K Number

Device Name

IBC GAS CELL COMPONENTS (1/2, 3/8, 1/4)

Manufacturer

INTERNATIONAL BIOPHYSICS CORP.

Date Cleared

1996-05-14

(172 days)

Product Code

DRY

Regulation Number

870.4330

Intended Use

The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The IBC Gas Cell Component may be substituted for the CDI Gas Cell Component in the construction of Extracorporeal Custom Tubing Packs either by the manufacturer of such packs or by the end user to modify his or her pack as needed.

Device Description

The IBC Gas Cell component was developed for use with the CDI Model 300 Blood Gas Monitoring System manufactured by 3M. The final geometry of the IEC Gas Cell component is identical to the final geometry of the 3M Gas Cell component, and both are fabricated from the same plastic materials. The functional properties of the Gas Cells are determined by the final assembly geometry and the materials employed in construction, especially the two membrane materials. The final geometry of the IBC and CDI components are identical. Using chemical analysis, electron microscopy and information in the public domain, the membranes were sourced from the same supplier used by 3M. The device employs three photochemical sensors to measure pO2, pCO2, and pH. Additionally, there is a thermo-electronic sensor for the direct measurement of temperature.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

CDI Gas Cell Component (Catalog Numbers 6620, 6630 & 6640)

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a component for a blood gas monitoring system that uses photochemical and thermo-electronic sensors. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".

Therapeutic

No
The device is a gas cell component that measures blood gas parameters (pO2, pCO2, pH, temperature) as part of a blood gas monitoring system. It is a diagnostic tool, not a therapeutic one, as it provides information for diagnosis and monitoring rather than directly treating a condition.

Diagnostic

Yes

Explanation: The device employs three photochemical sensors to measure pO2, pCO2, and pH, and a thermo-electronic sensor for temperature. These measurements of physiological parameters are used to assess the patient's condition, which is a diagnostic function. The "Intended Use" states it's for use with a "Blood Gas Monitoring System," further supporting its role in monitoring and thus diagnosing blood gas levels.

SaMD (Software as a Medical Device)

The device described is a physical component (Gas Cell) made of plastic materials with photochemical and thermo-electronic sensors. It is a hardware device intended for use with a blood gas monitoring system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The device is a component of a blood gas monitoring system used in an extracorporeal circuit during cardiovascular surgery. While it measures blood gases (pO2, pCO2, pH) and temperature, these measurements are taken in the extracorporeal circuit and are used to monitor the patient's blood during the procedure. This is considered in vivo monitoring rather than in vitro diagnostic testing.
Device Description: The description reinforces its role as a component within a system that measures parameters directly from the blood flowing through the extracorporeal circuit.
Anatomical Site: The anatomical site is the "Extracorporeal circuit," which is outside the patient's body but still part of the system circulating the patient's blood.
Performance Studies: The performance studies involve circulating blood through the device and comparing its readings to a blood gas analyzer (IL Blood Gas Analyzer and IL Co-Oximeter), which are IVD devices. This comparison is to validate the performance of the monitoring component, not to perform a diagnostic test itself.

IVD devices are typically used to examine specimens (like blood, urine, tissue) outside the body to provide information for the diagnosis, treatment, or prevention of disease. While this device measures parameters in blood, it does so within a system that is actively circulating the patient's blood during a medical procedure, which falls under the category of patient monitoring rather than in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Not Found

Product codes (comma separated list FDA assigned to the subject device)

74DRY

Device Description

The CDI Model 300 Blood Gas Monitoring System employ; three photochemical sensors to measure pOs pCO, and pH Additionally, there is a thermo-electronic sensor for the direct measurement of temperature. The Electronics also contain calculation programs which use the measured parameters to determine O, Saturation (Venous side only) and Base Excess/[HCO3] (Arterial side only). To complete the necessary calculations for these approximations, the Hemoglobin content is also required. This value is internally set at a Hematocrit of 25%. This value is corrected by the user during the initial and any subsequent on line recalibrations. The purpose of this report is to demonstrate the equivalence of the IBC Gas Cell component, as a substitute for the CDI Gas Cell component. The assumptions in the calculated values and any error which may be present as a result of the electronics, transdecer or sensors is not to be eva uated Consequently, only the measured parameters will be used in the functional analysis. The ca culated values were recorded for general interest only

