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™ 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

The provided text describes a 510(k) summary for the CDI™ Blood Parameter Monitoring System 500, a device for continuous, on-line monitoring of various blood parameters during cardiopulmonary bypass. The submission is for "Modifications to previously cleared system" and aims to demonstrate substantial equivalence to predicate devices K123039 and K972962.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document states that the performance testing was conducted to "verify/validate the changes to the CDI™ System 500". The conclusion section further states that the modified device has "substantially equivalent performance specifications as compared to the predicate device." However, no specific quantitative acceptance criteria or detailed results of device performance metrics (e.g., accuracy, precision for each parameter like pH, pO2, pCO2, etc.) are provided in this summary. The document only broadly mentions "System verification testing in a blood loop to simulate clinical use."

Since specific acceptance criteria and detailed device performance are not explicitly stated in the provided text, the table below will reflect the information that is present:

Parameter/Test	Acceptance Criteria	Reported Device Performance
Overall System Performance	Substantially equivalent to previously cleared predicate devices	Substantially equivalent to predicate devices K123039 and K972962
Software Verification and Validation Testing	Successful completion of testing	Performed and verified
System Verification Testing	Successful simulation of clinical use in a blood loop	Performed and validated

Study Information

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "System verification testing in a blood loop to simulate clinical use," but does not specify the number of blood samples, runs, or test conditions.
- Data Provenance: Not explicitly stated, though the testing was described as "in a blood loop," implying an in-vitro or ex-vivo setting rather than live human subjects. This suggests controlled laboratory conditions. The country of origin for the data is not mentioned. It is a retrospective summary of testing performed for the 510(k) submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not mentioned. The testing described is "System verification testing in a blood loop to simulate clinical use." This typically involves comparing the device's measurements against a reference method or standard in the blood loop, not against expert interpretation of data generated by the device itself. Therefore, ground truth would likely be established by precise laboratory reference measurements rather than expert consensus on device output.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned. Adjudication methods are typically used in studies involving human interpretation (e.g., image reading) to resolve discrepancies. This study focuses on the technical performance of a monitoring device against reference values in a lab setting, where disagreement on "ground truth" (e.g., from a calibrated reference sensor) is not resolved by adjudication.
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:
- No. An MRMC comparative effectiveness study is not relevant to this device. This device is a blood parameter monitoring system, not an AI-assisted diagnostic imaging or interpretation tool that assists human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Since this is a monitoring device, its primary function is standalone performance (i.e., the accuracy of its measurements). The "System verification testing" would have assessed the standalone performance of the device in measuring blood parameters in a simulated environment. While not explicitly called "standalone performance," this is the nature of the testing described for such a device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Based on the description "System verification testing in a blood loop to simulate clinical use," the ground truth would most likely be established by reference laboratory methods or highly accurate and calibrated reference sensors/analyzers used to measure the blood parameters (pH, pO2, pCO2, K+, SO2, Hct, Hgb, Temperature) in the blood loop. This ensures an objective and reliable comparison against the device's readings.
The sample size for the training set:
- Not applicable/Not mentioned. This is a monitoring device based on electro-optics modules, fluorescence chemistry, and optical reflectance technology, incorporating a microprocessor for calculations. It's not described as a machine learning or AI-driven algorithm that requires a "training set" in the conventional sense (i.e., for supervised learning). While its internal algorithms and calibrations are developed, this typically involves engineering and validation against physical and chemical principles and reference standards, not a "training set" of patient data.
How the ground truth for the training set was established:
- Not applicable for the reason given in point 7. For algorithms within such a device, "ground truth" during development would be established through meticulous engineering, physical modeling, chemical principles, and calibration against known standards and reference measurements.

