(70 days)
The MedAmicus Valved Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The MedAmicus Valved Peelable Introducer package consists of a thin-wall needle, a disposable syringe, and a flexible guidewire, packaged in a tray and a sealed pouch. Percutaneous introducers are small diameter tubular shaped devices with integrated proximal handles. The Valved Peelable Introducer is designed to provide a relatively atraumatic method for implanting catheters and pacemaker leads into the venous system. The Valved Peelable Introducer has a "tear-away" feature common to the predicate devices. This feature allows the user to remove the introducer without removing the inserted catheter or pacing lead. The Valved Peelable Introducer includes a sliding valve. When the valve is slid over the proximal end of the sheath, a device may be passed through the valve into the sheath, providing for reduced blood loss and reduced risk of air intake. The valve may be slid so that it is not covering the opening to the inner diameter of the sheath as well. The valve is constructed of a piece of silicon which snaps into a valve 'body' constructed of molded components.
Here's a breakdown of the acceptance criteria and study information for the MedAmicus Valved Peelable Introducer based on the provided text:
Acceptance Criteria and Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Valve Pressure Flowrate | Valve must reduce flow (Min 90% reduction before insertion, Min 78% reduction after dilator/guidewire removal) | 95% reduction (before device insertion) to 99% reduction (after dilator/guidewire removal) |
| Valve Vacuum Flowrate | Valve must reduce flow (Min 93% reduction before insertion, Min 80% reduction after dilator/guidewire removal) | 96% reduction (before device insertion) to 99% reduction (after dilator/guidewire removal) |
| Dilator Insertion Force | 2.0 lb. maximum | Mean: 0.66 lb. (Range: 0.47 lb. - 1.03 lb.) |
| Dilator Removal Force | 2.0 lb. maximum | Mean: 0.74 lb. (Range: 0.50 lb. - 1.09 lb.) |
| Catheter Insertion Force | 2.0 lb. maximum | Mean: 0.88 lb. (Range: 0.56 lb. - 1.09 lb.) |
| Valve Peeling Force | Valve must peel off catheter | Pass (Test results indicated "Pass") |
Study Information
2. Sample size used for the test set and the data provenance:
- Test set sample sizes:
- Valve Pressure Flowrate: 30 units
- Valve Vacuum Flowrate: 29 units
- Dilator Insertion Force: 29 units
- Dilator Removal Force: 29 units
- Catheter Insertion Force: 29 units
- Valve Peeling Force: 29 units
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies internal testing by MedAmicus.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The study appears to be engineering/performance testing against specifications, rather than a clinical study requiring expert ground truth for interpretation of observational data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. The tests are focused on quantifiable physical properties and performance against predefined engineering specifications, not on subjective interpretations requiring adjudication.
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 device is a medical introducer, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a physical medical device, not an algorithm. The testing described is "standalone" in the sense that it evaluates the device's physical performance independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth consists of predefined engineering specifications and performance benchmarks (e.g., maximum force, minimum reduction percentage). These are derived from design requirements and potentially industry standards, not from clinical expert consensus, pathology, or outcomes data in the typical sense.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. As there is no AI model or training set, this question is not relevant.
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).