(82 days)
Input TS & TL are indicated as percutaneous introducers that are used to facilitate placing a catheter through the skin into a vein or artery. Input TS & TL are recommended for initial percutaneous introduction of a closed end catheter, temporary pacing electrode catheter or probe, or a balloon catheter. They may also be used as an instrument to exchange catheters during a procedure.
Input TS & TL consists of an introducer sheath (uncoated), a locking dilator (may contain a single or double dilator), and a guide wire. Certain model numbers will also contain a locking obturator.
The provided text describes a medical device, the USCI® Input® TS and Input TL Percutaneous Arterial/Venous Catheter Introducer Set, and its similarity to a predicate device for 510(k) clearance. However, it does not contain any information regarding acceptance criteria, device performance studies, or details related to AI/algorithm performance.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth.
The document primarily focuses on:
- General Information: Device name, submitter, contact, date, common name, and classification.
- Predicate Device: Identifies the USCI® Input™ Introducer Set (K940092) as the predicate.
- Description and Intended Use: Describes the components (sheath, dilator, guidewire, obturator), materials used, and application (facilitating catheter placement, exchanging catheters, and providing support post-procedure).
- Material Equivalence: Emphasizes that new materials (latex gasket, Teflon sheath, polyurethane strain relief, black PE) are already used in other USCI introducers.
- Clinical Benefit: Highlights the introducer set's ability to allow patients to sit in a Semi-Fowler position post-PTCA, enhancing comfort, a feature also present in the predicate device.
To answer your request, information about acceptance criteria and study results would need to be present in the provided text, which it is not.
§ 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).