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 Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS).

The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms, alarms and alerts routed through the Vital Sync™ Informatics Manager from supported devices. The Vital Sync™ Virtual Patient Monitoring Platform is intended to be used by healthcare professionals in a hospital or hospital-type facility for the following purposes:

To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management.
To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.
To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.
To set and adjust alert thresholds on supported devices where this capability is not available on the device itself.
To access data, waveforms and alerts from supported devices where these capabilities are not enabled on the device itself.

WARNING: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform are notification systems and are not replacements for direct patient observation, patient assessment or clinical judgment

Device Description

The subject Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform VPMP) is a software only device that provides mobile and centralized remote monitoring. The Vital Sync™ Informatics Manager is intended to route and store medical device data from connected medical devices to the electronic medical record (eMR), clinical information system (CIS) and/or the Virtual Patient Monitoring Platform (VPMP). The Vital Sync™ Virtual Patient Monitoring Platform displays information received from the Informatics Manager on any webenabled device.

The subject Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform routes and displays parameters, waveforms and alarms for the connected medical devices in near-real time. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform allows users to set up a new default alarm priority across device types and allows for institutions to modify alarm priorities per their internal protocols. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform provides for the setting or adjusting of thresholds on supported devices where this capability is not available on the device itself; the platform can also act the primary display for patient data and alerts where this capability is not available of enabled on the device itself. Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform includes Turn Time functionality. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform allows the user the capability, via the software, to perform simple calculations from processed parameters, or from manual input by the user.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform:

Important Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than outright proving performance against specific acceptance criteria for a novel device. As such, direct acceptance criteria and detailed performance metrics are often not explicitly stated in the way a clinical trial report would. Instead, the document emphasizes verification and validation activities showing the new device functions similarly and safely to existing ones.

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, direct, quantifiable acceptance criteria with numerical performance targets are not explicitly stated. The evaluation relies on demonstrating that the new functionalities and the overall system perform as intended and are safe and effective, similar to the predicate devices. The "reported device performance" is described qualitatively through the successful completion of various tests.

Feature / Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Overall Safety & Effectiveness	Device is safe and effective for its intended use, comparable to predicate devices. No new questions of safety and effectiveness are raised.	"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."
Data Routing & Storage	Accurately routes and stores medical device data and diagnostic information to specified destinations (VPMP, 3rd Party Annunciation, eMR, CIS).	"The Vital Sync™ Informatics Manager is intended to route and store medical device data... to the Virtual Patient Monitoring Platform, 3rd Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS)." (Implied successful verification)
Display of Data/Alerts/Alarms	Provides accurate visual and audible renderings of physiological data, waveforms, alarms, and alerts from supported devices.	"The Vital Sync™ Virtual Patient Monitoring Platform (VPMP) is a display system that provides visual and audible renderings of physiologic data, waveforms, alarms and alerts routed through the Vital Sync™ Informatics Manager from supported devices." (Implied successful verification)
Remote Viewing/Review	Facilitates remote viewing and review of patient data, waveforms, alerts, and alarms to assist clinical management.	"To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management." (Implied successful verification)
Threshold Adjustment	Allows users to set and adjust alert thresholds on supported devices where the capability is not native to the device.	"To set and adjust alert thresholds on supported devices where this capability is not available on the device itself." (Implied successful verification)
Communication Network Integrity	Data passes over communication networks with consistency and integrity, addressing network factors like outages and latency.	"Testing was also conducted to ensure data passes over communication networks with consistency and integrity. Network factors such as outages and latency were addressed and/or mitigated through a risk-based approach." (Implied successful mitigation/performance)
UI/Usability	User interface is intuitive and usable for clinicians.	"User interface verification and usability validation." (Implied successful completion)
New Features (e.g., Alarm Norm.)	New features (alarm normalization, threshold settings, turn time, derived parameters, manual data entry, primary display) function as intended and do not raise new safety/effectiveness concerns compared to predicate devices with similar functionalities (K133882).	"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 alarm normalization, threshold settings, turn time, derived parameters, manual data entry, and primary display and substantially equivalent features to the GE Carescape Central Station." (Implied successful verification and validation of these features)

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

Sample Size: This information is not provided in the FDA 510(k) summary. The document mentions "system level verification, user interface verification and usability validation" and "testing was also conducted to ensure data passes over communication networks," but does not specify the number of test cases, data points, or user participants for these activities.
Data Provenance: This information is not provided. The document does not indicate the country of origin of the data or whether the data used in testing was retrospective or prospective. Given the nature of a software-only device routing data, simulated test data or internally generated data for verification and validation are common, but specifics are absent.

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

This information is not provided. The document details "user interface verification and usability validation," which would typically involve end-users, but does not specify the number or qualifications of these users, nor explicitly state their role in establishing a "ground truth" for a test set. This type of information is usually part of detailed validation protocols, not typically summarized in a 510(k).

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of system and usability testing for a data routing and display platform, formal adjudication methods like 2+1 or 3+1 consensus are less likely to be applicable compared to, for instance, a diagnostic AI device. The "verification and validation" would likely involve checking expected outputs against actual outputs, and usability findings based on user feedback.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "N/A - Clinical evidence was not necessary to show substantial equivalence." This type of study is more common for diagnostic devices where human readers interpret images or data with and without AI assistance. This device is a data management and display platform.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device itself, being software for routing and displaying data, operates primarily in a "standalone" or "algorithm only" fashion in its core function of data management. However, its purpose is to present data to a human-in-the-loop (clinician). The verification activities likely focused on the accuracy of this data routing, processing, and display as an "algorithm only" system. The subsequent usability validation assesses the human interaction. The document doesn't explicitly delineate "standalone performance" in the context of a diagnostic algorithm's performance metric, but the core functionalities (routing, storing, displaying, calculating parameters) would have been tested in an automated fashion before human interaction.

