Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a platform for data routing, storage, and display, without mentioning any analytical or predictive capabilities that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

No
The device is a software platform intended to display data, alarms, and diagnostic information to aid in clinical decisions. It does not directly provide therapy or interact with the patient's body for treatment purposes.

Diagnostic

No

The WAVE Clinical Platform is described as software that routes, stores, and displays data, alarms, results, and diagnostic information from other medical devices and systems. Its intended use is to aid healthcare professionals in clinical decisions by remotely reviewing patient data. It does not generate new diagnostic information itself but rather consolidates and presents existing information.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states it is a "software platform" that utilizes the hospital's existing network and hardware for installation and display on any web-enabled device. It does not include or control any hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, the WAVE Clinical Platform is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly states that the software is for routing, storing, and displaying data, alarms, results, and diagnostic information from medical devices, EMRs, and CIS. It is a platform for presenting existing data, not for performing tests on biological samples to provide diagnostic information itself.
Device Description: The description reinforces that the platform gathers and stores data from other devices and systems. It does not perform any analysis or testing on biological specimens.
Lack of IVD Characteristics: There is no mention of the device interacting with biological samples (blood, urine, tissue, etc.), performing chemical or biological tests, or generating diagnostic results based on such tests.

The WAVE Clinical Platform functions as a data management and display system for clinical information generated by other devices and systems. This falls outside the scope of an In Vitro Diagnostic device, which is defined as a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

MWI

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

healthcare professionals / hospital or hospital type environments

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance: 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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K140339

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

0

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);

1

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

2

Indications for Use

510(k) Number (if known) K171056

Device Name WAVE Clinical Platform

Indications for Use (Describe)

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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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 Proprietary
Name:	WAVE Clinical Platform
Common or Usual
Name:	Data Management, Visualization and Clinical
Decision Support Software
Classification:	Class II Device
Product Code:	MWI
Regulation Number:	CFR 870.2300
Regulation Name:	Cardiac Monitor (including Cardiotachometer and
Rate Alarm)
Classification Name:	Cardiac Monitor (including cardiotachometer and
rate alarm) Monitor, Physiological, Patient
(Without Arrhythmia Detection or Alarms)

4

| Review Panel: | Part 870, Subpart B Cardiovascular Diagnostic
Devices, Sec. 870.1425 Programmable
Diagnostic Computer |

---------------	-------------------------------------------------------------------------------------------------------------

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 Proprietary
Name:	Vital Sync™ Informatics Manager & Virtual Patient
Monitoring Platform
Classification:	Class II Device
510(k) Number:	K140339
Product Code:	MWI, OUG
Regulation Number:	CFR 870.2300
Regulation Name:	Cardiac Monitor (including Cardiotachometer and
Rate Alarm)
Classification Name:	Cardiac Monitor (including cardiotachometer and
rate alarm) Monitor, Physiological, Patient (Without
Arrhythmia Detection or Alarms)

5

| Review Panel: | Part 870, Subpart B Cardiovascular Diagnostic
Devices, Sec. 870.1425 Programmable Diagnostic
Computer |

---------------	-------------------------------------------------------------------------------------------------------------

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 Sync
Informatics Manager &
Virtual Patient
Monitoring Platform | WAVE Clinical
Platform | Data Storage | Hour to days of data is
buffered and then
archived to tape for
indefinite storage until
deleted | All data are archived to
and indefinitely stored
on disk drives until
deleted |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for 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 Sync
Informatics Manager
| 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 and
clinically relevant data,
waveforms, and alarms
routed through the
WAVE Clinical
Platform from
supported devices and
data systems. 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 and
historical patient data,
waveforms, alarms, and
results in order to utilize | Where Used | Anywhere clinicians
remotely consult on
patients | Anywhere clinicians
remotely consult on
patients |
| | 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
| this information to aid in
clinical decisions and
deliver patient care in a
timely manner.

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. | Wireless | Yes, handheld display
devices | Yes, handheld display
devices |
| Device Regulatory
Classification | 21 CFR 870.2300;
Cardiac monitor
(including
cardiotachometer and
| 21 CFR 870.2300;
Cardiac monitor
(including
cardiotachometer and
rate alarm) | Ability to View Near
Real-time Data | Yes | Yes |
| Product Code | MWI & OUG | MWI | Synopsis of
Functionality | Store, route and display
patient monitor, EMR
and CIS data, alarms,
and smart alarms
remotely to aid in
clinical decisions and
deliver patient care in a
timely manner | Store, route and display
patient monitor, EMR
and CIS data, alarms,
and smart alarms
remotely to aid in clinical
decisions and deliver
patient care in a timely
manner |
| Device Class | II | II | Target
Population/Demographi
CS | ICU and ER patients
that have Covidien
physiological sensors
attached. | In-hospital patients that
have physiological
sensors attached. |
| 510(k) Number | K140339 | TBD | | | |
| Other Technology Used | Standard computers,
network, and WIFI
technology | Standard computers,
network, and WIFI
technology | | | |
| Host server | Uses hospital's existing
server hardware or
server pre-loaded with
Vital Sync software and
off the shelf operating
system | Uses hospital's existing
server hardware or
server pre-loaded with
the WAVE Clinical
Platform software and
off-the-shelf operating
system | | | |

7

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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

9

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.