K Number
K113565
Date Cleared
2012-05-18

(168 days)

Product Code
Regulation Number
880.5200
Panel
HO
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Multi-Med catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media.

The Vantex central venous catheters are indicated for use in patients requiring administration of solutions, blood sampling, central venous pressure monitoring and injection of contrast media. All catheters include a soft tip to reduce the risk of vessel perforation.

Device Description

The Multi-Med Central Venous Catheters (Multi-Med CVCs) and Vantex Central Venous Catheters (Vantex CVCs) and their respective convenience kits are used with Edwards monitoring instruments. They are used in patients who require the administration of solutions, blood sampling, central venous monitoring and injection of contrast media. The Multi-Med CVCs and Vantex CVCs can be used with an uncoated stainless steel guidewire (SS guidewire) or a PTFE-coated Nitinol core guidewire (Nitinol guidewire). The guidewire is included with the Multi-Med CVCs and Vantex CVCs in convenience kits or the guidewire can be packaged as a separate component.

AI/ML Overview

The provided text describes the 510(k) summary for Multi-Med Central Venous Catheters and Vantex Central Venous Catheters. This document focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific performance acceptance criteria for a novel device through a primary study.

Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment, typically found in a new device's clinical or performance study report, is not available in this submission.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission states "Comparative Verification and validation testing was conducted to compare the performance and functionality of the Multi-Med CVCs and Vantex CVCs to the predicate devices." and "The results show that the performance functionality...is substantially equivalent to the predicate devices, and provides a marked improvement in the ease of use of the pending devices in comparison to the predicate devices." However, specific quantitative acceptance criteria and detailed performance metrics are not listed.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

  • Sample Size for Test Set: Not specified. The document mentions "bench studies" and "pre-clinical animal studies," but does not provide specific sample sizes for these tests.
  • Data Provenance: Not specified. The location or nature (retrospective/prospective) of the data for the bench and pre-clinical studies is not mentioned.

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):

Not applicable/Not specified. This type of information is usually relevant for studies involving subjective interpretation (e.g., image analysis by radiologists). For medical devices like central venous catheters, performance is typically evaluated through objective measurements and pre-clinical/animal models, not by expert consensus on clinical data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable/Not specified. Adjudication methods are typically used in clinical trials or studies requiring expert review of subjective outcomes. The testing described here is primarily functional and performance-based.

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:

No. This type of study (MRMC, AI assistance) is not relevant for the evaluation of central venous catheters, which are physical medical devices, not diagnostic software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No. This is not relevant. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not explicitly stated in detail. Given the nature of CVCs, "ground truth" would likely be established through:

  • Physical measurements against specifications (for bench testing).
  • Direct observation and physiological measurements in animal models (for pre-clinical studies).
  • Biocompatibility testing standards (for biocompatibility).

8. The sample size for the training set:

Not applicable/Not specified. This device is not an AI/ML algorithm that requires a training set. The performance testing is not based on a "training set" in that context.

9. How the ground truth for the training set was established:

Not applicable/Not specified. As there is no "training set" in the context of this device, this question is not relevant.


Summary of the Study:

The studies conducted for the Multi-Med Central Venous Catheters and Vantex Central Venous Catheters were primarily for comparative verification and validation testing to demonstrate substantial equivalence to existing predicate devices (K955839, K992532, K091709, K100739, K110167).

The testing regimen included:

  • Side-by-side comparative bench testing: This would involve comparing physical and functional characteristics of the new devices against the predicate devices.
  • Pre-clinical animal studies: These studies would evaluate the device's performance and safety in vivo in an animal model.
  • Biocompatibility testing: To ensure the materials used are safe for contact with the body.

The conclusion of these studies was that the Multi-Med CVCs and Vantex CVCs and the pending guidewire are substantially equivalent to the predicate devices in performance and functionality, and demonstrate a "marked improvement in the ease of use." This indicates that the device meets the regulatory threshold of substantial equivalence for its stated Indications for Use. Specific acceptance criteria or detailed raw performance data that would typically be found in a full study report are not part of this 510(k) summary.

§ 880.5200 Intravascular catheter.

(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).