(146 days)
The Edwards Lifesciences 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
The Acumen Hypotension Prediction Index Feature (DEN160044) consists of software running on the Edwards Lifesciences EV1000 Clinical Platform (DEN160044) and HemoSphere Advanced Monitoring Platform (K180881) paired with the FloTrac IQ or Acumen IQ extravascular blood pressure transducer (K152980) and a radial arterial catheter. The software includes the Acumen Hypotension Prediction Index (HPI), the Dynamic Arterial Elastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), and additional graphical user interface features. The Acumen Hypotension Prediction Index is an index related to the likelihood of a patient experiencing a hypotensive event (defined as mean arterial pressure < 65 mmHg for one minute in duration) within 15 minutes, where zero (0) indicates low likelihood and one hundred (100) indicates high likelihood. The Acumen Hypotension Prediction Index, HPI, should not be used exclusively to treat patients. A review of the patient's hemodynamics is recommended prior to initiating treatment.
Here's a breakdown of the acceptance criteria and study information for the Acumen Hypotension Prediction Index based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, the overall goal of the device, as described in the Indications for Use and Device Description, is to predict hypotensive events (MAP < 65 mmHg for at least one minute in duration) within 15 minutes. The Performance Data section states that "Clinical performance data were provided to demonstrate substantial equivalence of use of the Acumen™ Hypotension Prediction Index software."
The core performance attribute is the ability of the HPI to indicate the likelihood of a hypotensive event. The HPI values range from 0 (low likelihood) to 100 (high likelihood). While specific performance metrics like sensitivity, specificity, or AUC are not provided in this excerpt, the study aims to show that the performance in non-surgical patients is substantially equivalent to its established performance in surgical patients (as the predicate device, DEN160044, already had a grant decision).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Prediction of hypotensive events (MAP < 65 mmHg for at least one minute in duration) within 15 minutes in non-surgical patients. | Demonstrated "substantial equivalence of use" in non-surgical patients compared to surgical patients. (Specific metrics of prediction accuracy are not detailed in this document but would have been part of the original predicate device's clearance and likely referenced in the full submission). |
| HPI value range, with 0 indicating low likelihood and 100 indicating high likelihood. | The HPI device is designed to provide an index from 0 to 100 representing the likelihood. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the exact sample size for the test set. It only mentions that "Clinical performance data were provided."
Regarding data provenance:
- Country of origin of data: Not explicitly stated.
- Retrospective or prospective: Not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus of this 510(k) submission is on expanding the indications for use to non-surgical patients, demonstrating substantial equivalence to the predicate, rather than comparing AI-assisted performance against human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, a standalone study was done. The Acumen HPI is described as software that "provides the clinician with physiological insight" and "is considered to be additional quantitative information...for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This implies that the algorithm generates an output (the HPI score) independently, and its clinical performance data (as mentioned under "Performance Data") refers to this standalone algorithm's ability to predict hypotension.
7. Type of Ground Truth Used
The ground truth used for identifying a hypotensive event is clearly defined: mean arterial pressure (MAP) < 65 mmHg for at least one minute in duration. This is a physiological measurement, not expert consensus or pathology.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. The submission is focused on demonstrating equivalence for an expanded indication, so information about the original training of the algorithm (which likely happened for the predicate device DEN160044) is not detailed here.
9. How Ground Truth for the Training Set Was Established
The document does not explicitly state how the ground truth for the training set was established, but it can be inferred that it would have used the same physiological definition of hypotension (MAP < 65 mmHg for at least one minute) that is used for the device's indications for use and performance evaluation. This would involve continuous monitoring of MAP in a patient population.
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Edwards Lifeciences, LLC Lisa Gilman Senior Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K183646
Trade/Device Name: Acumen Hypotension Prediction Index Regulation Number: 21 CFR 870.2210 Regulation Name: Adiunctive Predictive Cardiovascular Indicator Regulatory Class: Class II Product Code: QAO Dated: May 16, 2019 Received: May 17, 2019
Dear Lisa Gilman:
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 (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 located 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.
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Matthew Hillebrenner 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) K183646
Device Name Acumen Hypotension Prediction Index
Indications for Use (Describe)
The Edwards Lifesciences 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 < 65 mmHg for at least one minute in duration) and the associated hemodynamics. The Acumen HPI feature is intended for nonsurgical patients receiving advanced hemodynamic monitoring. The Acumen HPI feature is considered to be additional quantitative information regarding the patient's physiological condition for reference only and no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter.