The functional properties of the Gas Cells are determined by the final assembly geometry and the materials employed in construction, especially the two membrane materials. The final geometry of the IBC and CDI components are identical . Using chemical analysis, electron microscopy and information in the public domain, the membranes were sourced from the same supplier used by 3M.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Twenty each frame /retainer assemblies were made using Standard Operating Procedures. These assemblies were assembled to the 3/5" flow through body. The membrane guard was snapped into place and the assembly was leak tested. Samples were subjected to the IBC standard sterilization cycle and placed in quarantine for 14 days. Control samples of CDI manufactured products were purchased from commercial sources. The test equipment used included: Instrumentation Laboratories Model 1420 Blood Gas Analyzer, Instrumentation Laboratories Model 482 Co-Oximeter, CDI Model 300 Blood Gas Monitor System (Monitor display, light head transducer, disposable photo-chemical sensors, and sensor calibrator), IBC Model 1200 VenOsat Monitor, Gambro Cardiovascular Heart-Lung Console Roller Pump, and Cincinnati Sub Zero Model 400 Heater/Cooler. The test circuit was assembled with a Cobe CML Oxygenator and primed with Human Blood preserved with Acid Citrate Dextrose A U.S.P. The experiment involved testing 10 pairs of gas cells from both manufacturers (IBC and CDI) in alternating procedures. For each test, pump flow was set to 3.5 Liters per Minute. Readings from the CDI Monitor Display and IBC VenOsat Monitor Display were observed. Samples were taken from the sample port and run through the IL Blood Gas Analyzer and IL Co-Oximeter. Readings from on-line monitors were documented, and recalibration was performed using values from the IL Co-Oximeter and Blood Gas Analyzer. Blood gases were altered using a Gas Blender, and samples were drawn for IL analyzers after stabilization. This procedure was repeated for ten different readings for each gas cell.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Functional Evaluation:
The study aimed to demonstrate the equivalence of the IBC Gas Cell component to the CDI Gas Cell component when used with the CDI Model 300 Blood Gas Monitoring System.
Sample Size: 10 test runs for each manufacturer (IBC and CDI), resulting in 200 data points for each measured parameter (pO2, pCO2, pH) when comparing against the IL readings.
Key Results:
Data was collected by recording CDI readings along with appropriate IL readings. Mean variance and mean percent variance were calculated and tabulated. Mean error and percent error for each of the ten runs were documented. The average error for all 200 data points for all measured and calculated parameters was calculated. Graphs were constructed comparing pO2, pCO2, and pH readings from both manufacturers' components against IL readings.
The conclusion was that the IBC Gas Cell Component was tested in comparison with the CDI Gas Cell Component within the CDI Model 300 Blood Gas Monitoring System, and the two products were identical relative to performance and function.

Assembly Integrity:
Assembly Leak Test: Sixty IBC Gas Cell Components were assembled, sterilized, and degassed. Twenty assemblies were subjected to temperature variations (4℃, 25℃, 60℃), shaking in a paint mixer, and multiple drops from fifteen feet. All assemblies were then pressurized at 10 F.S.I. under water to check for leaks, both with and without the membrane support clip. Results: No leaks were detected.

Clinical Simulation Leak Test: Sixty samples from the assembly leak test were used. Components were assembled in series with a Cobe CML Membrane Oxygenator and extracorporeal tubing. The circuit was primed with fresh Bovine Blood and recirculated at 6 Liters per Minute for one hour at 37℃, four hours at 25℃, and one hour at 37℃. After stopping the pump, Membrane Support Guards were removed, and observed for leaks. Results: No leaks were detected. Plasma on top of the membrane was straw-colored, with no cellular components, indicating no leaks.

