(24 days)
The Arrow arterial catheterization device permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when using the device.
The proposed device is a sharps-protected version of the Arrow Radial Artery Catheterization Set. It contains a radial artery catheter-over-needle assembly with an integral, passive needle protection feature.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Device reliability | Performed |
| Clinical simulation | Performed |
| Deactivation force of safety feature | Performed |
| Safeguard interference fit | Performed |
| Tensile | Performed |
| Corrosion | Performed |
Note: The document states that these tests were "performed to demonstrate substantial equivalence," implying that the device met the requirements for each criterion to establish equivalence with predicate devices. However, specific quantitative acceptance thresholds or detailed performance results (e.g., exact deactivation force values, tensile strength measures) are not provided in the summary.
Study that proves the device meets the acceptance criteria:
The study refers to a set of "Performance Tests" conducted by Arrow International, Inc. These tests are listed as:
- Device reliability
- Clinical simulation
- Deactivation force of safety feature
- Safeguard interference fit
- Tensile
- Corrosion
The document does not provide the following information:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not explicitly stated. The nature of the tests (e.g., "clinical simulation") suggests some form of testing, but details on the participants or data collection are absent.
- 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, as this device is a medical instrument (catheterization set) and not an AI/diagnostic tool requiring expert-established ground truth for image interpretation or diagnosis. The "ground truth" here would pertain to the physical performance of the device against engineering and safety specifications.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the type of performance tests described. Adjudication methods are typically used in clinical trials involving subjective assessments or diagnostic interpretations.
- 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 medical instrument, not an AI diagnostic or assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for this device would be engineering specifications, safety standards, and functional requirements for a radial artery catheterization set, including regulatory safety features for needle protection.
- The sample size for the training set: Not applicable. This device is a physical medical instrument and does not involve AI/machine learning models that require a training set.
- How the ground truth for the training set was established: Not applicable.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).