(163 days)
Not Found
No
The document describes standard hemodynamic monitoring techniques (thermodilution, pulse power analysis, reflectance spectrum) and mentions software validation according to established standards, but does not mention AI or ML.
No.
The device is for monitoring and diagnostic evaluation, not for providing therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for patients for whom the monitoring of CCO and calculated hemodynamic parameters is indicated for diagnostic and prognostic evaluation by a clinician."
No
The device description explicitly states that the Cogent HMS consists of a base unit (PIM), a dedicated touch-screen display unit (UIM), and associated cables, indicating it includes hardware components beyond just software.
Based on the provided information, the Cogent HMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Cogent HMS Functionality: The Cogent HMS directly monitors physiological parameters within the patient's body using catheters and sensors. It measures cardiac output, venous oxygen saturation, and other hemodynamic parameters. These measurements are taken in vivo, not from specimens collected outside the body.
- Intended Use: The intended use describes monitoring of CCO and calculated hemodynamic parameters for diagnostic and prognostic evaluation. While this information is used for diagnosis and prognosis, the method of obtaining the information is through direct patient monitoring, not through the analysis of collected specimens.
Therefore, the Cogent HMS falls under the category of a patient monitoring device rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
DXG, DQA
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.
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.
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
PulseCO functionality is limited to adult patients.
Intended User / Care Setting
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.
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 non-clinical tests were performed:
- Biocompatibility: The Cogent HMS is not considered to have direct patient or tissue contact.
- 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: 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: 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.
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
2
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
3
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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4
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 | |
| Number | 2025816 |
| Application Correspondent | |
| Name & Contact | Diane Stockman, Global Regulatory Affairs |
| 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; |
| DQA - Oximeter | |
| Legally marketed device(s) to | |
| which equivalence s claimed | K152006, CogentTM Hemodynamic Monitoring System (ICU |
| 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.
6
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 | ||
| List Number 58400-200 | |||
| CogentTM Hemodynamic Monitoring | |||
| System or Cogent HMS | ICU Medical CogentTM HMS | ||
| List Number 58400-000 | |||
| CogentTM Hemodynamic Monitoring | |||
| System or Cogent HMS | Same | ||
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | |||
| PREDICATE DEVICE | |||
| Characteristics | Subject Device | ||
| ICU 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 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 Hemodynamic Monitoring | ||
| System (HMS) is intended for patients | |||
| for whom the monitoring of continuous | |||
| cardiac output and calculated | |||
| hemodynamic parameters is indicated for | |||
| diagnostic and prognostic evaluation by a | |||
| clinician. Suitability for use on a patient | |||
| is up to the physician's judgment and the | |||
| diameter of the catheter to be used. | |||
| • The target population includes patients | |||
| for whom hemodynamic monitoring will | |||
| improve clinical care. The target | |||
| populations are identical to those for the | |||
| predicate devices and include: | |||
| o Critical Care Patients | |||
| o Trauma Patients | |||
| o Cardiac Surgery Patients | |||
| • 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 | Similar | ||
| The statement | |||
| was reworded | |||
| for clarity only. | |||
| 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. | • The intended environment for use is the | ||
| hospital including Critical Care Units | |||
| (such as Medical, Surgical, and | |||
| Coronary), Trauma and Accident | |||
| Emergency Units, Post Anesthesia Care | |||
| Units, Operating Rooms, and Cardiac | |||
| Catheterization labs. | |||
