(302 days)
Not Found
No
The description focuses on network communication and remote display/control of existing monitoring systems, with no mention of AI/ML algorithms for data analysis or interpretation.
No
The device is a central monitoring system for displaying and processing information from other medical devices; it does not directly provide therapy.
No
The Vectraplex CMS is a central monitoring system intended to transfer and process information from VectraplexECG Systems. While it can alarm if certain cardiac markers reach an alarm condition, its primary function is data management and display, not to independently diagnose a condition. It facilitates monitoring, but the diagnostic interpretation would come from the qualified medical professionals using the data from the VectraplexECG systems, not the CMS itself.
Yes
The device description explicitly states that the Vectraplex CMS is a "program" consisting of three software agents (Monitor Agent, Device Agent, and Proxy Agent) that facilitate communication and display of information from other medical devices (VectraplexECG Systems). It does not describe any hardware components that are part of the Vectraplex CMS itself, only the systems it interacts with.
Based on the provided information, the Vectraplex® CMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Vectraplex CMS Function: The Vectraplex CMS is a central monitoring system that transfers and processes information from other networked devices (specifically VectraplexECG Systems). It displays, manages, and alarms based on data already acquired by the ECG systems. It does not directly examine specimens from the human body.
- Intended Use: The intended use clearly states it's for "transferring information between networked devices," "remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems," and "centralized monitoring of patients through a network." These activities are related to data management and display, not in vitro examination of specimens.
- Device Description: The device description details software programs that facilitate communication and display of data from other devices. There is no mention of handling or analyzing biological specimens.
In summary, the Vectraplex CMS acts as a data hub and display system for information generated by other medical devices (VectraplexECG Systems). It does not perform any in vitro diagnostic tests itself.
N/A
Intended Use / Indications for Use
• Vectraplex® CMS in a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices
• The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control
• The device is intended to be used by qualified medical professionals
• The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition.
• The Vectraplex CMS' intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider.
• The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor's offices, and urgent care facilities.
• Not for home use
Product codes (comma separated list FDA assigned to the subject device)
MSX, MLD, MHX
Device Description
The Vectraplex CMS is a program that can allow a central monitoring system to view multiple VectraplexECG Systems through either an intranet or internet connection. There are three programs to the central monitoring system: the Monitor Agent, the Device Agent, and the Proxy Agent. The programs require Java version 1.7 or higher prior to installation. The Monitor Agent will remotely display and control another device's screen. The Device Agent (installed on the bedside monitoring device) will allow the Monitor Agent (remote central monitoring system) to access the Device Agent's system and control it on demand. The Proxy Agent is a "behind the scenes" program installed on a computer or server, running Windows 7 operating system, which integrates multiple systems (central monitoring system, bedside monitors) and allows them to communicate. The Monitor and Device Agents connect through the use of the Proxy Agent by utilizing a singular IP address, either through the internet or the intranet. Due to the separation of the Proxy Agent from the other systems, communication may occur over both intranet as well as internet connections.
The maximum capacity of the Vectraplex CMS is a total of 16 devices. Each Proxy Agent can withstand a maximum load of 16 devices displayed on 3 different monitors. These 3 monitors are duplicates of the same 16 devices.
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
qualified medical professionals / hospitals, Emergency Departments and Surgical Centers, doctor's offices, and urgent care facilities. Not for home use.
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
The maximum load test was done using 16 devices and 3 monitors over a single proxy agent.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification, validation and testing procedures were performed to assure that the new device works as was designed. Regression testing and latency supported the proposed label. The Vectraplex CMS is designed to meet the design specifications and was validated using multiple monitoring devices.
VectraCor has performed usability testing outlined in the Vectraplex CMS Usability Test Plan document. All performed testing was successful with no critical errors to report.
The maximum load test was done using 16 devices and 3 monitors over a single proxy agent. The average latency for this maximum load test was between 6 and 7 seconds.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The average latency for this maximum load test was between 6 and 7 seconds.
