(12 days)
The Poly Per-Q-Cath PICC is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling. For blood therapy, it is recommended that a 4 French or larger catheter be used.
The Poly Per-Q-Cath PICC Single and Dual Lumen Catheters are open-ended catheters extruded from polyurethane loaded with barium sulfate for radiopacity. All are 63 cm in length. The proximal ends of the catheter tubing are expanded to serve as strain reliefs for their connection to junctions with integral suture wings. Integral extension legs are attached to the proximal ends of all SL and DL junctions of PQC catheters. The extension legs serve as a conduit for fluids into and out of the catheters, and can be occluded with provided thumb clamps. Catheter tubing is marked with depth indicators, with "0" indicated to serve as a reference for catheter insertion point. Catheters are provided sterile with inserted hydrophilic stylets. They are packaged individually, or sold in procedural kits containing accessories that are provided to aid in their placement.
This document describes a 510(k) summary for the Poly Per-Q-Cath PICC Catheter. The submission focuses on modifications to an existing device, specifically changes to the strain relief design and increased barium sulfate content for enhanced radiopacity. As such, the emphasis is on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for a novel AI/ML device.
Therefore, many of the requested sections regarding acceptance criteria, study details for AI/ML performance, and ground truth establishment are not applicable based on the provided document. The document describes traditional medical device validation through engineering and biocompatibility testing.
Here's an analysis of the relevant information from the provided text:
1. A table of acceptance criteria and the reported device performance
The document states: "The modified devices met the acceptance criteria for the tests performed." And "The modified Poly Per-Q-Cath PICCs met predetermined performance acceptance criteria of testing performed and are substantially equivalent to the predicate."
However, the specific acceptance criteria and detailed reported device performance values for each test are not provided in this 510(k) summary. It only indicates that they were met. The new characteristics were evaluated through:
- Design Validation: Performed to meet recommendations of the FDA guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997.
- Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters (3/16/95): Used to determine appropriate methods for evaluating the modified device's performance.
- Relevant ISO 10555 Standards: Used for evaluating the modified device's performance.
- Biocompatibility requirements of ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing: Met for externally communicating, blood-contacting, long-term devices.
- FDA-Modified ISO 10993 Test Profile: Met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document describes "Design validation," "Verification and validation testing," and "performance data," but no details on sample sizes or data provenance are included.
3. 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)
This is not applicable as the document describes validation of a physical medical device (catheter) through engineering and biocompatibility testing, not an AI/ML diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes validation of a physical medical device, not an AI/ML diagnostic device requiring expert adjudication.
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
This is not applicable. The document describes validation of a physical medical device, not an AI/ML-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes validation of a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this medical device would be defined by engineering specifications, material properties, and established biological safety standards (e.g., ISO standards for catheters and biocompatibility). The testing aimed to confirm the device met these objective performance and safety criteria.
8. The sample size for the training set
This is not applicable as this is not an AI/ML device submission.
9. How the ground truth for the training set was established
This is not applicable as this is not an AI/ML device submission.
§ 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.”