The CDI System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

Device Description

The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

CDI™ 500 Monitor
Arterial and/or Venous Blood Parameter Modules (BPM)
CDI™ Hematocrit/Saturation (H/S) Probe
CDI™ 540 Gas Calibrator and Calibration Gases (A and B)
CDI™ 510H Shunt Sensor
Shunt Bypass Line
CDI™ H/S Cuvette with or without extension tubing
Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket)
Printer Paper

The CDI™ System 500 measures blood parameters in real time by utilizing a microprocessor based monitor, electro-optics modules (i.e., BPM and H/S probe), fluorescence chemistry technology, and optical reflectance technology. The electrooptics modules connect the monitor to the disposables (i.e., shunt sensor or cuvette) which are inserted into the extracorporeal circuit. Light is emitted from the modules, and the optical responses from the blood via the sensor(s) are measured by the monitor. The blood parameters are measured or calculated by the CDI™ 500 Monitor in real time, and displayed to the user via a graphical LCD display.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a 510(k) submission for a modification to the Terumo CDI™ System 500, a blood parameter monitoring system. The core of this submission is to demonstrate substantial equivalence to a predicate device, specifically focusing on a design change to improve the robustness of the Blood Parameter Module (BPM) Probe Cable-Head against moisture ingress.

Therefore, the acceptance criteria and the study primarily revolve around verifying the effectiveness and safety of this specific design change, rather than proving performance metrics for all blood parameters. The document explicitly states: "This design change did not alter the device indication for use or performance specifications."

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance/Verification Outcome
The BPM Probe Cable-Head functions as expected even in the presence of high humidity (85% RH)	"The design change was verified to meet predefined acceptance criteria and assure that: The BPM Probe Cable-Head functions as expected even in the presence of high humidity (85% RH)" (Section 4: 510(k) Summary, "Verification Testing on Device Modification")
The design change does not introduce new safety risks	"The design change was verified to meet predefined acceptance criteria and assure that: The design change does not introduce new safety risks"
The design change is effective over the expected life of the BPM probe cable-head	"The design change was verified to meet predefined acceptance criteria and assure that: The design change is effective over the expected life of the BPM probe cable-head"

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not explicitly state the sample size used for the verification testing. It only generally refers to "Design control activities identified the requirements for the design change, which drove the design change verification activities."
Data Provenance: Not specified. There is no mention of country of origin, or whether the study was retrospective or prospective. Given the nature of a design change verification, it would likely be prospective testing conducted in a controlled environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not mention the use of experts to establish ground truth for this specific verification testing. The testing appears to be objective engineering verification rather than a clinical study requiring expert interpretation of results.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

There is no mention of an adjudication method. This type of method is typically used in clinical trials where there's subjectivity in interpreting results and multiple readers are involved. For engineering verification of moisture ingress and function, such a method would not be applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. This device is a blood parameter monitor; it does not involve AI or human interpretation of images or complex data in a way that would necessitate an MRMC study. The verification focuses on the hardware's robustness.

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

This question is not applicable as the device is a measurement system, not an algorithm-based diagnostic or AI-driven tool. The "standalone performance" here refers to the device's ability to measure parameters, which is the inherent function it performs without human interpretation in the loop. The verification covered the robustness of a particular component.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for this design modification verification would be objective engineering measurements and functional tests. For example:
- Functional performance: The device successfully provides accurate blood parameter readings after exposure to high humidity (ground truth derived from reference methods for blood gas analysis).
- Safety: Absence of electrical malfunction or other hazards after moisture exposure (ground truth defined by safety standards and direct observation).
- Expected life: The component continues to perform functionally for a defined duration under simulated conditions (ground truth against design durability specifications).
- The document implies that the "predefined acceptance criteria" themselves represent the ground truth for success in these tests.

8. The sample size for the training set:

This question is not applicable as the device is not an AI/ML model that requires a training set. The "design change" refers to a hardware modification, not a software algorithm that learns from data.

9. How the ground truth for the training set was established:

This question is not applicable for the same reasons as #8.

