(244 days)
Not Found
No
The document describes a system for routing, storing, and displaying medical device data, alarms, and alerts. It focuses on data management, visualization, and basic calculations, with no mention of AI or ML algorithms for data analysis, prediction, or interpretation.
No
The device is described as a software system for routing, storing, managing, and displaying medical device data, waveforms, and alarms, aimed at facilitating remote viewing and collaboration for patient monitoring. It explicitly states it is a "notification system" and "not replacements for direct patient observation, patient assessment or clinical judgment," which indicates it does not directly treat or diagnose conditions.
No
The device is a notification and display system for medical device data. It facilitates remote viewing of patient data, waveforms, alerts, and alarms from supported devices, but it does not perform diagnostic functions itself. It explicitly states it is "not replacements for direct patient observation, patient assessment or clinical judgment."
Yes
The device description explicitly states, "The subject Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform VPMP) is a software only device".
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform is described as software that routes, stores, and displays medical device data and device diagnostic information. It provides visual and audible renderings of physiologic data, waveforms, alarms, and alerts from supported devices.
- Intended Use: The intended use is to remotely view and review patient data from supported devices, facilitate remote collaboration, access processed parameters, and set/adjust alert thresholds on devices.
- No mention of biological samples: There is no mention of the device analyzing or processing any biological samples from the patient. Its function is centered around managing and displaying data generated by other medical devices that are directly connected to the patient.
Therefore, the Vital Sync™ Informatics Manager & Virtual Patient Monitoring Platform falls under the category of medical device data management and display systems, not in vitro diagnostics.
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 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
Product codes (comma separated list FDA assigned to the subject device)
DRG, CBK, DQA, BZQ, CCK, MNR, MUD, OLW, OLT, OMC, ORT, DPS, DSI
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.
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 in a hospital or hospital-type facility
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. 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.
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
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
1
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
2
Indications for Use
510(k) Number (if known)
K160718
Device Name
Vital Sync™ Virtual Patient Monitoring Platform & Informatics Manager
Indications for Use (Describe)
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
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the Covidien logo. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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: | Covidien
6135 Gunbarrel Avenue
Boulder, CO 80301 |
|-----------------------------------|------------------------------------------------------------------------------------|
| Date: | November 14, 2016 |
| Contact Person: | Timothy Holwick
Sr. Regulatory Specialist
(303) 305-2345 |
| Proprietary Name: | Vital Sync™ Virtual Patient Monitoring
Platform & 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 & Virtual
Patient Monitoring Platform (K140339) |
| Secondary Predicate Device: | GE Carescape Central Station (K133882) |
4
K160718 Page 2 of 5
Image /page/4/Picture/1 description: The image shows the logo for Covidien. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
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.
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).
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 hospitaltype facility for the following purposes:
5
Image /page/5/Picture/0 description: The image shows the Covidien logo. The logo consists of a blue square with a white cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, and the colors are clean and professional.
-
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.
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.
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 product | |||
| codes | 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 |
6
Image /page/6/Picture/0 description: The image contains the logo for Covidien. The logo consists of a blue square with a light blue cross in the center, followed by the word "COVIDIEN" in blue, sans-serif font. The logo is simple and modern, with a focus on the company name.
K160718 Page 4 of 5
| Waveform Display | Yes | Yes | Yes |
|---|---|---|---|
| Manual Data Entry | Yes | No | Yes |
| Derived parameters | Yes | No | Yes |
| Ability to set alert | |||
| thresholds | Yes | No | Yes |
| eMR connectivity | Yes | Yes | Yes |
| Primary alerts for low | |||
| acuity 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.
7
K160718
Page 5 of 5
Image /page/7/Picture/1 description: The image shows the Covidien logo. The logo consists of a blue square with a lighter blue cross in the center, followed by the word "COVIDIEN" in blue sans-serif font. The logo is simple and modern, and the colors are clean and professional.