(150 days)
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 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.
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) < 65 mmHg for at least one minute in duration. This MAP target is adjustable and can be changed to 55, 60, 70, 75, 80 or 85 mmHg.
The Edwards Acumen Hypotension Prediction Index (HPI) software feature was evaluated through algorithm verification and a usability study. The key aspects of the evaluation are as follows:
1. Acceptance Criteria and Reported Device Performance:
The document primarily focuses on verifying that the changes to the HPI algorithm (adjustable MAP targets) and the expansion to non-surgical patients did not negatively impact its safety and effectiveness. Specific numerical acceptance criteria for performance metrics (e.g., sensitivity, specificity, accuracy) are not explicitly stated in the provided text. Instead, the document states:
- "The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device."
- "The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm."
Without specific performance metrics and their corresponding acceptance thresholds, a table of acceptance criteria versus reported performance cannot be fully constructed from the provided text. The overall reported performance is that the device meets the implicit acceptance criterion of not adversely affecting safety and effectiveness with the modifications.
2. Sample Size and Data Provenance for Test Set:
- Algorithm Verification: The algorithm verification was performed using "clinical data." For the expanded non-surgical indication, "non-surgical clinical data collected retrospectively" was used.
- Sample Size: The document does not specify the sample size for the clinical data used in the algorithm verification test set.
- Data Provenance: The data used for the non-surgical indication was "retrospectively" collected. The country of origin is not specified.
3. Number of Experts and Qualifications for Ground Truth:
The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test set.
4. Adjudication Method:
The document does not specify any adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide any effect size of human readers improving with AI vs. without AI assistance. The HPI is an "Adjunctive Predictive Cardiovascular Indicator" providing "additional quantitative information" and is "not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter," suggesting it is an aid rather than a replacement for human decision-making. However, the exact nature of human-in-the-loop studies, if any, is not detailed.
6. Standalone Performance:
Yes, a standalone (algorithm only) performance evaluation was done through the "Algorithm Verification" section. The verification confirmed that the modified algorithm, with adjustable MAP targets, did not adversely affect safety and effectiveness. This indicates an evaluation of the algorithm's performance independent of real-time human interaction.
7. Type of Ground Truth:
The ground truth used for algorithm verification appears to be based on observed "hypotensive events" defined by Mean Arterial Pressure (MAP) falling below user-defined thresholds (e.g., < 65 mmHg for at least one minute). The document mentions "clinical data" and "non-surgical clinical data," which implies real physiological measurements and outcomes from patients, rather than expert consensus on images or pathology.
8. Sample Size for Training Set:
The document does not specify the sample size for the training set. It mentions that the subject and predicate devices "have the same core predictive algorithm," but details on the original training of this algorithm are not provided in this submission summary.
9. How Ground Truth for Training Set was Established:
The document does not provide information on how the ground truth for the training set was established. It refers to the "core predictive algorithm" being the same as previously cleared devices (DEN160044 and K203687), suggesting that the original algorithm's development and training methods would be detailed in those previous submissions. This current submission focuses on verifying that modifications to the existing algorithm do not negatively impact its performance.
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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
| PrimaryPredicate Device: | HemoSphere Advanced Monitoring Platform manufactured by Edwards Lifesciences, K203687 cleared May 28th, 2021, utilized for the Acumen Hypotension Prediction Index software feature. |
|---|---|
| AdditionalPredicateDevices: | 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) < 65 mmHg for at least one minute in duration. This MAP target is adjustable and can be changed to 55, 60, 70, 75, 80 or 85 mmHg.
Indications for Use: V.
Note: The Indication for Use statement for Acumen Hypotension Prediction is similar to what was previously cleared in K203687 May 28th, 2021, with the exception of removal of the statement to define hypotensive event as the users will now have the option to use the default 65 target or alternatively select a MAP target of 55, 60, 70, 75, 80 or 85 mmHg for hypotension. In addition, the indication for Acumen HPI when used with the non-invasive (ClearSight) technology has been expanded to include non-surgical patients.
Acumen Hypotension Predication Index (HPI)
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
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only and is not intended to make therapeutic decisions solely on the Acumen Hypotension Prediction Index (HPI) parameter.
