Hypotension Decision Assist is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healtheare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

Device Description

Hypotension Decision Assist (HDA) is a clinical decision support Software as a Medical Device (SaMD) that is installed upon a medically-rated touch-screen computer. HDA connects to a multi-parameter patient monitor supplied by other manufacturers, from which it acquires vital signs data continuously including the arterial blood pressure waveform and cardiovascular-related numeric parameters.

HDA continually processes this data to display, in graphical charts and numeric format, vital signs data and derived variables including mean arterial pressure (MAP), heart rate, systolic and diastolic blood pressure, cardiac output and systemic vascular resistance. HDA compares MAP to user set targets to indicate when MAP is above or below the target range. It allows the user to mark the administration of vasopressors and volume challenges to the MAP trend.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device and meeting various technical and safety standards, rather than defining specific numerical performance acceptance criteria for clinical outcomes. However, it does highlight areas of verification.

Acceptance Criterion Type	Reported Device Performance (Verification Method)
System Functionality	Verified: Interactivity of the system interface and ability to process and display physiologic parameters for intended use.
Measurement Accuracy	Verified: Accuracy across the intended measuring range for each physiologic parameter, demonstrated via bench testing following IEC 60601-2-34 Edition 3.0 2011-05. Demonstrated substantial equivalence to reference devices. Verified equivalent performance when connected to specified vital signs monitors.
Artifact Detection	Verified: Capability to detect signal artifacts and anomalies that could impact performance, demonstrated via bench testing.
Predicate Comparison (Cardiac Output & SVR Events)	Comparable Performance: Demonstrated comparable performance to the predicate device with respect to the detection of cardiac output and systemic vascular resistance events via bench testing.
Power Interruption Tolerance	Verified: Tolerates sudden power interruption without data loss or change in operating mode, demonstrated via bench testing following IEC 60601-2-34 Edition 3.0 2011-05.
Summative Usability	Fulfilled Needs: Demonstrated that HDA fulfills the needs of its intended users, following FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices."
Software Verification & Validation (moderate level of concern)	Compliant: Documentation provided in accordance with FDA guidance for software in medical devices.
Electrical Safety & Electromagnetic Compatibility (EMC)	Compliant: Complies with FDA recognized standards ES60601-1-2005/(R)2012 and A1:2012 for safety and IEC60601-1-2:2014 for EMC.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not explicitly stated as a number of patients or cases for clinical performance assessment. The "test set" primarily refers to hardware and software testing.
Data Provenance: "Patient data sets obtained from internationally recognized databases" were used for the original system verification and "bench testing performed to compare the performance of HDA to the predicate device." The data was "representative of the range of data input and signal quality that will be encountered in the intended use population and environment of use of the device." No specific countries of origin or whether the data was retrospective or prospective are mentioned beyond being from "internationally recognized databases."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document states that "Clinical studies were not performed." Therefore, there was no expert consensus or ground truth established by human experts for a clinical test set in the traditional sense. The "ground truth" for the bench testing was derived from established standards (e.g., IEC 60601-2-34) and comparison to predicate/reference device measurements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Since no clinical studies were performed, there was no adjudication of clinical outcomes by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. A MRMC comparative effectiveness study was not performed. The device is a clinical decision support software, not an AI for image interpretation that would typically involve human readers. Clinical studies involving human users were not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "Performance Data" section describes "Measurement accuracy verification," "Artefact Detection Verification," and "Predicate comparison testing" which evaluate the algorithm's direct output and processing capabilities against established standards or predicate device outputs. This represents a standalone performance evaluation of the algorithms and software functionality, rather than human-in-the-loop performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the device's technical performance verification (e.g., measurement accuracy) was established through:

Bench testing methodologies derived from recognized standards (e.g., IEC 60601-2-34).
Comparison to predicate or reference devices' established performance for specific parameters (e.g., cardiac output, SVR events, physiological parameter derivation).
Pre-defined specifications for artifact detection and power interruption tolerance.

