(88 days)
The ViaPeel™ Peelable Introducer is intended for use in the percutaneous insertion of pacing leads or catheters in the venous system.
The ViaPeel Peelable Introducer will be available in 3.5F through 7F (micro), and 7F (macro) in lengths of 5cm or 10cm. The sheath handles are color coded for identification of French size. The locking configuration has been modified on the sheath and dilator to an annular snap fit. The dilator will lock into the hub without the use of a rotating collar allowing the user to lock and secure the dilator to the sheath.
Here's a breakdown of the acceptance criteria and study information for the ViaPeel™ Peelable Introducer, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Performance | Device functions per specification requirements. | "Test results verify that the device performs per specification requirements..." |
| Equivalence to Predicate | Device is equivalent to the predicate device without creating additional risk to the patient or user. | "...equivalent to the predicate device without creating additional risk to the patient or user." |
| Mechanical/Dimensional | Appropriate dimensions and locking mechanism function (annular snap fit on sheath and dilator, dilator locks into hub). | "The performance testing included the device specifications, functional and dimensional testing of the ViaPeel Peelable Introducer..." (Implied successful adherence to these designs) |
| Material Biocompatibility | Component materials are biocompatible. | "The material in the components used to create the ViaPeel Peelable Introducer has been demonstrated to be biocompatible through biocompatibility testing." |
2. Sample Size Used for the Test Set and Data Provenance
The summary does not provide details on the specific sample sizes used for the non-clinical performance testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any of the non-clinical tests. Since no clinical studies were performed, there is no clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Since no clinical studies were performed, there was no ground truth established by experts for a clinical test set. The non-clinical performance testing would have relied on engineering and quality assurance standards, not expert medical consensus on patient outcomes.
4. Adjudication Method for the Test Set
As there was no clinical test set involving human judgment, there was no adjudication method described. The non-clinical tests would involve repeatable measurements and objective criteria rather than expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was performed. The summary explicitly states: "No clinical evaluations of this product have been performed." Therefore, there is no information on how much human readers might improve with or without AI assistance, as AI is not part of this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No standalone study was performed as this device is a physical medical instrument (introducer) and does not involve an algorithm or AI.
7. Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" was established by engineering specifications, functional requirements, and material biocompatibility standards. These are objective, measurable criteria rather than expert consensus, pathology, or outcomes data in the typical sense for a diagnostic or AI device.
8. Sample Size for the Training Set
Since no AI or algorithm is involved, there was no training set for this device. The development process would have involved design, prototyping, and testing of physical units.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
§ 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).