Retrospective clinical data from multiple U.S. sites were used to validate the performance of the Risk Analytics Engine indices (IDO2, IVCO2, ACD, and HLA) by comparing them against established acceptance criteria.
Retrospective validation; Clinical site data; Performance evaluation
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Retrospective Validation of Adjunctive Status Indicators; Retrospective performance evaluation
Adult and pediatric patients in intensive care; Sample Size: 4,060 patients total (779 adult, 3,281 pediatric); Number of Sites: Multiple clinical sites in the United States
Not applicable for this study
Discriminatory power, range utilization, resolution/limitation, and robustness
Indications for Use
The Etiometry Platform™ software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4. The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes: - To remotely consult regarding a patient’s status and - To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner. The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices: - Airway flow, volume, and pressure - Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean) - Bispectral index (BIS, signal quality index, suppression ratio) - Cardiac Index - Cardiac output - Central venous pressure - Cerebral perfusion pressure - End-tidal CO2 - Heart rate - Heart rate variability - Intracranial pressure - Left atrium pressure - Oxygen saturation (intravascular, regional, SpO2) - Premature ventricular counted beats - Pulmonary artery pressure (systolic, diastolic, and mean) - Pulse pressure variation - Pulse Rate - Respiratory rate - Right atrium pressure - Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin) - Umbilical arterial pressure (systolic, diastolic, and mean) - Electrocardiogram - Plethysmograph. The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid. The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module. The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia. The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements. The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements. The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or decisions should be solely based on the indices. The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
Device Story
Software-only platform; aggregates/visualizes physiologic data from bedside monitors; calculates four indices (IDO2, IVCO2, ACD, HLA) via mathematical manipulation of inputs; used by ICU clinicians for remote consultation/review; web-based visualization; provides adjunctive status indicators; does not control bedside devices; not for alarm notification; aids clinical decision-making; improves patient care by highlighting risks of inadequate oxygen delivery, ventilation, acidemia, or hyperlactatemia.
Clinical Evidence
Retrospective validation using clinical site data. Adult dataset: 4,663 points (779 patients). Pediatric dataset: 16,016 points (3,281 patients). Evaluated against predicate acceptance criteria (discriminatory power, range utilization, resolution, robustness). No adverse effects noted.
Technological Characteristics
Software-only; web-based visualization; platform architecture; processes physiologic waveforms/numerics and lab data; adjunctive status indicators derived via mathematical models; cybersecurity controls implemented; moderate level of concern software.
Indications for Use
Indicated for ICU patients: IDO2 Index (post-surgical 0-12y, ≥2kg; adults ≥18y without Mechanical Circulatory Support); IVCO2 Index (invasively ventilated 0-12y); ACD Index (invasively ventilated 0-12y, ≥2kg); HLA Index (post-surgical 0-12y, ≥2kg).
Regulatory Classification
Identification
The adjunctive cardiovascular status indicator is a prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Software description, verification, and validation based on comprehensive hazard analysis must be provided, including:
(i) Full characterization of technical parameters of the software, including any proprietary algorithm(s);
(ii) Description of the expected impact of all applicable sensor acquisition hardware characteristics on performance and any associated hardware specifications;
(iii) Specification of acceptable incoming sensor data quality control measures; and
(iv) Mitigation of impact of user error or failure of any subsystem components (signal detection and analysis, data display, and storage) on accuracy of patient reports.
(2) Scientific justification for the validity of the status indicator algorithm(s) must be provided. Verification of algorithm calculations and validation testing of the algorithm using a data set separate from the training data must demonstrate the validity of modeling.
(3) Usability assessment must be provided to demonstrate that risk of misinterpretation of the status indicator is appropriately mitigated.
(4) Clinical data must be provided in support of the intended use and include the following:
(i) Output measure(s) must be compared to an acceptable reference method to demonstrate that the output measure(s) represent(s) the predictive measure(s) that the device provides in an accurate and reproducible manner;
(ii) The data set must be representative of the intended use population for the device. Any selection criteria or limitations of the samples must be fully described and justified;
(iii) Agreement of the measure(s) with the reference measure(s) must be assessed across the full measurement range; and
(iv) Data must be provided within the clinical validation study or using equivalent datasets to demonstrate the consistency of the output and be representative of the range of data sources and data quality likely to be encountered in the intended use population and relevant use conditions in the intended use environment.
(5) Labeling must include the following:
(i) The type of sensor data used, including specification of compatible sensors for data acquisition;
(ii) A description of what the device measures and outputs to the user;
(iii) Warnings identifying sensor reading acquisition factors that may impact measurement results;
(iv) Guidance for interpretation of the measurements, including warning(s) specifying adjunctive use of the measurements;
(v) Key assumptions made in the calculation and determination of measurements;
(vi) The measurement performance of the device for all presented parameters, with appropriate confidence intervals, and the supporting evidence for this performance; and
(vii) A detailed description of the patients studied in the clinical validation (
*e.g.,* age, gender, race/ethnicity, clinical stability) as well as procedural details of the clinical study.
