Cogent™ Hemodynamic Monitoring System; Cogent™ HMS

K232048 · Icu Medical · DXG · Dec 20, 2023 · Cardiovascular

Device Facts

• Record ID: K232048
• Device Name: Cogent™ Hemodynamic Monitoring System; Cogent™ HMS
• Applicant: Icu Medical
• Product Code: DXG · Cardiovascular
• Decision Date: Dec 20, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1435
• Device Class: Class 2

Intended Use

The Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients.

Device Story

Cogent HMS monitors hemodynamic parameters in hospital acute care (ICU, OR, trauma, cath lab). Inputs: patient data via ICU Medical pulmonary artery/central venous oximetry catheters and CardioFlo sensors; manual entry; or bedside monitor interface. System comprises base unit (PIM) and touch-screen display (UIM) communicating via wired/wireless connection. Device computes continuous cardiac output (CCO) via thermodilution or pulse power analysis, and venous oxygen saturation (SvO2) via reflectance spectrophotometry. Clinicians use output for diagnostic/prognostic evaluation. System supports patient care by providing real-time hemodynamic status. Operates on Windows 10 OS (v1.4.0).

Clinical Evidence

No clinical data. Bench testing only. Validation included PulseCO, Bolus CO, SvO2, and CCO algorithm validation, software verification/validation (IEC 62304), electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2).

Technological Characteristics

Base unit (PIM) material: Polycarbonate-Siloxane Copolymer (SABIC LEXAN EXL9330-BK1A068). Display unit (UIM) material: Polycarbonate (Sabic Cycoloy C2950). Sensing: Thermodilution, pulse power analysis, reflectance spectrophotometry. Connectivity: Ethernet, RS-232, wireless/tethered UIM-PIM. Power: 90-130/210-254 VAC. Software: Windows 10 OS, v1.4.0.

Indications for Use

Indicated for critical care, trauma, and cardiac surgery patients requiring hemodynamic monitoring. PulseCO functionality limited to adult patients. No specific contraindications; suitability determined by physician judgment.

Regulatory Classification

Identification

A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.

Predicate Devices

• Cogent™ Hemodynamic Monitoring System (K152006)

Submission Summary (Full Text)

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December 20, 2023

ICU Medical Diane Stockman Senior Regulatory Associate, Global Regulatory 915 Calle Amanecer San Clemente, California 92673

Re: K232048

Trade/Device Name: Cogent™ Hemodynamic Monitoring System (HMS) Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG, DQA Dated: December 5, 2023 Received: December 8, 2023

Dear Diane Stockman:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Stephen C. Browning -S

LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

#### K232048

Device Name

CogentTM Hemodynamic Monitoring System (HMS)

#### Indications for Use (Describe)

The Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients.

#### Target Population -

The target populations are critical care patients, trauma patients, and cardiac surgery patients. The Cogent HMS is restricted to one patient at a time, and the PulseCO functionality is limited to adult patients. There are no specific contraindications for the instrument. Suitability for use on a patient is judgment. The physician shall also decide on the diameter of the catheter to be used in conjunction with the Cogent HMS.

#### Environments for Use -

The Cogent HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and emergency units, coronary and intensive care units, and cardiac catheterization laboratories. The intended environment for use is the hospital, including the critical care units (i.e. medical, surgical, coronary), trauma and accident emergency units, post-anesthesia care units, operating rooms, and cardiac catheterization labs.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|---------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> |

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## 510(k) Summary

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21CFR 870.1435 for the Cogent™ Hemodynamic Monitoring System (HMS) is provided below:

## I. Submitter Information

| Company Name | ICU Medical, Inc. |
|---------------------------------------------|-----------------------------------------------------------|
| Company Address | 951 Calle Amanecer, San Clemente, CA 92673 |
| Establishment Registration<br>Number | 2025816 |
| Application Correspondent<br>Name & Contact | Diane Stockman, Global Regulatory Affairs<br>224-706-2521 |
| Date prepared | December 19, 2023 |

