(289 days)
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 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: Critical Care Patients, Trauma Patients, 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. 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 CogentTM HMS is restricted to one patient at a time.
The Cogent™ HMS system 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. Parameters include cardiac output and blood oxygen saturation levels, as well as other derived hemodynamic parameters. Measurements are obtained through ICU Medical pulmonary artery and central venous oximetry catheters, and ICU Medical CardioFloTM 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, using continuous thermodilution, and intermittently, using bolus thermodilution; monitors cardiac output continuously using Pulse Power analysis on an arterial pressure waveform; monitors venous oxygen saturation 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, PIM), a dedicated touch-screen display unit (user interface module, UIM) which allows for patient monitoring remotely (up to 50 feet), and the associated cables. The modules communicate with each other in docked, tethered (wired) or wireless mode. A physically separate optical module (OpMod) connects with an oximetry catheter. The Cogent™ HMS is designed for compatibility with PA catheters via connection to existing patient cables, i.e. unchanged cables as supplied with the primary predicate Q2 Plus. For the purpose of PulseCO™ data acquisition, the Cogent™ HMS is designed for compatibility with the CardioFloTM sensor and the new CardioFloTM reusable cable. In order to calculate blood oxygen saturation, the Cogent™ HMS is designed for compatibility with the existing optical module, its existing integrated cable and its associated compatible PA and oximetry catheters.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than defining specific acceptance criteria for a novel device performance. However, based on the content, we can infer some "acceptance criteria" through the comparison to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Equivalence Claims) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Continuous Cardiac Output (CCO) Measurement | Bench simulation: demonstrated "equivalent to that of the predicate devices, the Q2 Plus and the LiDCOrapid V2 Hemodynamic Monitor." Animal Study: "measurement performance of the Cogent™ HMS device is equivalent to the predicate device, the Q2 Plus." CCO_values were acquired and compared against measurements from accepted reference devices. |
| Thermodilution Cardiac Output (TdCO) Measurement | Bench simulation: demonstrated "equivalent to that of the predicate devices, the Q2 Plus and the LiDCOrapid V2 Hemodynamic Monitor." Animal Study: "measurement performance of the Cogent™ HMS device is equivalent to the predicate device, the Q2 Plus." TdCO_values were acquired and compared against measurements from accepted reference devices. |
| Venous Oxygen Saturation (SvO2 / SO2) Measurement | Bench simulation: demonstrated "equivalent to that of the predicate devices, the Q2 Plus and the LiDCOrapid V2 Hemodynamic Monitor." Animal Study: "measurement performance of the Cogent™ HMS device is equivalent to the predicate device, the Q2 Plus." SvO2_values were acquired and compared against measurements from accepted reference devices. |
| PulseCO Measurement (for adult patients) | Bench simulation: "Testing of the PulseCO algorithm using the same simulated physiological data set as was used for the secondary predicate device." Demonstrated "equivalent to that of the predicate devices, the Q2 Plus and the LiDCOrapid V2 Hemodynamic Monitor." |
| Electrical Safety and EMC | Complies with IEC 60601-1, IEC 60601-1-8, IEC 60601-2-34 (to the extent applicable), IEC 60601-2-49 standards for safety and the IEC 60601-1-2 standard for EMC. |
| Software Verification and Validation | Conducted and documentation provided as recommended by FDA guidance. Considered a "moderate" level of concern. Demonstrated device features are effective and function equivalently to the predicate device. |
| Hardware Functional Requirements | "Hardware testing carried out for the Cogent™ HMS indicates it meets design and performance functional requirements." |
| Biocompatibility | Not considered tissue contacting, therefore no biocompatibility testing was performed for the main device. (Implied acceptance criterion: no direct tissue contact). Catheters are covered under separate 510(k)s. |
| Intended Use | The device shares the same intended use as predicate devices, and differences in wording do not alter intended use or affect safety/effectiveness relative to predicates. (Implied acceptance criterion: intended use aligns with established predicate devices). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Tests (CCO, TdCO, SO2 algorithms): The sample size or specific dataset characteristics for the simulated physiological data are not explicitly provided. It simply states "bench simulation."
- Bench Test (PulseCO algorithm): The sample size or specific dataset characteristics are not explicitly provided. It states "the same simulated physiological data set as was used for the secondary predicate device."
- Animal Study: The sample size was 5 pigs. The provenance is not specified (e.g., country of origin, prospective/retrospective), but it describes an intervention-based study, suggesting it was prospective in design within the animal model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the bench tests, the ground truth was established by the simulated physiological data set. There is no mention of human experts establishing ground truth for these tests.
- For the animal study, the ground truth was established by "accepted reference devices." The number, qualifications, or adjudication method of human experts in establishing this "ground truth" or comparing to reference devices is not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- None explicitly mentioned. The ground truth for bench tests was simulated data, and for the animal study, it was "accepted reference devices." There's no indication of human expert adjudication.
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
- No MRMC study was done. The device (Cogent™ Hemodynamic Monitoring System) is a diagnostic computer for physiological parameters, not an imaging AI device where human readers interact directly with AI output. The document explicitly states: "No clinical performance testing was required to demonstrate device safety and effectiveness."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, standalone performance was assessed. The bench studies and the animal study evaluated the algorithms and hardware of the Cogent™ HMS independently against simulated data or accepted reference devices. The system is designed to compute and display parameters, not to provide an initial AI interpretation for a human to then review or modify.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Studies: Simulated physiological data.
- Animal Study: Measurements from "accepted reference devices" following pharmacological and ventilator interventions.
8. The sample size for the training set
- Since this is a 510(k) submission for a device primarily relying on established algorithms (continuous thermodilution, bolus thermodilution, oximetry, and PulseCO, which is also from a predicate), and not explicitly an AI/machine learning model that undergoes a distinct "training" phase with a large dataset, the concept of a "training set sample size" as typically understood for deep learning is not applicable or mentioned. The algorithms are described as being "measurement algorithms" or "analysis" algorithms, implying deterministic or well-defined computational processes rather than adaptive learning from a large training dataset.
9. How the ground truth for the training set was established
- As noted above, a distinct "training set" with ground truth in the context of machine learning is not applicable to the description of this device. The algorithms are based on established physiological measurement principles. For the PulseCO algorithm, it is stated to be "the PulseCO algorithm which is used in the secondary predicate device," suggesting its design and validation are tied to previous work on that predicate, not a new training process described here.
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).