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 healthcare 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

The Hypotension Decision Assist (HDA-OR2) device, as described in the provided FDA 510(k) summary, is a clinical decision support software intended to assist healthcare professionals in managing blood pressure and cardiovascular stability during surgery.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a quantitative table format with corresponding performance metrics for the HDA-OR2 device's intended use (i.e., assisting anesthesia healthcare professionals manage blood pressure, hemodynamic stability, and the cardiovascular system). Instead, the performance data focuses on system verification, measurement accuracy, artifact detection, and software validation.

The "Performance Data" section primarily details verification tests rather than clinical performance acceptance criteria directly related to the device's indications for use. The overall conclusion states that "the accuracy of its measurements is substantially equivalent to its predicate device and that HDA-OR2 performs as well as its predicate device."

Here's an interpretation of the performance data as it relates to implicit acceptance criteria:

Acceptance Criterion (Implicit)	Reported Device Performance
Measurement Accuracy	Verified: Bench testing following IEC 60601-2-34 Edition 3.0 2011-05 demonstrated measurement accuracy across the intended use measuring range for each physiologic parameter (systolic blood pressure, diastolic blood pressure, MAP, heart rate, cardiac output, systemic vascular resistance) over serial and network connections. The device's measurement accuracy is substantially equivalent to its predicate device.
Artefact Detection	Verified: Bench testing over a network connection confirmed the device's capability to detect each signal artifact and anomaly that has the potential to impact its performance.
Power Interruption Tolerance	Verified: Bench testing in accordance with IEC 60601-2-34 Edition 3.0 2011-05 demonstrated that HDA can tolerate a sudden power interruption without loss of user-input or patient data, remaining in the correct operating mode, including when the battery is disconnected.
Software Verification & Validation (Moderate Level of Concern)	Completed: Performed and documented in accordance with FDA guidance for "Software Contained in Medical Devices" requirements, indicating that potential malfunction or latent design flaws would likely lead to 'Minor Injury'. No specific performance metrics (e.g., uptime, error rate) are provided, but the V&V process itself is the compliance metric.
Electrical Safety and EMC Compliance	Compliant: The supplied touch screen computer complies with FDA recognized standards ES60601-1 2005/(R) 2012 and A1:2012 for safety, and IEC60601-1-2:2014 for EMC.
Remote Update Reliability in Noisy Environments	Verified: Testing confirmed HDA's ability to receive remote updates in electromagnetically noisy environments (hospital installation site), responding as designed, not installing interrupted updates, and detecting/rejecting malware masquerading as legitimate updates. This implies a successful update rate or error handling robustness, though specific numbers are not given.
Functional Equivalence to Predicate	Affirmed: The device has the "same intended use and indications for use" and "same technological characteristics" as the predicate (HDA-OR1), with minor differences (battery, connectivity options, internet features) that were also subject to verification testing. The conclusion explicitly states it "performs as well as its predicate device." This is the core "acceptance" for 510(k) cleared devices - substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document describes bench testing for verification of the device's technical performance (measurement accuracy, artefact detection, power interruption, remote updates, software V&V, electrical safety/EMC).

Test Set Sample Size: No specific "sample size" of patients or cases is mentioned for the performance data section, as the testing described is primarily technical and bench-level, not clinical. For example, for measurement accuracy, it mentions verification "across the intended use measuring range" and "over the serial and network connections available," implying a range of test conditions and inputs rather than a patient count.
Data Provenance: The data provenance is not specified as clinical patient data (e.g., country of origin, retrospective/prospective). The described tests are laboratory/bench tests, not studies on patient data. The device acquires data from "multi-parameter patient monitor supplied by other manufacturers," but the testing described here relates to the device's capability to process that signal and interact with its environment, not its performance in specific patient scenarios or outcomes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not Applicable: The studies described are technical verification tests (measurement accuracy, artefact detection, electrical safety, software validation), not clinical studies requiring expert ground truth establishment from patient data for diagnostic or prognostic performance. The "ground truth" for these technical tests would be derived from calibrated instruments, known signal inputs, and established engineering standards.

4. Adjudication Method for the Test Set

Not Applicable: As the described tests are technical verification rather than clinical performance studies using human experts evaluating patient cases, an adjudication method for a test set of clinical data is not mentioned or required.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC Study was done: The document does not mention any MRMC comparative effectiveness study, or any study involving human readers/users comparing performance with and without AI assistance. The device is a "clinical decision support" tool, implying assistance, but no study is presented to quantify this assistance's effect on human performance. The 510(k) pathway for this device did not require such a study, as it demonstrated substantial equivalence primarily through technical performance and predicate comparison.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Standalone Performance Studied (Technically): The performance data presented (measurement accuracy, artifact detection, power interruption, remote updates) represents the standalone technical performance of the algorithm and hardware. The device "continually processes this data to display... vital signs data and derived variables." The verification tests confirm the accuracy and robustness of these processing and display functions.
However, no clinical outcome study or diagnostic accuracy study (e.g., predicting hypotension with a specific accuracy) was performed in a standalone context. The device's role is to "assist" healthcare professionals, not autonomously diagnose or treat.