| 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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SECTION 5 – 510(k) SUMMARY
| Acumen™ Hypotension Prediction Index | |
|---|---|
| 510(k)Submitter | Edwards Lifesciences, LLC |
| ContactPerson | Lisa Gilman |
| Date Prepared | May 17, 2019 |
| Trade Name | Acumen™ Hypotension Prediction Index |
| CommonName | Adjunctive Predictive Cardiovascular Indicator |
| ClassificationName | Adjunctive Predictive Cardiovascular Indicator |
| RegulationClass / ProductCode | 21 CFR 870.2210/Class II/QAQ |
| PredicateDevice(s) | Acumen Hypotension Prediction Index, DEN160044 |
| DeviceDescription | The Acumen Hypotension Prediction Index Feature (DEN160044) consistsof software running on the Edwards Lifesciences EV1000 Clinical Platform(DEN160044) and HemoSphere Advanced Monitoring Platform (K180881)paired with the FloTrac IQ or Acumen IQ extravascular blood pressuretransducer (K152980) and a radial arterial catheter. The software includesthe Acumen Hypotension Prediction Index (HPI), the Dynamic ArterialElastance Parameter (Eadyn), the Systolic Slope Parameter (dP/dt), andadditional graphical user interface features.The Acumen Hypotension Prediction Index is an index related to thelikelihood of a patient experiencing a hypotensive event (defined as meanarterial pressure (MAP) $ < 65 $ mmHg for one minute in duration) within 15minutes, where zero (0) indicates low likelihood and one hundred (100)indicates high likelihood. The Acumen Hypotension Prediction Index, HPI,should not be used exclusively to treat patients. A review of the patient'shemodynamics is recommended prior to initiating treatment. |
| Indications forUse/IntendedUse | The Edwards Lifesciences Acumen Hypotension Prediction Index featureprovides the clinician with physiological insight into a patient's likelihoodof future hypotensive events (defined as mean arterial pressure < 65 mmHgfor at least one minute in duration) and the associated hemodynamics. TheAcumen HPI feature is intended for use in surgical or non-surgical patientsreceiving advanced hemodynamic monitoring. The Acumen HPI feature isconsidered to be additional quantitative information regarding the patient'sphysiological condition for reference only and no therapeutic decisionsshould be made based solely on the Hypotension Prediction Index (HPI)parameter. |
| Comparison toPredicateDevice | The Acumen™ Hypotension Prediction Index Feature Software(DEN160044, granted March 16, 2018)ModificationsThe labeling of the EV1000A Clinical Platform and theHemoSphere Advanced Monitoring Platform has been modified toexpand the indications for use from surgical [operating room (OR)]patients to surgical or non-surgical patients. The graphical user interface of the EV1000A Clinical Platform andthe HemoSphere Advanced Monitoring Platform has been modifiedto define:dP/dt parameter as systolic slope; and, Eadyn parameter as dynamic arterial elastance. There are no modifications to the hardware of the monitoringplatforms. |
| PerformanceData | Clinical PerformanceClinical performance data were provided to demonstrate substantialequivalence of use of the Acumen™ Hypotension Prediction Indexsoftware. |
| Conclusion | Overall ConclusionThe clinical performance data demonstrate that the Acumen™ HypotensionPrediction Index software used in non-surgical patients is substantiallyequivalent to use in surgical patients. |
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§ 870.2210 Adjunctive predictive cardiovascular indicator.
(a)
Identification. The adjunctive predictive cardiovascular indicator is a prescription device that uses software algorithms to analyze cardiovascular vital signs and predict future cardiovascular status or events. This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) A software description and the results of verification and validation testing based on a comprehensive hazard analysis and risk assessment must be provided, including:
(i) A full characterization of the software technical parameters, including algorithms;
(ii) A description of the expected impact of all applicable sensor acquisition hardware characteristics and associated hardware specifications;
(iii) A description of sensor data quality control measures;
(iv) A description of all mitigations for user error or failure of any subsystem components (including signal detection, signal analysis, data display, and storage) on output accuracy;
(v) A description of the expected time to patient status or clinical event for all expected outputs, accounting for differences in patient condition and environment; and
(vi) The sensitivity, specificity, positive predictive value, and negative predictive value in both percentage and number form.
(2) A scientific justification for the validity of the predictive cardiovascular indicator algorithm(s) must be provided. This justification must include verification of the algorithm calculations and validation using an independent data set.
(3) A human factors and usability engineering assessment must be provided that evaluates the risk of misinterpretation of device output.
(4) A clinical data assessment must be provided. This assessment must fulfill the following:
(i) The assessment must include a summary of the clinical data used, including source, patient demographics, and any techniques used for annotating and separating the data.
(ii) The clinical data must be representative of the intended use population for the device. Any selection criteria or sample limitations must be fully described and justified.
(iii) The assessment must demonstrate output consistency using the expected range of data sources and data quality encountered in the intended use population and environment.
(iv) The assessment must evaluate how the device output correlates with the predicted event or status.
(5) Labeling must include:
(i) A description of what the device measures and outputs to the user;
(ii) Warnings identifying sensor acquisition factors that may impact measurement results;
(iii) Guidance for interpretation of the measurements, including a statement that the output is adjunctive to other physical vital sign parameters and patient information;
(iv) A specific time or a range of times before the predicted patient status or clinical event occurs, accounting for differences in patient condition and environment;
(v) Key assumptions made during calculation of the output;
(vi) The type(s) of sensor data used, including specification of compatible sensors for data acquisition;
(vii) The expected performance of the device for all intended use populations and environments; and
(viii) Relevant characteristics of the patients studied in the clinical validation (including age, gender, race or ethnicity, and patient condition) and a summary of validation results.