(105 days)
Not Found
Yes
The document explicitly states that the device uses a "Predictive algorithm using a machine-learning model".
No
The device provides predictive risk information and specifically states that "no therapeutic decisions should be made based solely on the GHI algorithm predictions," indicating it is for information and not direct treatment.
Yes
The device provides "physiological insight into a patient's likelihood of future hemodynamic instability" and "provides the risk of a global hypoperfusion event," which are forms of diagnosis or risk stratification. Although it states "no therapeutic decisions should be made based solely on the GHI algorithm predictions," it is still providing information used in the diagnostic process.
No
The device is described as an "algorithm" and a "parameter" that provides physiological insight based on data from a Swan-Ganz catheter, which is a hardware device. While the algorithm itself is software, its function is directly tied to and dependent on data from a specific hardware medical device. The description does not indicate that the software operates independently of this hardware input.
Based on the provided information, 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. They are used to examine these samples outside of the body.
- Device Function: The Global Hypoperfusion Index (GHI) algorithm analyzes physiological data collected in vivo (within the patient's body) through a Swan-Ganz catheter. It provides a prediction based on this real-time physiological monitoring.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. Its input is physiological data from the monitoring equipment.
Therefore, the GHI algorithm falls under the category of a medical device that performs real-time physiological monitoring and analysis, not an in vitro diagnostic.
No
The document does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found".
Intended Use / Indications for Use
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes.
The GHI algorithm is intended for use in surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.
The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
Product codes (comma separated list FDA assigned to the subject device)
QNL
Device Description
The Global Hypoperfusion Index (GHI) parameter provides the clinician with physiological insight into a patient's likelihood of a global hypoperfusion event on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or nonsurgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
- Predictive algorithm using a machine-learning model
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult only
Intended User / Care Setting
- Intended Use: The Global Hypoperfusion Index (GHI) 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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Algorithm Performance Testing:
- Algorithm performance was tested using clinical data.
- Algorithm verification was performed per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) and ANSI/AAMI/IEC 62304:2006/A1:2016. Medical Device Software - Software Life Cycle Processes and FDA Guidance General Principles of Software Validation (issued January 11, 2022). The algorithm was tested at the algorithm level to ensure the safety of the device. All tests passed.
Clinical Performance:
- No clinical trial was performed in support of the subject 510(k). However, patient waveforms were collected in support of the development and validation of the GHI algorithm.
- Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from a diverse set of patients over the age of 18 years undergoing surgical procedures with invasive monitoring, were analyzed to verify the safety and performance of the subject device.
Key results:
- The subject Global Hypoperfusion Index (GHI) algorithm has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies.
- Completion of all performance verification and validation activities demonstrated that the subject device meets the predetermined design and performance specifications.
- Verification activities performed confirmed that the differences in the features did not adversely affect the safety and effectiveness of the subject device.
- The testing performed demonstrates that the Global Hypoperfusion Index (GHI) is substantially equivalent to its legally marketed predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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July 26, 2023
Edwards Lifesciences, LLC Michelle Ducca Manager, Regulatory Affairs 1 Edwards Way Irvine. California 92614
Re: K231038
Trade/Device Name: Global Hypoperfusion Index (GHI) Algorithm Regulation Number: 21 CFR 870.2210 Regulation Name: Adjunctive predictive cardiovascular indicator Regulatory Class: Class II Product Code: ONL Dated: June 14, 2023 Received: June 15, 2023
Dear Michelle Ducca:
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
1
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 medical devices and radiation-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,
forRobert T. Kazmierski -S
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
2
Indications for Use
510(k) Number (if known) K231038
Device Name Global Hypoperfusion Index (GHI)
Indications for Use (Describe)
The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes.
The GHI algorithm is intended for use in surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.
The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
| 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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K231038
| Sponsor: | Edwards Lifesciences LLC
One Edwards Way
Irvine, CA 92614 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment
Registration
Number: | 2015691 |
| Contact
Person: | Michelle Ducca
Manager, Regulatory Affairs
One Edwards Way
Irvine, CA 92614
michelle_ducca@edwards.com
Telephone: (949) 250-4113 |
| Date: | April 10, 2023 |
| Device/Trade
Name: | Global Hypoperfusion Index Feature ( subject ) |
| Common
Name: | Medium-term adjunctive predictive cardiovascular indicator |
| Classification
Name: | Medium-term adjunctive predictive cardiovascular
indicator
21 CFR 870.2210 |
| Product Code
and
Regulatory
Class: | QNL, Class II |
| Primary
Predicate: | HemoSphere Advanced Monitoring Platform, manufactured by Edwards
Lifesciences, K203687 cleared May 28, 2021, is being utilized for substantial
equivalence to the Acumen Hypotension Prediction Index (HPI) software
feature which has the same intended use and similar indications for use and
the same principle of operation as the HPI feature. The subject device has
similar technological characteristics and has been demonstrated to be safe and
effective and does not raise different questions of safety and effectiveness
from the primary predicate. |
| Additional
Predicates: | CLEWICU System (K200717, cleared January 9, 2021) manufactured by
CLEW Medical Ltd., is being utilized for substantial equivalence to the Global
Hypoperfusion Index (GHI) feature, which includes similar principles of |
510(k) Summary – HemoSphere Advanced Monitoring Platform
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operation and indications for use related to the patient's predicted future risk for clinical deterioration.
