(92 days)
0.9% Sodium Chloride Flush Syringes are intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices. Use according to the recommendations of the manufacture for the appropriate device.
The Predicate Device, 510(k) Number: K984590 (Baxter Healthcare), consists of a sterile plastic syringe aseptically filled with 0.9% Sodium Chloride Flush Solution. The predicate device is fluid path sterile with a Sterility Assurance Level (SAL) of 10 . This is a single use device. AMUSA is the legal owner of the Baxter 510(k) K984590.
The Modified Device, the subject of this 510 (k), consists of a non-sterile plastic syringe filled with 0.9% Sodium Chloride Flush Solution that is sterilized by the addition of terminal sterilization (Radiation). The modified device is fluid path sterility Assurance Level (SAL) of 10 This is a single use device.
The provided text describes a 510(k) summary for a medical device called "0.9% Sodium Chloride Flush Syringe". This document is a premarket notification to the FDA to demonstrate that the modified device is substantially equivalent to a legally marketed predicate device.
Crucially, this document is for a medical device (syringe) and not an AI/ML software device. Therefore, the concepts of "acceptance criteria for an AI device", "study that proves the device meets the acceptance criteria", "sample size for test set", "ground truth", "number of experts", "adjudication method", "MRMC study", "standalone performance", and "training set" are not applicable in the context of this 510(k) submission.
The document focuses on demonstrating substantial equivalence through non-clinical verification testing due to a change in the sterilization process, not on the performance of a diagnostic or predictive algorithm.
However, based on the provided text, I can extract information related to the device and its assessment:
1. A table of acceptance criteria and the reported device performance
Since this is a non-AI/ML device, the concept of "acceptance criteria" is related to its physical, chemical, and functional properties, as well as its sterility and stability, rather than diagnostic performance metrics.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ |
| Intended Use Equivalence | "The modified terminally sterilized syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended." |
| Design Equivalence | "The technical characteristics for the modified device do not differ from those of the currently marketed device. These devices have the same design, the same fundamental scientific characteristics, the same labeling, and have the same intended use." |
| Process Change Justification | Change from aseptically filled (predicate) to terminally sterilized (radiation) (modified device) |
| Non-clinical Verification Testing | Passed chemical-physical, functional, and product stability testing. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document refers to "non-clinical verification testing" which would involve a set of syringes, but the specific number tested is not provided in this summary.
- Data Provenance: Not applicable in the context of data for an AI/ML model. The testing was performed on the modified syringe product itself. Location of testing and specific methodology are not detailed in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. "Ground truth" in the AI/ML sense is not relevant here. The assessment is based on physical, chemical, and biological testing, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring expert adjudication of outputs.
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 medical device (syringe), not an AI/ML diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "truth" for this device relates to meeting established engineering and sterility standards through laboratory testing (e.g., measuring chemical composition, mechanical strength, sterility testing results, stability over time).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).