(240 days)
No
The description focuses on microprocessor-based real-time measurement using electro-optics, fluorescence chemistry, and optical reflectance. There is no mention of AI, ML, or related concepts like training/test sets or complex algorithms beyond standard parameter calculation.
No
The device is described as providing continuous, on-line monitoring and measurement of various blood parameters, which aids in diagnosis and patient management rather than directly treating a condition.
Yes
The device provides continuous, on-line monitoring of a range of blood parameters (e.g., oxygen, carbon dioxide, pH, potassium, etc.), and displays these values. This continuous measurement and display of physiological parameters for analysis and interpretation in a clinical context is characteristic of a diagnostic device.
No
The device description explicitly lists multiple hardware components (Monitor, Blood Parameter Modules, Probe, Calibrator, Shunt Sensor, etc.) that are integral to its function of measuring blood parameters. While it contains software, it is not a software-only device.
Based on the provided information, the CDI System 500 is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The device is intended for "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 specimen.
- Device Description: The device measures "blood parameters in real time." It utilizes components that interact directly with blood in an "extracorporeal circuit."
- Mechanism of Action: It uses "electro-optics modules," "fluorescence chemistry technology," and "optical reflectance technology" to measure parameters from the blood. These are typical methods used in in vitro diagnostics to analyze biological samples.
- Anatomical Site: While the blood is in an "extracorporeal" circuit, the measurements are still being performed on the blood itself, outside of the body. This is consistent with the definition of in vitro diagnostics, which involves testing biological specimens outside of the body.
The key characteristic of an IVD is that it is used to examine specimens derived from the human body (like blood) to provide information for the diagnosis, treatment, or prevention of disease. The CDI System 500 clearly fits this description by measuring various parameters in blood.
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™ 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Section 4: 510(k) Summary
JUL 2 5 2014
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 | John Chesney |
| Phone number | Tel: (734) 741-6410 |
| Fax number | Fax: (734) 741-6069 |
| 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) to | |
| which 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.
1
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
2
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
3
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 Device
Modified CDI™ Blood Parameter
Monitoring System 500 | Predicate Device K123039
CDI™ Blood Parameter Monitoring
System 500 | Predicate Device K972962
CDI™ Blood Parameter Monitoring
System 500 |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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 | Proposed Device
Modified CDI™ Blood Parameter
Monitoring System 500 | Predicate Device K123039
CDI™ Blood Parameter Monitoring
System 500 | Predicate Device K972962
CDI™ Blood Parameter Monitoring
System 500 |
| 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) | 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 | CDI500 Monitor with integral printer
Blood Parameter Module (BPM)
Probe - optionally one or two for
arterial 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 integral
printer
• Blood parameter module (BPM)
probe - optionally one of 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 of two for
arterial and/or venous use
• H/S probe
• Gas Calibrator
• Gas A / Gas B canisters
• Disposable accessories (see
below) |
| Item | Proposed Device | Predicate Device K123039 | Predicate Device K972962 |
| | Modified CDI TM Blood Parameter
Monitoring System 500 | CDI TM Blood Parameter Monitoring
System 500 | CDI TM Blood Parameter Monitoring
System 500 |
| | Disposable accessories (see below) | | |
| Disposable
Accessories | CDI510H Shunt Sensor (for arterial
and venous use) with heparin coating
Shunt Bypass Line
1/4", 3/8", and 1/2" sizes
18" male/female extension line
H/S Cuvettes, with or without 6"
extension tube | CDI510H Shunt Sensor (for arterial
and venous use) with heparin coating
Shunt Bypass Line
1/4", 3/8", and 1/2" sizes
18" male/female extension line
H/S Cuvettes, with or without 6"
extension tube
(cuvettes with heparin coating no
longer available)
1/4", 3/8", and 1/2" sizes | CDI510H Shunt Sensor (for arterial
and venous use) with heparin coating
In-line Sensor and In-line Cell,
1/4", 3/8", and 1/2" sizes
H/S Cuvettes, with or without 6"
extension tube, with or without
heparin coating
1/4", 3/8", and 1/2" sizes |
| Blood
Parameter
Module Cable-
Head (BPM) | Epoxy encapsulation | Epoxy encapsulation | No epoxy encapsulation |
TERUN
4
erumo Cardiovascular Systems Corporation
Section 4: 510(k) Summary
TTERUMO
Section 4 - Page 5 of 7
5
Section 4: 510(k) Summar
ﻤﻴﺰﻳﺔ ﺍ
6
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.
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, which is a common symbol associated with the United States.
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.
8
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.
Image /page/8/Picture/6 description: The image shows a logo with the text "KDA" in a stylized font. The text "Ken Skodacek Tor" is written below the logo. The logo appears to be a combination of letters and a geometric shape, possibly a triangle or an abstract design.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
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)
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)
Image /page/9/Picture/14 description: The image shows a logo with the letters "KDA" stacked on top of each other. Below the logo, the text "Ken Skodacek for Bram Zuckerman" is written in a smaller font size. The logo appears to be a stylized design, possibly representing the initials of the names mentioned in the text.
10
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