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K Number
K991001
Device Name
MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER
Manufacturer
EP MEDSYSTEMS
Date Cleared
1999-07-15

(112 days)

Product Code
DRF
Regulation Number
870.1220
Type
Special
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ProCath® Electrophysiology (EP or Electrode) Catheters are indicated for temporary use in electrophysiology studies, intracardiac pacing, stimulation, sensing and ECG recording only.

Device Description

Electrophysiology Catheter (Steering Modification)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device: "ProCath Electrophysiology Catheter (Steering Modification)". It confirms that the device is substantially equivalent to a legally marketed predicate device.

Unfortunately, the provided text does not contain the detailed information necessary to answer your specific questions regarding:

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

The letter focuses on the regulatory clearance process, stating that the device is substantially equivalent to existing devices and can be marketed. It does not elaborate on the specific performance studies, test methodologies, or data characteristics beyond stating the "Indications for use" of the catheter.

To get the information you are looking for, you would generally need to refer to the actual 510(k) submission document (if publicly available in more detail than this summary letter) or any related clinical/performance study reports.

§ 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).