| • The Cogent HMS is intended to be used | |||
| by trained and qualified individuals in | |||
| medical and surgical intensive care units, | |||
| operating rooms, trauma and accident | |||
| emergency units, coronary and intensive | |||
| care units and cardiac catheterization | |||
| laboratories. | |||
| • The Cogent HMS is restricted to one | |||
| patient at a time. | |||
| 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. | |||
| 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 | |||
| List Number 58400-200 | ICU Medical Cogent™ HMS | ||
| List Number 58400-000 | |||
| 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. | The target population includes | ||
| patients for whom hemodynamic | |||
| monitoring will improve clinical | |||
| care. The target populations are | |||
| identical to those for the predicate | |||
| devices and include: | |||
| o Critical Care Patients | |||
| o Trauma Patients | |||
| o Cardiac Surgery Patients | Similar | ||
| Reworded for | |||
| added clarity | |||
| only. | |||
| 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. | • The intended environment for use is | ||
| the hospital including Critical Care | |||
| Units (such as Medical, Surgical, and | |||
| Coronary), Trauma and Accident | |||
| Emergency Units, Post Anesthesia | |||
| Care Units, Operating Rooms, and | |||
| Cardiac Catheterization labs. | |||
| • The Cogent HMS is intended to be | |||
| used by trained and qualified | |||
| individuals in medical and surgical | |||
| intensive care units, operating rooms, | |||
| trauma and accident emergency | |||
| units, coronary and intensive care | |||
| units and cardiac catheterization | |||
| laboratories. | |||
| • The Cogent HMS is restricted to | |||
| one patient at a time. | Similar | ||
| Reworded for | |||
| added clarity | |||
| only. | |||
| Principle of Operation | A monitoring system to display | ||
| clinical measurements of a patient's | |||
| hemodynamic (cardiovascular) | |||
| function when connected to a | |||
| catheter or sensor attached to a | |||
| patient. | A monitoring system to display | ||
| clinical measurements of a patient's | |||
| hemodynamic (cardiovascular) | |||
| function when connected to a | |||
| catheter or sensor attached to a | |||
| patient. | Same | ||
| Mechanism/Mode of | |||
| Action | Displays entered, measured, and | ||
| derived hemodynamic monitoring | |||
| parameters via device | |||
| interconnection with compatible | |||
| cable, optical module, and/or | |||
| bedside monitor to a compatible | |||
| catheter or pressure sensor (attached | |||
| to the patient). | Displays entered, measured, and | ||
| derived hemodynamic monitoring | |||
| parameters via device | |||
| interconnection with compatible | |||
| cable, optical module, and/or bedside | |||
| monitor to a compatible catheter or | |||
| pressure sensor (attached to the | |||
| patient). | Same | ||
| VI. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE | |||
| PREDICATE DEVICE | |||
| Characteristics | Subject Device | ||
| ICU Medical Cogent™ HMS | |||
| List Number 58400-200 | Predicate Device (K152006) | ||
| ICU Medical Cogent™ HMS | |||
| 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 | |||
| 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 | ||
| ICU Medical Cogent™ HMS | |||
| List Number 58400-200 | Predicate Device (K152006) | ||
| ICU Medical Cogent™ HMS | |||
| List Number 58400-000 | Comparison | ||
| Compatibility - | |||
| Catheters and sensors | Compatible with currently marketed | ||
| ICU Medical catheters and pressure | |||
| sensors via patient interface cables. | Compatible with currently marketed | ||
| ICU Medical catheters and pressure | |||
| sensors via patient interface cables. | Same | ||
| Materials of | |||
| Construction | Base Unit (PIM): | ||
| Polycarbonate - Siloxane | |||
| Copolymer | |||
| SABIC, LEXAN Copolymer | |||
| EXL9330-BK1A068 Display Unit (UIM): | |||
| Polycarbonate -Sabic (E45329) | |||
| Cycoloy C2950 | Base Unit (PIM): | ||
| Polycarbonate - Siloxane | |||
| Copolymer | |||
| SABIC, LEXAN Copolymer | |||
| EXL9330-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 72 | ||
| hours each | Stores 4 patient records up to 72 | ||
| hours 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 | |||
| Operating | |||
| temperature: | 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) above | ||
| sea level | 0 to 8,000 feet (0 to 3,000 m) above | ||
| sea 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; 1-3 | ||
| inputs; 1-2 outputs Digital: RS-232 ports 1-2; | |||
| ethernet; UIM tether port | Analog input/output: ECG; 1-3 | ||
| inputs; 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.