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K Number
K033963
Device Name
EP DEFLECTABLE CATHETERS
Manufacturer
EP MEDSYSTEMS, INC.
Date Cleared
2004-04-15

(115 days)

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

The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

Device Description

EP Deflectable Catheters

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for the "EP Deflectable Catheter." This letter primarily addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market. It does not contain details about the specific performance metrics, clinical studies, or acceptance criteria that would typically be required to answer your request.

Therefore, I cannot provide:

  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.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or 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.

To obtain this kind of information, you would typically need to consult the original 510(k) submission, scientific publications about the device, or contact EPMedSystems directly.

§ 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).