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510(k) Data Aggregation
(194 days)
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
Here's a breakdown of the acceptance criteria and study information for the ArteriA Occlusion Balloon, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1, Biological Evaluation of Medical Devices (External communicating, blood contact, short duration <24 hrs.) | Test results confirmed biocompatibility. |
| Sterilization | ISO 11135, Validation and routine control of ethylene oxide sterilization (Sterility Assurance Level (SAL) of 10⁻⁶) | Validated to a SAL of 10⁻⁶. |
| Performance (Dimensional) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Balloon Compliance & Integrity) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Catheter Tensile Strength) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Torque Strength) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Flexibility) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
| Performance (Trackability) | ISO 10555, Sterile, single use intravascular catheters, Parts 1 and 4 | Meets or exceeds requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set for any of the performance studies. It also does not provide information on data provenance (e.g., country of origin, retrospective or prospective). The studies described are engineering/laboratory tests, not clinical studies with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the studies described are laboratory and engineering performance tests of the device itself, not evaluations of a diagnostic algorithm where expert ground truth would be established.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not reported. The information provided describes device performance and safety testing, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This information is not applicable. The device described is a physical medical device (an occlusion balloon catheter), not an algorithm or AI software. Therefore, there is no "algorithm only" performance to report.
7. The Type of Ground Truth Used
The "ground truth" for the tests described are the specified requirements and benchmarks within the referenced ISO standards (ISO 10993-1, ISO 11135, and ISO 10555 Parts 1 and 4). For example, a "ground truth" for tensile strength would be a minimum force required before failure, as defined by the standard.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" in the context of this device's testing, as it is a physical medical device, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
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