(163 days)
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.
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 provided text describes a 510(k) premarket notification for the ICU Medical Cogent™ Hemodynamic Monitoring System (HMS). However, the document focuses on demonstrating substantial equivalence to a predicate device (K152006) primarily due to updates to the operating system (Windows 7 to Windows 10), software (version 1.1.8 to 1.4.0), and minor hardware changes. The submission primarily relies on non-clinical testing and verification, rather than a clinical study with detailed acceptance criteria and performance metrics for a novel algorithm.
Based on the provided text, the device is an updated version of an already cleared hemodynamic monitoring system. Therefore, the "acceptance criteria" discussed are largely related to ensuring the updated device performs equivalently to its predicate and meets relevant safety and performance standards. No specific "acceptance criteria" in terms of clinical performance metrics of an AI algorithm are explicitly stated, as the device is not presented as an AI-powered diagnostic algorithm with a performance threshold to meet.
Here's a breakdown of the information based on your request, as much as can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As the submission is for an updated version of an existing device, the "acceptance criteria" largely revolve around demonstrating equivalent performance to the predicate device and compliance with relevant standards. The document doesn't provide a table of precise quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity for a diagnostic algorithm) and corresponding reported performance of a novel AI component. Instead, it states that "the measurement performance of the subject device is equivalent to that of the predicate device."
| Acceptance Criteria Category (Implied from text) | Reported Device Performance (Implied from text) |
|---|---|
| Software Performance | Verified and validated successfully (per IEC 62304 and FDA guidance). Software considered equivalent to predicate. |
| System Bench Testing (Simulated Use) | Measurement performance of the subject device is equivalent to that of the predicate device. |
| Electrical Safety | Complies with requirements per IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Complies with requirements per IEC 60601-1-2. |
| Cybersecurity | System is effective in addressing cybersecurity threats. |
| Risk Management | Risk management activities incorporated in accordance with ISO 14971:2019 and tested for correct implementation and effectiveness. |
| Functional Performance & Intended Use | Meets functional performance and intended use claims as described in device labeling. No different questions of safety and effectiveness introduced. |
| Biocompatibility | Not applicable, as the device itself does not have direct patient contact. (Patient-contacting accessories are cleared separately). |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No new human factors, animal, and/or clinical studies were conducted as was determined not required to demonstrate device safety and effectiveness for the subject device."
Therefore, there is no "test set" in the context of clinical data with a sample size or provenance for this specific 510(k) submission. The testing performed was primarily non-clinical (bench testing, software V&V).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since no new clinical studies were conducted for this submission, there is no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The device is a hemodynamic monitoring system, not an AI-assisted diagnostic imaging or interpretation tool. The submission focuses on software and hardware updates to an existing monitoring device, not the evaluation of an AI algorithm's impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Cogent System Software Validation" and various algorithm validations (PulseCO, Bolus CO, SO2, CCO) were performed, which could be considered standalone performance evaluations of the specific algorithms within the device. However, these are validations of established medical algorithms for physiological measurements, not novel AI algorithms in the common sense. The text implies these were bench validations, not clinical standalone performance studies.
7. The Type of Ground Truth Used
For the algorithm validations (e.g., PulseCO, Bolus CO, SO2, CCO), the ground truth was established through "in vitro validation" using flow simulators or electronically generated data. This suggests a controlled laboratory environment where the "true" physiological values could be precisely set or simulated.
