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510(k) Data Aggregation
(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.
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(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.
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(74 days)
The SecurAcath is a PICC and is indicated for short and long term use in peripheral vessels to access the central venous system. The catheter may be used for blood sampling and/or infusion therapy. 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 60 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 provided text describes a 510(k) premarket notification for the SecurAcath Catheter. This document is a regulatory submission for a medical device and, as such, focuses on demonstrating substantial equivalence to existing devices rather than a detailed clinical study proving performance against specific acceptance criteria with statistical rigor in the way a clinical trial for a new drug or complex diagnostic device might.
Here's an analysis based on the provided text, addressing the requested information where applicable:
Acceptance Criteria and Device Performance
The provided text does not explicitly state quantitative acceptance criteria in a table format with specific thresholds and corresponding reported device performance. Instead, it makes a general statement about performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Product Specifications are met | "The performance data demonstrates that the device meets all the product specifications." |
| Device is safe and effective for intended use | "Test results demonstrate that the device is safe and effective for its intended use." |
| Securement reliability | Performance testing included, and results demonstrate safety and effectiveness. |
| Catheter tensile strength | Performance testing included, and results demonstrate safety and effectiveness. |
| Dimensional verification | Performance testing included, and results demonstrate safety and effectiveness. |
| Substantially equivalent to predicate devices | "The SecurAcath™ has the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy." |
Note: The acceptance criteria here are inferred from the types of performance testing mentioned and the overall goal of a 510(k) submission, which is to show safety and effectiveness, often by demonstrating substantial equivalence to a legally marketed device. Specific numerical targets for these criteria are not provided in this excerpt.
Study Information:
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Sample size used for the test set and the data provenance:
- The document mentions "performance test data is provided in the 510(k) submission," but it does not specify the sample size for any test set or provide details about the data provenance (e.g., country of origin, retrospective or prospective). The tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are typically bench or engineering tests, not clinical studies involving human patients.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The performance tests mentioned (dimensional verification, securement reliability, catheter tensile strength) are engineering/bench tests and would not typically involve experts establishing "ground truth" in the clinical sense (like radiologists marking images). The "ground truth" for these tests would be derived from physical measurements and engineering standards.
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Adjudication method for the test set:
- Not applicable. As the tests are engineering/bench tests, there wouldn't be an adjudication method in the context of clinical expert review.
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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 device is a catheter, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI assistance is irrelevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the mentioned performance tests, the "ground truth" would be based on engineering specifications and measurements conforming to industry standards or internal design requirements. For example, tensile strength would be measured against a predefined breaking point, and dimensions would be verified against blueprint specifications.
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The sample size for the training set:
- Not applicable. As this is a physical medical device and not an AI/machine learning model, there is no "training set."
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How the ground truth for the training set was established:
- Not applicable. There is no training set for a physical medical device.
In summary: The provided document is a 510(k) summary for a physical medical device. It focuses on demonstrating that the device meets its own product specifications through various performance tests (dimensional, securement, tensile strength) and is substantially equivalent to predicate devices. It does not contain information related to clinical studies, AI performance, or ground truth establishment by experts in the context of diagnostic performance, as these are not relevant to this type of device and submission.
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