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 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.

This 510k is intended to add new features to the existing Vital Sync IM & VPMP:

Additional User Interface Additional Report Auto device Association Area (zone) Management Optional Off the Shelf Software/server

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the device is the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform. The document describes a 510(k) submission for new features being added to an existing and legally marketed device. Therefore, the "acceptance criteria" discussed are primarily related to establishing substantial equivalence to the predicate device, rather than explicit performance metrics for a new, first-of-its-kind device.

Acceptance Criteria	Reported Device Performance (as demonstrated by studies)
Safety and Efficacy for new features: To ensure the added features (Additional User Interface, Additional Report, Auto device Association, Area (zone) Management, Optional Off the Shelf Software/server) do not compromise the safety or effectiveness of the device compared to the predicate.	Demonstrated through: - System level verification - User interface verification - System validation - Device compatibility verification (The results of these tests showed that the subject device can be considered substantially equivalent to the legally marketed predicate.)
Identical Indications for Use: The new device (with added features) must retain the same intended uses as the predicate device.	The subject device has "identical indications for use" as the predicate device.
Does not alter parameters, waveforms, and alarms: The software must only route and display, not modify, the data from connected medical devices.	The device "does not alter the parameters, waveforms, and alarms displayed and does not control any of the medical devices connected."
No new questions of safety and effectiveness: The introduction of new features should not raise new concerns beyond those addressed by the predicate.	"No new questions of safety and effectiveness have been raised."
Substantial Equivalence: The overall determination that the subject device is as safe and effective as a legally marketed predicate device.	"Substantial equivalence is shown through systems level testing, user interface testing, and system validation."

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

The document does not specify sample sizes for any test sets used in the verification or validation activities. It also does not mention an explicit "test set" in the context of clinical data or patient data. The studies described are primarily non-clinical engineering and software validation tests.

The data provenance is therefore internal to the manufacturer's testing and validation processes. No external or patient-related data provenance (e.g., country of origin, retrospective/prospective) is provided.

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

This information is not provided in the document. The studies mentioned are primarily non-clinical, focusing on system functionality and equivalence, rather than diagnostic accuracy requiring expert ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant to the type of non-clinical testing described. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving expert review of clinical cases to establish ground truth, which is not the nature of the studies detailed here.

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, an MRMC comparative effectiveness study was not done. The device is software that routes and displays data; it is not an AI diagnostic tool and does not involve "human readers" in the context of an MRMC study. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence."

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

The device is a "Virtual Patient Monitoring Platform" that displays data for "healthcare professionals" to utilize for clinical decisions. Its very nature implies a human-in-the-loop interaction. Therefore, a standalone (algorithm only) performance assessment as typically understood for AI diagnostic algorithms was not done, nor would it be entirely applicable to this device's function. The "algorithm" here is the software's ability to accurately route and display data without alteration. The non-clinical tests (system level verification, user interface verification, system validation, device compatibility verification) confirm this core functionality.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Given that the studies are non-clinical engineering and software validation:

The "ground truth" for system level verification would likely be the defined technical specifications and requirements of the software.
The "ground truth" for user interface verification would be the design specifications and usability requirements.
The "ground truth" for system validation would be that the system performs as intended and meets its functional requirements in a simulated or controlled environment.
The "ground truth" for device compatibility verification would be the accurate transmission and display of data from connected predicate or representative medical devices.

No clinical "ground truth" (expert consensus, pathology, outcomes data) was used or needed for this 510(k) submission, as stated, "Clinical evidence was not necessary to show substantial equivalence."

8. The Sample Size for the Training Set

This device is not an AI/machine learning device that requires a "training set." Therefore, this information is not applicable and not provided.

9. How the Ground Truth for the Training Set was Established

As the device does not employ a training set (it's not an AI/ML algorithm), this information is not applicable and not provided.

Summary

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DEC 0 4 2013

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.

Covidien

Submitted By:

Date:

Contact Person:

Proprietary Name:

Common Name:

Device Classification Regulation:

Device Product Code & Panel:

Predicate Device:

August 16, 2013

Boulder, CO 80301

6135 Gunbarrel Avenue

Kelsey Lee Senior Regulatory Affairs Specialist (303) 305-2760

Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform

Cardiac Monitor (without alarms)

21 CFR 870.2300 - Class II

MWI. OUG

Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K130796)

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Device Description

This 510k is intended to add new features to the existing Vital Sync IM & VPMP:

Additional User Interface Additional Report Auto device Association Area (zone) Management Optional Off the Shelf Software/server

Indications for Use/Intended Use

The subject Vital Sync™ IM & VPMP has identical indications for use as the predicate Vital Sync™ IM & VPMP.

The Indications for use are as follows:

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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Technological Characteristics Comparison

The subject. Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform and the legally marketed predicate Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform have identical 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 subject device is an iteration of the predicate device in that it has additional features: Addition user interface, additional ventilation report, auto-device association, area (zone) management and optional Off the Shelf software/server.

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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 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 is shown through systems level testing, user interface testing, and system validation. The subject and predicate device have identical indications for use, similar display features and operating environments. The subject and predicate differ in that the subject device has an additional user interface type, auto device association, zone (area) management, an additional ventilation snapshot and optional Off the Shelf software/server. No new questions of safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject device can be considered substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that overlap and intersect.

Public Health Service

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

December 4, 2013

COVIDIEN Kelsey Lee Sr. Regulatory Affairs Specialist 6135 Gunbarrel Ave, Boulder CO 80301

Re: K132604
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, OUG Dated: October 9, 2013 Received: October 10, 2013

Dear Kelsey 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.

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Page 2 - Kelsey Lee

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Owen-Paris-S

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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Indications for Use

510(k) Number (if known): K132604

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.

x AND/OR Over-The-Counter Use 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)

Digitally signed by Owen P.
Date: 2003.12.04 09:18:48
-05'00'

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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).