(146 days)
Yes
The device description explicitly states that the Hypotension Prediction Index (HPI) is an "index related to the likelihood of a patient experiencing a hypotensive event". While it doesn't use the terms AI or ML, the concept of predicting a future event based on physiological data is a common application of machine learning algorithms. The fact that it provides a numerical index (0-100) further suggests a model-based prediction rather than a simple threshold or rule-based system. The lack of explicit mention of AI/ML in the "Mentions AI, DNN, or ML" section is not definitive proof of absence, as these terms are not always used in 510(k) summaries even when such technology is present. The focus on predicting likelihood strongly implies the use of predictive modeling, which falls under the umbrella of AI/ML.
No
The device provides "additional quantitative information regarding the patient's physiological condition for reference only" and explicitly states "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter." This indicates it is for monitoring/prediction, not direct therapy.
Yes
The device is described as providing "physiological insight into a patient's likelihood of future hypotensive events" and "additional quantitative information regarding the patient's physiological condition for reference," which aligns with the definition of a diagnostic device that provides information about health conditions.
No
The device description explicitly states that the software runs on specific hardware platforms (EV1000 and HemoSphere) and requires a physical transducer and arterial catheter. It is not solely software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device description: The description clearly states that the device consists of software running on monitoring platforms paired with an extravascular blood pressure transducer and a radial arterial catheter. It measures physiological parameters directly from the patient's body (blood pressure).
- Intended Use: The intended use is to provide physiological insight into a patient's likelihood of future hypotensive events based on real-time hemodynamic monitoring. This is not a test performed on a sample taken from the body.
Therefore, this device falls under the category of a medical device used for monitoring and providing physiological information, not an in vitro diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
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
§ 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.
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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
1
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 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 |
| Contact | |
| Person | Lisa Gilman |
| Date Prepared | May 17, 2019 |
| Trade Name | Acumen™ Hypotension Prediction Index |
| Common | |
| Name | Adjunctive Predictive Cardiovascular Indicator |
| Classification | |
| Name | Adjunctive Predictive Cardiovascular Indicator |
| Regulation | |
| Class / Product | |
| Code | 21 CFR 870.2210/Class II/QAQ |
| Predicate | |
| Device(s) | Acumen Hypotension Prediction Index, DEN160044 |
| Device | |
| Description | 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 (MAP) $ |