The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS).

The WAVE Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:

· To remotely consult regarding patients' statuses:

· To remotely review other standard or critical near real-time patient data, waveforms, and results in order to utilize this information to aid in clinical decisions.

Warning: The WAVE Clinical Platform is intended to supplement and not to replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.

Device Description

Excel Medical's WAVE Clinical Platform is a software platform that gathers and stores data from patient monitoring and other medical devices, hospital information systems, and clinical analytics data sources for near real-time and retrospective remote display for clinicians to use in clinical decision support. The WAVE Clinical Platform can also route and forward these data to third party systems.
The WAVE Clinical Platform can utilize the hospital's existing network and hardware for installation and display on any device that is web-enabled. The WAVE Clinical Platform does not control any of the medical devices or systems it is connected with.

AI/ML Overview

The provided document is a 510(k) summary for the Excel Medical Electronics WAVE Clinical Platform. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria with quantitative performance metrics.

Therefore, many of the requested elements for describing acceptance criteria and a study proving performance are not explicitly present in the given text. The document primarily outlines the device's functionality, intended use, and compares its technical characteristics to a predicate device to argue for substantial equivalence.

Based on the provided text, here's what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not explicitly provided in the format of specific, measurable acceptance criteria and corresponding performance values for the WAVE Clinical Platform. The document states that "Safety, efficacy and substantial equivalence was shown through system level tests, user interface verification, device compatibility verification, performance tests and safety testing," and concludes that "The WAVE Clinical Platform test results on non-clinical testing demonstrate the device is substantially equivalent to the predicate device - the Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform in terms of safety, features and performance." However, the exact criteria (e.g., latency thresholds, data accuracy percentages) and the numerical results are not detailed.

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

This information is not provided. The document mentions "system level tests, user interface verification, device compatibility verification, performance tests and safety testing" but does not specify the sample size of data, patients, or scenarios used in these tests, nor the origin (country, retrospective/prospective nature) of any data used.

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

This information is not provided. The concept of "ground truth" as typically used in AI/diagnostic device studies (e.g., expert consensus on medical images or diagnoses) is not discussed, as this 510(k) is for a data management and display platform, not a diagnostic AI.

4. Adjudication Method for the Test Set:

This information is not provided. Given that no specific "ground truth" or expert review process is detailed for performance evaluation, an adjudication method is also not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The device is a "Clinical Platform" for routing, storing, and displaying data, not a diagnostic AI that would be evaluated for human reader improvement. The document explicitly states: "Clinical Performance: Not Applicable. Clinical evidence was not necessary to show substantial equivalence."

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

The document describes "system level tests, user interface verification, device compatibility verification, performance tests and safety testing" (page 10). These non-clinical tests would represent a form of "standalone" evaluation of the system's technical functionality (e.g., data routing speed, display accuracy, alarm fidelity). However, specific metrics or a detailed account of these standalone performance evaluations are not provided. The focus is on demonstrating that its functions are similar to the predicate device rather than presenting quantitative performance data for these tests.

7. The Type of Ground Truth Used:

For the purpose of this device (a data management and display platform), the "ground truth" for non-clinical performance testing would likely refer to the correctness of data transmission, storage, and display as compared to the original source data or expected outputs. For example, verifying that a heart rate value displayed on the platform matches the value from the connected monitor. However, the document does not explicitly state how this "ground truth" was established or verified in detail. It refers broadly to "system level tests, user interface verification, device compatibility verification, performance tests and safety testing."

8. The Sample Size for the Training Set:

This information is not applicable/provided. The WAVE Clinical Platform is described as software for routing, storing, and displaying data, not an algorithm that learns from a training set (e.g., an AI/ML diagnostic algorithm).

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

This information is not applicable/provided. As above, the device is not an AI/ML algorithm that requires a "training set" with established ground truth.

