(29 days)
The Instylla Microcatheter is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Instylla Microcatheter includes a single lumen, multipurpose catheter intended for use in the peripheral vasculature. The basic operating principle is to advance the microcatheter through an outer guiding catheter and track coaxially over a steerable guidewire in order to access the treatment site. The microcatheter lumen is able to accommodate steerable guidewires that are ≤0.014in (0.36mm) in diameter. Once the target region has been accessed, the microcatheter can be used to deliver diagnostic, embolic, or therapeutic materials into vessels.
The microcatheter has a 1.7Fr (0.56mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.016in (0.41mm) along its length. The proximal end of the microcatheter incorporates a standard luer hub to enable the attachment of accessories, and a strain relief with a feature that allows for flexibility and securement inside a Tuohy-Borst adapter, for maintaining position inside a guiding catheter as needed. The microcatheter has a radiopaque marker at the distal tip to aid in fluoroscopic visualization. A 4Fr Tuohy-Borst with side-port adapter, a short extension adaptor, a long extension adapter and a duckbill check-valve are also included. The Instylla Microcatheter is available in 122cm, 142cm and 162cm usable lengths.
This document describes the Instylla Microcatheter with check-valve connector and asserts its substantial equivalence to a previously cleared predicate device (Instylla Microcatheter, K191731). As such, the study focuses on verifying that the modified device meets the same performance criteria as the predicate, rather than establishing entirely new acceptance criteria or conducting a clinical effectiveness study.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Attribute | Reported Device Performance |
|---|---|---|
| Functional Performance | Accessory Compatibility and Functionality | Met predetermined acceptance criteria. No new safety or performance issues raised. |
| Biocompatibility | Cytotoxicity | Successfully completed. |
| Sensitization | Successfully completed. | |
| Irritation or Intracutaneous Toxicity | Successfully completed. | |
| Acute Systemic Toxicity | Successfully completed. | |
| Material-Mediated Pyrogenicity | Successfully completed. | |
| Hemolysis | Successfully completed. | |
| Sterility | Sterility Assurance Level (SAL) | 10⁻⁶ (validated per ISO 11135) |
| Bacterial Endotoxin Level |
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).