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K Number
K973437
Device Name
HEWLETT-PACKARD MODELS M1001B ECG M1002B ECG/RESPIRATION PLUG-IN MODULES
Manufacturer
HEWLETT-PACKARD GMBH
Date Cleared
1997-12-03

(84 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
K882609
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The HP M1001B/M1002B ECG Plug-in Modules together with the Patient Monitor M1175A/M1176A are indicated for use in health care facilities by health care professionals when the patient's clinician deems it appropriate to use a device that:

  • Can measure and display multiple physiological parameters and waves' a) of one patient, and can generate alarms and printouts based on those measurements.
  • Can be used on adult, pediatric, and neonatal patients as specified in b) the Technical Data Sheets.
    1. List of supported measurements
    • ECG (a)
    • Respiration (b)
Device Description

The M1001B ECG and M1002B ECG/Respiration Modules are intended for monitoring, recording, and alarming of ECG and respiration for adult, pediatric, and neonatal patients. Existing hardware and software of the M1001B ECG and M1002B ECG/Respiration plug-in modules (which were originally cleared together with CMS under K882609) were modified. The CMS hardware and CMS software modules are unchanged. The modified M1001B ECG and M1002B ECG/Respiration plug-in modules were fully validated (including regression testing).

AI/ML Overview

This document is a 510(k) summary for the M1001B ECG and M1002B ECG/Respiration Modules. It describes the intended use and states that the devices were fully validated, including regression testing, after modifications to their hardware and software. It also claims substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria, specific device performance metrics, study design, sample sizes, ground truth establishment, or expert qualifications. The document focuses on regulatory approval and substantial equivalence rather than a detailed performance study.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the given input. The information you're asking for is not present in the provided text.

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).