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 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.

AI/ML Overview

The provided 510(k) summary for the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K130796) does not describe specific acceptance criteria or a detailed study of device performance with reported metrics.

Here's a breakdown of the information available based on your request:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics (e.g., accuracy, sensitivity, specificity). The document refers to "system level verification, user interface verification, system validation, and device compatibility verification" as methods to show safety, efficacy, and substantial equivalence. These are broad categories of testing, not specific performance criteria.
Reported Device Performance: No quantitative performance metrics are reported. The document states that "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." This is a qualitative conclusion rather than a presentation of data against specific criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified. The document indicates "Non-Clinical Evidence" and states "N/A - Clinical evidence was not necessary to show substantial equivalence." This implies no patient data (clinical data) was used in the evaluation for substantial equivalence, focusing instead on system and usability testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts & Qualifications: Not applicable. Since no clinical data or ground truth related to patient conditions was used, no experts were needed for this purpose. The device routes and displays data, it doesn't interpret or diagnose. "Summative usability testing" was mentioned, which would involve users, but details on their number or specific qualifications (beyond "healthcare professionals" as indicated in the Indications for Use) are not provided.

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

Adjudication Method: Not applicable, as there's no mention of a ground truth established by experts for a test set.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a data routing and display platform, not an AI-powered diagnostic tool that assists human readers. No AI components are mentioned.

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

Standalone Performance: Not applicable. This device is an "Informatics Manager & Virtual Patient Monitoring Platform" intended for "healthcare professionals" to remotely consult and review data. Its primary function is to route and display, explicitly stating it "does not alter the parameters, waveforms and alarms displayed and does not control any of the medical devices connected." It's an information display system for human use, not an automated algorithm for interpretation.

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

Type of Ground Truth: Not applicable regarding patient conditions or diagnoses. The "ground truth" for this type of device would relate to the accuracy of data transmission, display fidelity, and system functionality. This would be established through engineering verification and validation (e.g., comparing displayed data to source data, ensuring alarms are routed correctly).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device does not appear to employ machine learning or AI that would require a training set.

9. How the ground truth for the training set was established

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

In summary, the 510(k) submission for K130796 emphasizes substantial equivalence to a predicate device based on non-clinical testing (system verification, user interface verification, system validation, and device compatibility verification). It does not present detailed quantitative performance metrics, clinical study data, or information regarding AI/ML-driven performance evaluation.

Summary

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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:	Covidien6135 Gunbarrel AvenueBoulder, CO 80301
Date:	May 10, 2013
Contact Person:	Kelsey LeeSenior Regulatory Affairs Specialist(303) 305-2760
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
Predicate Device:	Airstrip Technology's Remote PatientMonitoring (RPM) Data Viewing Software(K122133)

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K130796

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Device Description

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:

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.

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

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 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

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).