WARD-CSS is a clinical decision support system that remotely integrates, analyzes and displays continuous vital sign data (via a mobile or web application) from medical devices for nonpediatric hospitalized patients within non-critical care units.

WARD-CSS uses a set of standardized rules based on scientific and clinical evidence to detect and alert on clinically relevant vital sign deviations when used by trained health care professionals in hospitals.

WARD-CSS is not intended to replace current monitoring practices or replace health care professionals' judgment. WARD-CSS is a tool intended to help health care professionals manage monitored patients and make clinical care decisions.

Device Description

WARD-CSS is a stand-alone software intended for use in continuous monitoring of patients and near real-time analysis of vital signs for the purpose of notifying healthcare professionals in case of clinically relevant vital sign deviations.

WARD-CSS utilizes knowledge-based algorithms to evaluate clinically relevant vital signs deviations to help drive clinical management.

The system is intended to be used as an adjunct to current monitoring practice in the general med/surg floors of the hospitals

The system assists healthcare professionals when monitoring patients on their wards by:

Providing a real-time monitoring overview of vital signs for all patients. ●
Alerting the healthcare professionals when a patient deteriorates. ●

The following types of alerts are detected by WARD-CSS in the vital sign data:

Desaturation ●
Hypertension
Hypotension ●
Bradypnea ●
Tachypnea ●
Tachycardia
Bradycardia
Hypotension and Bradycardia
Hypotension and Tachycardia ●
Bradypnea and Desaturation
Fever

The WARD-CSS consists of a Mobile App, Web App and Backend Server. The Mobile App is used by healthcare professionals (HCPs) to monitor patients. The HCP will receive notifications of the alerts to their mobile phones. Within this app, the HCP can also document vital signs into an electronic health record system. The Web App is used by administrative users to manage hospitals, wards, users, and monitors. The Backend Server is used to receive and process all incoming data and manage all data used in the apps.

AI/ML Overview

The provided text describes the acceptance criteria and a study to prove the device, WARD-CSS, meets these criteria, primarily focusing on alert reduction.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly related to the reduction of alert overload, as this is the primary focus of the clinical testing described for WARD-CSS. The performance is measured by the reduction in alert rates compared to a baseline (thresholds only) and an intermediate step (thresholds with time durations).

Acceptance Criteria Category	Specific Criteria	Reported Device Performance (WARD-CSS: Thresholds, Time Durations, and Alert Filters)
Alert Reduction (Overall)	Significant reduction in clinically irrelevant alerts compared to standard monitoring practices.	97.8% total reduction in alerts compared to monitors alerting only upon thresholds. (From 417.0 median alerts to 9.0 median alerts over all alert types).
Alert Reduction (Specific Alert Groups)	Reduction in alerts for individual vital sign deviation categories.	Hypertension + Hypotension: 0.0 median (mean 0.3) Bradypnea + Tachypnea: 1.6 median Tachycardia + Bradycardia: 0.0 median (mean 1.0) Desaturation + Desaturation/Bradypnea: 4.7 median Hypotension/Tachycardia + Hypotension/Bradycardia: 0.0 median (mean 0.0)

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

Sample Size: 794 patients
Data Provenance: Retrospective analysis of four cohorts from prospective clinical safety studies conducted from 2020-2024. The country of origin is not explicitly stated, but the submission is for the US FDA, implying an interest in data relevant to this regulatory body. The data consists of vital sign data.

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

This information is not provided in the document. The study focuses on quantifying alert rates based on set thresholds and algorithms rather than human expert-established ground truth for specific events that led to the alerts. The 'ground truth' here is the objective vital sign data and the predefined rules/thresholds that trigger alerts.