Sensor Seal Integrity: Ten samples from the assembly leak test were selected. Membranes were removed, and used sensors from the functional test section were inserted. The assemblies were pressurized under water at 10 P.S.I. and observed for leaks. Results: No leaks were detected.

Toxicity Testing:
U.S.P. Plastic Class 6 Testing: Plastic samples (housing, elastomer seal, opaque membrane, clear membrane) were prepared, sterilized with ethylene oxide, and aerated for 14 days. Samples were sent to an independent laboratory for U.S.P. Testing per current GLP's. Results: The samples were found to meet U.S.P. Plastic Class 6.

Hemolysis: Ten IBC gas cell components were assembled and sterilized, then aerated for 14 days. These were placed in series with a Cobe CML Membrane Oxygenator and extracorporeal tubing. The circuit was primed with fresh Bovine blood and recirculated at 6 Liters per minute for 6 Hours at 37℃. The test was repeated with ten CDI gas cell components. A representative sample from each test run and uncirculated blood was centrifuged, and the plasma fraction was observed for signs of free hemoglobin. Results: The samples were found to be Non-Hemolytic.

Bioburden and Sterilization Evaluation:
Bioburden: Samples were tested per C.G. Laboratories standard methods and GLP's. Results: The samples were found to contain an average bioburden of 20 colony forming units per assembly.
Ethylene Oxide Residues: Samples were tested per C.G. Laboratories standard methods and GLP's. Results: Specific Ethylene Oxide Residue levels were noted (data provided in table form).
Pyrogenicity: Samples were tested per the United States Pharmacopeia. Results: The samples were found to be Non-Pyrogenic, U.S.P.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found. The document reports ERROR and % ERR for pO2, pCO2, pH, [HCO3], BE, and SAT.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

CDI Gas Cell Component (Catalog Numbers 6620, 6630 & 6640)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 870.4330 Cardiopulmonary bypass on-line blood gas monitor.

(a)
Identification. A cardiopulmonary bypass on-line blood gas monitor is a device used in conjunction with a blood gas sensor to measure the level of gases in the blood.(b)
Classification. Class II (performance standards).

Summary

510 (K) SUMMARY

Image /page/0/Picture/1 description: The image shows a logo with the letters "IBC" in a stylized font. Each letter is filled with a world map design, giving the logo a global or international feel. The letters are bold and black, contrasting with the white background, which makes them stand out prominently. The overall design suggests a connection to international business, communication, or a similar global concept.

International Biophysics Corporation 4020 So. Industrial Drive, Suite 160 Austin, Texas 78744 (512) 326-3244. (512) 326-3299 fax Attn H. David Shockley, jr., President November 20, 1995

K955379

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Trade Name: IBC Gas Cell Component (Catalog Numbers 3000, 3010 & 3020) Common Name: Blood Gas Flow Through Connectors Classification Name: Sensor, Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Product Code: (74DRY) C.F.R. Section: 870.4410 Equivalent Device: CDI Gas Cell Component (Catalog Numbers 6620, 6630 & 6640)

Introduction

Materials, Methods and Results

I. Functional Evaluation.

A. Assembly of Test Samples.

Twenty each frame /retainer assemblies were made using Standard Operating Procedures.
These assemblies were assembled to the 3/5" flow through body .

The membrane guard was snapped into place and the 3. assembly was leak tested.

会

Samples were subjected to the IBC standard sterilization cycle and placed in quarantine for 14 days.
Control samples of CDI manufactured products were purchased from commercial sources.

B. Test Equipment.

Instrumentation Laboratories Model 1420 Blood Gas 1. Analyzer.