## II. Device Information

| Trade or proprietary name | CogentTM Hemodynamic Monitoring System (HMS) |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Common or usual name | Hemodynamic Monitor |
| Regulation Name | Computer, Diagnostic, Pre-Programmed, Single-Function |
| Classification / Reason | Class II per 21 CFR 870.1435 |
| Product Code(s) | DXG - Computer, Diagnostic, Pre-Programmed, Single-Function;<br>DQA - Oximeter |
| Legally marketed device(s) to<br>which equivalence s claimed | K152006, CogentTM Hemodynamic Monitoring System (ICU<br>Medical) with software version 1.1.8 |

## III. Reason for 510(k) Submission

The purpose of this submission is to introduce new design features including an update to the Operating System from Windows 7 to Windows 10, enhancements to the user interface, software updates (from version 1.1.8 to 1.4.0) which includes feature enhancements and addresses known anomalies associated with the Windows transition, and minor hardware changes for obsolescence of components.

The obsolescence of the Windows 7 operating system (by Microsoft) and board processors are driving the need to upgrade the Cogent Hemodynamic Monitoring System (HMS) hardware and software in both the Power Interface Module (PIM) and the User Interface Module (UIM).

In addition, this submission provides a description of non-substantial changes made since the Cogent HMS initial clearance (under K152006) which were assessed and found to not impact the cleared device design, intended use, or risk levels. These changes were implemented in both the

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Image /page/5/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the text "icumedical" in a sans-serif font. Below the text is the tagline "human connections" in a smaller, lighter font. The logo is simple and modern, and the blue color gives it a professional and trustworthy feel.

Windows 7 (list number 58400-000) and Windows 10 (list number 58400-200) configurations of the Cogent HMS device.

The fundamental technology, device parameters, mode of operation, and intended use of the Cogent HMS remain unchanged from the Predicate Device.

## IV. Device Description

The Cogent HMS is designed to compute and display cardiac and oximetry parameters relevant to patient care in the hospital acute care areas including Intensive Care Units and the Operating Room. Monitoring parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through the compatible ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFlo™ sensors.

Input data for derived parameters may be keyed in by a clinician or may be obtained from a bedside monitor.

The Cogent HMS provides the following functions:

- monitors patient cardiac output continuously (CCO) using continuous thermodilution -(TdCO), and intermittently, using bolus thermodilution (Bolus CO);
- monitors continuous cardiac output (CCO) using pulse power analysis on an arterial pressure waveform;
- monitors venous oxygen saturation (SvO2) by measuring the reflectance spectrum of the blood; and
- provides a general-purpose interface to the analog input/output channels of other monitoring devices.

The Cogent HMS consists of:

- a base unit (patient interface module or PIM);
- a dedicated touch-screen display unit (user interface module or UIM) which allows for patient monitoring remotely (up to 50 feet); and
- associated cables

The PIM and UIM modules communicate with each other in docked, tethered (wired) or wireless mode.

#### The Cogent HMS is designed for compatibility with:

- ICU Medical Pulmonary Artery (PA) catheters via connection to cardiac output patient cables for the purposes of thermodilution cardiac output measurement.
- ICU Medical CardioFlo sensor and the CardioFlo reusable cable for the purpose of pulse power cardiac output measurement.

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Image /page/6/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and features the text "icu medical" in a sans-serif font. Below the main text, in a smaller font, are the words "human connections."

ICU Medical optical module or OpMod reusable cable, and its associated compatible ICU Medical PA and Central Venous oximetry catheters to calculate blood oxygen saturation.

#### V. Indications for Use

The Cogent HMS is intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic evaluation by a clinician. The Cogent HMS is intended for use with ICU Medical pulmonary artery catheters and central venous oximetry catheters and with ICU Medical Cogent sensors. The Cogent HMS is intended to measure and calculate venous oxygen saturation in patients. PulseCO functionality is limited to adult patients.

#### Target Population

The target populations are critical care patients, trauma patients, and cardiac surgery patients. The Cogent HMS is restricted to one patient at a time, and the PulseCO functionality is limited to adult patients. There are no specific contraindications for the instrument. Suitability for use on a patient is up to the physician's judgment. The physician shall also decide on the diameter of the catheter to be used in conjunction with the Cogent HMS.

