The Ciba Corning 400 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

Device Description

The 400 Series system analyzer is a point of care and laboratory testing analyzer used to for the direct measure of whole blood samples for the determination of the following parameters:

partial pressures of carbon dioxide; pCO2
partial pressure of oxygen pO2
pH
sodium; Na*
potassium: K*
ionized calcium; Ca**
chloride: Cli
alucose
hematocrit: Hct

AI/ML Overview

The provided text describes a medical device, the Ciba Corning 400 System, an analyzer for blood gases, electrolytes, and metabolites. It details the device's function, intended use, and technological characteristics. However, it does not contain the acceptance criteria or a study proving the device meets said criteria.

Therefore, I cannot provide the requested information, particularly:

A table of acceptance criteria and reported device performance: This information is not present in the document.
Sample sized used for the test set and the data provenance: There is no mention of a test set or its sample size or origin.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a test set is not discussed.
Adjudication method for the test set: No test set or adjudication is mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This document predates widespread AI in medical devices and does not describe such a study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No such study is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth is not discussed in the context of device performance validation.
The sample size for the training set: There is no mention of a training set as this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable, as there's no training set mentioned.

The document is a "Summary of Safety and Effectiveness" from 1996 for a 510(k) submission, focusing on describing the device, its predicate, and its measurement technology. It doesn't include the detailed performance study results and acceptance criteria typically found in more extensive validation reports.

Summary

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Image /page/0/Picture/1 description: The image shows a sequence of handwritten characters, which appear to be 'K961657'. The characters are written in a bold, somewhat stylized font, with thick strokes. The overall impression is that of a handwritten code or identifier.

Summary of Safety and Effectiveness JUN 25 1996

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

1. Submitters Information

Contact person:	William J. Pignato
	Director of Regulatory Affairs

Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052

508 359-3825 Phone:

April 29, 1996 Date Summary Prepared:

2. Device Information

Proprietary Name:	Ciba Corning 400 System
Common Name:	Analyzer for Blood Gas, electrolytes and metabolites
Classification Name:	Electrode/Sensor measurement of blood gases, blood pH and blood electrolytes
Classification Number:	Calcium - 21 CFR 862.1145, Class II
	Chloride - 21 CFR 862.1170, Class II
	Glucose - 21 CFR 862.1345, Class II
	Hematocrit - 21 CFR 864.6400, Class II
	Potassium - 21 CFR 862.1600, Class II
	Sodium - 21 CFR 862.1665, Class II
	pCO2 - 21 CFR 862.1120, Class II
	p02 - 21 CFR 862.1120, Class II
	pH - 21 CFR 862.1120, Class II

1. Predicate Device Information

Name:	Model 860 Analyzer
Manufacturer:	Ciba Corning Diagnostics Corp.
510(k) Number:	D.C. # K934907

2. Device Description

The 400 Series system analyzer is a point of care and laboratory testing analyzer used to for the direct measure of whole blood samples for the determination of the following parameters:

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وء partial pressures of carbon dioxide; pCO2 ●
partial pressure of oxygen pO2 ●
. pH
sodium; Na* .
potassium: K* .
ionized calcium; Ca** .
chloride: Cli .
alucose .
hematocrit: Hct .

3. Statement of Intended Use

The Ciba Corning 400 System is intended for the point-of-care and laboratory testing of blood gases, electrolytes and metabolites in arterial, venous and capillary whole blood samples.

4. Summary of Technological Characteristics

The 400 Series System uses measurement technology that is based on electrochemical phenomena. The device use potentiometry, amperometry and conductimetric methods to convert the potential generated by the sensor to an electrical signal which the system then converts to a value that represents that concentration of a specific analyte in the whole blood sample.

The 400 Series sensors (i.e., electrodes) provide direct measurement of the specific analytes or substances in the sample. Each sensor in the 400 system is highly selective for one substances over others.

The sensors employ the use of thick-film hybrid technology and a solid-state design in place of the traditional electrodes that use internal fill solutions that are used in the traditional blood gas/electrolyte systems.

Features the planar-format sensors include:

. Suitability for use with the compact disposable measurement cartridge used with the 400 Series
Sensors require a small volume of sample (75 uL)
Sensors are maintenance free .

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The sensors use the following measurement technology:

Sensor	Measurement Technology
pH, Na+, K+, Ca++, Cl-	potentiometric method using ion-selective electrode technology
reference	silver electrode in potassium chloride and silver chloride
pCO2	potentiometric method
p02	amperometric method
glucose	amperometric method using an enzyme electrode that uses glucose oxidase
hematocrit	conductimetic method

Regulation Number and Section

§ 862.1120 Blood gases (P

CO2 , PO2 ) and blood pH test system.(a)
Identification. A blood gases (PCO2 , PO2 ) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2 , PO2 ) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.(b)
Classification. Class II.