(226 days)
The proposed Boston Scientific power injectable PICC is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.
The proposed PICC is designed for intravenous therapy and for use with power injectors at settings of 300 psi for the administration of contrast media for imaging studies (including, but not limited to, CT scans, MRIs). The proposed PICC is an open ended, non-valved catheter with proximally located luer lock hub(s), extension tube(s) and suture wing for catheter securement; available in single and dual lumen configurations (4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL); with a reverse tapered shaft to aid in staunching bleeding at the insertion site; and usable length of 45 cm lengths for the 4 Fr SL, 5 Fr DL lengths and 55 cm lengths for the 4 Fr SL, 5 Fr DL, 6 Fr DL, 6 Fr DL. The radiopaque catheter is marked with depth indicators every 1 cm along its length and with a "0" indicator to serve as a reference during catheter insertion and for user convenience in catheter sizing. The lumens are differentiated by proximally located colored clamps and hubs that indicate lumen size. Maximum power injection flow rates are indicated on the clamp(s). As is the predicate device, the proposed BSC PICC will be offered in convenience kits with other legally marketed products.
This document, K070002, is a 510(k) summary for the Boston Scientific Peripherally Inserted Central Catheter (PICC). It focuses on substantial equivalence to a predicate device, rather than a standalone performance study with acceptance criteria.
Therefore, it does not contain the information required to populate the fields related to acceptance criteria and device performance as it pertains to AI/algorithm performance. The device described in this document is a physical medical device (PICC), not an AI algorithm.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: Not present. This document demonstrates substantial equivalence through a comparison of technological characteristics and performance characteristics tested to a predicate device, not by defining and meeting specific acceptance criteria for a new, AI-based functionality.
- Sample size used for the test set and the data provenance: Not applicable. This is a physical device, not an AI algorithm with a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth establishment is irrelevant for this type of device submission.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary of available information from the document:
- Device Name: Boston Scientific Peripherally Inserted Central Catheter (PICC)
- Predicate Device: AngioDynamics, Inc. Morpheus™ CT PICC (K041420 and K060887)
- Intended Use: Short or long-term peripheral access to the central venous system for intravenous therapy (fluids, medications, nutrients, blood sampling) and power injection of contrast media.
- Substantial Equivalence Basis: Comparison of intended use, technological characteristics, and performance characteristics tested to the predicate device. The document states a "direct comparison of key characteristics demonstrates that the proposed device is substantially equivalent." However, the specific results of these characteristic tests or the defined criteria for "substantial equivalence" regarding measured performance are not detailed in this summary.
To obtain specific performance data and acceptance criteria for a physical device like a PICC, one would typically need to review the full 510(k) submission, which would include detailed testing protocols and results (e.g., burst pressure, flow rates, material compatibility, functional durability). This summary document does not provide those specifics.
§ 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.”