VECTRAPLEX CMS

{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. 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 the STAFF EMATL ADDRESS BELLOW." time to review instructions, search existing data sources, asthon aver respon time to review instructions, search existing data sources, gather and maintain the ata neded and can and review instructions, search existing data sources, gather and maintai and review the rollection. Send comments regarding the data needed and complete of this 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." 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 - 1. Submitters Name, Address: Brad S. Schreck 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 - 2. 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 - 3. Predicate Device Identification - Datex-Ohmeda S/5 Network and Central '02 – 510(k) K022507 - Mindray North America DPM Central Station – 510(k) K080192 {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. - 5. 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 - 6. 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<br>Network and Central '02 | Mindray North America<br>DPM Central Station | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Computer<br>Based System | Yes | Yes | Yes | | Display<br>Configuration | LCD Display | LCD Display | LCD display | | Bi-directional<br>Communication | Yes | No | Yes | | Single Monitor<br>Functionality | Yes | Yes | Yes | | Dual Monitor<br>Functionality | Yes | Yes | Yes | | Analysis<br>Program on<br>Central Monitor | No. However, if<br>monitoring the<br>VectraplexECG<br>System (which does<br>analyses), and<br>because the<br>Vectraplex CMS<br>duplicates the<br>screen of that<br>system, the CMS will<br>display the analysis | Yes it has an analysis<br>program | No. Requires a separate<br>analysis program. | | Transmit Data | LAN/WLAN | LAN/WLAN | PDS Gateway & HL7 | | Connection<br>Protocol | TCP/IP | TCP/IP | TCP/IP | | Stores Data | No | Yes | No | | Environmental<br>Conditions | Operating<br>Temperature: 0°C -<br>35°C<br>Non-Operating: -40°C<br>- 65°C<br>Relative humidity<br>Operating:<br>20 R.H. to 80 R.H.<br>Storage:<br>20 R.H. to 95 R.H. | Operating Temperature:<br>10°C - 35°C (50°F-95°F)<br>Non-Operating:<br>10°C - 50°C (14°F-<br>122°F) | Operating temperature<br>0°C to +45°C<br>Non-operating<br>temperature<br>-20°C to +65°C<br>Operating humidity 10%<br>to 95% (non-condensing)<br>Non-Operating humidity<br>5% to 95% | | Power source | 100-240 VAC<br>50/60 Hz, AC adapter<br>(external) | 100 - 240 V AC,<br>50/60 Hz, AC adapter<br>(external) | 100-240 VAC<br>50/60 Hz, AC adapter (external) | | Near Real Time | Yes | Not mentioned | Yes | | Remote Alarms | Yes | Yes | Yes | | Remote<br>Silencing | Yes | Yes | Yes (bedside device<br>silences the central<br>monitor) | | Displays ECG<br>Waveforms | Yes (3-4 leads<br>minimum with<br>remaining leads<br>viewable with scroll<br>feature) | Yes (1-2 leads) | Yes (up to 4 leads) | | Number of<br>Devices<br>Displayed on<br>Central<br>Monitor | Up to 16 | Up to 32 | Up to 32 | | Extra Display<br>Features | CEB, HR, up to 15<br>leads for rhythm<br>monitoring, can<br>display 15 lead ECG<br>report, CEB graph,<br>Voltage Time Data,<br>Vector Loops,<br>CEB/ECG/ Rhythm<br>Reports | 4 numerics | HR, SpO2, Pulse Rate, ST<br>Segment Analysis,<br>Arrhythmia detection | | Use<br>Environment: | Similar<br>Not intended for<br>home use | Similar<br>Does not give info on<br>Doctor Offices | Similar<br>Not intended for home<br>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.