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 an abstract symbol featuring three stylized human profiles facing to the right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 30, 2015
VectraCor, Inc. A.J. Schreck Quality/Regulatory Manager 785 Totowa Road, Suite 100 Totowa, NJ 07512
Re: K140852
Trade/Device Name: Vectraplex CMS Regulation Number: 21 CFR 870.2300 Regulation Name: System, Network and Communication, Physiological Monitors Regulatory Class: Class II Product Code: MSX, MLD, MHX Dated: January 21, 2015 Received: January 23, 2015
Dear Mr. Schreck:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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 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/Resourcesfor You/Industry/default.htm. 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 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,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Division Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140852
Device Name Vectraplex CMS
Indications for Use (Describe)
• Vectraplex® CMS in a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices
· The Central Monitoring System can's wires or writer of whites devices
of information from VectrapiexECG Sustam including smanagement, printing, viewing or otherwise process of information from VectraplexECG Systems including remote control
· The device is intended to be used by qualified medical professionals
• The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac
Electrical Biomarker, reacles an alarn condition Electrical Biomarker, reaches an alarm condition.
· The Vectraplex CMS' intended use population consists of those patients with certain medical conditions in whom
continuous cardiac monitoring is considerad to be a medical needical conditions in whom
• The Vectraplex CMS is intended to be a medical necessity in the judgment of the orde · The Vectraplex CMS is intended for centalized monitoring of patients of the ordering healthcare pro-· Departments and Surgical Centers, doctor's offices, and urgent care facilities.
· Not for home use
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated the STAFF EMATL ADDRESS BELLOW."
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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740 E
3
510(k) Summary ഗ്
510(k) Summary
As required per 807.92(c)
510(k) Notification
VectraCor's Vectraplex CMS
-
- Submitters Name, Address:
Brad S. Schreck
- Submitters Name, Address:
VectraCor, Inc.
785 Totowa Road
Suite 100
Totowa NJ, 07512
Phone: 973-904-0444
Email: bschreck@vectracor.com
Official Correspondent: Brad Schreck, President
Contact Person for this Submission: Brad Schreck
Date submission was prepared: April 1, 2014
-
- Trade Name, Common Name, and Classification Name:
- Vectraplex CMS Trade Name:
- Classification Name, Product Code, Classification and Regulation Number
Monitor, ST Segment with Alarm MLD Class II 870.1025 System, Network and Communication, Physiological Monitors MSX Class II 870.2300
- Monitor, Physiological, Patient (with arrhythmia detection or alarms) MHX Class II 870.1025
4
4. Device Description
The Vectraplex CMS is a program that can allow a central monitoring system to view multiple VectraplexECG Systems through either an intranet or internet connection. There are three programs to the central monitoring system: the Monitor Agent, the Device Agent, and the Proxy Agent. The programs require Java version 1.7 or higher prior to installation. The Monitor Agent will remotely display and control another device's screen. The Device Agent (installed on the bedside monitoring device) will allow the Monitor Agent (remote central monitoring system) to access the Device Agent's system and control it on demand. The Proxy Agent is a "behind the scenes" program installed on a computer or server, running Windows 7 operating system, which integrates multiple systems (central monitoring system, bedside monitors) and allows them to communicate. The Monitor and Device Agents connect through the use of the Proxy Agent by utilizing a singular IP address, either through the internet or the intranet. Due to the separation of the Proxy Agent from the other systems, communication may occur over both intranet as well as internet connections.
The maximum capacity of the Vectraplex CMS is a total of 16 devices. Each Proxy Agent can withstand a maximum load of 16 devices displayed on 3 different monitors. These 3 monitors are duplicates of the same 16 devices.
-
- Indications for Use:
- . Vectraplex® CMS is a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices
- The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control
- The device is intended to be used by qualified medical professionals
- The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition.
- The Vectraplex CMS' intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider.