7. Type of Ground Truth Used

Technical/Engineering Standards and Calibrated Inputs: The ground truth for the verification tests was established based on:
- IEC 60601-2-34 Edition 3.0 2011-05: For measurement accuracy verification using bench testing. This implies using known, precisely controlled electrical or physiological signals as inputs and comparing the device's output to these known inputs.
- Known Artefacts: For artifact detection, specific types of known signal aberrations were introduced to test the device's ability to detect them.
- Controlled Power Situations: For power interruption testing, the power supply was intentionally cut.
- Controlled Electromagnetic Environments: For remote update testing in noisy environments.
- Software Design Specifications and Requirements: For software verification and validation.

8. Sample Size for the Training Set

Not applicable / Not disclosed: The document describes a "Software as a Medical Device (SaMD)" but does not specify if it employs machine learning or AI models that require a training set in the conventional sense. The device "aquires, processes and displays" data and "derives and displays" variables. This sounds more like rule-based or signal-processing software rather than a learned AI model, at least not one that would typically require a large training dataset for its core function of calculating and displaying vital signs. If there are any internal predictive or pattern-recognition algorithms, their training data and sample size are not mentioned.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not disclosed: Since the existence and nature of a training set (in the context of machine learning) are not discussed, the method for establishing its ground truth is also not mentioned.

Summary

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November 23, 2021

Directed Systems Ltd Mark Leaning Chief Executive Officer 47-51 Norfolk Street Cambridge, Cambridgeshire CB1 2LD United Kingdom

Re: K212529

Trade/Device Name: Hypotension Decision Assist Model HDA-OR2 Regulation Number: 21 CFR 870.1435 Regulation Name: Single-function, preprogrammed diagnostic computer Regulatory Class: Class II Product Code: DXG Dated: October 27, 2021 Received: October 29, 2021

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.

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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 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.

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212529

Device Name

Hypotension Decision Assist HDA-OR2

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)
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510(k) Summary

This 510(k) summary for Hypotension Decision Assist HDA-OR2 is supplied as required by 21 CFR 807.92(c)

Applicant:

Directed Systems Ltd

47-51 Norfolk Street,

Cambridge

Cambridgeshire CB1 2LD

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:

27 October 2021

Trade / Proprietary Name:

Hypotension Decision Assist

Model #:

HDA-OR2

Common Name:

Clinical decision support software

Classification Name:

Single-function, preprogrammed diagnostic computer

Regulation:

21 CFR 870.1435

Product Code:

DXG

Predicate Device:

Hypotension Decision Assist HDA-OR1 (K190955)

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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-OR2 has the same intended use and indications for use as the HDA-OR1 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 ●
Allows serial connection to vital signs monitor ●
Input data received using same communications protocols ●
Acquires arterial waveform signal provided by the vital signs monitor ●

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Derives and displays from the input arterial waveform signal; systolic blood ● pressure, diastolic blood pressure, MAP, heart rate, and short term changes in heart rate, cardiac output and systemic vascular resistance
Provides clinicians with a graphical display of monitoring and support information ● as a visual aid in determining a patient's cardiovascular state.
Allows marking of the administration of bolus or infused vasopressors and volume . challenges

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

. HDA-OR2 is supplied with a tablet computer with an internal battery whereas the predicate HDA-OR1 is supplied with a mains powered all-in-one computer without a battery.
HDA-OR2 allows connection to Philips patient monitors via a wireless or wired network connection. The predicate HDA-OR1 only allows connections via a serial connection.
HDA-OR2 allows uploading of its log data to secure cloud storage over the internet. The predicate HDA-OR1 is not internet enabled and only allows log data to be downloaded to connected USB drives.
. HDA-OR2 can download software updates from a secure API over the internet. The predicate HDA-OR1 is not internet enabled and can only download software updates from connected USB drives.

Performance Data

System verification testing:

The subject device was subjected to the system regression testing for HDA. This system regression testing consolidates the performance testing that was presented in the submission for the predicate HDA-OR1 and included:

Measurement accuracy verification:

The measurement accuracy of HDA across the intended use measuring range for each of its measured physiologic parameters 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 demonstrated the measurement accuracy over the serial and network connections available for the subject device.

Artefact Detection Verification

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

Power Interruption testing

Bench testing 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 including when the battery is disconnected.

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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 supplied with HDA-OR2. The computer complies with the FDA recognized standards ES60601-1 2005/(R) 2012 and A1:2012 for safety and IEC60601-1-2:2014 for EMC.

Remote update of software in an electromagnetically noisy environment testing

Testing was performed of HDA's ability to receive remote updates in an electromagnetically noisy environment such as would be found in a hospital installation site. This testing confirmed that HDA can receive remote updates in such an electromagnetically noisy environment, that it will respond as designed and not install updates that are interrupted (interfered or dropped) during wireless communication and that it can detect and reject malware masquerading as legitimate updates.

Conclusion:

The bench testing and hardware and software verification support the safety of HDA-OR2 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 device and that HDA-OR2 performs as well as 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).