Search Results

The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The FloTrac Jr sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac Jr sensor is indicated for use in pediatric patients ≥ 12 years of age.

The Acumen IQ sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.

The VolumeView sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output.

The FloTrac, Acumen IQ, and VolumeView sensors are constructed from two disposable pressure transducers that convert a physiological signal (or mechanical pressure) to an electrical signal that is transmitted through the cable to the patient monitor. The sensors have a straight, flow-through design in which fluid is passed directly across the pressure sensor. The sensors are comprised of a pressure sensitive silicon chip with two electrodes for excitation voltage and two electrodes for signal output. A polycarbonate housing with an integral stopcock at one end, and an integral flush device at the other end, encloses the sensors.

The provided FDA 510(k) summary for the FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors does not contain detailed information about specific acceptance criteria and the study that proves the device meets those criteria in the typical format requested for an AI/ML-based medical device.

This document describes a substantial equivalence determination for extravascular blood pressure transducers (sensors) manufactured by Edwards Lifesciences, LLC. The core of the submission is that the subject devices are identical to the predicate devices in terms of intended use, indications for use, and technological characteristics, EXCEPT for changed pressure tubing and IV set component materials.

Therefore, the "study" described here is primarily focused on demonstrating that these material changes do not introduce new safety or effectiveness concerns, rather than validating an AI/ML algorithm's diagnostic performance against established ground truth.

Here's a breakdown based on the provided text, addressing your questions where possible, and noting where the information is not applicable or not present:

Overview of the Device and Study's Focus:

The devices in question are FloTrac, FloTrac Jr, Acumen IQ, and VolumeView sensors, which are intravascular pressure monitoring devices that also work with Edwards' arterial pressure-based cardiac output monitoring hardware. The 510(k) submission (K242909) is for modifications to these existing devices, specifically changes to the pressure tubing and IV set component materials. The premise of the submission is that these material changes do not alter the fundamental performance or safety in a way that would require new clinical performance studies typical for an AI/ML device.

1. Table of Acceptance Criteria and Reported Device Performance

The document states:

• "All testing met the existing predetermined acceptance criteria."
• "Based on the performance testing and the technological characteristics, the FloTrac sensors, Acumen IQ sensors, and VolumeView sensors meet the established performance criteria and are substantially equivalent to the predicate."

However, the specific quantitative acceptance criteria (e.g., accuracy +/- X mmHg, drift

Ask a specific question about this device

Swan-Ganz catheters:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of adult critically ill patients including but limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.
Models 096F6, 096F6P, TS105F5, 132F5, 131F7, 131F7P 831F75, 831F75P, 834F75, and 834F75P are intended for adult and pediatric patients:
The Swan-Ganz catheters are diagnostic and monitoring tools used for hemodynamic monitoring of critically ill adult and pediatric patients ≥ 12 years of age including but not limited to post major surgical recovery, trauma, sepsis, burns, pulmonary disease, pulmonary failure, cardiac disease including heart failure.

FloTrac sensors:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. They are intended to be used in adult patients.
Models MHD6, MHD8, MHD65, and MHD85 are intended for adult and pediatric patients:
The FloTrac sensor is indicated for use in intravascular pressure monitoring. It is also indicated for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware to measure cardiac output. The FloTrac sensor is indicated for use in adult and pediatric patients ≥ 12 years of age.

ClearSight finger cuffs:
The Acumen IQ are indicated for patients over 18 years of age to non-invasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.
The ClearSight finger cuffs are indicated for adult and pediatric patients ≥ 12 years of age to noninvasively measure blood pressure and associated hemodynamic parameters when used with EV1000 clinical platform or HemoSphere Advanced Monitoring Platform.

HemoSphere Advanced Monitor with HemoSphere Swan-Ganz Module:
The HemoSphere advanced monitor when used with the HemoSphere Swan-Ganz module and Edwards Swan-Ganz catheters is indicated for use in adult and pediatric critical care patients requiring monitoring of cardiac output (continuous [CO] and intermittent [iCO]) and derived hemodynamic parameters in a hospital environment. It may be used for monitoring hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards Swan-Ganz catheter indications for use statement for information on target patient population specific to the catheter being used.
Refer to the Intended Use statement for a complete list of measured and derived parameters available for each patient population.

HemoSphere Advanced Monitor with HemoSphere Pressure Cable (compatible with FloTrac sensors):
The HemoSphere advanced monitor when used with the HemoSphere pressure cable is indicated for use in adult and pediatric critical care patients in which the balance between cardiac function, fluid status, vascular resistance and pressure needs continuous assessment. It may be used for monitoring of hemodynamic parameters in conjunction with a perioperative goal directed therapy protocol in a hospital environment. Refer to the Edwards FloTrac sensor, Acumen IQ sensor, and TruWave DPT indications for use statements for information on target patient populations specific to the sensor/transducer being used.
The Edwards Acumen Hypotension Prediction Index feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events (defined as mean arterial pressure

Swan-Ganz Catheters:
The Swan-Ganz catheters are flow-directed pulmonary artery catheters used to monitor hemodynamic pressures. The Swan-Ganz thermodilution catheters provide diagnostic information to rapidly determine hemodynamic pressures and cardiac output when used with a compatible cardiac output computer.

FloTrac Sensors:
The FloTrac sensor is a sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. When connected to a compatible monitor, the FloTrac sensor minimally-invasively measures cardiac output and key hemodynamic parameters, which assist the clinician in assessing the patient's physiologic status and support clinical decisions related to hemodynamic optimization. The disposable sterile cable, with a red-connector interfaces, exclusively with an Edwards cable that is specifically wired for the pressure monitor being used. The disposable sterile cable, with a green-connector interfaces, exclusively with the Edwards cables for use with the Edwards arterial pressure based cardiac output monitoring devices or hardware.
The FloTrac sensor has a straight, flow-through design across the pressure sensors with an integral flush device.

