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K Number
K020890
Device Name
SPYGLASS 4 FR ANGIOGRAPHICY CATHETER
Manufacturer
ST. JUDE MEDICAL
Date Cleared
2002-04-17

(29 days)

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

Spyglass™ Angiographic Catheters are designed for the delivery of radiopaque contrast media during angiographic procedures.

Device Description

The Spyglass™ Angiographic Catheter is a fixed-curve, catheter that are allows introduction of contrast media to the body.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the Spyglass™ Angiographic Catheter. The provided text does not describe an AI device, and therefore does not contain information about acceptance criteria, device performance metrics (like sensitivity, specificity, AUC), sample sizes for test or training sets, ground truth establishment, or human-in-the-loop studies.

Instead, this document focuses on establishing substantial equivalence to a predicate device. The information provided is:

  • Device Name: Spyglass™ Angiographic Catheter
  • Intended Use: Designed for the delivery of radiopaque contrast media during angiographic procedures.
  • Predicate Device: Spyglass™ 6Fr & 5Fr Angiographic Catheters.
  • Comparison of Characteristics: "All technological characteristics of the Spyglass™ Angiographic Catheters are substantially equivalent to the predicate device including product design, packaging, sterilization, and labeling."

Since the document is about a traditional medical device and not an AI/ML diagnostic tool, the specific questions related to AI device performance and study methodology (like ground truth, expert adjudication, MRMC studies) are not applicable.

Therefore, I cannot provide the requested table or information because the provided text does not contain data related to an AI/ML device's acceptance criteria, performance metrics, or study design for evaluating such criteria.

§ 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).