8. The Sample Size for the Training Set
Not applicable. The document discusses updates to an existing device and its algorithms, not the training of a new AI algorithm that would require a distinct training set. The algorithms mentioned (e.g., thermodilution, pulse power analysis) are based on established physiological principles and are not typically "trained" in the machine learning sense with large datasets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for a novel AI algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 RegistrationNumber | 2025816 |
| Application CorrespondentName & Contact | Diane Stockman, Global Regulatory Affairs224-706-2521 |
| 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;DQA - Oximeter |
| Legally marketed device(s) towhich equivalence s claimed | K152006, CogentTM Hemodynamic Monitoring System (ICUMedical) 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 HMSList Number 58400-200CogentTM Hemodynamic MonitoringSystem or Cogent HMS | ICU Medical CogentTM HMSList Number 58400-000CogentTM Hemodynamic MonitoringSystem or Cogent HMS | Same |
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THEPREDICATE DEVICE | |||
| Characteristics | Subject DeviceICU Medical Cogent™ HMS | Predicate Device (K152006)ICU Medical Cogent™ HMS | Comparison |
| List Number 58400-200 | List Number 58400-000 | ||
| Intended Use/Indications for Use | The Cogent HMS is intended forpatients for whom the monitoring ofCCO and calculated hemodynamicparameters is indicated for diagnosticand prognostic evaluation by a clinician.The Cogent HMS is intended for usewith ICU Medical pulmonary arterycatheters and central venous oximetrycatheters and with ICU Medical Cogentsensors. The Cogent HMS is intended tomeasure and calculate venous oxygensaturation in patients. PulseCOfunctionality is limited to adult patients. | The Cogent Hemodynamic MonitoringSystem (HMS) is intended for patientsfor whom the monitoring of continuouscardiac output and calculatedhemodynamic parameters is indicated fordiagnostic and prognostic evaluation by aclinician. Suitability for use on a patientis up to the physician's judgment and thediameter of the catheter to be used.• The target population includes patientsfor whom hemodynamic monitoring willimprove clinical care. The targetpopulations are identical to those for thepredicate devices and include:o Critical Care Patientso Trauma Patientso Cardiac Surgery Patients• The Cogent HMS is intended for usewith ICU Medical pulmonary arterycatheters and central venous oximetrycatheters, and with ICU Medical Cogentsensors.• The Cogent HMS is intended tomeasure and calculate venous oxygensaturation in patients.• PulseCO functionality is limited toadult patients | SimilarThe statementwas rewordedfor clarity only. |
| Target Population -The target populations are critical carepatients, trauma patients, and cardiacsurgery patients. The Cogent HMS isrestricted to one patient at a time, andthe PulseCO functionality is limited toadult patients. There are no specificcontraindications for the instrument.Suitability for use on a patient is up tothe physician's judgment. The physicianshall also decide on the diameter of thecatheter to be used in conjunction withthe Cogent HMS. | • The intended environment for use is thehospital including Critical Care Units(such as Medical, Surgical, andCoronary), Trauma and AccidentEmergency Units, Post Anesthesia CareUnits, Operating Rooms, and CardiacCatheterization labs.• The Cogent HMS is intended to be usedby trained and qualified individuals inmedical and surgical intensive care units,operating rooms, trauma and accidentemergency units, coronary and intensivecare units and cardiac catheterizationlaboratories.• The Cogent HMS is restricted to onepatient at a time. | ||
| Environments for Use -The Cogent HMS is intended to be usedby trained and qualified individuals inmedical and surgical intensive careunits, operating rooms, trauma andemergency units, coronary and intensivecare units, and cardiac catheterizationlaboratories.The intended environment for use is thehospital, including the critical care units(i.e. medical, surgical, coronary),trauma and accident emergency units,post-anesthesia care units, operatingrooms, 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™ HMSList Number 58400-200 | ICU Medical Cogent™ HMSList Number 58400-000 | ||
| Target Population | The target populations are criticalcare patients, trauma patients, andcardiac surgery patients. TheCogent HMS is restricted to onepatient at a time, and the PulseCOfunctionality is limited to adultpatients. There are no specificcontraindications for the instrument.Suitability for use on a patient is upto the physician's judgment. Thephysician shall also decide on thediameter of the catheter to be usedin conjunction with the CogentHMS. | The target population includespatients for whom hemodynamicmonitoring will improve clinicalcare. The target populations areidentical to those for the predicatedevices and include:o Critical Care Patientso Trauma Patientso Cardiac Surgery Patients | SimilarReworded foradded clarityonly. |
