(269 days)
Neo Delta Self Safe Catheters are intravascular catheters intended for short term use for the intravenous administration of fluids.
The Delta Med Neo Delta Self Safe 'T' and Self Safe '1' IV Catheters are two ranges of color-coded, single-entry, polyurethane (PUR) IV catheters available in 'non-winged' (the 'T' version) and 'winged' (the '1' version) varieties, in sizes from 14 to 24 gauge. All versions include a passive safety mechanism to protect users from needlestick injuries together with three radiopaque lines to allow x-ray visualization.
Here's a summary of the acceptance criteria and study details for the Delta Med Neo Delta Self Safe T and Neo delta Self Safe 1 IV Catheters, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Metric) | Reported Device Performance |
|---|---|
| Safety mechanism activation | 100% of safety mechanisms activated correctly. |
| Test failures (as defined in Section 2.5) | No test failures occurred. |
| Confidence in failure rate for safety mechanism | 99.5% confidence level that the failure rate is no more than 0.5%. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 1,000 devices.
- Data Provenance: The study was conducted at four different hospitals; the country of origin is not explicitly stated but the manufacturer is Italian. The study appears to be prospective as it involves "Simulated Clinical Usage Test" with healthcare professionals.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: 20 healthcare professionals.
- Qualifications of Experts: Participants were recruited from different departments within each hospital, implying they were professionals who routinely use IV catheters. Specific qualifications (e.g., years of experience, specific medical roles) are not provided beyond "health care professionals who routinely use IV catheters."
4. Adjudication Method for the Test Set
The text describes an "Evaluation Questionnaire" submitted to the participants. While it states that "significant points were noted from review of the completed Evaluator Questionnaires," it does not specify a formal adjudication method (e.g., 2+1, 3+1, none). It implies a consensus or aggregation of feedback from the 20 professionals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly described. The study focused on the performance of the Delta Med device in a simulated clinical setting, comparing its safety mechanism activation and failure rates against predefined criteria. It did not directly compare human readers with and without AI assistance; rather, it evaluated the device's human-factors performance (ease of use, safety mechanism activation).
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone study focusing solely on an algorithm without human-in-the-loop performance was not done. This device is a physical medical device (IV catheter with a safety mechanism), not an AI algorithm. The performance evaluation was a simulated clinical usage test that inherently involves human interaction with the device.
7. The Type of Ground Truth Used
The ground truth for the safety mechanism's performance was established through expert consensus/observation during "Simulated Clinical Usage Tests." The "Evaluation Questionnaire" completed by healthcare professionals served as the primary data source to assess activation and failure rates.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable here as this is a physical medical device, not a machine learning algorithm.
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).