(41 days)
The SecurAcath device is intended to secure catheters by means of a subcutaneous anchor.
The SecurAcath Device is indicated for catheter securement to the access site by means of subcutaneous anchors in:
a) Short or long-term securement of percutaneous indwelling catheters for intravenous use
b) Short and long-term securement of percutaneous indwelling catheter for abscess/general drainage
The SecurAcath device is a standalone subcutaneous anchoring securement system used to secure the catheter to the access site. The securement is achieved by means of a blunt nitinol anchor deployed into the subcutaneous space at the catheter access site, and the clamping of the catheter shaft between the Base Assembly and Cover of the device.
The provided text is a 510(k) summary for a medical device called SecurAcath. It focuses on demonstrating substantial equivalence to a previously cleared device, not on proving the device meets general acceptance criteria through a specific clinical study with detailed performance metrics like sensitivity, specificity, or accuracy, which is typical for AI/ML-based medical devices or diagnostics.
The changes described are primarily related to manufacturing processes and materials (e.g., laser marking instead of pad printing, slight material formulation change in polypropylene, different anti-block additive in packaging, and an extended shelf life). The "performance data" section mentions engineering tests to confirm the device still meets product specifications after these changes.
Therefore, many of the requested items (e.g., sample size for test set, number of experts, adjudication method, MRMC study, ground truth types, training set details) are not applicable (N/A) for this type of submission because the device is a physical medical device (catheter securement system), not an AI/ML diagnostic or imaging device. The "acceptance criteria" here refer to ensuring the manufacturing changes do not negatively impact the device's original functionality and safety.
Here's an attempt to answer the questions based on the provided text, indicating N/A where information is not present or relevant to this type of device:
Description of Acceptance Criteria and Proving Device Meets Criteria (SecurAcath Device)
The device in question, SecurAcath, is a physical medical device (a catheter securement system), not a software or AI/ML-based diagnostic device. The acceptance criteria and "study" described in the provided document revolve around demonstrating that manufacturing/material changes to the device do not negatively impact its performance, safety, or effectiveness compared to its predicate device. The study performed is a series of engineering performance tests and material characterizations, not a clinical trial or AI model validation study.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria with specific thresholds (e.g., tensile strength > X N) alongside numerical reported performance values. Instead, it states that tests were performed to demonstrate the device "meets product specifications" and "is not negatively impacted by the material change or marking process change." The acceptance is qualitative in the sense that the new device performs "as intended" and "continues to meet the same specifications as its predicate devices."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material/Process Changes don't negatively impact performance/safety/effectiveness | The device continued to meet the same specifications as its predicate devices. Tests demonstrated that the device functions as intended. |
| Dimensional Integrity | Testing performed. (No specific numerical data provided) |
| Functional Performance | Testing performed for: |
- Joint Tensile Strength
- Base & Cover Interaction
- Hinge performance
(No specific numerical data provided, but it states results demonstrate "device functions as intended.") |
| Marking Durability | Testing performed per IEC 60601-1 for durability of markings. The laser marking does not impact safety and effectiveness. |
| Biocompatibility | Meets ISO 10993-1. (Same as predicate) |
| Sterilization & Sterility | EtO and SAL of 10-6. (Same as predicate, new packaging configuration passed testing) |
| Shelf Life | Extended to 4 years. Shelf life product was 2X sterilized, passed design verification testing including pouch seal peel and bubble leak tests. The extension does not impact safety and effectiveness. |
| Packaging Integrity | New packaging configuration passed ISTA 2A, ASTM D4169, sterile barrier performance testing and ISO 10993-7 testing. The new configuration does not impact safety and effectiveness. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a "test set" in the context of an AI/ML model. The "tests" mentioned are engineering and material verification tests (e.g., dimensional, functional, durability). The number of samples used for these engineering tests is not specified in this summary.
- Data Provenance: N/A for this type of device; no patient data or clinical data is mentioned for performance evaluation in this premarket notification. The tests are lab-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is an engineering/manufacturing change submission for a physical device. There is no "ground truth" derived from expert interpretation (e.g., radiologists, pathologists) in the context of a diagnostic or imaging study. The "truth" is established through engineering specifications and industry standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No expert adjudication of data is mentioned or relevant.
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:
- N/A. This is a physical medical device, not an AI/ML-assisted diagnostic device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The "ground truth" for this device's "performance" is its adherence to engineering specifications, material compatibility standards (e.g., ISO 10993), and functional requirements that ensure continuous safe and effective operation after manufacturing changes.
8. The sample size for the training set:
- N/A. This is a physical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established:
- N/A. Not applicable as no training set exists for this type of device submission.
§ 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.”