| Environments for Use | The Cogent HMS is intended to beused by trained and qualifiedindividuals in medical and surgicalintensive care units, operatingrooms, trauma and emergency units,coronary and intensive care units,and cardiac catheterizationlaboratories.The intended environment for use isthe hospital, including the criticalcare units (i.e. medical, surgical,coronary), trauma and accidentemergency units, post-anesthesiacare units, operating rooms, andcardiac catheterization labs. | • The intended environment for use isthe hospital including Critical CareUnits (such as Medical, Surgical, andCoronary), Trauma and AccidentEmergency Units, Post AnesthesiaCare Units, Operating Rooms, andCardiac Catheterization labs.• The Cogent HMS is intended to beused by trained and qualifiedindividuals in medical and surgicalintensive care units, operating rooms,trauma and accident emergencyunits, coronary and intensive careunits and cardiac catheterizationlaboratories.• The Cogent HMS is restricted toone patient at a time. | SimilarReworded foradded clarityonly. |
| Principle of Operation | A monitoring system to displayclinical measurements of a patient'shemodynamic (cardiovascular)function when connected to acatheter or sensor attached to apatient. | A monitoring system to displayclinical measurements of a patient'shemodynamic (cardiovascular)function when connected to acatheter or sensor attached to apatient. | Same |
| Mechanism/Mode ofAction | Displays entered, measured, andderived hemodynamic monitoringparameters via deviceinterconnection with compatiblecable, optical module, and/orbedside monitor to a compatiblecatheter or pressure sensor (attachedto the patient). | Displays entered, measured, andderived hemodynamic monitoringparameters via deviceinterconnection with compatiblecable, optical module, and/or bedsidemonitor to a compatible catheter orpressure sensor (attached to thepatient). | Same |
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THEPREDICATE DEVICE | |||
| Characteristics | Subject DeviceICU Medical Cogent™ HMSList Number 58400-200 | Predicate Device (K152006)ICU Medical Cogent™ HMSList 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 |
| MeasurementSpecifications | 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 DeviceICU Medical Cogent™ HMSList Number 58400-200 | Predicate Device (K152006)ICU Medical Cogent™ HMSList Number 58400-000 | Comparison |
| Compatibility -Catheters and sensors | Compatible with currently marketedICU Medical catheters and pressuresensors via patient interface cables. | Compatible with currently marketedICU Medical catheters and pressuresensors via patient interface cables. | Same |
| Materials ofConstruction | Base Unit (PIM):Polycarbonate - SiloxaneCopolymerSABIC, LEXAN CopolymerEXL9330-BK1A068 Display Unit (UIM):Polycarbonate -Sabic (E45329)Cycoloy C2950 | Base Unit (PIM):Polycarbonate - SiloxaneCopolymerSABIC, LEXAN CopolymerEXL9330-BK1A068 Display Unit (UIM):Polycarbonate -Sabic (E45329)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 72hours each | Stores 4 patient records up to 72hours each | Same |
| Dimensions: | 11" x 10" x 7"( 27.9 cm x 25.4 cm x 17.8 cm ) | 11" x 10" x 7"( 27.9 cm x 25.4 cm x 17.8 cm ) | Same |
| Weight: | 11 lbs ( 4.9 kg ) | 10lbs excluding power cables(11 lbs (4.9 kg) includes cables) | Same |
| Battery: | Li-ion Rechargeable | Li-ion Rechargeable | Same |
| Environmental Specifications | |||
| Operatingtemperature: | 50°F to 98.6°F ( 10°C to 37°C ) | 50°F to 98.6°F ( 10°C to 37°C ) | Same |
| Operating humidity: | 10% to 90% (noncondensing) | 10% to 90% (noncondensing) | Same |
| Operating altitude: | 0 to 8,000 feet (0 to 3,000 m) abovesea level | 0 to 8,000 feet (0 to 3,000 m) abovesea level | Same |
| Atmospheric pressure: | 70 to 104 kPa | 70 to 104 kPa | Same |
| Storage temperature: | -4°F to 140°F ( -20°C to 60°C ) | -4°F to 140°F ( -20°C to 60°C ) | Same |
| Storage humidity: | 10% to 90% noncondensing | 10% to 90% noncondensing | Same |
| Technical Specifications | |||
| Operating power range | 90 to 130 VAC Single Phase,2.0A RMS, 47-63Hz,210 to 254 VAC Single Phase,1.0A RMS, 47-63Hz | 90 to 130 VAC Single Phase,2.0A RMS, 47-63Hz,210 to 254 VAC Single Phase,1.0A RMS, 47-63Hz | Same |
| Alarm audio range | Off, and 45 to 85 dB at 0.5 meters | Off, and 45 to 85 dB at 0.5 meters | Same |
| Power Interface Module (PIM) | |||
| Port connections | Analog input/output: ECG; 1-3inputs; 1-2 outputs Digital: RS-232 ports 1-2;ethernet; UIM tether port | Analog input/output: ECG; 1-3inputs; 1-2 outputs Digital: RS-232 ports 1-2;ethernet; UIM tether port | Same |
| User Interface Module (UIM) | |||
| Alarm tones | High-priority; Low-priority;Informational | High-priority; Low-priority;Informational | Same |
Windows 7 OS
DXG - Computer, Diagnostic, Pre-
Programmed, Single-Function
DQA - Oximeter (secondary)
version 1.1.8
(primary)
જ્વ
Updated
Updated
Same
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Image /page/7/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is in blue, with the "icu" portion being a darker shade of blue. Below the logo, in a smaller font, is the text "human connections".
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Image /page/8/Picture/1 description: The image shows the logo for ICU Medical. The text "icu medical" is in a sans-serif font and is a light blue color. Below the company name is the tagline "human connections" in a smaller font size and lighter shade of blue.
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Image /page/9/Picture/1 description: The image shows the ICU Medical logo. The word "icumedical" is written in blue, with the "icu" part being bolded. Below the word "icumedical" is the phrase "human connections" in a smaller, lighter blue font.
