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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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(121 days)
The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.
The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.
The provided text is for a 510(k) premarket notification for a medical device called the "ArteriA Blood Filter," which is a blood administration filter. It describes the device, its intended use, and states its substantial equivalence to a predicate device.
*However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for the purpose of demonstrating performance.
The 510(k) summary provided here focuses on administrative details, device description, intended use, and comparison to a predicate device to establish substantial equivalence based on design, materials, and function, rather than a detailed performance study proving specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text. The document states: "The basic technologies, design and function of ArteriA Medical Science, Inc.'s ArteriA Blood Filter are substantially equivalent in design, materials of construction, and intended us to the predicate device." This indicates that the regulatory submission primarily relied on demonstrating equivalence to an already approved device rather than a de novo performance study against specific acceptance criteria.
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(348 days)
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