(29 days)
The Instylla Microcatheter 1.2 is intended for use in super selective anatomy for peripheral diagnostic and interventional procedures. The Instylla Microcatheter 1.2 can be used for the infusion of diagnostic, embolic, or therapeutic materials into vessels.
The Instylla Microcatheter 1.2 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 ≤0.010in (0.25mm) 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 1.2Fr (0.40mm) OD with a constant flexibility along its length. The ID of the microcatheter is 0.012in (0.30mm) 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 with side-port 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 FDA 510(k) summary describes a device, the Instylla Microcatheter 1.2, which is essentially a modification of a previously cleared predicate device (Instylla Microcatheter K200744). Therefore, the acceptance criteria and performance data mainly focus on demonstrating that the modified device's performance is equivalent to or better than the predicate, especially regarding the changes made.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the Instylla Microcatheter 1.2 "met the predetermined acceptance criteria ensuring substantial equivalence to the predicate device." However, specific numerical acceptance criteria values and reported performance values are not explicitly provided in this summary for most tests. The summary lists the types of tests performed.
| Acceptance Criteria Category | Specific Test/Performance Metric | Acceptance Criteria (Not Explicitly Stated Numerically) | Reported Device Performance (Not Explicitly Stated Numerically) |
|---|---|---|---|
| Bench Testing & Functional Testing | Visual Inspection of Components | Met specifications | Passed |
| Dimensional Verification of Components | Met specifications | Passed | |
| Trackability | Met specifications | Passed | |
| Kink Resistance | Met specifications | Passed | |
| Pushability and Torqueability | Met specifications | Passed | |
| Tip Radiopacity | Met specifications | Passed | |
| Fluid and Infusate Compatibility | Met specifications | Passed | |
| Injection of Fluids (Flowrate) and Tip Stability | Met specifications | Passed | |
| Freedom from Leakage | Met specifications | Passed | |
| Static Burst Pressure | Met specifications | Passed | |
| Catheter Shaft Tensile Strength | Met specifications | Passed | |
| Microcatheter Compatibility with Standard Microcatheters, Guidewires and Syringes | Met specifications | Passed | |
| Accessory Compatibility and Functionality | Met specifications | Passed | |
| Biocompatibility | Cytotoxicity | In accordance with ISO 10993-1 | Successfully completed |
| Sensitization | In accordance with ISO 10993-1 | Successfully completed | |
| Irritation or Intracutaneous Toxicity | In accordance with ISO 10993-1 | Successfully completed | |
| Acute Systemic Toxicity | In accordance with ISO 10993-1 | Successfully completed | |
| Material-Mediated Pyrogenicity | In accordance with ISO 10993-1 | Successfully completed | |
| Hemolysis | In accordance with ISO 10993-1 | Successfully completed | |
| Complement Activation | In accordance with ISO 10993-1 | Successfully completed | |
| Partial Thromboplastin Time | In accordance with ISO 10993-1 | Successfully completed | |
| In Vivo Thromboresistance - Jugular Vein | In accordance with ISO 10993-1 | Successfully completed | |
| Sterility | Sterility Assurance Level (SAL) | 10⁻⁶ | Achieved via validated EO process |
| EO and ECH levels | Acceptable in accordance with ISO 10993-7 | Acceptable | |
| 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).