VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

K140339 · Covidien · MWI · Apr 10, 2014 · Cardiovascular

Device Facts

• Record ID: K140339
• Device Name: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
• Applicant: Covidien
• Product Code: MWI · Cardiovascular
• Decision Date: Apr 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 Sync™ 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 regarding 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.

Device Story

Software platform routing/storing medical device data/waveforms/alarms to EMR/CIS; displays data on web-enabled devices for remote clinical review. Inputs: physiologic data/alarms from connected medical devices. Outputs: visual display of patient data/alarms. Used in hospital settings by healthcare professionals. Supplements existing hospital monitoring; does not control connected devices or replace primary monitoring. Features include smart alarms, ADT connectivity, and alarm forwarding to 3rd party systems. Benefits: enables remote consultation and timely clinical decision-making by providing near real-time access to patient status.

Clinical Evidence

No clinical data; bench testing only. Safety and efficacy demonstrated through system-level verification, user interface verification, and usability validation.

Technological Characteristics

Software-based informatics and monitoring platform. Operates on hospital network/hardware or optional server with off-the-shelf OS. Web-enabled display. Features include smart alarms, ADT connectivity, and alarm forwarding. Standalone software application.

Indications for Use

Indicated for use by healthcare professionals to remotely consult on patient status and review near real-time physiologic data, waveforms, and alarms from connected medical devices to aid in clinical decision-making and patient care delivery.

Regulatory Classification

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.

Predicate Devices

• Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K132604)
• Cardiopulmonary Corp's Bernoulli Management System (K091461)

Submission Summary (Full Text)

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# K140339 Page 1 of 4

# 510(K) SUMMARY

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 510k Summary for the use of the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform.

| Submitted By: | Covidien<br>6135 Gunbarrel Avenue<br>Boulder, CO 80301 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 10, 2014 |
| Contact Person: | Brianna Reynolds<br>Regulatory Affairs Specialist<br>[phone] |
| Proprietary Name: | Vital Sync™ Informatics Manager & Virtual<br>Patient Monitoring Platform |
| Common Name: | Cardiac Monitor (without alarms) |
| Device Classification Regulation: | 21 CFR 870.2300 - Class II |
| Device Product Code & Panel: | MWI, OUG |
| Predicate Devices: | Vital Sync™ Informatics Manager & Virtual<br>Patient Monitoring Platform (K132604)<br>Cardiopulmonary Corp's Bernoulli<br>Management System (K091461) |

# Device Description

The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled. The Vital Sync™ IM & VPMP can utilize the hospital's

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K140339 Page 2 of 4

network and existing hardware for installation and display or an optional server pre-loaded with the Vital Sync software and off the shelf operating system can be provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected.

The new features on the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform include smart alarms, ADT connectivity and alarm forwarding to 30 party.

#### Indications for Use/Intended Use

The subject Vital Sync™ IM & VPMP has identical indications for use as the predicate Vital Sync™ IM & VPMP and similar indications for use as the Bernoulli Management System.

The Indications for use are as follows:

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 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 regarding 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.

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K140339 Page 3 of 4

# Technological Characteristics Comparison

The subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform has identical features to the legally marketed predicate Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform with the addition of smart alarms, ADT and alarm forwarding to 3rd party annunciation systems and substantially equivalent features to the Bernoulli Management System.

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K140339 Page 4 of 4

### Substantial Equivalence - Non-Clinical Evidence

Safety, efficacy and substantial equivalence was shown through system level verification, user interface verification and usability validation. The results of the tests show that the subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform can be considered substantially equivalent to the legally marketed predicates.

### Substantial Equivalence - Clinical Evidence

N/A - Clinical evidence was not necessary to show substantial equivalence

#### Substantial Equivalence - Conclusions

Substantial equivalence is shown through systems level testing, user interface testing, and usability validation. The subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform has identical features to the legally marketed predicate Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform with the addition of smart alarm, ADT and Alarm forwarding to 3rd party annunciation systems and substantially equivalent features to the Bernoulli Management System.

No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subiect device can be considered substantially equivalent.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

April 10, 2014

Covidien Ms. Brianna Reynolds Regulatory Affairs Specialist 6135 Gunbarrel Ave. Boulder, CO 80301 US

Re: K140339

> Trade/Device Name: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Without Alarms) Regulatory Class: Class II Product Code: MWI Dated: February 7, 2014 Received: February 10, 2014

Dear Ms. Brianna Reynolds:

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

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Page 2 - Ms. Brianna Reynolds

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR 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.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours

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

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#### K140339

# Indications for Use

510(k) Number (if known): K140339

Device Name: Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform

Indications for Use:

The Vital Sync TM 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 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 regarding 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.

> Prescription Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

> > (PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

#### CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

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