VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

K130796 · Covidien · MWI · May 9, 2013 · Cardiovascular

Device Facts

• Record ID: K130796
• Device Name: VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
• Applicant: Covidien
• Product Code: MWI · Cardiovascular
• Decision Date: May 9, 2013
• 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

Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is software routing physiologic data, waveforms, and alarms from connected medical devices to web-enabled displays. System utilizes existing hospital network infrastructure; does not control connected devices or alter data. Used by healthcare professionals for remote patient status consultation and near real-time data review. Output aids clinical decision-making and timely patient care. Intended as a supplement to, not a replacement for, primary hospital monitoring systems.

Clinical Evidence

No clinical data; bench testing only. Evidence based on system-level verification, user interface verification, system validation, and device compatibility verification.

Technological Characteristics

Software-based informatics and remote monitoring platform. Operates on hospital network infrastructure. Web-based interface accessible via any web-enabled device. Does not control connected medical devices. No specific hardware materials or energy sources defined as it utilizes existing hospital hardware.

Indications for Use

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

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

• Airstrip Technology's Remote Patient Monitoring (RPM) Data Viewing Software (K122133)

Submission Summary (Full Text)

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# K130796 P 1/3

# 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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 Summary of Safety and Effectiveness 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: | May 10, 2013 |
| Contact Person: | Kelsey Lee<br>Senior 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 |
| Predicate Device: | Airstrip Technology's Remote Patient<br>Monitoring (RPM) Data Viewing Software<br>(K122133) |

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K130796

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# 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 utilize the hospital's network and existing hardware for installation and display. 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.

# Indications for Use/Intended Use

The subject Vital Sync™ System has similar indications for use as the predicate Airstrip Medical Remote Data Viewing Software.

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.

# Technological Characteristics Comparison

The subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform and the legally marketed predicate Airstrip Medical Remote Data Viewing Software have similar indications for use and both display parameters and waveforms from connected medical devices to a mobile display. Neither the subject nor the predicate can control the connected devices. The

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K130796 P 3/3

Subject device can be accessed from any web-enabled device, whereas the predicate software is operating system specific.

### Substantial Equivalence - Non-Clinical Evidence

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

### Substantial Equivalence - Clinical Evidence

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

# Substantial Equivalence - Conclusions

Substantial equivalence, safety and efficacy are shown through systems level testing, user interface testing, and system validation, including summative usability testing. The subject and predicate device have similar indications for use, display features, principles of operation and operating environments. The subject and predicate differ in that the subject device displays alarms and can be accessed through any web enabled device whereas the predicate is operating system specific. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be expected to perform at least as well as the predicate.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 9, 2013

Covidien c/o Ms. Kelsey Lee Senior Regulatory Affairs Specialist 6135 GunBarrel Avenue Boulder, CO 80301

Re: K130796

> Trade/Device Name: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform Regulatory Number: 21 CFR 870.2300

Regulation Name: Physiological Patient Monitor (without arrhythmia detection or alarms) Regulatory Class: II (two) Product Code: 74 MWI

Dated: March 28, 2013

Received: March 29, 2013

Dear Ms. Lee:

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. Kelsey Lee

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.htm for 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,

Image /page/4/Picture/6 description: The image shows the text "Owen Poly Faris -S". The text is written in a simple, sans-serif font. The word "Poly" is stylized with a complex, geometric pattern, making it stand out from the rest of the text. The overall impression is a combination of straightforward text and a decorative element.

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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#### K130796

# Indications for Use

510(k) Number (if known):

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

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 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 AND/OR Over-The-Counter 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)

Owen P. Faris
2013.05.09
16:16:41 -04'0