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K Number
K061977
Device Name
PELEX-04 WIRELESS ELECTROCARDIOGRAPH WITH SOFTWARE ACCESSORIES
Manufacturer
PINMED, INC
Date Cleared
2006-07-21

(8 days)

Product Code
DXH
Regulation Number
870.2920
Type
Traditional
Panel
Cardiovascular
Reference & Predicate Devices
N/A
Predicate For
K100813
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • 1-12 lead electrocardiograph capable of recording and transmitting standard ECGs for . the purpose of cardiac monitoring and diagnosis; the system incorporates recording/ transmitting circuitry, a package of firmware and software, and is intended for use by a medical professional
  • . The ECG can be recorded and transmitted to a local or remote receiving station for consultation with a medical professional
  • The ECG can be recorded and transmitted to a local or remote hand-held device or a . Personal Computer or a printer for viewing and processing
  • . Allows patients at remote locations to display and transmit their ECG data to medical professionals via a communication device to a remote server
  • . Intended for self-testing by patients and by healtheare professionals at home and in medical settings
Device Description

Pelex-04 wireless electrocardiograph with software accessories (Personal Heart Expert software, Pelex Server&Database software, and Pelex Explorer software)

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Pelex-04 Wireless Electrocardiograph with Software Accessories." It does not contain information about acceptance criteria or specific study data to prove the device meets acceptance criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information. The document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for the test set or data provenance.
  3. Number of experts or their qualifications for ground truth.
  4. Adjudication method for the test set.
  5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Information on a standalone algorithm performance study.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

§ 870.2920 Telephone electrocardiograph transmitter and receiver.

(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).