Intended Use: The Acumen Hypotension Prediction Index (HPI) software feature used on a compatible monitoring platform is intended to be used by qualified personnel or trained clinicians in a critical care environment in a hospital setting.
| Parameter | Description | PatientPopulation | HospitalEnvironment |
|---|---|---|---|
| HPI | Acumen Hypotension PredictionIndex | Adult only | Surgical andnon-surgical |
VI. Comparison of Technological Characteristics with the Predicate Device
The subject and predicate devices are based on the following same technological elements:
-
Predictive Algorithm: The subject and predicate (initially cleared in DEN160044 and later cleared in K203687 on May 28th, 2021, for Edwards noninvasive technology have the same core predictive algorithm for Acumen Hypotension Predication Index (HPI).
The following technological difference exist between the subject and predicate devices: -
. Acumen HPI algorithm enhancement: An enhancement has been made to the existing HPI software feature cleared in K203687 (May 28th, 2021) to include an option to allow the clinician to adjust the Mean Arterial Pressure (MAP) target for hypotension (55, 60, 70, 75, 80, 85 mmHg) in addition to the existing default MAP target of 65 mmHg without making any changes to the core HPI algorithm and the original HPI algorithm parameters.
The purpose of this 510(k) submission is to obtain clearance for the following modifications to the Acumen Hypotension Prediction Index (K203687 (May 28th, 2021):
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-
- Modification to the Acumen Hypotension Prediction Index (HPI) software feature to introduce adjustable MAP targets for hypotension (previously cleared in K203687 on May 28th, 2021):
- Algorithm Modification: Update to the existing Acumen™ HPI Algorithm
- Modification to the Acumen Hypotension Prediction Index (HPI) software feature to introduce adjustable MAP targets for hypotension (previously cleared in K203687 on May 28th, 2021):
The existing Acumen Hypotension Prediction Index software feature for Edwards minimally invasive and noninvasive technology has been modified to include an option to allow the clinician to adjust the Mean Arterial Pressure (MAP) target for hypotension (55, 60, 70, 75, 80, 85 mmHg) in addition to the existing default MAP target of 65 mmHg.
- & Modifications to the labelling related to the Acumen Hypotension Prediction Index software feature cleared in K203687, cleared May 28th, 2021):
- Updated Indication for Use statement and the Clinical . validation information to align with the proposed adjustable MAP targets for hypotension:
The current Acumen Hypotension Prediction Index software feature for minimally invasive and noninvasive technology, cleared in K203687 on May 28th, 2021, defines a hypotensive event as mean arterial pressure < 65 mmHg for at least one minute in duration. Due to the proposed change to introduce adjustable MAP targets for hypotension, users will now have the option to use the default 65 target or alternatively select a MAP target of 55, 60, 70, 75, 80 or 85 mmHg. Hence the current definition of a hypotensive event "(defined as mean arterial pressure < 65 mmHg for at least one minute in duration)" is no longer applicable and has been removed from the indication for use statement.
In addition, the clinical validation section for Acumen HPI has been updated to represent the clinical validation results for the proposed adjustable MAP targets for hypotension.
- Indication expansion to include nonsurgical patients for Acumen HPI for noninvasive technology:
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The current indication for Acumen Hypotension Prediction Index when used with Edwards ClearSight (Noninvasive) technology has been expanded to include nonsurgical patients.
Performance The following verification activities were performed in support of a Data: substantial equivalence determination for the modifications being made as part of this submission.
Algorithm Verification:
Algorithm performance was tested using clinical data. The results establish that the usage of the HPI algorithm with the adjustable Mean Arterial Pressure (MAP) targets for hypotension (55, 60, 70, 75, 80, 85 mmHg) did not adversely affect the safety and effectiveness of the subject device.
In addition, algorithm verification is completed using non-surgical clinical data collected retrospectively to support expanded non-surgical indication for Acumen Hypotension Prediction Index when used with Edwards ClearSight (Noninvasive) technology.
Usability Study
Usability study was conducted per FDA's guidance document "Applying Human Factors and Usability Engineering to Medical Devices" to validate the updated instructions and to assess the success of the proposed modification to reduce the risks to acceptable levels without introducing any new unacceptable risks.
The usability study demonstrated that the intended users can perform primary operating functions and critical tasks of the system without any usability issues that may lead to patient or user harm.
Conclusions
The technological characteristics of the subject and predicate devices are identical. The modified Acumen Hypotension Prediction Index feature with adjustable MAP targets for hypotension algorithm has successfully passed the functional and performance testing including software verification and validation and bench studies. The testing performed demonstrates that the Acumen Hypotension Prediction Index with the subject modification and expanded indication is substantially equivalent to the legally marketed predicates.
§ 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.