(270 days)
Yes
The device is described as providing a "Hypotension Prediction Index" which is an "index related to the likelihood of a patient experiencing hemodynamic instability defined as a hypotensive event* within 15 minutes". While the terms AI or ML are not explicitly used, the concept of predicting a future physiological event based on current and potentially historical physiological data strongly suggests the use of a predictive algorithm, which is a common application of machine learning in healthcare. The description of the device as providing "physiological insight into a patient's likelihood of future hypotensive events" further supports this interpretation. The fact that it is an "index" derived from physiological data points towards a model or algorithm processing this data to generate the prediction.
No.
The device provides "additional quantitative information" and states that "no therapeutic decisions should be made based solely on the Hypotension Prediction Index (HPI) parameter" and "should not be used exclusively to treat patients."
Yes
The device provides "physiological insight into a patient's likelihood of future hypotensive events" and "additional quantitative information regarding the patient's physiological condition," which helps clinicians understand the patient's status.
No
The device description explicitly states that the Acumen Hypotension Prediction Index feature consists of software running on the Edwards Lifesciences HemoSphere Advanced Monitoring Platform paired with the Acumen IQ extravascular blood pressure transducer and a peripheral arterial catheter. This indicates the software is dependent on and integrated with specific hardware components (the HemoSphere platform, transducer, and catheter) for its function, making it a hardware-software system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 the diagnosis, treatment, or prevention of disease.
- Device Function: The Acumen Hypotension Prediction Index feature analyzes physiological data (blood pressure) obtained directly from the patient through an arterial catheter and transducer. It does not process or analyze specimens taken from the body.
- Intended Use: The intended use is to provide "physiological insight into a patient's likelihood of future hypotensive events" and associated hemodynamics, based on real-time physiological measurements.
Therefore, since the device operates on real-time physiological data from the patient rather than analyzing specimens in vitro (outside the body), it does not fit the definition of an In Vitro Diagnostic.
No
The letter does not explicitly state 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 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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July 30, 2021
Edwards Lifesciences, LLC Lisa Gilman Distinguished Regulatory Affairs Program Manager One Edwards Way Irvine, California 92614
Re: K203224
Trade/Device Name: Acumen™ Hypotension Prediction Index Regulation Number: 21 CFR 870.2210 Regulation Name: Adjunctive predictive cardiovascular indicator Regulatory Class: Class II Product Code: QAQ Dated: October 30, 2020 Received: November 2, 2020
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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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,
for
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
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Indications for Use
510(k) Number (if known) K203224
Device Name Acumen Hypotension Prediction Index
Indications for Use (Describe)
The Edwards Lifesciences Acumen Hypotension 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 | |
|---|---|
| Sponsor | Edwards Lifesciences LLC |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Establishment | |
| Registration | |
| Number | 2015691 |
| Contact | |
| Person | Lisa Gilman |
| Distinguished Regulatory Affairs Program Manager | |
| One Edwards Way | |
| Irvine, CA 92614 | |
| Telephone: (949) 250-1478 | |
| Fax: (949) 809-2996 | |
| Date | |
| Prepared | June 16, 2021 |
| 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 (HemoSphere Advanced Monitoring |
| Platform, K201446 (Primary Predicate) | |
| Acumen Hypotension Prediction Index, DEN160044 (Reference Predicate) | |
| The Acumen Hypotension Prediction Index feature consists of software | |
| running on the Edwards Lifesciences HemoSphere Advanced Monitoring | |
| Platform paired with the Acumen IQ extravascular blood pressure transducer | |
| (K152980) and a peripheral arterial catheter. The monitoring system includes | |
| the Acumen Hypotension Prediction Index (HPI), and graphical user | |
| interface features displaying hemodynamic parameters relevant to assessing | |
| the root cause of a potential hypotensive event.* | |
| Device | |
| Description | The Acumen Hypotension Prediction Index is an index related to the |
| likelihood of a patient experiencing hemodynamic instability defined as a | |
| hypotensive event* within 15 minutes, where zero (0) indicates low | |
| likelihood and one hundred (100) indicates a hypotensive event is occurring. | |
| The Acumen Hypotension Prediction Index parameter (HPI), should not be | |
| used exclusively to treat patients. A review of the patient's hemodynamics is | |
| recommended prior to initiating treatment. | |
| * A hypotensive event is defined as mean arterial pressure (MAP) 1 Shah NJ, Mentz G, Kheterpal S. The incidence of intraoperative hypotension in moderate to high risk patients undergoing non-cardiac surgery: A retrospective multicenter observational analysis. J Clin Anest. 2020: 66; 109961. |
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The primary safety endpoint was the percentage of serious adverse events to include perioperative events, postoperative complications, and device-related serious adverse events. The secondary objective for this study (secondary safety endpoint) was to determine if the guidance provided by the Acumen HPI Feature reduced a composite measure of complications as indicated below:
- Post-operative episodes of non-fatal cardiac arrest;
- In-hospital death; ●
- . Stroke:
- Acute Kidney Injury (AKI) within 30 days of the procedure; ●
- Myocardial Injury in non-cardiac surgery (MINS) within 30 days of . the procedure.
