(150 days)
Not Found
Yes
The device description explicitly mentions an "algorithm" that provides a "likelihood" of a future event based on physiological data, which is characteristic of predictive modeling often implemented using AI/ML techniques. The testing section also refers to "algorithm performance." While the terms "AI" or "ML" are not explicitly used, the function and description strongly suggest the use of such technology.
No.
The device provides physiological insight and additional quantitative information for reference only, and is explicitly stated as "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter." Its purpose is to predict the likelihood of hypotensive events, not to deliver therapy.
Yes
Explanation: 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 in identifying or assessing a medical condition (hypotension risk).
No
The device description explicitly states it is a "software feature" of the Edwards Acumen Hypotension Prediction Index, which is intended for use with "advanced hemodynamic monitoring" and specifically mentions use with "Edwards ClearSight (Noninvasive) technology." This indicates the software is part of a larger system that includes hardware for data acquisition (hemodynamic monitoring).
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- This device analyzes physiological data from the patient in vivo (within the body) through advanced hemodynamic monitoring. It's processing real-time physiological signals, not analyzing a sample taken from the patient.
The device's function is to provide predictive information based on continuous physiological monitoring, which falls under the category of a monitoring or predictive software feature, not an IVD.
No
The provided input 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 Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events 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 is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.
Product codes (comma separated list FDA assigned to the subject device)
QAQ
Device Description
The Acumen Hypotension Prediction Index parameter (HPI) provides the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients.
By default, the software defines a hypotensive event as mean arterial pressure (MAP)
§ 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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June 8, 2023
Edwards Lifesciences LLC Varad Raghuwanshi Manager, Regulatory Affairs One Edwards Way Irvine, California 92614
Re: K230057
Trade/Device Name: Acumen Hypotension Prediction Index (HPI) Regulation Number: 21 CFR 870.2210 Regulation Name: Adjunctive Predictive Cardiovascular Indicator Regulatory Class: Class II Product Code: QAQ Dated: January 6, 2023 Received: January 9, 2023
Dear Varad Raghuwanshi:
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.
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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.
Robert T. Kazmierski -S
for
LCDR 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) K230057
Device Name Acumen Hypotension Prediction Index
Indications for Use (Describe) Acumen Hypotension Prediction Index:
The Edwards Acumen Hypotension Prediction Index software feature provides the clinician with physiological insight into a patient's likelihood of future hypotensive events and the associated hemodynamics. The Acure 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 is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – Acumen Hypotension Prediction Index (HPI)
I. Submitter:
- Edwards Lifesciences LLC Sponsor: One Edwards Way Irvine, CA 92614 Establishment 2015691 Registration Number: Contact Person: Varad Raghuwanshi Manager, Regulatory Affairs One Edwards Way Irvine, CA 92614 Telephone: (949) 756-4502
Fax: (949) 809-2972
Date Prepared: June 8, 2023
II. Device Information:
| Device Name | Acumen Hypotension Prediction Index (HPI) |
|---|---|
| Trade Name: | Acumen Hypotension Prediction Index (HPI) feature for Minimally Invasive and Non-Invasive technology |
| Common Name: | Adjunctive Predictive Cardiovascular Indicator |
| Classification Name: | Adjunctive Predictive Cardiovascular Indicator 21 CFR 870.2210 |
| Product Code and Regulatory Class: | QAQ, Class II |
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III. Predicate Device
| Primary
| Predicate Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards Lifesciences, K203687 cleared May 28th, 2021, utilized for the Acumen Hypotension Prediction Index software feature. |
|---|---|
| Additional | |
| Predicate | |
| Devices: | Acumen Hypotension Prediction Index feature by Edwards Lifesciences DEN160044, granted March 16, 2018, utilized for the Acumen Hypotension Prediction Index software feature. |
IV. Device Description
The Acumen Hypotension Prediction Index parameter (HPI) provides Device Description: the clinician with the likelihood that the patient may be trending toward a hypotensive event. The Acumen HPI feature is intended for use in surgical or non-surgical patients.
By default, the software defines a hypotensive event as mean arterial pressure (MAP)