify sample sizes for each test in the ISO standards, nor the country of origin or whether the studies were retrospective or prospective. It only generically states that tests were conducted.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For these types of device performance tests (e.g., sterility, material strength, retraction mechanism function), a "ground truth" established by experts in the clinical or diagnostic sense is not relevant. The ground truth is defined by the objective pass/fail criteria of the engineering and biocompatibility standards.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The tests against ISO standards typically involve objective measurements or pass/fail observations, not subjective adjudication methods.
- 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 a physical medical device (safety syringe), not an AI/software-based diagnostic or imaging device. There are no "human readers" or "AI assistance" involved in its intended use.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as detailed above.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" implicitly referred to is the objective criteria and methodologies defined within the cited ISO standards for device performance and safety (e.g., successful retraction, material biocompatibility limits, sterility assurance levels).
- 8. The sample size for the training set: Not applicable. This device does not involve a "training set" in the context of machine learning.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the document details a regulatory submission for a physical medical device. Its "acceptance criteria" and "study" revolve around demonstrating compliance with established international standards for the design, manufacturing, and biological safety of such devices, rather than clinical performance metrics of an AI or diagnostic tool.
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