4. Adjudication Method for the Test Set

This information is not provided as the study's focus is on algorithmic alert reduction based on vital sign data and predefined rules, not on expert adjudication of alert significance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

A MRMC study comparing human readers with and without AI assistance was not done. The study's objective was to quantify the reduction in system-generated alerts due to the WARD-CSS algorithms, not to measure human performance improvement.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the study described is a standalone (algorithm only) performance assessment of the WARD-CSS system's alert reduction methodology. It retrospectively analyzes vital sign data against the different alert generation methodologies (thresholds only, thresholds + time durations, and WARD-CSS's full algorithm including alert filters) to demonstrate the reduction in the number of alerts produced by the algorithm itself.

7. The Type of Ground Truth Used

The ground truth used in this study is objective vital sign data combined with predefined, standardized rules and thresholds based on scientific and clinical evidence. The analysis quantifies how often these pre-defined rules would trigger an alert under different algorithmic conditions (basic thresholds, thresholds with time durations, and thresholds with time durations and alert filters). It is not based on expert consensus, pathology, or outcomes data in the traditional sense of clinical event validation.

8. The Sample Size for the Training Set

The document does not explicitly mention a separate training set size. The clinical testing section refers to a "literature review to support software algorithm development and determine the alert thresholds," suggesting that the rules and thresholds were established based on existing clinical knowledge and literature. The 794 patients were used for the retrospective analysis of alert rates, which effectively acts as a test/validation set for the alert reduction logic rather than a dataset for algorithm training in a machine learning sense.

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

Since an explicit training set (for machine learning) is not detailed, the "ground truth" for the algorithm's rules and thresholds was established through a "literature review to support software algorithm development and determine the alert thresholds." This implies that the rules are based on scientific and clinical evidence from medical literature.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 14, 2025

WARD 24/7 ApS % Melissa DeHass Principal Consultant ROM+ 2790 Mosside Boulevard Suite 800 Monroeville, Pennsylvania 15146

Re: K241958

Trade/Device Name: WARD-CSS (v1.2.x) Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II Product Code: MWI Dated: July 3, 2024 Received: July 3, 2024

Dear Melissa Dehass:

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.

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

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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 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-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 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-device-advicecomprehensive-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-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-regulatory

{2}------------------------------------------------

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,

Jennifer W. Shih -S

Jennifer Kozen 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

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

Indications for Use

510(k) Number (if known) K241958

Device Name WARD-CSS

Indications for Use (Describe)

WARD-CSS is a climical decision support system that remotely integrates, analyzes continuous vital sign data (via a mobile or web application) from medical devices for non-pediatric hospitalized patients within non-critical care units.

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)

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."

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

510(k) Summary

DATE PREPARED

December 20, 2024

MANUFACTURER AND 510(k) OWNER

Ward 24/7ApS HealthTechHub Copenhagen Danneskiold-Samsøes Allé 41 1434 København K Denmark Official Contact: Madolina Christina Telephone: +45 53845636 Email: madolina.christian@ward247.com

REPRESENTATIVE/CONSULTANT

Melissa DeHass Principal RQM+ Telephone: 717-476-0702 Email: mdehass(@rqmplus.com

DEVICE INFORMATION

Proprietary Name/Trade Name	WARD-Clinical Software Support (WARD-CSS)
Common Name	Monitor, physiological, patient (with arrhythmia detection ofalarms)
Regulation Number	870.2300
Class	2
Product Code	MWI
Premarket Review	Traditional 510(k)
Review Panel	Cardiovascular

PREDICATE DEVICE IDENTIFICATION

WARD-CSS is substantially equivalent to the following predicate:

510(k) Number	Predicate Device Name / Manufacturer	PrimaryPredicate
K213335	Capsule Surveillance System /Capsule Surveillance Technologies, SAS /Capsule Tech, Inc.	✓

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

DEVICE DESCRIPTION

WARD-CSS utilizes knowledge-based algorithms to evaluate clinically relevant vital signs deviations to help drive clinical management.

