(139 days)
The SecurAcath PICC is indicated for short or long term peripheral access to the central venous system. The catheter may be used for intravenous therapy, power injection of contrast media, blood sampling and/or infusion therapy. The maximum recommended infusion rate is 5 m/sec and the maximum pressure of power injectors may not exceed 300 psi. The SecurAcath PICC includes means to secure the catheter via a subcutaneous anchor below the insertion site.
The SecurAcath is a single use, sterile, flexible PICC catheter with a useful lengths of up to 55 cm. The length of the catheter has markings at 1 cm interval to allow the user to trim the catheter to the required length. The catheter has a built in subcutaneous securement mechanism to stabilize and keep the catheter in place. The catheter has two lumens which are identical in properties and characteristics.
The device is compatible with all 0.018" and smaller guidewires. The proximal end of the catheter has the standard radiology PICC configuration plus the activation mechanism of the securement system built into the Y-body. The catheter has been tested to be compatible with MRI (MR conditional) and use with power contrast injectors.
This document describes the 510(k) summary for the SecurAcath PICC, a catheter used for central venous access. Since the provided text focuses on regulatory approval and substantial equivalence, the performance data section is brief, and specific acceptance criteria with reported device performance in a detailed table or a structured study narrative are not explicitly presented.
Based on the provided information, the following can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device meets all the product specifications." However, specific acceptance criteria values and corresponding reported performance metrics are not detailed in the provided text.
The document lists broader categories of performance testing:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Meets specifications |
| Dimensional Verification | Meets specifications |
| Securement Reliability | Meets specifications |
| Catheter Tensile Strength | Meets specifications |
| Power Injection Capabilities | Meets specifications |
Additionally, it states:
- Maximum recommended infusion rate: 5 ml/sec
- Maximum pressure of power injectors: 300 psi
- MRI Compatibility: MR conditional
- Guidewire compatibility: 0.018" and smaller guidewires
These points could be considered part of the performance specifications the device aims to meet.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The performance data mentioned appears to be derived from in-house testing rather than clinical study data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The performance data seems to be based on engineering and laboratory testing rather than expert-derived ground truth from human interpretation.
4. Adjudication Method
This information is not provided in the document. Given the nature of the listed performance tests (e.g., biocompatibility, tensile strength), an adjudication method in the context of expert review would likely not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study, nor any assessment of human readers improving with or without AI assistance. This device is a medical catheter, not an AI-assisted diagnostic tool.
6. Standalone Performance Study (Algorithm Only)
This information is not applicable. The SecurAcath PICC is a physical medical device, not an algorithm or software. Standalone performance for an algorithm would not be relevant in this context.
7. Type of Ground Truth Used
The "ground truth" for the device's performance appears to be established through engineering specifications, laboratory test methods, and compliance with industry standards for similar medical devices. For example, biocompatibility would be assessed against established biological safety standards, and tensile strength against predefined mechanical limits.
8. Sample Size for the Training Set
This information is not applicable. As a physical medical device, it does not involve a "training set" in the context of machine learning or AI.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this device.
§ 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.”