| | Description | HPI
(Intent-to-Treat) | HPI
(Full Analysis Set) | MPOG
(Full Analysis Set) |
|----------------------------|-----------------------------------|--------------------------------|----------------------------|-----------------------------|
| # of patients (N) | | 460 | 406* | 22,109 |
| Gender (%) | Male | 51.7 (n=238) | 52.96 (n=215) | 57.8 (n=12,770) |
| Gender (%) | Female | 48.3 (n=222) | 47.04 (n=191) | 42.2 (n=9330) |
| Age (year) | Mean ± SD | 63.0 ± 13.0 | 62.8 ± 13.0 | 63.3 ± 13.8 |
| Age (year) | Median | 65 (19 - 94) | 65 (19 - 89) | 65 (18 - 90) |
| BMI | Median (25th and 75th percentile) | 28.09 (24.37, 32.81) | 28.09 (24.41, 32.86) | 28.1 (24.2, 32.9) |
| ASA Score (%) | II** | 0.2 (n=1) | 0.25 (n=1) | 0.0 (n=0) |
| ASA Score (%) | III | 91.5 (n=421) | 92.12 (n=374) | 80.83 (n=17,870) |
| ASA Score (%) | IV | 8.0 (n=37) | 7.64 (n=31) | 19.17 (n=4,239) |
| ASA Score (%) | Not specified | 0.2 (n=1) | 0.0 (n=0) | 0.0 (n=0) |
| Surgery duration (minutes) | Mean ± SD | 338.1 ± 145.38
(n = 458) | 363.6 ± 134.04 | 355.2 ± 145.8 |
| Surgery duration (minutes) | Median (25th and 75th percentile) | 315.5 (235 - 416)
(n = 458) | 336 (262 - 430) | 317 (245, 427) |
Patient Demographics
*The Full Analysis Set (FAS) represent those subjects from the Intent-to-Treat (ITT) population that had a surgery duration of ≥3 hours.
** ASA II subject was identified as a protocol deviation, though not excluded from ITT and FAS populations as this subject met the defined criteria ( surgery > 3 hours and hemodynamic monitoring data). This subject was included in the efficacy and safety analyses, although by inclusion/exclusion criteria should not have been enrolled in the study.
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| Procedure Type (HPI) | |
|---|---|
| Procedure Type | % (n/N) |
| Spine Surgery | 18.5 (85 / 460) |
| Hepatectomy | 13.7 (63 / 460) |
| Whipple | 10.0 (46 / 460) |
| Major, vascular | 8.5 (39 / 460) |
| Other | 8.5 (39 / 460) |
| Nephrectomy | 5.7 (26 / 460) |
| Other Genitourinary Surgery | 5.4 (25 / 460) |
| Cystectomy | 5.0 (23 / 460) |
| Pancreatectomy | 5.0 (23 / 460) |
| Renal Transplant | 4.3 (20 / 460) |
| Head & Neck Surgery | 3.9 (18 / 460) |
| Complex Combined Oncologic Surgery | |
| (including 2 or more distinct organs) | 3.0 (14 / 460) |
| Exploratory Laparotomy | 3.0 (14 / 460) |
| Colectomy | 2.8 (13 / 460) |
| Adrenalectomy | 2.6 (12 / 460) |
| Gastrectomy | 2.0 (9 / 460) |
| Other Gastrointestinal Surgery | 2.0 (9 / 460) |
| Hip Revision | 1.7 (8 / 460) |
| Prostatectomy | 1.7 (8 / 460) |
| HIPEC | 1.3 (6 / 460) |
| Hysterectomy with Debulking | 1.3 (6 / 460) |
| Cholecystectomy | 0.9 (4 / 460) |
| Reoperative Orthopedic Surgery | 0.9 (4 / 460) |
| Splenectomy | 0.9 (4 / 460) |
| Bariatric Surgery | 0.4 (2 / 460) |
| Liver Transplant | 0.4 (2 / 460) |
| Sigmoidectomy | 0.4 (2 / 460) |
| Not Specified | 0.2 (1 / 460) |
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Study Results
Effectiveness
The HPI Study was designed to evaluate the ability of the Acumen HPI Feature, as a decision support tool, to reduce the duration of IOH by at least 25% in surgical patients that require advanced hemodynamic monitoring. An episode of intraoperative hypotension (IOH) was defined as a mean arterial pressure (MAP) below 65 for three (3) or more consecutive 20 second events for each subject, across all sites.
The primary effectiveness endpoint is a weighted average of site means and standard deviations combined in the same proportion of subjects that were included in the MPOG cohort. This weighted average and its properly computed standard deviation was compared to the estimates obtained from the subjects of the MPOG cohort.
The HPI Study met its primary effectiveness endpoint. The HPI Pivotal Subjects of the full analysis set experienced a mean IOH duration of 11.97 ± 13.92 minutes compared with the MPOG historical control mean IOH of 28.20 ± 42.60 minutes. The table below demonstrates that this result was a reduction of 57.6% compared to the MPOG historical control (p 25% reduction in its mean duration of IOH, with all sites but one exceeding 35%; ranging from a23% to 72% mean IOH reduction. The findings of the study showed a reduction of the duration of IOH to 11.97 mins (SD 13.92), representing a 57.6% reduction (p