Summary of available information regarding the "study" proving acceptance criteria (non-clinical performance):

Study Type: Non-clinical performance testing, including system level tests, user interface verification, device compatibility verification, performance tests, and safety testing.
Purpose: To demonstrate substantial equivalence to the predicate device (Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform) in terms of safety, features, and performance.
Conclusion: "The WAVE Clinical Platform test results on non-clinical testing demonstrate the device is substantially equivalent to the predicate device... in terms of safety, features and performance." "No new questions of safety and effectiveness have been raised."
Lack of Detail: Specific acceptance criteria, quantitative performance results, sample sizes, methodology details for establishing ground truth, or expert involvement are not provided in this 510(k) summary document.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' and 'ADMINISTRATION' in blue text.

January 4, 2018

Excel Medical Electronics, LLC Lance Burton General Manager 801 Maplewood Dr. Suite 25 Jupiter, Florida 33458

Re: K171056

Trade/Device Name: WAVE Clinical Platform Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI Dated: November 30, 2017 Received: December 4, 2017

Dear Lance Burton:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Lance Burton

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

M& Hillelneme

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171056

Device Name WAVE Clinical Platform

Indications for Use (Describe)

· To remotely consult regarding patients' statuses:

· To remotely review other standard or critical near real-time patient data, waveforms, and results in order to utilize this information to aid in clinical decisions.

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

WAVE Clinical Platform

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a 510(k) Summary for the use of the WAVE Clinical Platform.

April 7, 2017 1. Date:
1. SUBMITTED BY: Excel Medical Electronics, LLC 801 Maplewood Drive, Suite 25 Jupiter, Florida 33458
1. CONTACT PERSON: Lance Burton General Manager Email: lance.burton@excelmedical.com Phone: 866-573-8807 Fax: 561-748-8889

4. DEVICE INFORMATION: WAVE Clinical Platform

	Device Information
Device ProprietaryName:	WAVE Clinical Platform
Common or UsualName:	Data Management, Visualization and ClinicalDecision Support Software
Classification:	Class II Device
Product Code:	MWI
Regulation Number:	CFR 870.2300
Regulation Name:	Cardiac Monitor (including Cardiotachometer andRate Alarm)
Classification Name:	Cardiac Monitor (including cardiotachometer andrate alarm) Monitor, Physiological, Patient(Without Arrhythmia Detection or Alarms)

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Review Panel:	Part 870, Subpart B Cardiovascular DiagnosticDevices, Sec. 870.1425 ProgrammableDiagnostic Computer
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1. PREDICATE DEVICE: COVIDIEN VITAL SYNC™ INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM (K140339; MWI, OUG)
  INTENDED USE: "The Vital Sync™ Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Electronic Medical Record (eMR) and Clinical Information System (Cis).

The Vital Sync™ Virtual Patient Monitoring Platform is a remote monitoring platform that displays physiologic data. waveforms and alarms routed through the Vital Svnc™ Informatics Manager for supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals for the following purposes:

· To remotely consult reqarding a patient's status
· To remotely review other standard or critical near real-time patient data, waveforms and alarms in order to utilize this information to aid in clinical decisions and deliver patient care in a timely manner.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are intended to supplement and not to replace any part of the hospital's device monitoring. Do not rely on the Vital Sync™ Informatics Manager &Virtual Patient Monitoring Platform as the sole source of alarms."

	Predicate Device Information
Device ProprietaryName:	Vital Sync™ Informatics Manager & Virtual PatientMonitoring Platform
Classification:	Class II Device
510(k) Number:	K140339
Product Code:	MWI, OUG
Regulation Number:	CFR 870.2300
Regulation Name:	Cardiac Monitor (including Cardiotachometer andRate Alarm)
Classification Name:	Cardiac Monitor (including cardiotachometer andrate alarm) Monitor, Physiological, Patient (WithoutArrhythmia Detection or Alarms)

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Review Panel:	Part 870, Subpart B Cardiovascular DiagnosticDevices, Sec. 870.1425 Programmable DiagnosticComputer
---------------	-------------------------------------------------------------------------------------------------------------