Predicate Devices
Etiometry Platform version DAV 5.4 RAE 9.2 (K241479)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
April 3, 2026
Etiometry, Inc.
Timothy Hanson
VP of QA RA
770 Legacy Place
Floor 2, Suite 34
Dedham, Massachusetts 20206
Re: K254066
Trade/Device Name: Etiometry Platform (DAV 5.8 RAE 9.4)
Regulation Number: 21 CFR 870.2200
Regulation Name: Adjunctive Cardiovascular Status Indicator
Regulatory Class: Class II
Product Code: PPW
Dated: December 18, 2025
Received: December 18, 2025
Dear Timothy Hanson:
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 (the 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 available 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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K254066 - Timothy Hanson
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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assistance/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,
**STEPHEN C. BROWNING -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
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# Indications for Use
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254066 | ? |
| --- | --- | --- |
| Please provide the device trade name(s). | | ? |
| Etiometry Platform (DAV 5.8 RAE 9.4) | | |
| Please provide your Indications for Use below. | | ? |
| The Etiometry Platform™ software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4.
The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- To remotely consult regarding a patient’s status and
- To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices:
- Airway flow, volume, and pressure
- Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- Bispectral index (BIS, signal quality index, suppression ratio)
- Cardiac Index
- Cardiac output
- Central venous pressure
- Cerebral perfusion pressure
- End-tidal CO2
- Heart rate
- Heart rate variability
- Intracranial pressure
- Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2)
- Premature ventricular counted beats
- Pulmonary artery pressure (systolic, diastolic, and mean)
- Pulse pressure variation
- Pulse Rate
- Respiratory rate
- Right atrium pressure
- Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
- Umbilical arterial pressure (systolic, diastolic, and mean)
- Electrocardiogram
- Plethysmograph | | |
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The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module.
The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.
The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
## WARNINGS:
- Do not use the application as an active patient monitoring system.
- Do not use the application to replace any part of the hospital's device monitoring.
- Do not rely on the application as the sole source of patient status information.
- Do not use any of the indices as a substitute for taking blood samples.
- Do not use the IDO2 Index for adults patients on Mechanical Circulatory Support.
- The indices present qualitative and potentially imperfect information about the patient's condition, and in certain scenarios, the indices may contradict each other.
- The primary data should be reviewed as part of standard patient evaluations, and no decisions should be
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solely based on the indices.
Please select the types of uses (select one or both, as applicable).
☑ Prescription Use (21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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etiemetry
Apr 3, 2026
This 510(k) summary has been prepared following Title 21 CFR §807.92 and FDA's guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 510(k)" July 28, 2014.
K254066
## 1. Contact Details
Timothy Hanson, VP of Regulatory Affairs and Quality Assurance at Etiometry, Inc.
770 Legacy Place, Floor 2, Suite 34, Dedham, MA 02026
Tel: 857.366.9333 ext. 2020
Email: thanson@etiometry.com
## 2. Device Name
| Item | Description |
| --- | --- |
| Device Trade Name | Etiometry Platform (DAV 5.8 RAE 9.4) |
| Common Name | Adjunctive Cardiovascular Status Indicator |
| Classification Name | Adjunctive Cardiovascular Status Indicator |
| Regulation Number | 870.2200 |
| Product Code(s) | PPW |
## 3. Legally Marketed Predicate Devices
The predicate device is the platform version DAV 5.4 RAE 9.2, cleared under K241479, with the PPW product code.
## 4. Device Description Summary
The Etiometry Platform allows ICU clinicians and quality improvement teams to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data. The platform features include:
- Adjunctive status indicators
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- Customizable display of physiologic parameters over the entire patient stay
- Configurable annotation
- Web-based visualization that may be used on any standard browser
- Minimal IT footprint
- Software-only solution – no new bedside hardware required
- Highly reliable and robust operation
- Auditable data storage
## 5. Intended Use/Indications For Use
The Etiometry Platform™ software features the Data Aggregation & Visualization software module version 5.8 and the Risk Analytics Engine software module version 9.4.
The Data Aggregation & Visualization software module is intended to record and display multiple physiological parameters of adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
- To remotely consult regarding a patient’s status and
- To remotely review other standard or critical near real-time patient data in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.