ClearSight finger cuffs:
The ClearSight finger cuffs, when used with an appropriate Edwards monitoring system, provide continuous, noninvasive hemodynamic monitoring. The ClearSight finger cuffs utilize the volume-clamp method to measure blood pressure with an inflatable bladder wrapped around the middle phalanx of the finger.

HemoSphere Advanced Monitor Platform:
The HemoSphere Advanced Monitoring Platform was designed to simplify the customer experience by providing one platform with modular solutions for their hemodynamic monitoring needs. The user can choose from the available optional sub-system modules or use multiple sub-system modules at the same time. This modular approach provides the customer with the choice of purchasing and/or using specific monitoring applications based on their needs. Users are not required to have all of the modules installed at the same time for the platform to function.

This document is a 510(k) summary for Edwards Lifesciences' Swan-Ganz catheters, FloTrac sensors, ClearSight finger cuffs, and HemoSphere Advanced Monitoring Platform. The core of this submission is to expand the indications for use of these devices to include pediatric patients (≥12 years of age), in addition to their existing adult indications.

The information regarding acceptance criteria and the study that proves the device meets those criteria, as detailed in your request, is primarily found in the "Device Verification and Validation" and "Conclusion" sections. However, the FDA summary document only provides a high-level overview. It does not contain the detailed acceptance criteria table, precise performance metrics, sample sizes, ground truth establishment methods, or specific details about expert adjudication or MRMC studies, which are typically found in the full 510(k) submission or supporting clinical trial reports.

Based on the provided text, here's what can be extracted and what information is not present:

Key Takeaway from the FDA 510(k) Summary:

The primary purpose of this 510(k) submission is to expand the indicated patient population for the listed devices from adult-only to include pediatric patients aged 12 years and older. The submission claims that the devices perform similarly in this expanded pediatric population compared to adults, meeting predefined acceptance criteria.

Table of Acceptance Criteria and Reported Device Performance

Not Provided in this Document. The document states "within predefined acceptance criteria" but does not list these criteria or the specific reported device performance metrics against them.

Study Details (Based on available information):

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "the target pediatric population in a clinical study" but does not provide the number of patients.
   • Data Provenance:
     • Country of Origin: Not specified in this summary. Clinical studies are often multi-center, but no specific locations are mentioned.
     • Retrospective or Prospective: Not explicitly stated, but the phrase "clinical study" typically implies prospective data collection for regulatory submissions, especially for expanding indications to a new population.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: Not specified. Given the nature of these hemodynamic devices, ground truth would likely be established by clinical measurements and potentially other validated reference methods, rather than expert interpretation of images or signals in the same way a radiologist might interpret an X-ray. Clinical experts (e.g., intensivists, anesthesiologists, cardiologists) would be involved in patient selection, data collection, and overseeing the study.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Adjudication Method: Not specified. This type of adjudication (e.g., multi-reader consensus) is more common in image-based diagnostic AI studies. For device performance measurement, agreement with a reference standard is the typical method.

4. 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:

   • MRMC Study: Not applicable/not performed for this type of device and study. MRMC studies are primarily for evaluating AI's impact on human interpretation tasks (e.g., radiologists reading images). This submission is for devices that directly measure physiological parameters and provide data, with one feature (Acumen HPI) providing "physiological insight" for reference. The study focuses on the device's performance in a new patient population, not on how it assists human readers in interpreting complex cases, except perhaps by providing accessible data. The Acumen HPI feature specifically states "no therapeutic decisions should be made based solely on the Acumen Hypotension Prediction Index (HPI) parameter," indicating it's an informational tool rather than a definitive diagnostic AI assist requiring a MRMC study.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Standalone Performance: The study evaluated the devices' performance in the pediatric population. The devices themselves are "standalone" in that they acquire and process physiological signals to output parameters. The statement "The data demonstrate the performance in the expanded pediatric population ≥ 12 years of age and is substantially equivalent to their respective predicate devices for adult patient population ≥ 18 years of age" suggests an evaluation of the device's measurement accuracy and consistency.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Type of Ground Truth: Not explicitly stated, but for hemodynamic monitoring devices, ground truth is typically established by:
     • Reference Standards/Comparative Measurements: Comparing the device's measurements (e.g., cardiac output, blood pressure) against established, precise, and often more invasive or gold-standard methods (e.g., thermodilution, invasive arterial line measurements from validated transducers).
     • Clinical Outcomes/Safety Data: Demonstrating safety and effectiveness in the target population through clinical monitoring and observation.
   • The document states "clinical data presented in this 510(k) demonstrates the performance of hemodynamic parameters expanded to pediatric patients ≥ 12 years of age... are consistent and within predefined acceptance criteria," implying comparisons to a reference or expected range.

7. The sample size for the training set:

   • Training Set Size: Not applicable/not specified. These devices measure physiological parameters; they are not "AI algorithms" in the sense of needing a large training dataset to learn patterns for classification or prediction (except for the Acumen HPI feature, but no details on its development or training are provided here). The focus of this 510(k) is the application of existing technology to a new age group, not the development of a new pattern-recognition algorithm.

8. How the ground truth for the training set was established:

   • Ground Truth for Training Set: Not applicable, as there's no mention of a traditional AI training set. The devices likely use established physiological models and algorithms for calculating parameters. If the Acumen HPI feature involved machine learning, its training ground truth would likely be based on recorded physiological data and subsequent hypotensive events. However, the document does not elaborate on the development of this specific feature in the context of this 510(k).

Ask a specific question about this device