Summary

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NOV 2 0 2012

Terumo Cardiovascular Systems Corporat№0V 2 0 2012 CDI™ System 500 510(K)

Section 4: 510(k) Summary

This section includes a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

Submitter Information
Name	Terumo Cardiovascular Systems Corporation
Address	6200 Jackson RoadAnn Arbor MI, 48103
Name of Contact Person	Kevin Kong, RAC
Phone number	Tel: (734) 663-4145
Fax number	Fax: (734) 741-6069
E-mail	Kevin.Kong@terumomedical.com
Establishment Registration #	1828100
Date prepared	September 21, 2012
Name of Device
Trade or proprietary name	CDITM Blood Parameter Monitoring System 500
Common or usual name	Extracorporeal blood gas monitor
Classification name	Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Classification panel	74 Cardiovascular
Regulation	21 CFR §870.4330
Product Code(s)	DRY
Legally marketed device(s) towhich equivalence is claimed	3M CDI Blood Parameter Monitoring System 500,K972962
Reason for 510(k)	Modification to previously cleared system

September 21, 2012

Section 4 - Page 1 of 7

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Terumo Cardiovascular Systems Corporation

CDI™ System 500 510(k)

Section 4 - Page 2 of 7

Section 4: 510(k) Summary

The CDI System 500 provides continuous, on-line monitoring of Indication for Use: the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

Device Description: The CDI™ System 500 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories:

CDI™ 500 Monitor
Arterial and/or Venous Blood Parameter Modules (BPM)
CDI™ Hematocrit/Saturation (H/S) Probe
CDI™ 540 Gas Calibrator and Calibration Gases (A and B)
CDI™ 510H Shunt Sensor
Shunt Bypass Line
CDI™ H/S Cuvette with or without extension tubing
Monitor Mounting Hardware (Pole Clamp and Cable Head Bracket)
Printer Paper

September 21, 2012

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39

Terumo Cardiovascular Systems Corporation

CDI™ System 500 510(k)

Section 4 - Page 3 of 7

Section 4: 510(k) Summary

Image /page/2/Picture/4 description: This image is an illustration of a medical device. The illustration includes labels for the different parts of the device, including the monitor, calibrator, blood parameter module, cable heads, microsensors, shunt/vent/purge line, disposable shunt sensor, H/S probe, disposable H/S cuvette, and optical window. The device appears to be used for monitoring blood parameters.

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olease find a side-by-side comparison of the modified to the original CDI™ System