#### Environments for Use

Operating System

Software version

Product

Code

Windows 10 OS

DXG - Computer, Diagnostic, Pre-

Programmed, Single-Function

DQA - Oximeter (secondary)

version 1.4.0

(primary)

જ

The Cogent HMS is intended to be used by trained and qualified individuals in medical and surgical intensive care units, operating rooms, trauma and emergency units, coronary and intensive care units, and cardiac catheterization laboratories. The intended environment for use is the hospital, including the critical care units (i.e. medical, surgical, coronary), trauma and accident emergency units, postanesthesia care units, operating rooms, and cardiac catheterization labs.

| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | | | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| PREDICATE DEVICE | | | |
| Characteristics | Subject Device | Predicate Device (K152006) | Comparison |
| Device Name | ICU Medical CogentTM HMS<br>List Number 58400-200<br>CogentTM Hemodynamic Monitoring<br>System or Cogent HMS | ICU Medical CogentTM HMS<br>List Number 58400-000<br>CogentTM Hemodynamic Monitoring<br>System or Cogent HMS | Same |
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE<br>PREDICATE DEVICE | | | |
| Characteristics | Subject Device<br>ICU Medical Cogent™ HMS | Predicate Device (K152006)<br>ICU Medical Cogent™ HMS | Comparison |
| | List Number 58400-200 | List Number 58400-000 | |
| Intended Use/<br>Indications for Use | The Cogent HMS is intended for<br>patients for whom the monitoring of<br>CCO and calculated hemodynamic<br>parameters is indicated for diagnostic<br>and prognostic evaluation by a clinician.<br>The Cogent HMS is intended for use<br>with ICU Medical pulmonary artery<br>catheters and central venous oximetry<br>catheters and with ICU Medical Cogent<br>sensors. The Cogent HMS is intended to<br>measure and calculate venous oxygen<br>saturation in patients. PulseCO<br>functionality is limited to adult patients. | The Cogent Hemodynamic Monitoring<br>System (HMS) is intended for patients<br>for whom the monitoring of continuous<br>cardiac output and calculated<br>hemodynamic parameters is indicated for<br>diagnostic and prognostic evaluation by a<br>clinician. Suitability for use on a patient<br>is up to the physician's judgment and the<br>diameter of the catheter to be used.<br>• The target population includes patients<br>for whom hemodynamic monitoring will<br>improve clinical care. The target<br>populations are identical to those for the<br>predicate devices and include:<br>o Critical Care Patients<br>o Trauma Patients<br>o Cardiac Surgery Patients<br>• The Cogent HMS is intended for use<br>with ICU Medical pulmonary artery<br>catheters and central venous oximetry<br>catheters, and with ICU Medical Cogent<br>sensors.<br>• The Cogent HMS is intended to<br>measure and calculate venous oxygen<br>saturation in patients.<br>• PulseCO functionality is limited to<br>adult patients | Similar<br>The statement<br>was reworded<br>for clarity only. |
| | Target Population -<br>The target populations are critical care<br>patients, trauma patients, and cardiac<br>surgery patients. The Cogent HMS is<br>restricted to one patient at a time, and<br>the PulseCO functionality is limited to<br>adult patients. There are no specific<br>contraindications for the instrument.<br>Suitability for use on a patient is up to<br>the physician's judgment. The physician<br>shall also decide on the diameter of the<br>catheter to be used in conjunction with<br>the Cogent HMS. | • The intended environment for use is the<br>hospital including Critical Care Units<br>(such as Medical, Surgical, and<br>Coronary), Trauma and Accident<br>Emergency Units, Post Anesthesia Care<br>Units, Operating Rooms, and Cardiac<br>Catheterization labs.<br>• The Cogent HMS is intended to be used<br>by trained and qualified individuals in<br>medical and surgical intensive care units,<br>operating rooms, trauma and accident<br>emergency units, coronary and intensive<br>care units and cardiac catheterization<br>laboratories.<br>• The Cogent HMS is restricted to one<br>patient at a time. | |