For claims of "clinical decision support" or "assisting healthcare professionals," the ground truth implicitly relies on the widely accepted understanding that accurate display and processing of vital signs aid clinical decision-making, rather than a specific clinical outcome study being performed with this device.

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or AI model development. The device is described as "clinical decision support software" that "continually processes this data." If machine learning was used implicitly, no details are provided about its training data. The "patient data sets obtained from internationally recognized databases" were used for "original system verification" and "bench testing," which might imply they were used for validation or testing, but not necessarily for training a model.

9. How the ground truth for the training set was established

Not applicable, as a clear "training set" and its ground truth establishment are not described in the provided text. The device's functionality appears to be primarily based on processing established physiological parameters and rules, rather than learning from a labeled training dataset in the AI sense.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.

November 27, 2019

Directed Systems Ltd Mark Leaning Chief Executive Officer St John's Innovation Centre, Cowley Road Cambridge, CB4 0WS Gb

Re: K190955

Trade/Device Name: Hypotension Decision Assist Regulation Number: 21 CFR 870.1435 Regulation Name: Single-Function, Preprogrammed Diagnostic Computer Regulatory Class: Class II Product Code: DXG Dated: May 10, 2019 Received: May 17, 2019

Dear Mark Leaning:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

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,

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)

K190955

Device Name Hypotension Decision Assist

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑Prescription Use (Part 21 CFR 801 Subpart D) ☐Over-The-Counter Use (21 CFR 801 Subpart C)	☑Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)
☑Prescription Use (Part 21 CFR 801 Subpart D)	☐Over-The-Counter Use (21 CFR 801 Subpart C)

|X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff @fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary (K190955)

This 510(k) summary for Hypotension Decision Assist is supplied as required by 21 CFR 807.92(c)

Applicant:

Directed Systems Ltd

St John's Innovation Centre,

Cowley Road,

Cambridge CB4 0WS,

United Kingdom

Telephone: 011 44 7552 747389

Contact:

Mark S. Leaning

Chief Executive Officer

Telephone: 011 44 7552 747389

Email: markleaning@directedsystems.com

Preparation Date:

09 April 2019

Trade / Proprietary Name:

Hypotension Decision Assist

Common Name:

Clinical decision support software

Classification Name:

Single-function, preprogrammed diagnostic computer

Regulation:

21 CFR 870.1435

Product Code:

DXG

Predicate Device:

Navigator™ (K092219) from Applied Physiology Pty Ltd

Reference Devices:

CardioQ-EDM+ (K172457) from Deltex Medical Ltd

IntelliVue Patient Monitor MX550 (K161531) from Philips Medizin Systeme Boeblingen GmbH

CARESCAPE Monitor B450 (K132533) from GE Healthcare

{4}------------------------------------------------

Device Description:

Intended Use:

HDA is a clinical decision support medical device intended to assist healthcare professionals in managing blood pressure and the cardiovascular system in patients undergoing anesthesia during surgical procedures.

Indications for Use:

HDA is indicated to acquire, process and display arterial pressure and other key cardiovascular characteristics of adult patients who are at least eighteen years of age that are undergoing surgery where their arterial pressure is being continuously monitored by a vital-signs monitor. It is indicated for use to assist anesthesia healthcare professionals manage the blood pressure, hemodynamic stability and the cardiovascular system during such surgery.

Comparison of Technological Characteristics with the Predicate Device:

HDA has the same intended use as the Navigator predicate. They are both intended to assist physicians to manage the blood pressure and cardiovascular stability of patients undergoing anesthesia during surgery.

