(53 days)
Not Found
No
The description focuses on microprocessor-based real-time measurement using electro-optics, fluorescence chemistry, and optical reflectance. There is no mention of AI or ML algorithms for data analysis or interpretation. The performance study is related to a design change for moisture ingress, not algorithmic performance.
No
The device is described as a "continuous, on-line monitoring" system that measures and displays various blood parameters. Its purpose is to provide real-time data for "documentation purposes," indicating a diagnostic or monitoring function rather than a direct therapeutic intervention.
Yes
The device continuously monitors and displays various blood parameters such as partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin, and temperature. These measurements are used to provide information about a patient's physiological state, which is indicative of a diagnostic function.
No
The device description clearly outlines multiple hardware components including a monitor, modules, probes, calibrator, and sensors, in addition to the software.
Based on the provided information, the CDI System 500 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states that the device provides "continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature." These are all parameters measured in blood, which is a biological sample.
- Device Description: The device description details how the system measures "blood parameters in real time" using various technologies and components that interact with the blood in the extracorporeal circuit.
- Extracorporeal: The anatomical site is listed as "extracorporeal," meaning outside the body. This is consistent with IVD devices that analyze samples taken from the body.
IVD devices are defined as those intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The CDI System 500 clearly fits this definition by analyzing blood parameters extracorporeally for monitoring purposes.
N/A
Intended Use / Indications 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.
Product codes
DRY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extracorporeal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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 |
| Ann Arbor MI, 48103 | |
| Name of Contact Person | Kevin Kong, RAC |
| Phone number | Tel: (734) 663-4145 |
| Fax number | Fax: (734) 741-6069 |
| 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) to | |
| which 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
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
Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter
Monitoring System 500, K972962 |
|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. |
| Item | New Device: Modified CDI™ Blood Parameter
Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter
Monitoring System 500, K972962 |
| Blood Parameters
Monitored
(measured or
calculated) | Arterial and/or Venous:
pH
pCO2 (partial pressure of carbon dioxide)
pO2 (partial pressure of oxygen)
K+ (potassium)
SO2 (oxygen saturation)
Hct (hematocrit)
Hgb (hemoglobin)
Temperature
BE (base excess)
HCO3 (bicarbonate)
VO2 (oxygen consumption)
Blood flow rate (Q) | Arterial and/or Venous:
pH
pCO2 (partial pressure of carbon dioxide)
pO2 (partial pressure of oxygen)
K+ (potassium)
SO2 (oxygen saturation)
Hct (hematocrit)
Hgb (hemoglobin)
Temperature
BE (base excess)
HCO3 (bicarbonate)
VO2 (oxygen consumption)
Blood flow rate (Q) |
| System
Components | Monitor/control unit with integral printer
Blood parameter module (BPM) probe - optionally
one or two for arterial and/or venous use
H/S probe
Gas calibrator
Gas A / Gas B canisters
Disposable accessories (see below) | Monitor/control unit with integral printer
Blood parameter module (BPM) probe - optionally one
or two for arterial and/or venous use
H/S probe
Gas calibrator
Gas A / Gas B canisters
Disposable accessories (see below) |
| Item | New Device: Modified CDI TM Blood Parameter
Monitoring System 500 | Predicate Device: 3M CDI Blood Parameter
Monitoring 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 coating
In-line Sensor and In-line Cell
¼", 3/8", and ½" sizes |
| Accessories | Shunt Bypass Line
¼", 3/8", and ½" sizes
18" male/female extension line
H/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 or
without heparin coating
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
. . .
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
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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 (800) 638-2041 or (301) 796-7100 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