(382 days)
The COOK Spectrum® Silicone Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring. The catheter is impregnated with the antimicrobials minocycline and rifampin to help provide protection against catheter-related bloodstream infections (CRBSI). It is not intended to be used as a treatment for existing infections. Catheters are available in single and double lumen PICC: and single, double and triple lumen CVC. The device is supplied sterile and intended for one-time use.
The COOK Spectrum® Silicone Catheters are single, double or triple lumen central venous catheters; and single and double lumen peripherally inserted central catheters available in sizes ranging from 4Fr single lumen to 12Fr double lumen. including an 8Fr triple lumen device. Catheter lengths range from 8 to 60 cm. The catheter is impregnated with an antimicrobial combination of minocycline and rifampin. The device is supplied sterile and intended for one-time use.
The document describes a 510(k) premarket notification for the COOK Spectrum® Silicone Catheter, but it does not provide explicit acceptance criteria with numerical thresholds or a detailed study report that proves the device meets specific acceptance criteria for outcomes related to AI or algorithmic performance.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices and describes various non-clinical and clinical tests conducted to assure safety and effectiveness.
Here's an analysis based on the provided text, addressing your points where possible, and noting what information is not available in the document:
Description of Acceptance Criteria and Device Performance (Based on provided text)
The document describes several aspects tested to ensure safety and effectiveness, but it doesn't present these as explicit "acceptance criteria" with numerical targets and reported performance in a table format as you requested. Moreover, the focus is on a medical device (catheter) with antimicrobial properties, not an AI or algorithmic device.
Table 1: Acceptance Criteria and Reported Device Performance (Reconstructed from available information)
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from text) |
|---|---|
| Biocompatibility: Device material is safe for human contact. | Biocompatibility testing was performed. (No specific results or acceptance levels reported in this summary). |
| Mechanical Integrity (Tensile, Vacuum, Pressure): Catheter can withstand expected forces and pressures. | Tensile Testing, Vacuum and Pressure Testing were performed. (No specific results or acceptance levels reported). |
| Antimicrobial Effectiveness (Minocycline and Rifampin): Catheter impregnation effectively inhibits microbial growth. | HPLC and Zone of Inhibition Testing were performed. |
| Flow Performance: Catheter maintains adequate flow rates for intended use. | Flow Testing was performed. (No specific results or acceptance levels reported). |
| Shelf-Life Stability: Device maintains its properties over its shelf life. | Shelf-Life Testing was performed. (No specific results or acceptance levels reported). |
| Reduction of Catheter-Related Bloodstream Infection (CRBSI): Significantly reduces the rate of CRBSI. | In a prospective, randomized clinical trial, results indicate the COOK Spectrum® Silicone Catheter can significantly reduce the rate of catheter-related bloodstream infection (CRBSI). |
| Clinical Safety (Other Complications): Does not increase other complications compared to control. | Clinical safety was evaluated by comparing rates of each complication (other than CRBSI) for treatment vs. control cohort. (Implied that no significant increase was found, but no specific data provided). |
| Prevention of Catheter Colonization: Reduces microbial colonization on the catheter. | Catheters were evaluated after removal by zone of inhibition testing against MRSA (CI4371) and culture techniques (roll plate and sonication). (Relates to mechanism of CRBSI reduction, specific results not detailed). |
| Catheter Performance (Mechanical): Low incidence of leaks, bleeding, thrombosis, or need for repositioning. | Performance was evaluated by comparing incidence of catheter removal due to leak, bleeding, thrombosis, and incidence of repositioning between study groups. (Implied no adverse performance, specific data not detailed). |
Detailed Study Information (Where Available or Not Applicable)
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document mentions a "prospective, randomized clinical trial" with "well matched treatment and control cohorts" but does not specify the sample size for either cohort.
- Data Provenance: The study was a "prospective, randomized clinical trial," implying real-world data collection, likely from clinical sites where the study was conducted. The country of origin is not specified, but Cook Incorporated is a US-based company.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This document describes a clinical trial for a physical medical device (catheter) and does not involve experts establishing "ground truth" for a test set in the context of an AI/algorithmic device. Clinical outcomes (CRBSI, complications) served as the primary endpoints, assessed by standard clinical methods.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable in the context of an AI/algorithmic medical device. Clinical trial outcomes are typically adjudicated by an independent clinical events committee or defined clinical criteria, but this is not detailed in the provided summary.
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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 study is for a physical medical device, not an AI or image-reading algorithm.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This study is for a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the clinical trial, the "ground truth" for effectiveness was outcomes data, specifically the occurrence of "definite CRBSI" as the primary outcome measure. Clinical safety was also based on the incidence of various complications. Catheter colonization was determined by laboratory culture techniques (roll plate and sonication) and zone of inhibition testing against MRSA for removed catheters.
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The sample size for the training set:
- Not applicable. This document describes a traditional medical device, not an AI/ML model that requires a training set. The clinical trial described is for validating the device's performance directly.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no AI/ML training set involved.
§ 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).