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K Number
K131048
Device Name
LIDCO CNAP MODULE
Manufacturer
LIDCO LTD.
Date Cleared
2013-08-28

(135 days)

Product Code
DXG
Regulation Number
870.1435
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LiDCO CNAP Module is Indicated for the continuous, non-invasive monitoring of arterial blood pressure in adults and pediatric patients from the age of 4 years by medical professionals. The LiDCO CNAP Module is intended to be used with, and display on, the LiDCOrapid V2 Monitor. The LiDCO CNAP Module supports the following parameters: Continuous and oscillometric arterial blood pressure Arterial systolic pressure Arterial diastolic pressure Arterial mean pressure Heart rate Locations of Use: Suitable patients will be receiving treatment in the following areas: Medical and Surgical Intensive Care Units Operative Sultes Step Down / High Dependency Units Trauma / Accident & Emergency Departments Coronary Intensive Care Units Cardiac Catheter Laboratories

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the LiDCO CNAP Module. It outlines the device's indications for use and regulatory classification but does not contain information about acceptance criteria or a study proving its performance.

Therefore, I cannot fulfill your request for:

  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, or its effect size
  6. If a standalone performance (algorithm only) 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

This document is a regulatory approval, not a technical performance report. To find the information you're looking for, you would typically need to consult the full 510(k) submission, scientific publications, or the manufacturer's technical documentation.

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).