(204 days)
The Peripherally Inserted Central Vein Access Catheters with valve technology are designed for Long or Short-term peripheral access to the central venous system for intravenous therapy and blood sampling, and allows for central venous pressure monitoring.
The Vascu-PICC® with Valve Technology is available in various configurations; they are a 3F & 4F single lumen and 4F & 5F double lumen. The catheter lumen terminates through an extension to a female luer-lock connector. Assembled within each huer is a bi-directional valve that can control fluid flow in two directions. The valve is normally closed but opens when flow is induced in either direction. Each extension is marked with the lumen gauge size and "Valved catheter". The transition between lumen and extension is housed within a molded hub. The hub is marked with catheter French size. The outside diameter of the lumen increases gradually near the hub to aid in kink resistance and to provide a mechanical obstruction to bleeding from the venotomy. The lumen is marked with depth marks every centimeter. The catheter is packaged sterile in a variety of tray configurations with the necessary accessories to facilitate catheter insertion.
This document describes a 510(k) submission for the Medcomp Vascu-PICC with Valve Technology, which is a medical device and not an AI/ML powered device. Therefore, the typical acceptance criteria and study designs relevant to AI/ML devices, such as those involving sensitivity, specificity, AUC, human readers, ground truth establishment by experts, and training/test set sample sizes, are not applicable here.
The provided document details the regulatory submission for a physical medical device (a catheter). The "acceptance criteria" in this context refer to the device meeting performance standards for physical and functional characteristics, and its "study" is the performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy.
Here's an analysis based on the provided document, addressing the closest relevant points where possible, and explicitly stating where AI/ML-specific questions are not applicable:
1. A table of acceptance criteria and the reported device performance
Since this is a physical medical device submission for substantial equivalence, the "acceptance criteria" are implied by the performance standards required for intravascular catheters and the demonstration of equivalence to predicate devices. The document does not provide a table of precise quantitative acceptance criteria in terms of, for example, minimum burst pressure, maximum flow rate, or specific material properties with exact thresholds. Instead, it states that performance was evaluated against "applicable international standards and FDA guidance documents" and "internal engineering testing methods."
The "reported device performance" is summarized as:
| Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Equivalence | Substantially equivalent to predicate devices (K121094 & K072230) | The Vascu-PICC® with valve technology catheter is substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization. The only difference is the addition of valve technology to the luer. The results of performance tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices. |
| Performance Testing | Compliance with international standards, FDA guidance, internal methods. Pressure injection not established by FDA. | Performance testing was conducted in accordance with applicable international standards and FDA guidance documents. Testing is based upon internal engineering testing methods. Specific results (e.g., flow rates, pressure resistance) are not publicly reported in this summary, but are affirmed to meet criteria. |
| Biocompatibility | Meet requirements of ISO 10993. | All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993. |
| Technological Characteristics | Similar to predicate devices. | Technological similarities between the proposed device and predicate devices remain the same. |
| Safety and Effectiveness | No new issues of safety and effectiveness. | There are no differences that raise new issues of safety and effectiveness. |
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 summary for the engineering/performance testing. As this is not an AI/ML diagnostic or prognostic device, the concept of a "test set" for diagnostic performance metrics (like sensitivity/specificity) is not directly applicable. The testing would involve physical samples of the device undergoing various mechanical and functional evaluations. The number of samples tested for each specific bench test (e.g., burst pressure, flow rate, kink resistance) is not detailed in this summary. The provenance of the "data" would be internal laboratory testing by Medcomp.
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 question is not applicable as this is a physical medical device. Ground truth, in the context of AI/ML, refers to a label or diagnosis established by human experts, pathology, or outcomes for comparison with AI performance. For a catheter, the "ground truth" would be established by objective, measurable physical properties and compliance with engineering specifications and regulatory standards, evaluated by engineers and quality control personnel, not by medical experts making diagnostic assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies or expert labeling processes to resolve discrepancies in human assessments, which is not relevant for the bench testing of a physical device's performance.
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 question is not applicable. This submission is for a physical medical device (catheter), not an AI-powered diagnostic or assistive tool. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. There is no "algorithm" in the sense of AI/ML in this device. Standalone performance refers to the AI's diagnostic accuracy without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed, the concept of "ground truth" in the AI/ML sense is not applicable. For this device, "ground truth" would refer to objective physical and chemical properties and performance characteristics measured through engineering and biocompatibility testing (e.g., the material is biocompatible per ISO 10993, the a specific flow rate is achieved under certain pressure).
8. The sample size for the training set
This question is not applicable. This is a physical device submission; there is no "training set" as understood in machine learning. The design and manufacturing processes are informed by engineering principles, historical data (including predicate device performance), and regulatory standards, not by training an algorithm on a dataset.
9. How the ground truth for the training set was established
This question is not applicable for the same reasons as #8.
§ 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.”