Summary

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Section 4: 510(k) Summary

JUL 2 5 2014

K133658

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	John Chesney
Phone number	Tel: (734) 741-6410
Fax number	Fax: (734) 741-6069
E-mail	john.chesney@terumomedical.com
Establishment Registration #	1828100
Date prepared	July 22, 2014
Name of Device
Trade or proprietary name	CDI™ 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	CDI Blood Parameter Monitoring System 500,K123039 and K972962
Reason for 510(k)	Modifications to previously cleared system

Image /page/0/Picture/7 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 bold, sans-serif font. There is a small circle above and to the right of the letter O.

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Section 4: 510(k) Summary

Device Information

Indication for Use: 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™ 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.

Image /page/1/Picture/16 description: The image shows the Terumo company logo. The logo consists of a circle with the letter T inside of it, followed by the word "TERUMO" in all capital letters. The logo is black and white and appears to be a high-resolution image.

Section 4 - Page 2 of 7

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Section 4: 510(k) Summary

Image /page/2/Picture/3 description: This image is a device illustration. The illustration includes a monitor, calibrator, blood parameter module (BPM), cable heads, microsensors, a disposable shunt sensor, a shunt/vent/purge line, an H/S probe, a disposable H/S cuvette, and an optical window. The illustration shows how these components are connected and arranged.

Image /page/2/Picture/4 description: The image shows the logo for Terumo. The logo consists of a stylized letter "T" inside a circle, followed by the word "TERUMO" in bold, sans-serif font. A small registration mark is present to the right of the word "TERUMO".

Section 4 - Page 3 of 7

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umo Cardiovascular Systems Corpora

ction 4: 510(k) Summ

ibstantial Equivaler

modife OD™ Systemials en the between to the classes of Present of Krasen som serzegas and Krasas and Krasas and Krasas and Krasas and Krasas enal produktion and manual manuma functions or operating principle

Item	Proposed DeviceModified CDI™ Blood ParameterMonitoring System 500	Predicate Device K123039CDI™ Blood Parameter MonitoringSystem 500	Predicate Device K972962CDI™ Blood Parameter MonitoringSystem 500
Indication for Use	The CDI System 500 providescontinuous, on-line monitoring of theextracorporeal partial pressure ofoxygen and carbon dioxide, pH,potassium, oxygen saturation,hematocrit, hemoglobin andtemperature. In addition, calculatedvalues of base excess, bicarbonate,oxygen saturation, and oxygenconsumption may also be provided.These parameters are displayed ateither actual temperature or adjustedto 37°C. For documentationpurposes, the system 500's integralprinter provides a hard copy ofdisplayed parameters.	The CDI System 500 providescontinuous, on-line monitoring of theextracorporeal partial pressure ofoxygen and carbon dioxide, pH,potassium, oxygen saturation,hematocrit, hemoglobin andtemperature. In addition, calculatedvalues of base excess, bicarbonate,oxygen saturation, and oxygenconsumption may also be provided.These parameters are displayed ateither actual temperature or adjustedto 37°C. For documentationpurposes, the system 500's integralprinter provides a hard copy ofdisplayed parameters.	The CDI System 500 providescontinuous, on-line monitoring of theextracorporeal partial pressure ofoxygen and carbon dioxide, pH,potassium, oxygen saturation,hematocrit, hemoglobin andtemperature. In addition, calculatedvalues of base excess, bicarbonate,oxygen saturation, and oxygenconsumption may also be provided.These parameters are displayed ateither actual temperature or adjustedto 37°C. For documentationpurposes, the system 500's integralprinter provides a hard copy ofdisplayed parameters.
Item	Proposed DeviceModified CDI™ Blood ParameterMonitoring System 500	Predicate Device K123039CDI™ Blood Parameter MonitoringSystem 500	Predicate Device K972962CDI™ Blood Parameter MonitoringSystem 500
BloodParametersMonitored(measured orcalculated)	Arterial and/or Venous:pHpCO2 (partial pressure of carbondioxide)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 carbondioxide)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 carbondioxide)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	CDI500 Monitor with integral printerBlood Parameter Module (BPM)Probe - optionally one or two forarterial and/or venous use• Optional H/S Probe for venous use• CDI540 Gas calibrator• Gas A / Gas B canisters• Mounting hardware• Printer paper	• Monitor/control unit with integralprinter• Blood parameter module (BPM)probe - optionally one of two forarterial and/or venous use• H/S probe• Gas Calibrator• Gas A / Gas B canisters• Disposable accessories (seebelow)	• Monitor/control unit with integralprinter• Blood parameter module (BPM)probe - optionally one of two forarterial and/or venous use• H/S probe• Gas Calibrator• Gas A / Gas B canisters• Disposable accessories (seebelow)
Item	Proposed Device	Predicate Device K123039	Predicate Device K972962
	Modified CDI TM Blood ParameterMonitoring System 500	CDI TM Blood Parameter MonitoringSystem 500	CDI TM Blood Parameter MonitoringSystem 500
	Disposable accessories (see below)
DisposableAccessories	CDI510H Shunt Sensor (for arterialand venous use) with heparin coatingShunt Bypass Line1/4", 3/8", and 1/2" sizes18" male/female extension lineH/S Cuvettes, with or without 6"extension tube	CDI510H Shunt Sensor (for arterialand venous use) with heparin coatingShunt Bypass Line1/4", 3/8", and 1/2" sizes18" male/female extension lineH/S Cuvettes, with or without 6"extension tube(cuvettes with heparin coating nolonger available)1/4", 3/8", and 1/2" sizes	CDI510H Shunt Sensor (for arterialand venous use) with heparin coatingIn-line Sensor and In-line Cell,1/4", 3/8", and 1/2" sizesH/S Cuvettes, with or without 6"extension tube, with or withoutheparin coating1/4", 3/8", and 1/2" sizes
BloodParameterModule Cable-Head (BPM)	Epoxy encapsulation	Epoxy encapsulation	No epoxy encapsulation

