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K Number
K082382
Device Name
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039
Manufacturer
POSSIS MEDICAL, INC.
Date Cleared
2008-12-12

(115 days)

Product Code
QEZ,DXE,OEZ
Regulation Number
870.5150
Type
Traditional
Panel
CV
Reference & Predicate Devices
K073441
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The AngioJet Ultra AVX Thrombectomy Set is intended for use with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits ≥ 3 mm in diameter.

Device Description

Each AngioJet Ultra AVX Thrombectorny Set is a sterile, single use, disposable set that includes the AngioJet AVX Thrombectomy catheter and pump in one combined unit. The AngioJet Ultra AVX Thrombectomy Set is used with the AngioJet Ultra Console. A 3-port catheter manifold is used, so that contrast media and other fluids can be injected into the vascular where the catheter is positioned.

AI/ML Overview

The provided text is a 510(k) summary for the AngioJet Ultra AVX Thrombectomy Set, indicating its substantial equivalence to a predicate device. It briefly mentions "Bench and biocompatibility testing supported using a 3-port catheter manifold and adding labeling instructions for using the AngioJet Ultra AVX Thrombectomy Set to inject contrast media and other fluids into the vascular site where the catheter is positioned." However, the document does not contain detailed information about the acceptance criteria or a specific study that proves the device meets those criteria, as requested.

Therefore, most of the requested information cannot be extracted from this document.

Here's what can be stated based on the provided text:

  • 1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the document. The document only generally states that "Bench and biocompatibility testing supported" certain aspects.

  • 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided.

  • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not provided.

  • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.

  • 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: This device is an embolectomy catheter, not an AI diagnostic tool, so an MRMC study is not applicable in this context.

  • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is an embolectomy catheter, not an AI algorithm. Its performance is inherent to its physical design and function, not an algorithm.

  • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly stated, beyond general "Bench and biocompatibility testing."

  • 8. The sample size for the training set: Not applicable for this type of device, as it's not an AI model requiring a training set.

  • 9. How the ground truth for the training set was established: Not applicable for this type of device.

§ 870.5150 Embolectomy catheter.

(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).