CDI BLOOD PARAMETER MONITORING SYSTEM 500

K123039 · Terumo Cardiovascular Systems Corp. · DRY · Nov 20, 2012 · Cardiovascular

Device Facts

• Record ID: K123039
• Device Name: CDI BLOOD PARAMETER MONITORING SYSTEM 500
• Applicant: Terumo Cardiovascular Systems Corp.
• Product Code: DRY · Cardiovascular
• Decision Date: Nov 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4330
• Device Class: Class 2

Intended 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 Story

CDI System 500 is a microprocessor-based, AC-powered monitor for extracorporeal blood gas and parameter monitoring. System inputs include real-time optical signals from blood via disposable shunt sensors or H/S cuvettes inserted into the extracorporeal circuit. Electro-optics modules (BPM and H/S probe) emit light and measure optical responses using fluorescence chemistry and optical reflectance technology. The monitor processes these signals to calculate blood parameters and displays them on a graphical LCD; an integral printer provides hard-copy documentation. Used in clinical settings (e.g., during cardiopulmonary bypass) by healthcare professionals. The device provides real-time data to assist clinicians in managing patient blood chemistry and oxygenation status during extracorporeal procedures.

Clinical Evidence

Bench testing only. Verification activities confirmed the modified BPM probe cable-head functions as expected in high humidity (85% RH) and meets predefined acceptance criteria for the design change.

Technological Characteristics

Microprocessor-based monitor; electro-optics modules (BPM and H/S probe); fluorescence chemistry and optical reflectance sensing; graphical LCD display; integral printer; AC-powered with battery backup; disposable shunt sensors and cuvettes (heparin-coated options).

Indications for Use

Indicated for continuous, on-line monitoring of blood parameters (pH, pCO2, pO2, K+, SO2, Hct, Hgb, temperature) and calculated values (base excess, bicarbonate, oxygen consumption) in patients undergoing extracorporeal circulation.

Regulatory Classification

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.

Predicate Devices

• 3M CDI Blood Parameter Monitoring System 500 (K972962)

Submission Summary (Full Text)

{0}------------------------------------------------

## 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 Road<br>Ann Arbor MI, 48103 |
| Name of Contact Person | Kevin Kong, RAC |
| Phone number | Tel: [phone] |
| Fax number | Fax: [phone] |
| E-mail | [e-mail] |
| 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) to<br>which equivalence is claimed | 3M CDI Blood Parameter Monitoring System 500,<br>K972962 |
| Reason for 510(k) | Modification to previously cleared system |

September 21, 2012

Section 4 - Page 1 of 7

{1}------------------------------------------------

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

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.

September 21, 2012

{2}------------------------------------------------

## 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.

{3}------------------------------------------------

o Cardiovascular Systems Corpor

™ System 500 51

ction 4: 510(k) Summa

## ubstantial Equivaler

modied OD ™ System 50 is subsiding the original CD" System Old sered under to 2202 beaus
dicaled use and indical more and provins and same personal comments and croses coun

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

| | New Device: Modified CDI™ Blood Parameter<br>Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter<br>Monitoring System 500, K972962 |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for Use | The CDI System 500 provides continuous, on-line<br>monitoring of the extracorporeal partial pressure of<br>oxygen and carbon dioxide, pH, potassium, oxygen<br>saturation, hematocrit, hemoglobin and temperature.<br>In addition, calculated values of base excess,<br>bicarbonate, oxygen saturation, and oxygen<br>consumption may also be provided. These<br>parameters are displayed at either actual<br>temperature or adjusted to 37°C. For documentation<br>purposes, the system 500's integral printer provides<br>a hard copy of displayed parameters. | The CDI System 500 provides continuous, on-line<br>monitoring of the extracorporeal partial pressure of<br>oxygen and carbon dioxide, pH, potassium, oxygen<br>saturation, hematocrit, hemoglobin and temperature.<br>In addition, calculated values of base excess,<br>bicarbonate, oxygen saturation, and oxygen<br>consumption may also be provided. These<br>parameters are displayed at either actual temperature<br>or adjusted to 37°C. For documentation purposes, the<br>system 500's integral printer provides a hard copy of<br>displayed parameters. |
| Item | New Device: Modified CDI™ Blood Parameter<br>Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter<br>Monitoring System 500, K972962 |
| Blood Parameters<br>Monitored<br>(measured or<br>calculated) | Arterial and/or Venous:<br>pH<br>pCO2 (partial pressure of carbon dioxide)<br>pO2 (partial pressure of oxygen)<br>K+ (potassium)<br>SO2 (oxygen saturation)<br>Hct (hematocrit)<br>Hgb (hemoglobin)<br>Temperature<br>BE (base excess)<br>HCO3 (bicarbonate)<br>VO2 (oxygen consumption)<br>Blood flow rate (Q) | Arterial and/or Venous:<br>pH<br>pCO2 (partial pressure of carbon dioxide)<br>pO2 (partial pressure of oxygen)<br>K+ (potassium)<br>SO2 (oxygen saturation)<br>Hct (hematocrit)<br>Hgb (hemoglobin)<br>Temperature<br>BE (base excess)<br>HCO3 (bicarbonate)<br>VO2 (oxygen consumption)<br>Blood flow rate (Q) |
| System<br>Components | Monitor/control unit with integral printer<br>Blood parameter module (BPM) probe - optionally<br>one or two for arterial and/or venous use<br>H/S probe<br>Gas calibrator<br>Gas A / Gas B canisters<br>Disposable accessories (see below) | Monitor/control unit with integral printer<br>Blood parameter module (BPM) probe - optionally one<br>or two for arterial and/or venous use<br>H/S probe<br>Gas calibrator<br>Gas A / Gas B canisters<br>Disposable accessories (see below) |
| Item | New Device: Modified CDI TM Blood Parameter<br>Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter<br>Monitoring System 500, K972962 |
| Disposable | CDI510H Shunt Sensor (for arterial and venous use)<br>with heparin coating | CDI510H Shunt Sensor (for arterial and venous use)<br>with heparin coating<br>In-line Sensor and In-line Cell<br>¼", 3/8", and ½" sizes |
| Accessories | Shunt Bypass Line<br>¼", 3/8", and ½" sizes<br>18" male/female extension line<br>H/S Cuvettes, with or without 6" extension tube<br>(cuvettes with heparin coating no longer available)<br>¼", 3/8", and ½" sizes | H/S Cuvettes, with or without 6" extension tube, with or<br>without heparin coating<br>¼", 3/8", and ½" sizes |

K12 3039

ection 4

TERUM

eptember 21, 201

{4}------------------------------------------------

umo Cardiovascular Systems Corporatio

CDI™ System 500 510(K)

ection 4: 510(k) Summar S

. . .

K123039

9

Section 4 - Page

D TERUMO

September 21, 2012

{5}------------------------------------------------

Terumo Cardiovascular Systems Corporati

## CDI™ System 500 510(k

# Section 4: 510(k) Summar

123039

Section 4 - Page 6 of 7

Terumo

September 21, 2012

,

. . .

: i

. .

.

:

.

. . . . . .

. . .

. ત્વ

{6}------------------------------------------------

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

{7}------------------------------------------------

## 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

{8}------------------------------------------------

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 [phone] or [phone] or at its Internet address

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

Sincerely yours/

A

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

## Enclosure

{9}------------------------------------------------

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