7. The Type of Ground Truth Used:

For the technical verification of this device (data routing, display accuracy, alarm handling), the "ground truth" would likely be derived from:
- Expected System Behavior/Specifications: The system's output (routed data, displayed waveforms, triggered alarms) is compared against pre-defined engineering and software requirements and technical specifications.
- Reference Data/Simulated Data: Known input data (e.g., simulated patient physiological data, device diagnostic messages) would be fed into the system, and its output would be checked against the expected output based on the input.
- Predicate Device Behavior: Some aspects might involve comparing the behavior or output of the new device to that of the predicate devices under similar conditions, to confirm "substantial equivalence."
For usability validation, the "ground truth" would be established through user feedback, observations, and adherence to usability standards (e.g., IEC 62366-1).

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is described as a data routing, storage, and display system. It does not appear to involve machine learning or artificial intelligence in a way that requires a "training set" for model development. The software performs defined functions based on established rules and programming, not learned patterns.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no mention of a training set for machine learning.

Summary

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

November 14, 2016

Covidien Timothy Holwick Sr. Regulatory Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K160718

Trade/Device Name: Vital Sync Informatics Manager & Virtual Patient Monitoring Platform Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, CBK, DQA, BZQ, CCK, MNR, MUD, OLW, OLT, OMC, ORT, DPS, DSI Dated: October 21, 2016 Received: October 20, 2016

Dear Timothy Holwick:

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Mude Jellman
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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Indications for Use

510(k) Number (if known)

K160718

Device Name

Vital Sync™ Virtual Patient Monitoring Platform & Informatics Manager

Indications for Use (Describe)

To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management.
To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.
To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.
To set and adjust alert thresholds on supported devices where this capability is not available on the device itself.
To access data, waveforms and alerts from supported devices where these capabilities are not enabled on the device itself.

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)

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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™ Virtual Patient Monitoring Platform & Informatics Manager

Submitted By:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	November 14, 2016
Contact Person:	Timothy HolwickSr. Regulatory Specialist(303) 305-2345
Proprietary Name:	Vital Sync™ Virtual Patient MonitoringPlatform & Informatics Manager
Common Name:	Central Monitor
Device Classification Regulation:	21 CFR 870.2910
Device Primary Product Code:	DRG
Device Secondary Product Codes :	CBK, DQA, BZQ, CCK, MNR, MUD, OLW, OLT, OMC, ORT, DPS, and DSI.
Primary Predicate Device:	Vital Sync™ Informatics Manager & VirtualPatient Monitoring Platform (K140339)
Secondary Predicate Device:	GE Carescape Central Station (K133882)

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Device Description

Indications for Use/Intended Use

The subject Vital Sync™ IM & VPMP has similar indications for use as the predicate Vital Sync™ IM & VPMP and the GE Carescape Central Station.

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 Virtual Patient Monitoring Platform, 3td Party Annunciation Systems, Electronic Medical Record (eMR) and Clinical Information System (CIS).

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To remotely view and review patient data, waveforms, alerts and alarm information from supported devices and clinical information systems to facilitate clinical management.
To facilitate remote collaboration with other healthcare professionals regarding patient data from supported devices.
To access additional processed parameters to facilitate patient monitoring, assessment and clinical management.
To set and adjust alert thresholds on supported devices where this capability is not available on the device itself.
To access data, waveforms and alerts from supported devices where these capabilities are not enabled or available on the device itself.

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 alarm normalization, threshold settings, turn time, derived parameters, manual data entry, and primary display and substantially equivalent features to the GE Carescape Central Station.

Device characteristics	K160718	K140339	K133882
Classification	DRG 870.2910	MWI 870.2300	DXJ 870.2450
Secondary productcodes	CBK, DQA, BZQ,CCK, MNR, MUD,OLW, OLT, OMC,ORT, DPS, and DSI	-	DXJ, CBQ, CBS,CCK, CBR, BZQ,CCL, NHQ, NHP,DSK, CCI, DSB,FLL, GWQ, DPT,DXN, BSE, NHO,DOA, JEG
Mobile Monitoring	Yes	Yes	No
Patient Reports	Yes	Yes	Yes
Zone Support	Yes	Yes	Yes
Alarm Delays	Yes	Yes	Yes
Intended Users	Clinicians	Clinicians	Clinicians
Alarm Display	Yes	Yes	Yes

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K160718 Page 4 of 5

Waveform Display	Yes	Yes	Yes
Manual Data Entry	Yes	No	Yes
Derived parameters	Yes	No	Yes
Ability to set alertthresholds	Yes	No	Yes
eMR connectivity	Yes	Yes	Yes
Primary alerts for lowacuity devices	Yes	No	Yes
Alarm Normalization	Yes	No	Yes
Turn Timer	Yes	No	No

Substantial Equivalence - Non-Clinical Evidence

Safety, efficacy and substantial equivalence was shown through system level verification, user interface verification and usability validation. Testing was also conducted to ensure data passes over communication networks with consistency and integrity. Network factors such as outages and latency were addressed and/or mitigated through a risk-based approach. 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 alarm normalization, threshold settings, turn time, derived parameters, manual data entry, and primary display and substantially equivalent features to the Ge Carescape Central Station.

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.

The term "equivalence" as used in this document is limited to the definition found in the Federal Food, Drug, and Cosmetic Act, 21 CFR 807, Subpart E, and relates only to whether the proposed device may be marketed without prior reclassification or clinical approval. This submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement law suit or any other patent matters.

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K160718
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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).