The subject and predicate device have the following same technological characteristics:

Clinical decision support software
Supplied on a medical grade touch screen computer
. Used with patients whose arterial pressure is being continuously monitored by a vital signs monitor.
Input data received from a vital signs monitor ●
Input data received using same communications protocols (HDA supports a subset ● of Navigator's supported communications protocols)
Provides clinicians with a graphical display of monitoring and support information as a visual aid in determining a patient's cardiovascular state.
Displays information on mean arterial pressure (MAP), cardiac output and ● systemic vascular resistance

{5}------------------------------------------------

The following differences in technological characteristics exist between the subject and predicate device:

. The predicate device acquires MAP and cardiac output from the arterial waveform signal provided by the vital signs monitor whereas the subject device derives these parameters from the arterial waveform input. The CardioO-EDM+ (K172457), IntelliVue Patient Monitor MX550 (K161531) and CARESCAPE Monitor B450 (K132533) from GE Healthcare are provided as reference devices for the derivation of physiological parameters from input arterial waveform input.
The subject device displays systolic blood pressure, diastolic blood pressure and heart rate values that are not displayed by the predicate device. These values are derived from the input arterial waveform signal as is the case with the IntelliVue Patient Monitor MX550 (K161531) reference device.
. The predicate device acquires Right Arterial Pressure (RAP) and oxygen saturation data from the vital signs monitor which are not relevant to HDA.

Performance Data

System verification testing:

The initial system verification was performed to confirm the interactivity of the system interface and to confirm that HDA could process and display the physiologic parameters required for its intended use.

Measurement accuracy verification:

The measurement accuracy of HDA across the intended use measuring range for each of its measured physiologic parameters was verified by bench testing following the approach of the IEC 60601-2-34 Edition 3.0 2011-05 standard that is recognized by FDA. This testing also demonstrated the substantial equivalence of this measurement accuracy to that of the reference devices and verified that the performance of HDA is equivalent when connected to the vital signs monitors types that it is specified for use with.

Artefact Detection Verification

Bench testing was performed to confirm that HDA is capable of detecting each of the signal artefacts and anomalies that have the potential to impact its performance.

Predicate comparison testing

Bench testing was performed to compare the performance of HDA to that of its predicate device with respect to the detection of cardiac output and systemic vascular resistance events.

Power Interruption testing

Bench testing was performed in accordance with the IEC 60601-2-34 Edition 3.0 2011-05 standard that is recognized by FDA to verify that HDA can tolerate a sudden power interruption without loss of either user-input data, or patient data while remaining in the correct operating mode.

Summative Usability Testing

Summative usability testing was performed following the FDA guidance "Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff' to demonstrate that HDA fulfils the needs of its intended users.

{6}------------------------------------------------

Software Verification and Validation Testing

Software verification and validation testing was performed and documentation was provided in accordance with the FDA guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" requirements for a moderate level of concern device. HDA is considered a moderate level of concern device because a malfunction of, or a latent design flaw in the device could lead to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing was conducted on the touch screen computer on which HDA is installed. The computer complies with the FDA recognized standards ES60601-12005/(R)2012 and A1:2012 for safety and IEC60601-1-2:2014 for EMC.

Clinical studies

Clinical studies were not performed. However, patient data sets obtained from internationally recognized databases were used in the original system verification and the bench testing performed to compare the performance of HDA to the predicate device. These patient data sets were selected because they are representative of the range of data input and signal quality that will be encountered in the intended use population and environment of use of the device.

Conclusion:

The non-clinical bench testing and hardware and software verification support the safety of HDA and verify that it can accurately measure the physiologic parameters associated with its intended use. Bench testing has demonstrated that the accuracy of its measurements is substantially equivalent to its predicate or reference devices. Direct comparison testing of HDA to its predicate has demonstrated that it performs comparably to its predicate device.

Regulation Number and Section

§ 870.1435 Single-function, preprogrammed diagnostic computer.

(a)
Identification. A single-function, preprogrammed diagnostic computer is a hard-wired computer that calculates a specific physiological or blood-flow parameter based on information obtained from one or more electrodes, transducers, or measuring devices.(b)
Classification. Class II (performance standards).