(141 days)
VPS Catheters are indicated for short or long-term central access to the central venous system for intravenous therapy, central venous pressure monitoring and contrast studies. For blood or hyperalimentation delivery, 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. Each VPS Catheter is indicated for use by itself or with the VPS System (Stylet and Console).
The VPS Catheter is designed for use with or without the VPS Console. When sold together, the VPS Catheter is preloaded with the Stylet and supplied in a tray. The VPS Catheter is sterile, single use, non-pyrogenic and non-toxic.
VPS Catheters are single lumen (3F and 4F) or dual lumen (5F) open-ended central venous access catheters fabricated from a soft, radiopaque, biocompatible polyurethane material with a working length of 50 or 55 cm and catheter markings at 1 cm intervals and 5 cm increments. VPS Catheters are packaged sterile with the VPS Stylet in a tray with accessories necessary for a percutaneous micro-introducer placement (Modified Seldinger or Seldinger technique). The VPS Catheters feature a reverse-taper design.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static, burst and dynamic pressure | Not specified | Device "meets all acceptance criteria" |
| Physical characteristics | Not specified | Device "meets all acceptance criteria" |
| Flexural fatigue and flexibility | Not specified | Device "meets all acceptance criteria" |
| Flow rate | Not specified | Device "meets all acceptance criteria" |
| Tensile and torque strength | Not specified | Device "meets all acceptance criteria" |
| Freedom from air leakage | Not specified | Device "meets all acceptance criteria" |
| Priming volume | Not specified | Device "meets all acceptance criteria" |
| Mechanical hemolysis | Not specified | Device "meets all acceptance criteria" |
| Collapsibility and elongation | Not specified | Device "meets all acceptance criteria" |
Note: The document states that "Previously provided in vivo and in vivo testing demonstrated that the subject device meets all acceptance criteria." However, the specific quantitative acceptance criteria for each test are not detailed in the provided text.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "in vivo and in vitro testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The performance data section refers to "in vivo and in vitro testing" results, but there is no mention of expert-established ground truth for these tests.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned in the provided text. The performance data focuses on device and material characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance was assessed.
7. The Type of Ground Truth Used
The ground truth for the performance tests described (e.g., static pressure, flow rate, tensile strength) would be the objective measurements obtained during the actual physical and mechanical testing of the catheter. This is not explicitly detailed but implied by the nature of the tests. There is no mention of expert consensus, pathology, or outcomes data as a form of ground truth for these specific performance criteria.
8. The Sample Size for the Training Set
This question is not applicable as the device is a physical catheter and not an AI/ML algorithm that would require a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a physical catheter and not an AI/ML algorithm.
§ 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.”