(255 days)
The Biowy PICC catheter S Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injection of contrast media. For blood sampling, infusion or therapy, use 4 French or larger catheter. The maximum recommended infusion rate is 5ml/sec for power injection of contrast media. The maximum pressure of power injectors used with the Biowy catheter may not exceed 300psi. The catheter is available in a kit configuration.
The Biowy PICC catheters are opened-ended radiopaque polyurethane catheters. The catheters are sterile and for single use. They are available in 4F single lumen with 55cm usable length and 5F dual lumen with 60cm usable length. The catheters have a reverse taper design. Catheter shaft is marked with depth indicators, with "0" indicated to serve as a reference for the catheter taper point. Catheters are provided sterile in radiology and nursing configurations for single use. Colorants were added to the catheter shaft and hub to differentiate components. The extension leg, junction and clamp were printed with markings to identify the catheter and to include information to facilitate proper use of the device. The Catheter is provided in a kit with multiple components that includes a stylet, torque adapter and T-lock to facilitate catheter insertion and flushing which are subject to this submission. The stylet has a torque adapter at the end to facilitate handling and withdrawal of the stylet. The catheter and other components in the kit are unchanged from the predicate device.
This document is a 510(k) Pre-market Notification for a medical device (Biowy PICC Catheter S Kit), not a study proving a device meets AI-related acceptance criteria. Therefore, most of the requested information regarding AI acceptance criteria and study design for AI performance evaluation is not present in the provided text.
The document focuses on demonstrating substantial equivalence to a predicate device (Biowy PICC Catheter K173956) based on non-clinical bench testing for the physical catheter and its new accessories.
Here's the information that can be extracted, and where the requested information is not applicable (N/A) because the document describes a traditional medical device clearance, not an AI/ML powered device:
Device: Biowy PICC Catheter S Kit (K192246)
Type of Device: Percutaneous, implanted, long-term intravascular catheter (PICC)
1. Table of Acceptance Criteria and Reported Device Performance
The document lists "Tests" and "Results" which indicate whether the device "Passed" or "Met requirements" for various physical and material properties. These are not acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC).
| Test | Standards | Acceptance Criteria (Implied by "Passed/Met Requirements") | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | ISO 10993-1 | Meets ISO 10993-1 requirements | Passed / met requirements |
| Sterility Assurance Level (SAL) | ISO 11135-1:2014 | SAL of 10-6 | 10-6 |
| Particulates | USP | Meets USP requirements | Passed / met requirements |
| Stylet Inspections and Lock Test | Internal | Meets internal specifications | Passed / met requirements |
| Catheter Burst test after stylet insertion | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet Adapter Tensile Test | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet-Adapter Separation Force | ISO 10555-1:2013 | Meets ISO 10555-1:2013 requirements | Passed / met requirements |
| Stylet performance | ISO 10555-1:2013 / Internal | Meets ISO 10555-1:2013 and internal specifications | Passed / met requirements |
| Stylet - Materials | ASTM 138-13 | Meets ASTM 138-13 requirements | Passed |
Since this is not an AI-powered device, the following points are Not Applicable (N/A) to the information provided in the document:
2. Sample size used for the test set and the data provenance: N/A (No AI test set described)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (No AI ground truth establishment described)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No AI test set described)
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A (Not an AI-assisted device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (Not an AI algorithm)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (Ground truth as understood for AI performance is not relevant here. "Ground truth" for this device's performance is based on physical property testing and material standards.)
8. The sample size for the training set: N/A (No AI training set described)
9. How the ground truth for the training set was established: N/A (No AI training set described)
Summary for this document: The provided text is a 510(k) premarket notification for a physical medical device. It demonstrates substantial equivalence through non-clinical bench testing of the device's physical properties and materials against established medical device standards. It does not involve artificial intelligence, machine learning, or associated performance metrics and study designs that would typically address the questions posed about AI acceptance criteria and studies.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”