Instrumentation Laboratories Model 482 Co-Oximeter.
CDI Model 300 Blood Gas Monitor System (Monitor display, light head transducer, disposable photo-chemical sensors, and sensor calibrator).
IBC Model 1200 VenOsat Monitor.

5 Gambro Cardiovascular Heart-Lung Console Roller Pump.

Cincinnati Sub Zero Model 400 Heater/Cooler.

Cobe CML Oxygenators.
Heart Lung Tubing and connectors.

C. Test Circuit and Set up.

Assemble the circuit as shown in Test Assembly 1. schematic drawing.

Using the '/2" spike, prime the integral hard shell 2. reservoir on the Cobe CML with Human Blood which has been typed and cross matched and preserved with Acid Citrate Dextrose A U.S.P.. Fill to a level which is approximately 1" above the Heat Exchanger (Approximately four units).

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Using the Roller Pump Head, prime the oxygenator ಗ circuit with a clamp at point B. After the oxygenator is fully primed, move the clamp to Point A and continue to prime the oxygenator bypass line. Recuculate at 2 liters per minute.

Calibrate the CDI Gas Cell Sensors per the operating instructions.
Draw a test sample for the Blood Gas Analyzer and C0-Oximeter.
Using the oxygenator and Gas Blender adjust the blood to physiological conditions. Using 5% Sodium Bicarbonate in Normal Saline, adjust the pH to physiological levels. -

D. Test Procedure.

Stop Pump Head to discontinue the recirculation.
Remove the membrane guard from the two CDI Gas

Image /page/3/Figure/0 description: This image shows a diagram of a test assembly with several components. The diagram includes a COBE CML, a GAMBRO gas blender with inputs for O2, N2, and CO2, and a GAMBRO pump. There are also venous and arterial sensors, a haemosat, and a sampling syringe, with labels indicating flow direction and clamp points.

Cells and snap the calibrated sensors in place and attach the light head transducers.

Resume the operation of the Pump Head, setting a flow rate of 3.5 Liters per Minute.
Observe the readings in the CDI Monitor Display and the IBC VenOsat Monitor Display. If the readings are suitable and stable, Take a sample from the sample port and run it through the IL Blood Gas Analyzer and the IL Co-Oximeter. Simultaneously document the readings from both on-line monitors and press the recalibration button on the CDI Model 300 Monitor.

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Recalibrate the monitor using the values obtained from the IL Co-Oximeter and Blood Gas Analyzer.
Move the clamp from Point A to Point B and, using the Gas Blender, alter the blood gases. Move the clamp from Point B back to Point A and wait for the on line readings to stabilize(5 minutes).
After the five minute period, draw another blood sample for the IL analyzers and document the readings on the CDI monitor. Repeat this procedure (steps 6. and 7.) until ten different readings are obtained.
Stop the Pump Head .
Calibrate two fresh Gas Stat Sensors and snap them into the IBC flow through cells.
Resume operation of the Roller Pump at a flow rate of 3.5 Liters per Minute
Repeat steps 4., 5., 6. and 7. and then stop the pump and change the circuit using fresh disposables and blood for

the next test samples.

Repeat the test using IBC manufactured components first and CDI manufactured components second.
Follow this alternating procedure for ten runs (until ten pairs of gas cells have been tested from both manufacturers).

E. Data Collection and Treatment.

Record each CDI reading along with the appropriate IL readings.

Calculate the mean variance and mean per cent variance for each test sample and tabulate at the bottom of the log sheets.
Tabulate the mean error and % error from each of the ten runs on the Gas Stat Test Data Analysis Log.
Calculate the average error for all 200 data points for all measured and calculated parameters. Record these calculations on the Analysis log.
Construct a graph for comparison of all 200 pairs of readings for the measured parameters, pO2, pCO, and pH, obtained from testing components of both manufacturers.
The following pages contain summary of the findings.

.S CELLI CD.

