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K Number
K961401
Device Name
HP CATHSTATION - MODEL M1264B
Manufacturer
HEWLETT-PACKARD CO.
Date Cleared
1996-10-08

(180 days)

Product Code
DPS
Regulation Number
870.2340
Type
Traditional
Panel
CV
Reference & Predicate Devices
K903771
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

As for the current HP Cathstation, the added NBP module is intended for use in the cardiac cath lab on adult, pediatic, and nonatal patients undergoing cardiac cath procedures. The intended use for the HP Cathstation NBP module is the same as the intended use for the legally marketed predicate device and several other products currently on the market.

Device Description

The HP Cathstation is modified by the addition of the HP M1008B Noninessive Blood Pressure (NBP) plug-in moduled by the HD M1008) Noninvasive Blood Pressure (NBP) plug-in module for display and recording of NBP numerics on the HP Cathstation.

AI/ML Overview

The provided text describes a 510(k) submission for a modification to the Hewlett-Packard Model M1264B Cathstation, specifically the addition of an HP M1008B Noninvasive Blood Pressure (NBP) plug-in module.

However, the document is a Summary of Safety and Effectiveness, which typically outlines the device and its intended use, but does not contain the detailed acceptance criteria and study results for performance validation. It states that "Performance specifications for this modification have been validated," but it does not provide the specifics of those validations.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The document explicitly mentions:

  • No detailed acceptance criteria.
  • No reported device performance figures.
  • No information on sample sizes for test or training sets.
  • No details on data provenance.
  • No mention of experts or ground truth establishment.
  • No adjudication method is described.
  • No MRMC or standalone study details are provided.
  • No information on how ground truth was established for training or testing.

The document focuses on:

  • Identifying the device and predicate device.
  • Stating its intended use.
  • Claiming substantial equivalence based on technological characteristics and the general statement that performance specifications have been validated, along with compliance to safety standards.

§ 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).