- The Global Hypoperfusion Index (GHI) parameter provides the clinician with Device Description: physiological insight into a patient's likelihood of a global hypoperfusion event on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The GHI feature is intended for use in surgical or nonsurgical patients. The product predictions are adjunctive for reference only and no therapeutic decisions should be made based solely on the GHI parameter.
Indications Global Hypoperfusion Index (GHI) Software Feature
for Use: The Global Hypoperfusion Index (GHI) algorithm provides the clinician with physiological insight into a patient's likelihood of future hemodynamic instability. The GHI algorithm provides the risk of a global hypoperfusion event (defined as SvO2 ≤ 60% for at least 1 minute) occurring in the next 10-15 minutes.
The GHI algorithm is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter.
The GHI algorithm is considered to provide additional information regarding the patient's predicted future risk for clinical deterioration, as well as identifying patients at low risk for deterioration. The product predictions are for reference only and no therapeutic decisions should be made based solely on the GHI algorithm predictions.
- Intended Use: The Global Hypoperfusion Index (GHI) 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 | Patient
Population | Hospital Environment |
|-----------|-------------------------------|-----------------------|-------------------------------|
| GHI | Global Hypoperfusion
Index | Adult only | Surgical and non-
surgical |
Comparison The HemoSphere Advanced Monitoring Platform, manufactured by Edwards Lifesciences, with Acumen Hypotension Prediction Index, K203687 cleared to Predicate May 28, 2021 for Edwards technology and CLEWICU System, K200717 Device: cleared January 9, 2021 are chosen as predicates since both are predictive algorithms for hemodynamic instability/ deterioration with the same indications for use/intended use, principle of operation and similar technological characteristics as the subject GHI algorithm.
The Global Hypoperfusion Index (GHI) algorithm provides an index from 0 to 100 where the higher the value, the increased likelihood that a global
5
hypoperfusion event will occur. The GHI algorithm alerts the clinician on average 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%. The subject device has the same intended use as the primary predicate (HPI) to be used by qualified personnel or trained clinicians in the critical care setting. The subject and primary predicate (HPI) and additional predicate (CLEWICU) are all intended for use in adult patients and provide physiological insight into future likelihood of hemodynamic instability. Both the subject GHI and additional predicate (CLEWICU) provide the user with a predicted future risk for clinical deterioration.
Performance testing executed shows that there are no new concerns of safety and effectiveness.
The purpose of this Traditional 510(k) is to obtain clearance for the Global Hypoperfusion Index (GHI) algorithm.
Comparison of Technological Characteristics with Predicates:
The subject, Primary and Additional predicate devices are based on the following same technological elements:
- Predictive algorithm using a machine-learning model
- 트 Calculation of the risk and likelihood of a future clinically significant hemodynamic cardiovascular event
- I Device inputs use real-time patient health data for analysis to generate prediction
- I Alert the physician when the patient's risk has reached a predefined threshold. Both devices provide predictions in a timeframe that permits appropriate clinical review and action
- Performance The following verification activities were performed in support of a substantial equivalence determination for the modifications being made as Data: part of this submission.
Algorithm Verification
Algorithm performance was tested using clinical data. Algorithm verification was performed per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005) and ANSI/AAMI/IEC 62304:2006/A1:2016. Medical Device Software - Software Life Cycle Processes and FDA Guidance General Principles of Software Validation (issued January 11, 2022). The algorithm was tested at the algorithm level to ensure the safety of the device. All tests passed.
6
No clinical trial was performed in support of the subject 510(k). However, patient waveforms were collected in support of the development and validation of the GHI algorithm.
Clinical Performance
Prospective analyses of retrospective clinical data from multiple independent datasets, comprised of data from a diverse set of patients over the age of 18 years undergoing surgical procedures with invasive monitoring, were analyzed to verify the safety and performance of the subject device.
Conclusions Overall Conclusion:
The subject Global Hypoperfusion Index (GHI) algorithm has successfully passed functional and performance testing, including software and algorithm verification and validation and bench studies. Completion of all performance verification and validation activities demonstrated that the subject device meets the predetermined design and performance specifications. Verification activities performed confirmed that the differences in the features did not adversely affect the safety and effectiveness of the subject device. The testing performed demonstrates that the Global Hypoperfusion Index (GHI) is substantially equivalent to its legally marketed predicates.