| | Environments for Use -<br>The Cogent HMS is intended to be used<br>by trained and qualified individuals in<br>medical and surgical intensive care<br>units, operating rooms, trauma and<br>emergency units, coronary and intensive<br>care units, and cardiac catheterization<br>laboratories.<br>The intended environment for use is the<br>hospital, including the critical care units<br>(i.e. medical, surgical, coronary),<br>trauma and accident emergency units,<br>post-anesthesia care units, operating<br>rooms, and cardiac catheterization labs. | | |
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | | | |
| PREDICATE DEVICE | | | |
| Characteristics | Subject Device | Predicate Device (K152006) | Comparison |
| | ICU Medical Cogent™ HMS<br>List Number 58400-200 | ICU Medical Cogent™ HMS<br>List Number 58400-000 | |
| Target Population | The target populations are critical<br>care patients, trauma patients, and<br>cardiac surgery patients. The<br>Cogent HMS is restricted to one<br>patient at a time, and the PulseCO<br>functionality is limited to adult<br>patients. There are no specific<br>contraindications for the instrument.<br>Suitability for use on a patient is up<br>to the physician's judgment. The<br>physician shall also decide on the<br>diameter of the catheter to be used<br>in conjunction with the Cogent<br>HMS. | The target population includes<br>patients for whom hemodynamic<br>monitoring will improve clinical<br>care. The target populations are<br>identical to those for the predicate<br>devices and include:<br>o Critical Care Patients<br>o Trauma Patients<br>o Cardiac Surgery Patients | Similar<br>Reworded for<br>added clarity<br>only. |
| Environments for Use | The Cogent HMS is intended to be<br>used by trained and qualified<br>individuals in medical and surgical<br>intensive care units, operating<br>rooms, trauma and emergency units,<br>coronary and intensive care units,<br>and cardiac catheterization<br>laboratories.<br>The intended environment for use is<br>the hospital, including the critical<br>care units (i.e. medical, surgical,<br>coronary), trauma and accident<br>emergency units, post-anesthesia<br>care units, operating rooms, and<br>cardiac catheterization labs. | • The intended environment for use is<br>the hospital including Critical Care<br>Units (such as Medical, Surgical, and<br>Coronary), Trauma and Accident<br>Emergency Units, Post Anesthesia<br>Care Units, Operating Rooms, and<br>Cardiac Catheterization labs.<br>• The Cogent HMS is intended to be<br>used by trained and qualified<br>individuals in medical and surgical<br>intensive care units, operating rooms,<br>trauma and accident emergency<br>units, coronary and intensive care<br>units and cardiac catheterization<br>laboratories.<br>• The Cogent HMS is restricted to<br>one patient at a time. | Similar<br>Reworded for<br>added clarity<br>only. |
| Principle of Operation | A monitoring system to display<br>clinical measurements of a patient's<br>hemodynamic (cardiovascular)<br>function when connected to a<br>catheter or sensor attached to a<br>patient. | A monitoring system to display<br>clinical measurements of a patient's<br>hemodynamic (cardiovascular)<br>function when connected to a<br>catheter or sensor attached to a<br>patient. | Same |
| Mechanism/Mode of<br>Action | Displays entered, measured, and<br>derived hemodynamic monitoring<br>parameters via device<br>interconnection with compatible<br>cable, optical module, and/or<br>bedside monitor to a compatible<br>catheter or pressure sensor (attached<br>to the patient). | Displays entered, measured, and<br>derived hemodynamic monitoring<br>parameters via device<br>interconnection with compatible<br>cable, optical module, and/or bedside<br>monitor to a compatible catheter or<br>pressure sensor (attached to the<br>patient). | Same |