1. DEVICE DESCRIPTION: Excel Medical's WAVE Clinical Platform is a software platform that gathers and stores data from patient monitoring and other medical devices, hospital information systems, and clinical analytics data sources for near real-time and retrospective remote display for clinicians to use in clinical decision support. The WAVE Clinical Platform can also route and forward these data to third party systems.
  The WAVE Clinical Platform can utilize the hospital's existing network and hardware for installation and display on any device that is web-enabled. The WAVE Clinical Platform does not control any of the medical devices or systems it is connected with.
1. INTENDED USE / INDICATIONS FOR USE: The WAVE Clinical Platform is software intended to route, store, and display data, alarms, results and diagnostic information from medical devices, Electronic Medical Records (EMR), and Clinical Information Systems (CIS). The WAVE Clinical Platform is a remote monitoring platform that displays physiologic data, waveforms, alarms, results and diagnostic information routed through the WAVE Clinical Platform from supported devices and systems. The WAVE Clinical Platform is intended for use in hospital or hospital type environments. The WAVE Clinical Platform is intended to be used by healthcare professionals for the following purposes:
  To remotely consult regarding patients' statuses;

To remotely review other standard or critical near real-time patient data, waveforms, alarms, and results in order to utilize this information to aid in clinical decisions.

Warning: The WAVE Clinical Platform is intended to supplement and not replace any part of the hospital's device monitoring or electronic data management systems. Do not rely on the WAVE Clinical Platform product as the sole source of alarms.

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8. TECHNOLOGICAL CHARACTERISTIC AND SUBSTANTIAL EQUIVALENCE:

	Predicate - Vital SyncInformatics Manager &Virtual PatientMonitoring Platform	WAVE ClinicalPlatform	Data Storage	Hour to days of data isbuffered and thenarchived to tape forindefinite storage untildeleted	All data are archived toand indefinitely storedon disk drives untildeleted
Indications for Use	The Vital SyncInformatics Manager issoftware that isintended to route andstore medical devicedata and devicediagnostic informationfrom supported devicesto the ElectronicMedical Record (EMR)and Clinical InformationSystem (CIS).The Vital Sync VirtualPatient MonitoringPlatform is a remotemonitoring platform thatdisplays physiologicdata, waveforms andalarms routed throughthe Vital SyncInformatics Manager	The WAVE ClinicalPlatform is softwareintended to route, store,and display data,alarms, results anddiagnostic informationfrom medical devices,Electronic MedicalRecords (EMR), andClinical InformationSystems (CIS).The WAVE ClinicalPlatform is a remotemonitoring platform thatdisplays physiologic andclinically relevant data,waveforms, and alarmsrouted through theWAVE ClinicalPlatform fromsupported devices anddata systems. TheWAVE ClinicalPlatform is intended tobe used by healthcareprofessionals for thefollowing purposes:• To remotely consultregarding patients'statuses;• To remotely reviewother standard or criticalnear real-time andhistorical patient data,waveforms, alarms, andresults in order to utilize	Where Used	Anywhere cliniciansremotely consult onpatients	Anywhere cliniciansremotely consult onpatients
	this information to aid inclinical decisions anddeliver patient care in atimely manner.WARNING: The VitalSync InformaticsManager & VirtualPatient MonitoringPlatform are intendedto supplement and notto replace any part ofthe hospital's device	this information to aid inclinical decisions anddeliver patient care in atimely manner.WARNING: The WAVEClinical Platform isintended to supplementand not to replace anypart of the hospital'sdevice monitoring orelectronic datamanagement systems.Do not rely on theWAVE ClinicalPlatform product as thesole source of alarms.	Wireless	Yes, handheld displaydevices	Yes, handheld displaydevices
Device RegulatoryClassification	21 CFR 870.2300;Cardiac monitor(includingcardiotachometer and	21 CFR 870.2300;Cardiac monitor(includingcardiotachometer andrate alarm)	Ability to View NearReal-time Data	Yes	Yes
Product Code	MWI & OUG	MWI	Synopsis ofFunctionality	Store, route and displaypatient monitor, EMRand CIS data, alarms,and smart alarmsremotely to aid inclinical decisions anddeliver patient care in atimely manner	Store, route and displaypatient monitor, EMRand CIS data, alarms,and smart alarmsremotely to aid in clinicaldecisions and deliverpatient care in a timelymanner
Device Class	II	II	TargetPopulation/DemographiCS	ICU and ER patientsthat have Covidienphysiological sensorsattached.	In-hospital patients thathave physiologicalsensors attached.
510(k) Number	K140339	TBD
Other Technology Used	Standard computers,network, and WIFItechnology	Standard computers,network, and WIFItechnology
Host server	Uses hospital's existingserver hardware orserver pre-loaded withVital Sync software andoff the shelf operatingsystem	Uses hospital's existingserver hardware orserver pre-loaded withthe WAVE ClinicalPlatform software andoff-the-shelf operatingsystem