TERUN

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erumo Cardiovascular Systems Corporation

Section 4: 510(k) Summary

TTERUMO

Section 4 - Page 5 of 7

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Section 4: 510(k) Summar

ﻤﻴﺰﻳﺔ ﺍ

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Section 6: 510(k) Summary

Performance Testing

The following safety and performance testing was conducted to verify/validate the changes to the CDI™ System 500:

Software verification and validation testing .
. System verification testing in a blood loop to simulate clinical use

onclusion

The modified CDI™ System 500 is substantially equivalent to the currently marketed CDI™ System 500 because it has the same intended use and substantially equivalent performance specifications as compared to the predicate device.

Image /page/6/Picture/9 description: The image shows the logo for Terumo Corporation. The logo consists of a stylized letter "T" inside a circle, followed by the company name "TERUMO" in bold, sans-serif font. The logo is black and white.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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July 25, 2014

Public Health Service

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

Terumo Cardiovascular Systems Corp. John Chesney 6200 Jackson Rd. Ann Arbor, MI 48103 US

Re: K133658

Trade/Device Name: CDI Blood Parameter Monitoring System 500 Regulation Number: 21 CFR 870.4330 Regulation Name: Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass Regulatory Class: Class II Product Code: DRY Dated: June 23, 2014 Received: June 24, 2014

Dear Mr. Chesney:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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 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 devicerelated 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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K133658

Device Name CDI™ Blood Parameter Monitoring System 500

Indications for Use (Describe)

The CDIT* System 500 provides continuous, on-ine monitoring of the extracorpored partial pressure of oxygen and carbon divxide, pH, potassium, oxygen saturation, 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 ether actual temperature or adjusted to 37°C. For documentation purposes, the system 500's interprovides a hard copy of displayed parameters.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

[] Over-The-Counter Use (21 CFR 801 Subpart C)

. . . . . . . .

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

CONSTITUTION OF THE OR FOR INCLEOR FOR USE ONLY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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).