The system is intended to be used as an adjunct to current monitoring practice in the general med/surg floors of the hospitals

The system assists healthcare professionals when monitoring patients on their wards by:

Providing a real-time monitoring overview of vital signs for all patients. ●
Alerting the healthcare professionals when a patient deteriorates. ●

The following types of alerts are detected by WARD-CSS in the vital sign data:

Desaturation ●
Hypertension
Hypotension ●
Bradypnea ●
Tachypnea ●
Tachycardia
Bradycardia
Hypotension and Bradycardia
Hypotension and Tachycardia ●
Bradypnea and Desaturation
Fever

Intended use/Indications for use

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

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

WARD 24/7 ApS believes that the WARD-CSS is substantially equivalent to the predicate device based on the information summarized here:

The subject device has a similar design and dimensions, and uses similar or identical materials, as the device cleared in K21335. The subject device has the same intended use and similar technological characteristics to the devices cleared in K213335, and the subject device has undergone testing to ensure the device is as safe and effective as the predicate.

WARD-CSS(Subject Device)	Capsule Surveillance System (K213335)(Predicate Device)	Comments
Product Code	MWI	MWI	Same
Regulation	870.2330	870.2330	Same
Indications for Use	WARD-CSS is a clinicaldecision support systemthat remotely integrates,analyzes and displayscontinuous vital sign data(via a mobile and webapplication) from medicaldevices for non-pediatrichospitalized patientswithin non-critical careunits.WARD-CSS uses a set ofstandardized rules basedon scientific and clinicalevidence to detectclinically relevant vitalsign deviations (alerts)when used by trainedhealth care professionalsin hospitals.WARD-CSS is notintended to replace healthcare professionals'judgment, but rather toassist health careprofessionals in makingtimely, informed, higherquality decisions.WARD-CSS is notintended to replacecurrent monitoringpractices but is intendedto help drive clinical	Capsule SurveillanceSystem is a clinicaldecision support devicethat integrates, analyzes,and displays data frommultiple sourcesincluding medical devicesand healthcareinformation systems. Ituses standardized rulesthat are based oncustomer approvedclinical practices,protocols and policies tocreate clinically relevantalerts in health carefacilities when used byclinician physicians orappropriate medical staffunder the direction ofphysicians. It is notintended to replaceclinicians' judgement, butrather to assist cliniciansin making timely,informed, higher, qualitydecisions. CapsuleSurveillance may beconfigured for secondarymonitoring and alertingintended to be relied uponin deciding to takeimmediate clinical action.Capsule Surveillance mayalso be configured for	Similar
	WARD-CSS(Subject Device)	Capsule SurveillanceSystem (K213335)(Predicate Device)	Comments
	management.	remote display ofphysiological data andalerts not intended to berelied upon in deciding totake immediate clinicalaction.
Intended User	Healthcare professionals		Same
IntendedPatientPopulation	Hospitalized adultpatients (non-pediatricpopulation) hospitalizedpatients within non-critical departments.	Hospital patients	Same,WARD-CSS andCapsuleSurveillanceSystem areutilized byadultpatients notin theintensivecare unit(ICU).
PatientMonitoring	Adjunctive	Adjunctive	Same
Vital Signs	Heart rate Oxygen saturation Respiration rate Temperature Blood pressure	Heart rate Oxygen saturation Respiration rate Temperature Blood pressure	Same
Platforms	Mobile AppWeb App	Mobile AppWeb App	Same
Algorithms	Threshold-based	Threshold-based	Same
Vital SignMonitoringResolution	1-minute
Alerts	Direct detection fromvital sign data	Direct detection fromvital sign data	Same

{7}------------------------------------------------

{8}------------------------------------------------

SUMMARY OF NON-CLINICAL TESTING

The following tests were performed to demonstrate safety based on current industry standards:

. Software Testing (IEC 62304)
. Human Factors (IEC 62366-1)

The results of these tests indicate that WARD-CSS is substantially equivalent to the predicate device, the Capsule Surveillance System (K213335).