TA ANALYS GAS STAT TEST

SAMPLE	pO2	pCO2	pH	[HCO3]	BE	SAT
CDI #1 ERROR	-11	2	-0.01	1	0.0	6
CDI #1 % ERR	-10%	4%	0%	3%	-1%	7%
CDI #2 ERROR	-6	1	0.00	1	0.6	1
CDI #2 % ERR	-6%	1%	0%	5%	-8%	2%
CDI #3 ERROR	-3	1	-0.03	-2	-2.5	-2
CDI #3 % ERR	-3%	1%	0%	-8%	60%	-2%
CDI #4 ERROR	5	7	-0.03	-2	-3.8	-1
CDI #4 % ERR	4%	15%	0%	-9%	-408%	-1%
CDI #5 ERROR	2	1	0.01	0	0.4	-9.1
CDI #5 % ERR	1%	2%	0%	1%	-6%	-10%
CDI #6 ERROR	-4	0	-0.01	-1	-0.8	1.6
CDI #6 % ERR	-3%	1%	0%	-4%	17%	2%
CDI #7 ERROR	-1	2	0.00	1	0.7	-8
CDI #7 % ERR	-1%	4%	0%	5%	-9%	-9%
CDI #8 ERROR	-9	2	0.00	1	0.7	-3
CDI #8% ERR	-8%	6%	0%	4%	-18%	-4%
CDI #9 ERROR	-1	-2	0.00	-1	-1.0	-6
CDI #9% ERR	-1%	-4%	0%	-5%	12%	-7%
CDI #10 ERROR	-5	1	-0.02	-2	-2.5	-2
CDI #10% ERR	-5%	1%	0%	-8%	60%	-2%
AVERAGE ERROR	-3	1	-0.01	0	-0.8	-2
AVG % ERROR	-3%	3%	0%	-1%	-30%	-2%
SAMPLE	pO2	pCO2	pH	[HCO3]	BE	SAT
IBC #1 ERROR	-7	1	0.02	2	2.1	-4
IBC #1 % ERR	-6%	1%	0%	11%	-36%	-4%
IBC #2 ERROR	-1	2	-0.03	-1	-2.3	-1
IBC #2 % ERR	-1%	4%	0%	-5%	39%	-1%
IBC #3 ERROR	3	0	0.00	0	0.11	-8
IBC #3 % ERR	3%	-1%	0%	0%	-4%	-9%
IBC #4 ERROR	8	1	0.00	-1	-0.9	-14
IBC #4 % ERR	7%	3%	0%	-3%	25%	-16%
IBC #5 ERROR	-1	0	-0.01	-1	-0.6	-0.4
IBC #5 % ERR	-1%	0%	0%	-2%	14%	0%
IBC #6 ERROR	9	0	-0.02	-2	-0.5	-10.3
IBC #6 % ERR	10%	-1%	0%	-8%	12%	-12%
IBC #7 ERROR	3	-0.6	0.05	3	3.8	-8
IBC #7 % ERR	3%	-1%	1%	16%	-98%	-9%
IBC #8 ERROR	-5	2	0.00	1	0.5	-12
IBC #8 % ERR	-4%	5%	0%	4%	-8%	-13%
IBC #9 ERROR	-1	0	0.00	-1.4	-0.7	-6
IBC #9 % ERR	-1%	1%	0%	-7%	8%	-7%
IBC #10 ERROR	-2	1	-0.02	-2	-2.5	-2
IBC #10 % ERR	-2%	1%	0%	-8%	60%	-2%
AVERAGE ERROR	1	1	0.00	0	-0.1	-6
AVG % ERROR	1%	1%	0%	0%	1%	-7%

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GAS STAT TEST .TA ANALYSIS

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Image /page/8/Figure/0 description: This image is a scatter plot titled "GRAPH 1". The x-axis is labeled "CDI DATA WITH COI CELLS", and the y-axis is labeled "IL DATA". The x and y axis both range from 0 to 300, and there is a dashed line going from the origin to the point (300,300). There are many points plotted on the graph.