	New Device: Modified CDI™ Blood ParameterMonitoring System 500	Predicate Device: 3M CDI Blood ParameterMonitoring System 500, K972962
Indication for Use	The CDI System 500 provides continuous, on-linemonitoring of the extracorporeal partial pressure ofoxygen and carbon dioxide, pH, potassium, oxygensaturation, hematocrit, hemoglobin and temperature.In addition, calculated values of base excess,bicarbonate, oxygen saturation, and oxygenconsumption may also be provided. Theseparameters are displayed at either actualtemperature or adjusted to 37°C. For documentationpurposes, the system 500's integral printer providesa hard copy of displayed parameters.	The CDI System 500 provides continuous, on-linemonitoring of the extracorporeal partial pressure ofoxygen and carbon dioxide, pH, potassium, oxygensaturation, hematocrit, hemoglobin and temperature.In addition, calculated values of base excess,bicarbonate, oxygen saturation, and oxygenconsumption may also be provided. Theseparameters are displayed at either actual temperatureor adjusted to 37°C. For documentation purposes, thesystem 500's integral printer provides a hard copy ofdisplayed parameters.
Item	New Device: Modified CDI™ Blood ParameterMonitoring System 500	Predicate Device: 3M CDI Blood ParameterMonitoring System 500, K972962
Blood ParametersMonitored(measured orcalculated)	Arterial and/or Venous:pHpCO2 (partial pressure of carbon dioxide)pO2 (partial pressure of oxygen)K+ (potassium)SO2 (oxygen saturation)Hct (hematocrit)Hgb (hemoglobin)TemperatureBE (base excess)HCO3 (bicarbonate)VO2 (oxygen consumption)Blood flow rate (Q)	Arterial and/or Venous:pHpCO2 (partial pressure of carbon dioxide)pO2 (partial pressure of oxygen)K+ (potassium)SO2 (oxygen saturation)Hct (hematocrit)Hgb (hemoglobin)TemperatureBE (base excess)HCO3 (bicarbonate)VO2 (oxygen consumption)Blood flow rate (Q)
SystemComponents	Monitor/control unit with integral printerBlood parameter module (BPM) probe - optionallyone or two for arterial and/or venous useH/S probeGas calibratorGas A / Gas B canistersDisposable accessories (see below)	Monitor/control unit with integral printerBlood parameter module (BPM) probe - optionally oneor two for arterial and/or venous useH/S probeGas calibratorGas A / Gas B canistersDisposable accessories (see below)
Item	New Device: Modified CDI TM Blood ParameterMonitoring System 500	Predicate Device: 3M CDI Blood ParameterMonitoring System 500, K972962
Disposable	CDI510H Shunt Sensor (for arterial and venous use)with heparin coating	CDI510H Shunt Sensor (for arterial and venous use)with heparin coatingIn-line Sensor and In-line Cell¼", 3/8", and ½" sizes
Accessories	Shunt Bypass Line¼", 3/8", and ½" sizes18" male/female extension lineH/S Cuvettes, with or without 6" extension tube(cuvettes with heparin coating no longer available)¼", 3/8", and ½" sizes	H/S Cuvettes, with or without 6" extension tube, with orwithout heparin coating¼", 3/8", and ½" sizes

K12 3039

ection 4

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CDI™ System 500 510(K)

ection 4: 510(k) Summar S

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K123039

Section 4 - Page

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September 21, 2012

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Terumo Cardiovascular Systems Corporati

CDI™ System 500 510(k

Section 4: 510(k) Summar

123039

Section 4 - Page 6 of 7

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Terumo Cardiovascular Systems Corporation

CDI™ System 500 510(k)

Section 4: 510(k) Summary

Verification Testing on Device Modification

This 510(k) was submitted for a design change intended to improve the robustness of the CDI 500 Blood Parameter Module (BPM) Probe Cable-Head against moisture ingress. This design change did not alter the device indication for use or performance specifications.

Design control activities identified the requirements for the design change, which drove the design change verification activities. The design change was verified to meet predefined acceptance criteria and assure that:

. The BPM Probe Cable-Head functions as expected even in the presence of high humidity (85% RH)
The design change does not introduce new safety risks .
The design change is effective over the expected life of the BPM probe cablehead

Conclusion

The modified CDI™ System 500 is substantially equivalent to the 3M CDI™ System 500 cleared under K972962 because it has the same intended use and substantially equivalent performance specifications as compared to these predicate devices.

September 21, 2012

Image /page/6/Picture/13 description: The image shows the logo for Terumo. The logo consists of a circle with the letter "T" inside, followed by the word "TERUMO" in block letters. There is a small symbol to the right of the word "TERUMO".

Section 4 - Page 7 of 7

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Terumo Cardiovascular Systems Corp. c/o Kevin Kong Regulatory Affairs Specialist 6200 Jackson Road Ann Harbor, MI 48103

NOV 2 0 2012

Re: K123039

Trade/Device Name: CDI Blood Parameter Monitoring System 500 Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: DRY Dated: September 21, 2011 Received: September 28, 2012

Dear Mr. Kong:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must

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Page 2 – Mr. Kevin Kong

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours/

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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123039

Terumo Cardiovascular Systems Corporation

CDI™ System 500 510(k)

Section 3: Indication for Use

510(k) Number: FBD KI23039

Device Name: CDI™ Blood Parameter Monitoring System 500

Indications for Use:

500 provides continuous, on-line monitoring of the The CDI System extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the system 500's integral printer provides a hard copy of displayed parameters.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K123039

Section 3 - Page 1 of 1

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).