(59 days)
Not Found
No
The document describes software for routing and displaying medical device data and alarms. While it mentions "smart alarms," there is no indication or description of AI/ML being used to generate or process these alarms. The document explicitly states it does not alter parameters, waveforms, or alarms and does not control connected devices. There is no mention of AI, ML, or related concepts like training or test sets.
No
The device is a software platform intended for managing and displaying patient data, waveforms, and alarms to aid clinical decisions, not for directly treating or diagnosing physiological conditions.
No
The device is described as software that routes and stores medical device data and displays physiologic data, waveforms, and alarms. Its purpose is to aid in clinical decisions and deliver patient care by allowing healthcare professionals to remotely consult and review patient status. It does not perform diagnostic functions itself but rather presents data from other devices.
No
The device description explicitly states that an "optional server pre-loaded with the Vital Sync software and off the shelf operating system can be provided," indicating that hardware can be included as part of the device offering.
Based on the provided text, 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 and storing medical device data and displaying physiologic data, waveforms, and alarms for remote monitoring and clinical decision support. This involves processing data from medical devices that are monitoring the patient directly.
- Device Description: The description reinforces that the software routes and displays data from connected devices and does not alter the data or control the devices.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health status. The provided text does not mention any interaction with patient specimens or in vitro analysis.
The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is a medical device software that facilitates the management and display of patient data acquired from other medical devices. It does not perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes
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.
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.
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 setting
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only
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
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: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date: | April 10, 2014 |
| Contact Person: | Brianna Reynolds
Regulatory Affairs Specialist
(303) 305-2727 |
| Proprietary Name: | Vital Sync™ Informatics Manager & Virtual
Patient 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 & Virtual
Patient Monitoring Platform (K132604)
Cardiopulmonary Corp's Bernoulli
Management System (K091461) |
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
1
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).
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.
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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.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
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
5
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
Image /page/5/Picture/6 description: The image shows a logo with the letters FDA. The letters are stylized and have a geometric design. There are lines drawn through the logo, which may indicate that it is being crossed out or invalidated. The logo is black and white.
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:
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.
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)
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