p02 COMPARISON BETWEEN INSTRUMENTATION LABORATORIES AND CDI USING CDI CELLS

ﻴﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺴﺘﻘﺒﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Image /page/9/Figure/0 description: This image is a scatter plot titled "GRAPH 2". The x-axis is labeled "CDI DATA WITH IBC CELLS" and ranges from 0 to 300. The y-axis is labeled "IL DATA" and ranges from 0 to 300. There is a dashed line going through the origin of the graph, and there are many points scattered around the line.

p02 COMPARISON BETWEEN INSTRUMENTATION LABORATORIES and cdi USING IBC CELLS

ﺒﺔ

Image /page/10/Figure/0 description: This image is a scatter plot comparing 'IL DATA' and 'CDI DATA WITH CDI CELLS'. The x-axis represents 'CDI DATA WITH CDI CELLS', ranging from 0 to 75, while the y-axis represents 'IL DATA', also ranging from 0 to 75. A dashed line runs diagonally across the plot, and the data points are clustered around this line, indicating a positive correlation between the two variables. The plot is labeled 'GRAPH-3' at the bottom.

pC02 COMPARISON BETWEEN INSTRUMENTATION LABORATORIES AND CDI USING CDI CELLS

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Image /page/11/Figure/0 description: This image is a scatter plot titled "GRAPH 4". The x-axis is labeled "CDI DATA WITH IBC CELLS" and ranges from 0 to 75. The y-axis is labeled "L DATA" and also ranges from 0 to 75. There are many points plotted on the graph, and a dashed line runs diagonally across the plot.

pC02 comparison between instrumentation lae oratories and cdi using ibc cells

ﻴﻨﻴ

Image /page/12/Figure/0 description: This image is a scatter plot titled "GRAPH 5". The x-axis is labeled "CDI DATA WITH CDI CELLS" and ranges from 7.00 to 7.50. The y-axis is labeled "IL DATA" and ranges from 7.00 to 7.50. There are many data points plotted on the graph, and a dashed line runs diagonally across the plot.

ph COMPARISON BETWEEN INSTRUMENTATION LABORATORIES AND CDI USING CDI CELLS

Image /page/13/Figure/0 description: This image is a scatter plot titled "GRAPH 6" that compares "IL DATA" to "CDI DATA WITH IBC CELLS". The x-axis represents "CDI DATA WITH IBC CELLS" and ranges from 7.00 to 7.50, while the y-axis represents "IL DATA" and ranges from 7.00 to 7.50. The plot shows a positive correlation between the two variables, with most of the data points clustered around a diagonal line.

pH Comparison BETWEEN INSTRUMENTATION LABORATORIES and cdi using ibc cells

II Assembly Integrity.

A. Assembly Leak Test.

Assemble sixty IBC Gas Cell Components using 1. Standard Operating Procedure, using the clear and opaque membranes as designed.

Subject the assemblies to the IBC standard sterilization procedure and allow a fourteen day cegassing period.

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Store twenty of the assemblies 24 hrs at 4℃, 25℃ and 60°C.

Place the assemblies to fit loosely in a drum type 4. container. Shake the container in a paint mixer for 5 minutes.

Package the assemblies per Standard Operating న్న Procedure and drop from a height of fifteen feet ten times.

Pressurize the assemblies at 10 F.S.I. under water and check for leaks with the membrane support in place.
Remove the membrane support clip from the assemblies, fully wet the opaque membrane to establish the bubble point and check for leaks at 10 P.S.I. under water.
No leaks were detected.