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE<br>PREDICATE DEVICE | | | |
| Characteristics | Subject Device<br>ICU Medical Cogent™ HMS<br>List Number 58400-200 | Predicate Device (K152006)<br>ICU Medical Cogent™ HMS<br>List Number 58400-000 | Comparison |
| Displayed parameters | CCO using continuous thermodilution CCO using arterial pressure waveform analysis Intermittent CO using bolus thermodilution Venous oxygen saturation (SvO2) using reflectance spectrophotometry Data via interface to other bedside monitoring devices | CCO using continuous thermodilution CCO using arterial pressure waveform analysis Intermittent CO using bolus thermodilution Venous oxygen saturation (SvO2) using reflectance spectrophotometry Data via interface to other bedside monitoring devices | Same |
| Measurement<br>Specifications | Oxygen Saturation: range: 10% to 100% repeatability: delta $\le$ 2% for a mean in the range of 40% to 100% Blood Temperature range: 77°F to 107.6°F (25°C to 42°C) accuracy: $\pm$ 0.54°F ( $\pm$ 0.3°C) for a measurement at 98.6°F (37°C) CCO (using PA catheter) range: 1 LPM through 20 LPM repeatability: CV $\le$ 3% using a flow simulator temperature range: 86°F to 104°F (30°C to 40°C) CCO measurement range Bolus CO (Thermodilution) range: 0.1 LPM through 20 LPM repeatability: CV $\le$ 2% averaged over 20 measurements using electronically generated data CCO (using CardioFlo sensor) range: 1 LPM through 20 LPM repeatability: CV $\pm$ 6% or 0.1 LPM, whichever is greater, when simulated with patient-recorded signal Heart Rate using ECG analog Range: 30 bpm through 200 bpm Heater output 7.5 Watts max, 6.0 Watts nominal External values displayed SpO2, MAP, CVP, HR SpO2 display range: 10 to 100% Blood temp. display range 60.8°F to 122°F (16°C to 50°C) | Oxygen Saturation: range: 10% to 100% repeatability: delta $\le$ 2% for a mean in the range of 40% to 100% Blood Temperature range: 77°F to 107.6°F (25°C to 42°C) accuracy: $\pm$ 0.54°F ( $\pm$ 0.3°C) for a measurement at 98.6°F (37°C) CCO (using PA catheter) range: 1 LPM through 20 LPM repeatability: CV $\le$ 3% using a flow simulator temperature range: 86°F to 104°F (30°C to 40°C) CCO measurement range Bolus CO (Thermodilution) range: 0.1 LPM through 20 LPM repeatability: CV $\le$ 2% averaged over 20 measurements using electronically generated data CCO (using CardioFlo sensor) range: 1 LPM through 20 LPM repeatability: CV $\pm$ 6% or 0.1 LPM, whichever is greater, when simulated with patient-recorded signal Heart Rate using ECG analog Range: 30 bpm through 200 bpm Heater output 7.5 Watts max, 6.0 Watts nominal External values displayed SpO2, MAP, CVP, HR SpO2 display range: 10 to 100% Blood temp. display range 60.8°F to 122°F (16°C to 50°C) | Same |
| Characteristics | Subject Device<br>ICU Medical Cogent™ HMS<br>List Number 58400-200 | Predicate Device (K152006)<br>ICU Medical Cogent™ HMS<br>List Number 58400-000 | Comparison |
| Compatibility -<br>Catheters and sensors | Compatible with currently marketed<br>ICU Medical catheters and pressure<br>sensors via patient interface cables. | Compatible with currently marketed<br>ICU Medical catheters and pressure<br>sensors via patient interface cables. | Same |
| Materials of<br>Construction | Base Unit (PIM):<br>Polycarbonate - Siloxane<br>Copolymer<br>SABIC, LEXAN Copolymer<br>EXL9330-BK1A068 Display Unit (UIM):<br>Polycarbonate -Sabic (E45329)<br>Cycoloy C2950 | Base Unit (PIM):<br>Polycarbonate - Siloxane<br>Copolymer<br>SABIC, LEXAN Copolymer<br>EXL9330-BK1A068 Display Unit (UIM):<br>Polycarbonate -Sabic (E45329)<br>Cycoloy C2950 | Same |
| Physical and Mechanical Specifications | | | |
| Display type: | Color LCD touch screen | Color LCD touch screen | Same |
| Memory: | Stores 4 patient records up to 72<br>hours each | Stores 4 patient records up to 72<br>hours each | Same |
| Dimensions: | 11" x 10" x 7"<br>( 27.9 cm x 25.4 cm x 17.8 cm ) | 11" x 10" x 7"<br>( 27.9 cm x 25.4 cm x 17.8 cm )…