SUMMARY OF CLINICAL TESTING

A literature review to support software algorithm development and determine the alert thresholds.

WARD-CSS reduces the number of alerts in comparison to standard patient monitors which alert immediately and repeatedly when a vital sign threshold is surpassed. (Standard patient monitors do not include a time duration component or any other alert filter).

WARD-CSS reduces the number of alerts in comparison to these standard patient monitors (indicating a basic threshold) by:

1. the introduction of a 'time duration' for a threshold to be surpassed within the alerting condition
1. additional 'alert filters' after the detection of the alerting conditions:
- 1. Reissue time filter: an alert of the same type is not allowed to trigger again within a specific time duration (in order to reduce the amount of alerts when a patient is continuously fulfilling an alerting condition).
- 1. Prioritization filter: an alert of lower priority is not allowed to trigger when an alert of higher priority is already active (this logic is only valid within the same alert groups like desaturation, bradycardia, tachycardia, hypertension, hypotension).

The combination of the '(alert)time duration' and 'alert filters', in addition to basic thresholds, theoretically lowers the number of alerts.

A retrospective analysis has been performed on four cohorts from prospective clinical safety studies conducted from 2020-2024 to measure the impact of these alert reduction methodologies.

The vital sign data of 1115 subjects (the number of subjects included in the WARD-CSS safety clinical studies) was primarily used to to confirm safety and not all data have been extracted for alert analysis.

Of the 1115 patients included in the safety studies, 794 patients were used to analyze the number of alerts. These patients are representative of both hospitalized medical and surgical cohorts.

Alert rates were analyzed for the three following cases:

Thresholds only ●
Thresholds with time durations .
Thresholds with time durations and alert filters (WARD-CSS) .

In Table 1 below, the median and interquartile range for these cases are shown for all alert groups and each individual (bucketed) alerting group. A mean value is added to the results when the median is zero.

{9}------------------------------------------------

Table 1. Alert Reduction Analysis

Methodology	All alert groups	Hypertension + Hypotension	[Bradypnea + Tachypnea]	[Tachycardia + Bradycardia]	[Desaturation + Desaturation/ Bradypnea]	[Hypotension/Tachycardia + Hypotension/Bradycardia]
Only thresholds	417.0[177.9-831.5]	0.0 [0.0-1.0](mean 1.0)	33.7[6.8-157.9]	11.9 [0.8-61.2](mean 76.3)	256[86.5-560.3]	0.0 [0.0-0.0](mean 0.1)
Thresholds and time durations	111[26.5-338.3]	0.0 [0.0-0.0](mean .04)	4.7[0.3-37.4]	0.0 [0.0-1.9](mean 29.0)	63.2[9.2-227.6]	0.0 [0.0-0.0](mean 0.0)
Thresholds, time durations and alert filters (WARD-CSS)	9.0[3.8-18.1]	0.0 [0.0-0.0](mean 0.3)	1.6[0.3-4.9]	0.0 [0.0-0.3](mean 1.0)	4.7[1.3 - 11.5]	0.0 [0.0-0.0]mean (0.0)

The introduction of time durations gives a 74% reduction in alerts (over all alert types).

The alert filters reduce the alerts even further resulting in a total reduction of alerts by 97.8% by W ARD-CSS in comparison to patient monitors that alert only upon thresholds.

*WARD does not have any data within these studies on temperature, so it is not possible to calculate alert reduction numbers for fever (but the alert reduction follows the same methodologies).

Summary

WARD-CSS reduces alert numbers compared to alert systems without- or with artefact removal.

{10}------------------------------------------------

CONCLUSION

Based on the testing performed, including software verification, bench performance testing, and clinical testing, it can be concluded that the subject device does not raise new issues of safety or effectiveness compared to the predicate device. The proposed WARD-CSS software and the Capsule Surveillance System, cleared under K213335 have the same intended use and indications, similar technological characteristics, and the same principles of operation. Thus, the proposed WARD-CSS software is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).