B. Clinical Simulation Leak Test.

Remove the sixty samples from the Assembly leak test section and allow them to dry for use in this section.
Assemble the components in series using a Cobe CML

Image /page/15/Figure/0 description: This image shows a diagram of a leak test assembly. The assembly includes a COBE CML, a Gambro gas blender, and a pump. The gas blender is connected to three gas sources labeled O2, N2, and CO2. The diagram also shows a sampling syringe and a series of IBC cells, with a note indicating 60 total cells and a flow direction.

Membrane Oxygenator and extracorporeal tubing and connectors as shown in Leak Test Assembly schematic drawing.

Prime the circuit with Bovine Bood which has been 3. freshly collected and preserved in ACD A U.S.P. for less than twenty four hours.

Recirculate at 6 Liters per Minute flow rate for one hour at 37℃, for four hours at 25℃ and for one hour at 37℃.
Stop the pump, remove the Membrane Support Guards and observe for leaks. There should be a straw colored plasma present on top of the membrane but no cellular (Red) components.
No leaks were detected.

C. Sensor Seal Integrity.

Select ten samples from the Assembly leak test section.
Remove the membranes completely using a scalpel.
Insert the used sensors from the functional test section.
Pressurize under water at 10 P.S.I. and observe for leaks.
No leaks were detected.

III. Toxicity Testing.

A. U.S.P. Plastic Class 6 Testing.

Prepare plastic samples of the clear plastic housing material, the elastomer seal material, the opaque white membrane and the clear membrane as needed.

Subject the samples to the IBC standard ethylene oxide sterilization cycle.
Allow 14 days for aeration.
Provide samples to an independent laboratory for U.S.P. Testing per current GLP's.
The samples were found to meet U.S.P. Plastic Class 6.

B. Hemolysis.

Assemble and sterilize 10 IBC gas cell components and allow 14 days for aeration.
Place all ten connectors in series using a Cobe CML Membrane Oxygenator and extracorporeal tubing and connectors as shown in the Hemolysis schematic diaphragm.

Prime the circuit with fresh Bovine blood that is 3. preserved in ACD A U.S.P. and stored for less than 24 hours.

Recirculate at 6 Liters per minute for 6 Hours at 37℃.
Repeat the test with 10 CDI gas cell components.
Centrifuge a representative sample from each test run and from the uncirculated blood.
Observe the plasma fraction for signs of free hemoglobin. It should be straw colored if free of hemolysis induced plasma hemoglobin. Plasma hemoglobin will give the plasma a distinct pink to red tint.
The samples were found to be Non-Hemolytic.

Subject the samples to the IBC standard ethylene oxide sterilization cycle.
Allow 14 days for aeration.
Provide samples to an independent laboratory for U.S.P. Testing per current GLP's.
The samples were found to meet 1J.S.P. Plastic Class 6.

B. Hemolysis.

Assemble and sterilize 10 IBC gas cell components and allow 14 days for aeration.

Place all ten connectors in series using a Cobe CML 2. Membrane Oxygenator and extracorporeal tubing and connectors as shown in the Hemolysis schematic diaphragm.

Prime the circuit with fresh Bovine blood that is 3. preserved in ACD A U.S.P. and stored for less than 24 hours.

Recirculate at 6 Liters per minute for 6 Hours at 37℃.
Repeat the test with 10 CDI gas cell components.
Centrifuge a representative sample from each test run and from the uncirculated blood.
Observe the plasma fraction for signs of free hemoglobin. It should be straw colored if free of hemolysis induced plasma hemoglobin. Plasma hemoglobin will give the plasma a distinct pink to red tint.
The samples were found to be Non-Hemolytic.

Image /page/19/Figure/1 description: This image shows a diagram of a hemolysis test assembly. The assembly includes a COBE CML, a Gambro gas blender, a pump, and a sampling syringe. The gas blender is connected to sources of O2, N2, and CO2. There are 10 total cells in the assembly, and the flow is indicated by an arrow.

IV. Bioburden and Sterilization Evaluation.

A. Bioburden. Per C.G. Laboratories standard methods and GLP's, the samples were found to contain an average bioburden of 20 colony forming units per assembly.