The Data Aggregation & Visualization software module can display numeric physiologic data and waveforms captured by other medical devices:
- Airway flow, volume, and pressure
- Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
- Bispectral index (BIS, signal quality index, suppression ratio)
- Cardiac Index
- Cardiac output
- Central venous pressure
- Cerebral perfusion pressure
- End-tidal CO2
- Heart rate
- Heart rate variability
- Intracranial pressure
- Left atrium pressure
- Oxygen saturation (intravascular, regional, SpO2)
- Premature ventricular counted beats
- Pulmonary artery pressure (systolic, diastolic, and mean)
- Pulse pressure variation
- Pulse Rate
- Respiratory rate
- Right atrium pressure
- Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
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- Umbilical arterial pressure (systolic, diastolic, and mean)
- Electrocardiogram
- Plethysmograph
The Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
The Data Aggregation & Visualization software module can display information captured by the Risk Analytics Engine software module.
The Risk Analytics Engine software module calculates four indices: the IDO2 Index™ for inadequate delivery of oxygen, the IVCO2 Index™ for inadequate ventilation of carbon dioxide, the ACD Index™ for acidemia, and the HLA Index™ for hyperlactatemia.
The IDO2 Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care and patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the IDO2 Index is increasing, it means that there is an increasing risk of inadequate oxygen delivery, and attention should be brought to the patient. The IDO2 Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The IVCO2 Index is indicated for use by healthcare professionals with invasively ventilated patients 0 to 12 years of age under intensive care. The IVCO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module. When the IVCO2 Index is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation, and attention should be brought to the patient. The IVCO2 Index™ presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The ACD Index is indicated for use by health care professionals with invasively ventilated patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The ACD Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation and Visualization software module. When the ACD Index is increasing, it means that there is an increasing risk of acidemia, and attention should be brought to the patient. The ACD Index presents partial quantitative information about the patient's respiratory condition, and no therapy or drugs can be administered based solely on the interpretation statements.
The HLA Index is indicated for use by health care professionals with post-surgical patients 0 to 12 years of age and weighing 2 kg or more under intensive care. The HLA Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the Data Aggregation & Visualization software module. When the HLA Index is increasing, it means that there is an increasing risk of hyperlactatemia, and attention should be brought to the patient. The HLA Index presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.
WARNINGS:
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- Do not use the application as an active patient monitoring system.
- Do not use the application to replace any part of the hospital's device monitoring.
- Do not rely on the application as the sole source of patient status information.
- Do not use any of the indices as a substitute for taking blood samples.
- Do not use the IDO2 Index for adult patients on Mechanical Circulatory Support.
- The indices present qualitative and potentially imperfect information about the patient's condition, and in certain scenarios, the indices may contradict each other.
- The primary data should be reviewed as part of standard patient evaluations, and no decisions should be solely based on the indices.
## 6. Indications For Use Comparison
The indications for use are the same.
## 7. Technological Comparison
The subject device uses the same fundamental technology and platform architecture as the predicate (software-only data aggregation/visualization and adjunctive analytics). However, the subject device includes the following technological differences relative to the predicate: (1) support for an institution-defined classification of cardiogenic shock implemented within the existing Clinical Pathways framework; (2) the ability to process additional EHR data types; and (3) cybersecurity maintenance updates.
## 8. Non-Clinical And/Or Clinical Tests Summary
Documentation was provided consistent with the FDA guidance, Software as a Medical Device (SaMD): Clinical Evaluation, to support software of moderate concern and to provide objective evidence that the software was correctly constructed. Cybersecurity information was provided in accordance with the FDA guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Evaluations were completed to demonstrate output consistency across the range of data sources and data quality likely to be encountered.
Documentation was also provided consistent with the FDA guidance, Software as a Medical Device (SaMD): Clinical Evaluation, to support that the software yields a clinically meaningful output associated with the target use of the output in the target healthcare situation or condition identified in the definition statement. The adjunctive status indicators are produced by a model designed according to physiological principles, with parameters chosen to reflect those specified in the medical literature. Test datasets were used during development to evaluate the impact of changes. After development was complete, independent validation datasets were used to validate performance. The adjunctive status indicators were validated using data from different clinical sites in the United States. The clinical study data were obtained using the platform, and no adverse effects or complications were noted. The adjunctive status indicators were retrospectively computed on all de-identified patients and evaluated against the same acceptance criteria as the predicate device, including discriminatory power, range utilization, resolution/limitation, and robustness. The adult validation dataset comprised 4,663 points across 779 patients. The pediatric validation dataset comprised 16,016 points across 3,281 patients. All results met the same acceptance criteria as the predicate device.
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# 9. Conclusion
In conclusion, the subject device has been demonstrated to be substantially equivalent to the identified predicate devices. Based on the provided testing and performance data, the device does not raise any new safety or effectiveness concerns and is suitable for its intended use.
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