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.

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 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.

AI/ML Overview

The provided document describes the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K140339). However, it does not contain specific acceptance criteria, detailed study results with performance metrics, or information about sample sizes for test/training sets, expert qualifications, or adjudication methods.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical evidence, primarily system-level verification, user interface verification, and usability validation. It explicitly states, "N/A - Clinical evidence was not necessary to show substantial equivalence."

Therefore, I cannot provide a table of acceptance criteria and reported device performance tailored to the metrics typically found in efficacy studies (e.g., sensitivity, specificity, AUC), nor can I detail the specifics of a study proving those criteria, as such a study is not described in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Type Described in Document	Reported Device Performance
System level verification	Successfully met
User interface verification	Successfully met
Usability validation	Successfully met
Substantial equivalence to predicate devices	Achieved

Explanation: The document indicates that substantial equivalence was shown because the device successfully underwent "system level verification, user interface verification and usability validation." It does not provide specific quantitative performance metrics for these verifications.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: Not specified in the provided document.
Data Provenance: Not specified in the provided document. The testing was non-clinical, implying internal testing and validation rather than clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified. Given the non-clinical nature of the evidence, this information is not expected to be present.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no MRMC study or any clinical effectiveness study comparing human readers with and without AI assistance was performed or submitted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is software that routes and displays medical device data, waveforms, and alarms. Its "performance" is primarily related to its ability to accurately route, store, and display this information, and its new features (smart alarms, ADT connectivity, alarm forwarding). The "validation" performed (system, UI, usability) would assess functionality rather than a standalone diagnostic accuracy in the way an AI diagnostic algorithm might be evaluated. The documentation does not describe a standalone algorithm performance study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the non-clinical tests (system, UI, usability), the ground truth would typically be defined by engineering specifications, software requirements, and usability standards rather than medical ground truth like pathology or expert consensus. Specific details are not provided.

8. The sample size for the training set:

Not applicable. This device is an informatics manager and monitoring platform, not a machine learning model that requires a "training set" in the conventional sense for AI diagnostic or predictive tasks.

9. How the ground truth for the training set was established:
* Not applicable, as there is no "training set" for this type of device mentioned.

Summary

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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:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	April 10, 2014
Contact Person:	Brianna ReynoldsRegulatory Affairs Specialist(303) 305-2727
Proprietary Name:	Vital Sync™ Informatics Manager & VirtualPatient 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 & VirtualPatient Monitoring Platform (K132604)Cardiopulmonary Corp's BernoulliManagement System (K091461)

Device Description

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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).

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.

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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 (800) 638 2041 or (301) 796-7100 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:

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.

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

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CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION (ODE)

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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).