(106 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as routing and displaying data without altering it or controlling connected devices.
No.
The device is intended to display and route medical device data and diagnostic information to aid in clinical decisions, but it does not directly provide therapy or alter physiological parameters.
No
The device is a remote monitoring platform that displays physiological data, waveforms, and alarms. It is intended to aid in clinical decisions and patient care by allowing healthcare professionals to remotely consult on a patient's status and review patient data. It does not perform diagnostic functions itself but rather presents data from other devices.
Yes
The device is explicitly described as "software that is intended to route and store medical device data" and "software that routes parameters, waveforms and alarms from connected devices and displays them on any device that is web-enabled." While it can utilize existing hospital hardware or an optional server, the core medical device functionality is presented as software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for routing, storing, and displaying medical device data (physiologic data, waveforms, alarms) from supported devices to aid in clinical decisions and patient care. It does not mention analyzing biological samples or providing diagnostic information based on such analysis.
- Device Description: The description reinforces that the software routes and displays data from connected devices and does not alter the parameters, waveforms, or alarms. It does not describe any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), diagnostic tests, or providing diagnostic results based on laboratory analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device focuses on managing and displaying data from other medical devices that are monitoring the patient directly.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, OUG
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals / hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform (K130796)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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)
1
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
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:
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.
2
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.
3
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.
4
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.
5
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
6
Indications for Use
510(k) Number (if known): K132604
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.
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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