LogoFDA 510(k) Search
K Number
K955847
Device Name
GYRO TIP EP CATHETER
Manufacturer
CARDIAC ASSIST DEVICES, INC.
Date Cleared
1997-01-29

(400 days)

Product Code
DRF
Regulation Number
870.1220
Type
Traditional
Panel
CV
Reference & Predicate Devices
K912213,K904080,K891908,K900765
Predicate For
K012520
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Monitor and record intra-cardiac electrical activities

Device Description

Not Found

AI/ML Overview

This document is a premarket notification (510(k)) for a medical device called the "Gyro Tip EP Catheter." It is for a device used to "monitor and record intra-cardiac electrical activities."

Unfortunately, the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria. The document is primarily a summary for a 510(k) submission, focusing on:

  • Device Identification: Name, classification, intended use.
  • Regulatory Information: Manufacturer registration, classification.
  • Labeling: Mention of draft labeling, including directions for use, indications, cautions, warnings, and precautions.
  • Substantial Equivalence: A claim that the device is substantially equivalent to existing devices (Bard Dynamic Tip Catheter, Bard Tip Deflecting Catheter, Bard Tip Deflecting Electrode Catheter, and Steerocath).
  • General Information: Reference to a more comprehensive summary for material biocompatibility, physical characteristics, and results of electrical and mechanical tests.

There is no mention of specific acceptance criteria, performance metrics, a study design, sample sizes, ground truth establishment, or expert involvement as requested. The "None Established Performance Standards" point further reinforces that no specific numerical performance standards are detailed in this summary.

Therefore, I cannot populate the table or answer the specific questions about the study from the provided text.

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).