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K Number
K092118
Device Name
ANGIOGRAPHIC CATHETER, MODEL ANGIOS
Manufacturer
Oscor Inc.
Date Cleared
2010-01-13

(183 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The model Angios angiographic catheters are designed to be used for delivering radiopaque media to selected sites in the vascular system in conjunction with routine diagnostic procedure.

Device Description

Not Found

AI/ML Overview

There is no information in the provided document about the acceptance criteria or a study that proves the device meets specific performance criteria. The document is an FDA 510(k) clearance letter for the Angiographic Catheter, Model Angios™. It confirms that the device is substantially equivalent to legally marketed predicate devices for its intended use, but it does not detail performance statistics or study results.

Therefore, I cannot provide the requested information about:

  1. A table of acceptance criteria and the reported device performance.
  2. Sample size used for the test set and data provenance.
  3. Number of experts used to establish ground truth and their qualifications.
  4. Adjudication method for the test set.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study, if done, and its effect size.
  6. Standalone performance study for the algorithm.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).