(85 days)
The FAS Endoluminal Brush is intended to collect a biofilm or fibrin sample, which is suitable for microbiological analysis, from the inner lumen surface of an in-dwelling central venous catheter.
The FAS Endoluminal Brush is a single use, sterile disposable medical device. The device itself consists of nylon bristles wound into a stainless steel flexible wire, which is further wound into a stainless steel tubular handle. The brush is enclosed in a plastic sterile sheath that is heat sealed at the proximal end and is attached to a Luer lock at its distal end. The Luer lock attachment provides the brush access to the catheter lumen in a sterile environment.
The FAS Endoluminal Brush kit also contains accessory items including a measuring tape, patient drape, instructions for use, wire clippers, and specimen container and cap, and a patient identification label.
The provided information for K993614, the FAS Endoluminal Brush, does not contain a detailed study proving the device meets specific performance acceptance criteria. The submission states, "Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally and by a third party conforms to the device performance specifications." However, it does not provide the concrete acceptance criteria (e.g., sensitivity, specificity, accuracy, or a specific metric for collecting biofilm/fibrin samples), nor does it present the study data, sample sizes, or methods used to establish ground truth.
Therefore, many of the requested details cannot be extracted from the given text.
Here's what can be inferred or explicitly stated based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document | "Actual device performance satisfies the design intent." |
| Not explicitly stated in the document | "Actual device performance as tested internally and by a third party conforms to the device performance specifications." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document globally refers to "Testing" but does not give specific numbers of cases or samples.
- Data Provenance: Not specified. It mentions testing was done "internally and by a third party," but it does not detail the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified.
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
- MRMC Study: No, this device is a physical medical device (brush for sample collection), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: No, this device is a physical medical device, not an algorithm. Therefore, a standalone algorithm performance study is not applicable and was not performed. The performance described relates to the physical characteristics and function of the brush.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified. Given the device's function (collecting biofilm or fibrin for microbiological analysis), the ground truth would likely involve laboratory confirmation of successful sample collection and microbiological analysis of those samples. However, the document does not detail how this was established or what metrics were used to define "successful collection" or "suitable for microbiological analysis."
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the context of this physical device. This device is not an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable for this physical device.
Summary of available information regarding testing:
The 510(k) summary for the FAS Endoluminal Brush focuses on demonstrating substantial equivalence to predicate devices (Digene Cervical Brush, Mill-Rose Microbiology Brush) for its intended use: collecting biofilm or fibrin samples from central venous catheters for microbiological analysis. The review indicates that "Testing was performed according to international standards to assure biocompatibility, sterility assurance, and clinical safety of the device." The conclusion is that "Test results support the conclusion that actual device performance satisfies the design intent" and "conforms to the device performance specifications," based on internal and third-party testing. However, the specific details of these performance specifications, the exact test protocols, the data obtained, and the statistical analysis are not provided in this summary.
§ 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.”