B. Ethylene Oxide Residues. Per C. G. Laboratories standard methods and GLP's, the following Ethylene Oxide Residue levels were noted.

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C. Pyrogenicity. Per the United States Pharmacopeia, the samples were found to be Non-Pyrogenic, U.S.P.

Discussion

Functionally, the CDI Model 300 Blood Gas Monitoring System is reasonably accurate when used in accordance with the Operator's Manual. The primary variations seen during the testing were attributed to variations from sensor to sensor. The calibration of the sensor using calibration gases and the buffer solution would in most cases vield reasonable results. The device became exceedingly accurate after one on line recalibration. The largest variations as seen on the graphs are generally attributable to the first readings taken after going on-line.

The oxygen sensor is located on the clear membrane window. This membrane is non porous and also susceptible to the greatest error. This was particularly noticeable at high pO, levels. This is probably attributable to the lack of porosity. This sensor, however does require the clarity of the membrane to function properly. The Model 400 employs a porous membrane which is clear when wetted. The apparent superiority of the IBC cells relative to the CDI cells is a result of a greater number of high readings with CDI. The products actually showed no significant difference relative to the pC, readings.

The remainder of the sensors are located on the opaque membrane. This membrane is microporous (0.2 u) and allows a free flow of ions and gases through it while maintaining a sterile barrier. The free flow of Hydrogen ions to the sensor provides the stimulus that allows the transducer to measure pH. On the arterial channel, this pH

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The assemblies of IBC product were found to be sound and free of leaks. The assembly methods vield bond strengths far in excess of the requirements that might be encountered in a clinical setting. The bond between the membrane and the support frame was evaluated with the clear membrane very closely for two reasons. First, the opaque membrane is porous and easily bonded to the polycarbonate with the UV adhesive we selected. Secondly, the clear membrane is made of a material that is inherently reluctant to bond with most adhesives.

The materials, four in all, used to fabricate the I3C Gas Cell Component all meet U.S.P. Plastic Class 6 Testing. The materials are non toxic after Ethylene Oxide Sterilization and meet the FDA recognized standards for ethylene oxide residues after 14 day aeration. The fabrication methods result in low bioburden assuring adequate margins of safety in normally validated ethylene oxide sterilization cycles.

The hemolysis testing was designed to be five times more stringent than the exposure the blood would get in the most severe clinical instance. In spite of this extreme protocol, there was no detectable free hemoglobin in the plasma fraction. The use of the IBC product in place of the CDI product will result in no differences relative to trauma to the blood. While hemolysis is not the only form of damage that the blood might encounter in the extracorporeal setting, it is generally recognized as representative of the level of trauma the blood is experiencing.

Conclusion

The IBC Gas Cell Component was tested in comparison with the CDI Gas Cell Component within the CDI Model 300 Blood Gas Monitoring System. The two products were identical relative to performance and function.
The IBC Gas Cell component was tested for its integrity and found to be sound and free of leaks and assembly weaknesses. The product is safe for its intended use in extracorporeal circuits.
The IBC Gas Cell component was evaluated for Toxicity and found to be nontoxic. It is suitable for use in the intended extracorporeal applications.
The IBC Gas Cell component was evaluated for its compatibility with Ethylene Oxide Sterilization. The IBC component may be safely used in tubing packs which are

gas sterilized and may be sold after gas sterilization for insertion into the appropriate tubing line by the Cardiovascular surgical team.

The IBC Gas Cell component is not hemolytic when used in the extracorporeal circuit in accordance with normal clinical practice.
The membranes used in the IBC Gas Cell component are identical to those used in the CDI product.
The IBC Gas Cell Component may be substituted for the CDI Gas Cell Component in the construction of Extracorporeal Custom Tubing Packs either by the manufacturer of such packs or by the end user to modify his or her pack as needed.