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.

AI/ML Overview

The provided text describes a 510(k) summary for the IBC Gas Cell Component, demonstrating its equivalence to the CDI Gas Cell Component for use with the CDI Model 300 Blood Gas Monitoring System. The study primarily focuses on functional equivalence, assembly integrity, toxicity, and sterilization compatibility.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of predetermined acceptance criteria in a quantitative format as one might expect for a modern regulatory submission. Instead, the acceptance criterion for the functional evaluation appears to be that the IBC Gas Cell component performs identically or shows no significant difference compared to the predicate CDI Gas Cell component. For other evaluations (assembly integrity, toxicity, sterilization), the criterion is generally "no leaks detected," "meet U.S.P. Plastic Class 6," "non-hemolytic," "low bioburden," and "meet FDA recognized standards for ethylene oxide residues."

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit)	Reported Device Performance
Functional Equivalence	Equivalent performance to CDI Gas Cell (predicate device) in CDI Model 300 System.	"The two products were identical relative to performance and function."
	Measured Parameters: pO2, pCO2, pH must show comparable error to predicate.	Average errors for IBC and CDI cells were comparable (e.g., pO2: IBC 1% Avg Err, CDI -3% Avg Err; pCO2: IBC 1% Avg Err, CDI 3% Avg Err; pH: IBC 0% Avg Err, CDI 0% Avg Err). Graphs show similar correlation to IL data.
Assembly Integrity	No leaks detected after stress tests (temperature, shaking, drop, pressure).	"No leaks were detected" after assembly leak test (temperature, shaking, drop, pressure) and clinical simulation leak test.
Clinical Simulation Leak	No cellular (Red) components present on top of the membrane after recirculation.	"No leaks were detected." (straw colored plasma, no cellular components).
Sensor Seal Integrity	No leaks detected at 10 P.S.I. after sensor insertion.	"No leaks were detected."
Toxicity Testing	Meet U.S.P. Plastic Class 6.	"The samples were found to meet U.S.P. Plastic Class 6."
Hemolysis	Non-Hemolytic (no free hemoglobin in plasma).	"The samples were found to be Non-Hemolytic."
Bioburden	Low bioburden to assure safety with ETO sterilization.	"Average bioburden of 20 colony forming units per assembly."
ETO Residues	Meet FDA recognized standards for ethylene oxide residues.	Specific EO and ECH levels provided (e.g., EO 0.11 ppm, ECH 0.011 ppm), implying compliance.
Pyrogenicity	Non-Pyrogenic per USP.	"The samples were found to be Non-Pyrogenic, U.S.P."

2. Sample Size Used for the Test Set and Data Provenance

Functional Evaluation:
- Test Set Size: 10 IBC Gas Cell components and 10 CDI Gas Cell components were tested. Each component was subjected to a procedure that yielded 10 different readings for each parameter (pO2, pCO2, pH), resulting in 100 readings per component type for measured parameters. The table of results shows 10 samples (runs) for CDI and 10 samples (runs) for IBC, with averages based on these. For each run, multiple parameters were measured. The report mentions "200 data points for all measured and calculated parameters" which implies 100 for each.
- Data Provenance: Prospective, simulated clinical setting using human blood (for initial priming) and later bovine blood (for clinical simulation leak test, hemolysis). The description doesn't explicitly state the country of origin of the blood, but the context is a US submission (510(k)).
Assembly Integrity: 60 IBC Gas Cell Components.
Clinical Simulation Leak Test: The same 60 samples from the Assembly Leak Test.
Sensor Seal Integrity: 10 samples from the Assembly Leak Test section.
Toxicity Testing (USP Class 6): Samples of clear plastic housing, elastomer seal, opaque white membrane, and clear membrane. (Number of samples not specified, but typically conducted on material batches).
Hemolysis: 10 IBC gas cell components and 10 CDI gas cell components.
Bioburden, ETO Residues, Pyrogenicity: Samples of the device (number not explicitly stated but sufficient for testing).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Functional Evaluation: The "ground truth" for the blood gas parameters (pO2, pCO2, pH) was established by an Instrumentation Laboratories Model 1420 Blood Gas Analyzer and an Instrumentation Laboratories Model 482 Co-Oximeter. These are reference laboratory instruments, not human experts.
Other Tests (Integrity, Toxicity, Hemolysis, etc.): Ground truth was established by laboratory testing using established protocols (e.g., visual inspection for leaks, USP standards, GLP's, centrifugation for hemolysis). No human experts are mentioned as establishing ground truth in the sense of consensus reading from images or complex diagnoses.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for functional performance was objective measurements from laboratory instruments. For other tests, it was objective laboratory results or visual inspection against defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, this was not an MRMC comparative effectiveness study. This study evaluated the performance of a medical device (a gas cell component) in measuring blood gas parameters, not a diagnostic imaging algorithm that would typically involve multiple human readers interpreting cases. The comparison was device-to-device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, this study is inherently a "standalone" evaluation of the device component. The IBC Gas Cell Component is a physical component that functions within a larger blood gas monitoring system. Its primary output is the measurement of blood gas parameters. The study directly measures how accurately this component (in conjunction with the monitoring system) determines these parameters compared to a laboratory reference standard. There is no "human-in-the-loop" interaction in the output of the measurements that are being specifically evaluated for the gas cell component itself.

7. The Type of Ground Truth Used

Functional Evaluation (pO2, pCO2, pH): Objective measurements from reference laboratory instruments (Instrumentation Laboratories Model 1420 Blood Gas Analyzer and Model 482 Co-Oximeter).
Calculated Parameters ([HCO3], BE, SAT): These were derived from the measured parameters by the CDI Model 300 system's internal programs. The accuracy of these calculations themselves was not the primary focus of the equivalence study, but their errors were reported for general interest.
Assembly Integrity/Leak Tests: Visual inspection (e.g., for leaks, presence of cellular components).
Toxicity: Compliance with USP Plastic Class 6 standards (laboratory testing).
Hemolysis: Visual inspection of plasma fraction after centrifugation (straw colored vs. pink/red).
Bioburden, ETO Residues, Pyrogenicity: Laboratory analysis per established methods (e.g., C.G. Laboratories standard methods, USP).

8. The Sample Size for the Training Set

Not applicable. This device is a physical component, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The term "training" in this document refers to calibration of equipment.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for an AI/ML algorithm.

Summary

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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

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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

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.

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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.

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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.

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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

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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.

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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

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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.

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.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

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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

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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

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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

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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

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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

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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.

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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.

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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.

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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.

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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.

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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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175	-750
010111	010101	0.011

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

ﻴﺔ

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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

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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.

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).