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Image /page/10/Picture/1 description: The image shows the logo for ICU Medical. The text "icumedical" is in a sans-serif font, with "icu" in a bold, dark blue and "medical" in a lighter blue. Below the company name, in a smaller, light blue font, are the words "human connections."
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Image /page/11/Picture/1 description: The image shows the logo for ICU Medical. The logo is in two lines, with the first line showing the text "icumedical" in a sans-serif font. The "icu" part of the text is in blue, while the "medical" part is in light blue. The second line shows the text "human connections" in a smaller, light blue font.
VII. Comparison Summary
The modified Cogent HMS (with Windows 10 OS, software version 1.4.0, and hardware updates) is designed with the same fundamental technology, mode of operation, intended use/indications for use, mechanical design, and material of construction as the predicate Cogent HMS (cleared under K152006).
The differences between the subject device compared to the predicate device are the following:
- Updated operating system from Windows 7 to Windows 10 due to Windows 7 obsolescence (by Microsoft).
- Updated software version from 1.1.8 to 1.4.0 to support Windows transition and to address known anomalies.
- Modified software and hardware (power management board; display) in Power Interface Module (PIM) and User Interface Module (UIM) to support Windows transition and parts obsolescence.
In addition, modifications were made to the Cogent HMS compatible ICU Medical OpMod Cable in software revision from 3.1 to 3.2, and a like-for-like change to the detector component and epoxy material for improved manufacturability. These changes do not affect the cleared device's functionality or performance, and no new risks or modifications to existing risks were introduced.
VIII. Summary of Simulated Use (Non-Clinical) Testing
To demonstrate substantial equivalence between the subject device and the predicate device the following non-clinical tests were performed:
- Biocompatibility
The Cogent HMS is not considered to have direct patient or tissue contact, therefore no biocompatibility testing was performed or required. The patient contacting accessories such as catheters and sensors are out of scope for this submission and are 510(k) cleared under separate premarket notifications.
- Simulated Use - System Bench Testing
Bench studies were conducted in simulated use environments to verify and validate the safety and efficacy of the Cogent HMS. These studies demonstrate that the measurement performance of the subject device is equivalent to that of the predicate device.
- · PulseCO Algorithm Validation
- Bolus CO Algorithm In Vitro Validation
- · SO2 Algorithm In Vitro Validation
- · CCO Algorithm In Vitro Validation
- · Cogent System Software Validation
- Software Verification and Validation Testing
Software verification and validation testing were successfully conducted in accordance with ICU Medical Software Verification and Validation process per IEC 62304 and 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 the subject device is considered equivalent to the predicate device, as a "moderate" level of concern since a failure or latent flaw in the software could not directly result in serious injury or death to the patient or operator.
- Electrical Safety and Electromagnetic Compatibility
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Image /page/12/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and consists of the letters "icu" in bold, followed by the word "medical" in a thinner font. Below the word "medical" is the phrase "human connections" in a smaller font.
Electrical Safety per IEC 60601-1 and Electromagnetic Compatibility (EMC) per IEC 60601-1-2 testing were conducted at an Independent Nationally Recognized Testing Laboratory (NRTL). Results conclude the subject device complies with requirements per these standards.
- Cybersecurity
Cybersecurity testing was performed and concludes that the system is effective in addressing cybersecurity threats. FDA Cybersecurity Guidance followed during development include Content of Premarket Submissions for Management of Cybersecurity, issued October 2, 2014 and Postmarket Management of Cybersecurity in Medical Devices, issued December 28, 2016.
- Risk Management
Risk management activities have been incorporated into the design updates in accordance with ISO 14971:2019 and have been tested for correct implementation and effectiveness as part of verification and validation.
- Human Factors/Animal/ Clinical Studies
No new human factors, animal, and/or clinical studies were conducted as was determined not required to demonstrate device safety and effectiveness for the subject device. No changes were made to the User Interface and the device maintained the same screen layout, menu selections layout and system navigation for added features/functions.
IX. Conclusion
The modified Cogent HMS (including new Operating System, software and 'like' hardware updates) meets functional performance and intended use claims as described in the device labeling. The modifications to the subject device consider the same questions of safety and effectiveness as the predicate device, and there are no different questions of safety and effectiveness introduced.
The results of software, electrical safety, system verification testing conclude that the Cogent HMS with Windows 10 Operating System, software version 1.4.0, and hardware modifications is safe and effective for intended users, uses, and use environments, and that no clinical investigation or further testing is needed. The methods and results described in the validation reports support this conclusion. The results of these tests have demonstrated the overall safety of the subject device and ultimately supports a substantial equivalence determination of the modified Cogent HMS to the predicate device cleared under K152006.
§ 870.1435 Single-function, preprogrammed diagnostic computer.
(a)
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.(b)
Classification. Class II (performance standards).