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9. Substantial Equivalence Discussion on Comparison to Predicate Device:

Excel Medical's WAVE Clinical Platform and Covidien's Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform perform the same functions with no difference in how the devices are used. The WAVE Clinical Platform is a single medical device that performs the functions of (a) storing, (b) routing and (c) displaying data from patient monitors, EMR and CIS systems, and smart alarms. Covidien's two devices (Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform) perform these same functions. The WAVE Clinical Platform's data is displayed remotely to aid in clinical decisions and deliver patient care in a timely manner. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform's data is displayed remotely to aid in clinical decisions and deliver patient care in a timely manner. Excel

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Medical's WAVE Clinical Platform data are archived to and indefinitely stored on disk drives until deleted. Covidien's Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform Hour to days of data is buffered and then archived to tape for indefinite storage until deleted. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform gathers ICU and ER patient data from Covidien physiological sensors. Excel Medical's WAVE Clinical Platform gathers data from in-hospital patients that have physiological sensors attached. These differences have no effect on how these devices are used. The patient's in-hospital location and the physiological sensors may be different, but Excel Medical's WAVE Clinical Platform and Covidien's Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform function and intended use are the same. Risk and Hazards are the determined to be the same for both devices.

10. Substantial Equivalence Discussion on Safety and Effectiveness:

There are three differences between Excel Medical's WAVE Clinical Platform and Covidien's Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform:

(1) The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are essentially two products and the WAVE Clinical Platform is one product that perform the same functionality.

(2) The WAVE Clinical Platform gathers data from inhospital patients that have physiological sensors attached. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform gathers ICU and ER patient data from Covidien physiological sensors. This is based on a business decision to include other manufacturer's devices and systems and is no difference in functionality or intended use of the product.

(3) The WAVE Clinical Platform has the ability to store a larger volume of data and made available online. Whereas, the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform requires long term storage of data to be archived offline.

These differences have no effect on safety and effectiveness or the intended use for the device.

11.Summary of Technology Characteristics

Technology characteristics of the WAVE Clinical Platform and the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are determined to be the same. Both devices are software devices with client server architecture and support web-

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enabled displays of data. Both software devices acquire and distribute data across general purpose hospital networks, both wired and wireless. Both devices have server software that run on general purposes server computer hardware and use data storage technology mediums widely available in hospitals. Both devices allow users to access and display data from web-enabled devices over wired and wireless general purpose networks. All of these technologies are proven and any risks and their mitigations are widely understood in hospital environments. The platforms have identical indications for use and both display parameters and waveforms from connected medical devices to a remote, webenabled display.

12. Non-clinical Performance: Bench

Safety, efficacy and substantial equivalence was shown through system level tests, user interface verification, device compatibility verification, performance tests and safety testing. The WAVE Clinical Platform test results on non-clinical testing demonstrate the device is substantially equivalent to the predicate device - the Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform in terms of safety, features and performance. No new questions of safety and effectiveness have been raised.

13. Clinical Performance:

Not Applicable. Clinical evidence was not necessary to show substantial equivalence.

14. Conclusions from Non-clinical Performance Testing:

The WAVE Clinical Platform test results on non-clinical testing demonstrate the WAVE Clinical Platform is substantially equivalent to the predicate device - the Covidien Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform in terms of safety, features and performance.

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).