(146 days)
The SafeTouch PSV Winged Infusion Set with/without filter is intended to be used for insertion into a patient's vascular system for single use as an indwelling device to administer fluids intravenously. Secondly it is designed with an active sharp feature that requires physical action by the clinician to prevent accidental needlesticks.
The SafeTouch PSV winged Infusion Set with/without filter consists of a winged needle (25 gauge x 3/4 inch) with an integrated safety mechanism connected to PVC tubing and a female luer connector with cap. An optional filter has been added to prevent the flow of particulate matter.
The provided text describes a 510(k) submission for the "SafeTouch PSV winged Infusion Set with/without filter." This submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing. It explicitly states that no clinical testing was required or performed.
Therefore, many of the requested categories related to clinical studies, ground truth establishment, expert adjudication, multi-reader studies, and training/test set details are not applicable to this submission.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists the types of performance tests conducted but does not provide specific acceptance criteria or quantitative results for each test in a table format. It only states that "The results and conclusions of these tests are included in this submission" and that these tests "verify that the device is safe and effective for its intended use" and "demonstrate that the SafeTouch PSV performs equivalent to the predicate device."
| Test Category | Description of Test (from text) | Acceptance Criteria (Not explicitly stated in provided text) | Reported Device Performance (Not explicitly stated in provided text) |
|---|---|---|---|
| Appearance | Appearance | Not provided | "Results and conclusions... included in this submission" |
| Dimensional | Dimensional | Not provided | "Results and conclusions... included in this submission" |
| Package Integrity | Package integrity testing | Not provided | "Results and conclusions... included in this submission" |
| Functional Testing | Penetration force (puncture resistance testing) | Not provided | "Results and conclusions... included in this submission" |
| Pull force of connections | Not provided | "Results and conclusions... included in this submission" | |
| Safety Mechanism Deactivation force | Not provided | "Results and conclusions... included in this submission" | |
| Needle Clogging Test | Not provided | "Results and conclusions... included in this submission" | |
| Leakage of product | Not provided | "Results and conclusions... included in this submission" | |
| Luer Cap Separation | Not provided | "Results and conclusions... included in this submission" | |
| Connector Taper Leakage | Not provided | "Results and conclusions... included in this submission" | |
| Internal/external surface of cannula | Not provided | "Results and conclusions... included in this submission" | |
| Cannula Elasticity | Not provided | "Results and conclusions... included in this submission" | |
| Cannula Bending Strength | Not provided | "Results and conclusions... included in this submission" | |
| Product Air Tightness | Not provided | "Results and conclusions... included in this submission" |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text, as the testing was non-clinical (bench testing).
- Data Provenance: Not applicable, as no human data was used. The testing was non-clinical bench testing.
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 was established through non-clinical test methods and device specifications, not expert human evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no human adjudication for a test set.
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:
- No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a medical device (infusion set), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm or AI device. The testing was standalone in the sense that it was non-clinical bench testing of the physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance was based on engineering specifications and established test methods for medical devices (e.g., penetration force, leakage, material strength).
8. The sample size for the training set:
- Not applicable. There was no training set, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. There was no training set.
§ 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).