(83 days)
The Vida PTV Dilatation Catheter is recommended for Percutaneous Transluminal Valvuloplasty (PTV) of the pulmonary valve in the following:
- A patient with isolated pulmonary valve stenosis .
- A patient with valvular pulmonary stenosis with other minor congenital heart . disease that does not require surgical intervention.
The Vida PTV Dilatation Catheter is a high performance balloon catheter consisting of an over-the-wire catheter with a balloon fixed at the distal tip. The proprietary, noncompliant, low profile balloon is designed to provide consistent balloon diameters and lengths even at high pressures. Two radiopaque markers delineate the working length of the balloon and aid in balloon placement. The coaxial catheter includes an atraumatic tip to facilitate advancement of the catheter to and through the valve. The over-the-wire catheter is compatible with .035" quidewire and is available in 100 cm working length. The proximal portion of the catheter includes a female luer-lock hub connected to the inflation lumen, and a female luer-lock hub connected to the guidewire lumen. Packaged with every product is a profile reducing sheath that is positioned over the balloon for protection before use. A re-wrapping tool is also provided on the catheter shaft. This product is not manufactured with any latex.
Here's a breakdown of the acceptance criteria and the study information for the Vida PTV Dilatation Catheter, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance:
The document provides a table of acceptance criteria for several in-vitro tests but does not provide the reported device performance for each criterion. It only states that the device "met all predetermined acceptance criteria."
| Test Performed | Acceptance Criteria | Vida PTV Dilatation Catheter Reported Performance |
|---|---|---|
| Visual Inspection | The catheters shall be free from contamination, discoloration, and any form of damage that could impact the proper functioning of the device. | Met criteria |
| Media Interaction (i.e. Balloon Preparation Test) | Each catheter shall be prepped per the procedure without any functional difficulties or anomalies. Guidewire lumen must be flushable (saline appears at distal end when injected from proximal end) with 5 ml of saline utilizing a 10-ml syringe or equivalent. | Met criteria |
| Catheter Shaft Length | 100 ± 3 cm | Met criteria |
| Trackability | Using the IDTE, the trackability into an appropriately-sized 23-cm Cordis Avanti introducer or B.Braun Intradyn 23-cm (sheath sizes ≥ 12 Fr.) and through a worst-case pulmonary valve model should have forces ≤ 700 gF. | Met criteria |
| Inflation/Deflation Time (i.e. Balloon Inflation/Deflation Test, and Balloon Inflatability Test) | Inflation Time: Inflation achieved ≤ 20 seconds using 25:75 contrast: saline ratio. | |
| Simulated Use Deflation Time: Deflation achieved ≤ 20 seconds using 25:75 contrast:saline ratio. | ||
| Removal Deflation Time: Deflation time ≤ 90 seconds with 25:75 contrast:saline ratio. | Met criteria |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for each of the in-vitro tests listed. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The tests are described as "in vitro tests."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study describes in-vitro performance testing of a medical device, not a diagnostic or AI-driven system that would require expert-established ground truth. The acceptance criteria are based on physical and functional requirements.
4. Adjudication Method for the Test Set:
Not applicable. As this is an in-vitro performance study, there is no mention of adjudication methods typically associated with clinical or expert review studies.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This document describes the performance testing of a physical medical device (catheter), not a diagnostic tool or an AI system that would assist human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI algorithm. The performance tests are for the physical properties and function of the catheter itself.
7. The Type of Ground Truth Used:
The "ground truth" for the in-vitro tests are the predefined acceptance criteria based on physical measurements, functional performance (e.g., inflation/deflation times), and visual inspection standards. These criteria are established based on "FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures."
8. The Sample Size for the Training Set:
Not applicable. This is not a study involving a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established:
Not applicable. No training set, as this is not an AI or machine learning study.
§ 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).