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K Number
K973401
Device Name
TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS)
Manufacturer
CORDIS CORP.
Date Cleared
1997-11-18

(70 days)

Product Code
DQO
Regulation Number
870.1200
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K991673
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Cordis TempoTM 4 Angiography Catheter is designed to deliver radiopaque contrast medium to selected sites in the vascular system.

Device Description

The Cordis Tempo™ 4 Angiography catheter is a single lumen catheter consisting of polyamide and polyurethane materials with a proximal strain relief and hub. The catheters are available in various lengths and tip configurations and accept guidewires with diameters of 0.035" or 0.038" depending on the configuration.

AI/ML Overview

The provided documentation is a 510(k) premarket notification for the Cordis Tempo™ 4 Angiography Catheter. This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device and does not typically include the detailed performance study information requested for AI/software-based devices.

Therefore, the information requested in points 1-9 cannot be extracted from this document.

The document states:

  • The Cordis Tempo™ 4 Angiography Catheter is similar in design, construction, indication for use and performance characteristics to other commercially available angiography catheters. This is the basis for its substantial equivalence, rather than a detailed study proving performance against specific acceptance criteria.
  • All appropriate Biocompatibility tests were successfully performed on the materials used for the Cordis Tempo™ 4 Angiography Catheters per ISO 10993-1. This is a general statement about biocompatibility, not a performance study for the device's primary function as an angiography catheter.
  • Performance standards have not been established by the FDA under Section 514 of the Food, Drug, and Cosmetic Act. This means there are no pre-defined, FDA-mandated performance metrics the device had to meet.

In summary, this document is a regulatory submission for a traditional medical device, not a software-driven or AI-based device, and as such, it does not contain the type of AI/ML performance study details requested.

§ 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).