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510(k) Data Aggregation
(128 days)
This device is intended for 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 consisting of a calibrated hollow barrel and a movable plunger.
The covers are offered sterile, single use. 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 consisting of a calibrated hollow barrel and a movable plunger.
The provided document describes the acceptance criteria and testing summary for the International Medsurg Connections Piston Syringe and Needles, submitted for 510(k) clearance (K022159).
1. Table of Acceptance Criteria and Reported Device Performance
| Testing Items | Acceptance Criteria | Reported Device Performance (Summary) |
|---|---|---|
| Syringe Column Sealing (Positive Pressure) | No leakage at 300 Kpa | No leakage |
| Syringe Column Sealing (Negative Pressure) | No leakage at 88 Kpa | No leakage |
| Volume | ± 4% | Met criteria (implied) |
| Tip Sealing Property | No Leakage | No Leakage |
| Indicating Ruler - 0 level line | Within ¼ range | Met criteria (implied) |
| Tip size, Draw Strength | No separation at 25N | No separation at 25N |
| Residue Contents | < 0.075 mL | Met criteria (implied) |
| Sliding Property | Average <10N | Met criteria (implied) |
| Appearance | Clean, Smooth | Clean, Smooth |
| Non-Bacteria | Non-Bacteria | Non-Bacteria |
| Pyrogen | Pyrogen-Free | Pyrogen-Free |
| Toxicity | Non-toxic, no toxicity reaction for human body | Non-toxic, no toxicity reaction for human body |
Note: The document provides the criteria and states that all materials used were "evaluated for" these criteria. For each criterion, the "Reported Device Performance" column implies that the device met these criteria, as the submission was granted 510(k) clearance, indicating substantial equivalence. Specific numerical results for each test (e.g., exact volume deviation, actual residue content) are not provided in this summary.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set for any of the individual tests. The data provenance is not explicitly stated in terms of country of origin, nor whether the data was retrospective or prospective. It is implied to be prospective testing conducted by the manufacturer as part of the submission for market clearance in the US.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This submission describes the testing of physical properties and biological compatibility of a medical device (syringes and needles). It does not involve medical image analysis or diagnostic tasks where human expert-established ground truth would be relevant. Therefore, this question is not applicable to the provided document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device testing does not involve human adjudication of results in the typically understood context of diagnostic or interpretive tasks. The evaluation is based on objective measurements against predefined criteria.
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 submission for a physical medical device (syringes and needles), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement effect size are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This involves a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is based on established industry standards and regulatory requirements for medical devices of this type. This includes objective physical measurements (e.g., pressure, volume, strength), chemical analyses (e.g., residue content), and biological tests (e.g., bacterial, pyrogen, toxicity). These "ground truths" are derived from recognized standards and scientific principles rather than expert consensus on diagnostic interpretations, pathology, or outcomes data in the usual sense.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" for this type of submission.
9. How the ground truth for the training set was established
Not applicable. See response to question 8.
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