(345 days)
The SecurAcath Universal Device is indicated for short or long term securement of percutaneous indwelling catheters for intravenous use to the access site by means of a subcutaneous anchor.
The SecurAcath Universal is a single use, sterile device for securing indwelling catheters. The device is a stand-alone accessory to percutaneous indwelling catheters and consists of a subcutaneous anchor that is deployed in the subcutaneous space at the catheter access site to reduce catheter migration and pull-out.
The provided 510(k) summary for the Interrad Medical, Inc. SecurAcath Universal device states that "The company performed testing to demonstrate that the device meets all product specifications. In all instances, the SecurAcath Universal functioned as intended." However, it does not provide explicit details on specific acceptance criteria values or the results of those tests. Instead, it broadly references "product specifications" and general function.
Therefore, the following information is based on the limited data available in the provided document. If a more detailed performance study report were available, this response could be more comprehensive.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Product Specifications (specific values not provided in this document) | "In all instances, the SecurAcath Universal functioned as intended." |
| Substantial Equivalence to predicate devices (SecurAcath, Statlock, Arrow Stapling device) | "The SecurAcath Universal has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the device and its predicate devices raise no new issues of safety or effectiveness as demonstrated by performance testing conducted. Thus, the SecurAcath Universal is substantially equivalent." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "performance testing conducted" but does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective nature of the study).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not indicate the use of experts or the establishment of ground truth in the context of human interpretation of data for the performance testing. The testing appears to be focused on the device's physical function and adherence to technical specifications.
4. Adjudication Method for the Test Set
As there's no mention of expert-based ground truth establishment or human interpretation of data, an adjudication method is not applicable in the context of the information provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted, as the device is a physical catheter securement device and not an AI-powered diagnostic or interpretive tool that would involve human readers.
6. Standalone (Algorithm Only) Performance
A standalone performance study for an algorithm was not conducted, as this device is a physical medical device, not a software algorithm. The "performance testing" referred to likely involves mechanical and biocompatibility testing, not algorithmic performance.
7. Type of Ground Truth Used
The ground truth for the "performance testing" would be the device's adherence to its predefined technical specifications and functional requirements. This would likely involve objective measurements for aspects like securement strength, material integrity, ease of deployment, and biocompatibility, rather than expert consensus on interpretive tasks or pathology/outcomes data in the traditional sense.
8. Sample Size for the Training Set
As this is a physical medical device and not an AI/ML algorithm that requires a training set, the concept of a "training set" and its "sample size" does not apply.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for an AI/ML algorithm, this question does not apply.
§ 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.”