(121 days)
VPS Catheters are indicated for short or long-term peripheral access to the central venous system for intravenous therapy and injection of contrast media. For blood sampling, infusions, or therapies, use a 4F or larger catheter. The maximum recommended injection rate is 2cc/sec for the 3F catheter and 5cc/sec for the 4F and 5F catheters. The VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console) sold separately.
The VPS Catheter and VPS Stylet are designed for use together and with the VPS Console. The VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter/Stylet is sterile, single use, non-pyrogenic and non-toxic.
The VPS Catheters are single lumen (3 and 4 Fr) or dual lumen (5 Fr) central venous access catheters made from soft, radiopaque medical grade polyurethane and packaged with the VPS Stylet in a tray with the accessories necessary for a percutaneous microintroducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper open ended design with a working length of 50 or 55 cm. VPS Catheters are marked at 1 cm intervals and labeled every 5 cm for the entire length.
The VPS Stylet is a 6 foot long polymeric tube which contains a Doppler sensor at the distal tip and an intravascular electrocardiogram (ivECG) signal sensing wire. The Doppler sensor and the ivECG signal sensing wire, when connected to the VPS Stylet are used to detect and transmit physiological information to the VPS Console (available separately). The VPS Stylet has an outer diameter of 0.019 inches and is designed to be used with the compatible VPS Catheter with an inner lumen of 0.021 inches.
The provided text describes the VasoNova VPS Catheter and its 510(k) submission (K083920). However, the document focuses on regulatory approval based on in vitro performance data for substantial equivalence to a predicate device, rather than a clinical study evaluating AI performance with human readers, or a standalone AI algorithm. It does not mention any AI components in the context typically found in AI/ML medical device submissions.
Therefore, many of the requested sections about AI-specific studies (e.g., MRMC studies, standalone AI performance, training set details, expert ground truthing for AI) cannot be answered from the provided text. The device is a central venous catheter with a stylet containing a Doppler sensor and an ivECG sensing wire, implying it facilitates sensing, but there is no mention of an AI algorithm interpreting these signals for diagnostic or predictive purposes.
Here's a breakdown of the information that can be extracted or inferred from the provided text, and where gaps exist for AI-specific questions:
Acceptance Criteria and Device Performance (based on in-vitro testing)
| Acceptance Criteria Category | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Mechanical/Physical | Meets acceptance criteria for: |
| Static, burst and dynamic pressure | - |
| Physical characteristics | - |
| Flexural fatigue and flexibility | - |
| Flow rate | - |
| Collapsibility and elongation | - |
| Tensile and torque strength | - |
| Freedom from air leakage | - |
| Priming volume | - |
| Biocompatibility | Meets acceptance criteria for: |
| Mechanical hemolysis |
Note: The document states that "In vitro testing demonstrates that the subject device meets all acceptance criteria." However, it does not provide specific numerical values or detailed acceptance limits for each criterion. It only lists the categories of tests performed.
Study Details (based on what's available in the text)
Given that this is a 510(k) summary for a physical medical device (catheter) and not an AI/ML device, the following details are either not applicable or not provided:
1. Sample sized used for the test set and the data provenance:
* Test Set Sample Size: Not applicable. The performance data is based on "in vitro testing," which generally involves laboratory measurements on device prototypes or production samples, not a clinical "test set" of patient data. The specific number of samples tested for each in vitro criterion is not provided.
* Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, as it's in-vitro testing.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable. Ground truth, in the context of expert consensus, is typically for clinical or imaging data interpretation, which is not the subject of this 510(k) summary. The acceptance criteria for the in-vitro tests would be defined by engineering standards and internal specifications.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable for in-vitro physical performance testing.
4. 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 a catheter, not an AI-powered diagnostic tool requiring human reader studies.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
* Not applicable. There is no mention of an "algorithm only" component for this device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* For the in-vitro tests, the "ground truth" would be established by validated measurement techniques and adherence to predefined engineering specifications and standards (e.g., ASTM, ISO standards for catheters). It is not expert consensus, pathology, or outcomes data.
7. The sample size for the training set:
* Not applicable. This document does not describe an AI/ML algorithm or a training set.
8. How the ground truth for the training set was established:
* Not applicable. This document does not describe an AI/ML algorithm or a training set.
Summary of AI Relevance:
The provided 510(k) summary describes a central venous catheter and its approval based on in-vitro performance testing demonstrating substantial equivalence to predicate devices. It does not contain any information regarding Artificial Intelligence (AI) components, algorithms, or associated studies (such as MRMC, standalone AI performance, or details on training/test sets for AI models). The questions regarding AI performance criteria are not applicable to the content of this specific regulatory document.
§ 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.”