- The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor's offices, and urgent care facilities.
- Not for home use
-
- Comparison to Predicate Device:
The Vectraplex CMS is similar to the predicate devices:
- Datex-Ohmeda S/5 Network and Central '02 – 510(k) K022507
- Mindray North America DPM Central Station– 510(k) K080192
5
Comparison Between the Vectraplex CMS, the Mindray North America DPM Central Station, and Datex-Ohmeda S/5 Network and Central '02
| Parameter | Vectraplex CMS | Datex-Ohmeda S/5
Network and Central '02 | Mindray North America
DPM Central Station |
|------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer
Based System | Yes | Yes | Yes |
| Display
Configuration | LCD Display | LCD Display | LCD display |
| Bi-directional
Communication | Yes | No | Yes |
| Single Monitor
Functionality | Yes | Yes | Yes |
| Dual Monitor
Functionality | Yes | Yes | Yes |
| Analysis
Program on
Central Monitor | No. However, if
monitoring the
VectraplexECG
System (which does
analyses), and
because the
Vectraplex CMS
duplicates the
screen of that
system, the CMS will
display the analysis | Yes it has an analysis
program | No. Requires a separate
analysis program. |
| Transmit Data | LAN/WLAN | LAN/WLAN | PDS Gateway & HL7 |
| Connection
Protocol | TCP/IP | TCP/IP | TCP/IP |
| Stores Data | No | Yes | No |
| Environmental
Conditions | Operating
Temperature: 0°C -
35°C
Non-Operating: -40°C
- 65°C
Relative humidity
Operating:
20 R.H. to 80 R.H.
Storage:
20 R.H. to 95 R.H. | Operating Temperature:
10°C - 35°C (50°F-95°F)
Non-Operating:
10°C - 50°C (14°F-
122°F) | Operating temperature
0°C to +45°C
Non-operating
temperature
-20°C to +65°C
Operating humidity 10%
to 95% (non-condensing)
Non-Operating humidity
5% to 95% |
| Power source | 100-240 VAC
50/60 Hz, AC adapter
(external) | 100 - 240 V AC,
50/60 Hz, AC adapter
(external) | 100-240 VAC
50/60 Hz, AC adapter (external) |
| Near Real Time | Yes | Not mentioned | Yes |
| Remote Alarms | Yes | Yes | Yes |
| Remote
Silencing | Yes | Yes | Yes (bedside device
silences the central
monitor) |
| Displays ECG
Waveforms | Yes (3-4 leads
minimum with
remaining leads
viewable with scroll
feature) | Yes (1-2 leads) | Yes (up to 4 leads) |
| Number of
Devices
Displayed on
Central
Monitor | Up to 16 | Up to 32 | Up to 32 |
| Extra Display
Features | CEB, HR, up to 15
leads for rhythm
monitoring, can
display 15 lead ECG
report, CEB graph,
Voltage Time Data,
Vector Loops,
CEB/ECG/ Rhythm
Reports | 4 numerics | HR, SpO2, Pulse Rate, ST
Segment Analysis,
Arrhythmia detection |
| Use
Environment: | Similar
Not intended for
home use | Similar
Does not give info on
Doctor Offices | Similar
Not intended for home
use |
6
7. Testing and Conclusions:
Verification, validation and testing procedures were performed to assure that the new device works as was designed. Regression testing and latency supported the proposed label. The Vectraplex CMS is designed to meet the design specifications and was validated using multiple monitoring devices.
VectraCor has performed usability testing outlined in the Vectraplex CMS Usability Test Plan document. All performed testing was successful with no critical errors to report.
The maximum load test was done using 16 devices and 3 monitors over a single proxy agent. The average latency for this maximum load test was between 6 and 7 seconds.
VectraCor has determined, based on the performance testing, that the Vectraplex CMS conforms to the design specifications and is substantially equivalent to the predicate devices. The device, as designed, is as safe and effective as the predicate devices.