CDI Blood Parameter Monitoring System 550

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November 2, 2018 Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer- Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103 Re: K182110 Trade/Device Name: CDI Blood Parameter Monitoring System 550 Regulation Number: 21 CFR 870.4330 Regulation Name: Cardiopulmonary Bypass On-Line Blood Gas Monitor Regulatory Class: Class II Product Code: DRY Dated: August 3, 2018 Received: August 6, 2018 Dear Bryan Hann: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Michael John -S 2018.11.02 14:27:53 -04'00' for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K182110 Device Name CDI® Blood Parameter Monitoring System 550 Indications for Use (Describe) The CDI System 550 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters. Type of Use (*Select one or both, as applicable*): | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ CDI® Blood Parameter Monitoring System 550 510(k) Summary This section is prepared in accordance with 21 CFR Part 807.92 ## General Information | Submitter's Name and Address | Terumo Cardiovascular Systems Corporation<br>6200 Jackson Road<br>Ann Arbor MI, 48103 | |------------------------------|---------------------------------------------------------------------------------------| | Name of Contact Person | Bryan K. Hann | | Phone number | Tel: (734) 741-5816 | | Fax number | Fax: (734) 741-6069 | | email | bryan.hann@terumomedical.com | | Establishment Registration # | 1828100 | | Date prepared | 3 August 2018 | ## Device Information | Trade Name | CDI® Blood Parameter Monitoring System 550 | |----------------------|--------------------------------------------| | Common/Genric Name | Extracorporeal blood-gas monitor | | Classification name | Monitor, Blood-gas, Cardiopulmonary Bypass | | Classification panel | 74 Cardiovascular | | Device Class | Class II | | Regulation Number | 21 CFR §870.4330 | | Product Code(s) | DRY | # Predicate Device Information The CDI Blood Parameter Monitoring System 550 is substantially equivalent in function and intended use to the CDI Blood Parameter Monitoring System 500 cleared in Premarket Notification K133658. Image /page/3/Picture/10 description: The image shows the logo for Terumo, a medical device company. The logo consists of the company name in green, bold, sans-serif font. Above the word "TERUMO" is a red swoosh that curves from left to right. {4}------------------------------------------------ ## Indications for Use and Device Description #### Indications for Use The CDI System 550 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, oxygen delivery and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37°C. For documentation purposes, the systems integral printer provides a hard copy of displayed parameters. #### Device Description The CDI System 550 is an AC-powered (battery back-up) microprocessor-based device used with the following components/accessories: - CDI 550 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 550 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 electro-optics 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 550 Monitor in real time, and displayed to the user via a graphical LED display. Image /page/4/Picture/19 description: The image shows the word "TERUMO" in green, with a red angled line above the "T". The font is bold and sans-serif. The red line is angled upwards from left to right. {5}------------------------------------------------ Image /page/5/Figure/3 description: This image is an illustration of a device with several components labeled. The components include a monitor, calibrator, blood parameter module (BPM), cable heads, microsensors, a shunt/vent/purge line, a disposable shunt sensor, an H/S probe, a disposable H/S cuvette, and an optical window. The illustration provides a detailed view of the device and its various parts. ## Device Illustration Image /page/5/Picture/5 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and slightly to the left of the word. {6}------------------------------------------------ ## Comparison of Technological Characteristics to Predicate Device The CDI System 550 uses a microprocessor based monitor, electro-optics modules, fluorescence chemistry technology, and optical reflectance technology for measuring blood parameters in real time. The technology between the subject and predicate devices is equivalent and provides the basis for the following system functions: - Blood parameters are measured or calculated by the monitor in real time and . displayed to users via a graphical LED display. - . Monitors and displays the following blood parameters: #### Measured using the BPM - Partial pressure of oxygen (PO2) O - Partial pressure of carbon dioxide (PCO2) o - pH O - Potassium (K+) O - O Temperature Calculated from the above BPM measured values - Bicarbonate (HCO3) O - Base Excess (BE) O - Oxygen saturation (SO2) (if the measured value is not available from the H/S O Probe) Measured using the H/S Probe - Oxygen saturation (SO2) O - Hematocrit (Hct) o - Hemoglobin (Hgb) O - . Blood flow rate. O. is either entered manually or via a serial interface between the CDI Monitor and the heart-lung machine. Blood flow rate can be displayed and is used to calculate oxygen consumption (VO2). The following differences exist between the subject and predicate devices: - A new calculated blood monitoring parameter, Oxygen Delivery (DO2), was ● added allowing users to monitor patient DO2 levels during cardiopulmonary bypass. The Indications for Use statement was also updated to reflect this new parameter. - . Modifications to the alarms scheme pursuant to IEC 60601-1-8 (Edition 2.1): Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. - . Expanded hematocrit (HCT) and hemoglobin (Hgb) operating ranges and their corresponding modified accuracy claims. Image /page/6/Picture/27 description: The image shows the logo for Terumo, a medical device company. The logo consists of the company name in green, block letters. To the left of the name is a red, stylized graphic that appears to be an abstract representation of a wing or a checkmark. {7}------------------------------------------------ - Improved temperature correction algorithm which resulted in modified blood parameter module (BPM) accuracy claims. - . Improved performance prior to in vivo calibration as measured by the HSAT Module. ## Performance Data #### Biocompatibility Testing The CDI System 550 Monitor and 540 Calibrator do not come into contact with the patient, and there have been no changes to the disposable accessories. Biocompatibility testing was not required to demonstrate the substantial equivalence of the CDI System 550 to the predicate device and is not included as part of this premarket notification. #### Electrical Safety and Electromagnetic Compatibility (EMC) Evaluation for electrical safety and EMC testing was conducted on the CDI System 550. The CDI System 550 complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC. #### Software Verification and Validation Testing Software verification and validation testing was completed successfully. The fullfillment documentation is provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for CDI System 550 is considered a "moderate" level of concern since a malfunction or latent design flaw of the software device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to minor injury. #### Design Verification and Validation Testing Design verification testing was conducted and demonstrates that the CDI System 550 performs pursuant to the defined design input requirements for the subject device. Design validation, including simulated use testing, was conducted and demonstrates that the CDI System 550 meets the defined design input requirements for the subject device. #### Animal Study Animal testing was not required to demonstrate the substantial equivalence of the CDI System 550 to the predicate device and is not included as part of this premarket notification. #### Clinical Studies Clinical testing was not required to demonstrate the substantial equivalence of the CDI System 550 to the predicate device and is not included as part of this premarket notification. 3 August 2018 Image /page/7/Picture/19 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The font is sans-serif and bold. {8}------------------------------------------------ # Conclusion The technological characteristics and fundamental scientific technology of the subject device have not changed from the predicate device. Software, design verification, and design validation testing have confirmed that the modifications do not adversely impact system performance. The CDI System 550 is substantially equivalent to the currently marketed CDI System 500 cleared under K133658. Image /page/8/Picture/5 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and slightly to the left of the word.