(499 days)
VitalCom MPC 1100 (K942147)
No
The summary describes a networked monitoring system for vital signs and ventilator data, focusing on hardware connectivity and data transmission. There is no mention of AI, ML, or any algorithms that would suggest learning or intelligent analysis of the data beyond basic monitoring and display.
No.
The device is a monitoring system that collects and displays patient data, not a device that provides treatment or therapy.
No
This device is for monitoring vital signs and patient data from other devices like ECG leads, bedside monitors, and ventilators in a hospital setting. It does not perform diagnostic functions itself but rather collects and displays data.
No
The device description explicitly mentions hardware components like ambulatory ECG transmitters (V-Pak), radio transmitters (V-Link), bedside monitors, ventilators, hardwire paths, RF transmitters, and commercially available interface hardware. The performance studies also include testing for EMI compatibility and susceptibility, which are hardware-related.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The VitalCom Networked Monitoring™ system is described as a system for monitoring patients by receiving data from ECG leads, bedside monitors, and ventilators. It focuses on collecting and displaying physiological data directly from the patient or connected medical equipment.
- Lack of Specimen Analysis: There is no mention of the device analyzing any biological specimens. Its function is to network and display real-time patient data from other monitoring devices.
Therefore, the VitalCom Networked Monitoring™ system falls under the category of patient monitoring devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are:
Monitoring of Recognized Conditions
An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators.
Hospital areas that have the capability of installing hardwire paths to the VitalCom's Central Monitoring Station (VCOM) from the rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or NPB 7200 series ventilators is transferred via an RF transmitter to the Central Monitoring Station (VCOM),
The Target Population
Those patients who are connected through the VitalCom Networked Monitoring™ system via ambulatory ECG transmitters, bedside monitors or NPB 7200 series ventilators.
Important Limitations
Each VitalCom Network Monitoring™ system can monitor up to a maximum of 10 patients per Central Monitoring Station (VCOM) and 200 patients per VitalCom Networked Monitoring™ system.
The VitalCom Central Monitoring Station (VCOM) is to be installed at the point of care locations that have the capability of installing hardwire paths to a VCOM from rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
If employing wide area networking technology, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated telephone lines and commercially available interface hardware.
The VitalCom Networked Monitoring™ system is not for use in the home.
The Central Monitoring Station (VCOM), is only used at the point of care location and is capable of operating independently of any IRVS/RVS connections.
Product codes
74 MSX
Device Description
Not Found
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
adult patient population
Intended User / Care Setting
qualified personnel who are acting on the orders of a physician and trained in the use of the equipment; in which, multiple central stations (VCOM hulss) are commented via a local area network (identical to its predicate system, K942147). The network communication has been expanded to provide the means for clinicians from a supplementary care (primary or tertiary care) hospital to assist the medical staff at the point of care hospital to over read and interpret physiological waveforms and patient data using VitalComs proprietary WAN (wide area network) technology (SiteLink). The VCOM is used only at the noint of care location and is capable of operating independently of any IRVS (interactive remote view station) and RVS (remote view station) connections.
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
The determination of substantial equivalence was based on an assessment of non-clinical performance data. The data includes testing for EMI compatibility and susceptibility, software verification and validation of both the system software performance as well as the operating system software pcrformance, environmental testing and stress testing both at the integration level and the system level. The conclusion drawn from a review of the data indicates that the VitalCom Networked Monitoring™ system, 7200 Ventilator V-I.ink, and Generic V-Link are substantially cquivalent to the predicate devices.
The determination of substantial equivalence was also based on an assessment of clinical performance data, which was provided in summary format for the study conducted between St. Mark's Hospital and Allen Memorial Hospital.
Key Metrics
Not Found
Predicate Device(s)
VitalCom MPC 1100 (K942147)
Reference Device(s)
Spacelabs' PCMS Monitor, Model 90845 (K913038) with Flexport Interface (K903702)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
PREMARKET NOTIFICATION [510(k)] SUMMARY વેલું એ JUNE 20, 1996
| VitalCom Contact Person: | Mr. Ray Pizinger or Ms. Penni Pannell |
|---|---|
| Trade Name: | VCOM Central Monitoring Station |
| V-PAK and V-LINK Transmitters | |
| Arrhythmia and ST Segment | |
| Common Name: | Central Monitoring Station |
| Transmitters and Receivers | |
| Arrhythmia and ST Segment | |
| Classification Name: | Monitors, Electrocardiographic |
| Transmitters and Receivers, Physiological Signal, Radiofrequency | |
| Arrhythmia and ST Segment | |
| Substantially Equivalent to: | VCOM Central Monitoring Station (K942147) |
| V-PAK and V-LINK Transmitters (K942147) | |
| Arrhythmia and ST Segment (K942147) |
Image /page/0/Picture/11 description: The image shows a black and white drawing of a round object. The object has a textured surface with many small dots and specks. The bottom of the object is darker than the top, suggesting a light source from above.
SUMMARY
INTENDED USE
1.1.1. PURPOSE AND FUNCTION OF VERSION 8.0 SOFTWARE RELEASE
The purpose of this premarket notification is to expand the use of this device to also include patient monitoring using the V-Link transmitters connected to ventilators that have digital outputs that conform to either the Digital Communications Interface (DCI of the 7200 series ventilators) or the V-Link Host Protocol. Like the predicate V-Link transmitter, the V-Link with the Host Protocol (Generic V-Link) will also transmit the physiological parameters of the bedside monitors. The predicate device and this expanded intended use (ventilators) will continue to receive, display, monitor, store and distribute patient data and alarms to clinical personnel utilizing VitalCom's LAN technology. Options will still include Arrhythmia detection and alarms, ST Segment and Full Disclosure (history).
As with the predicate device, the physiological parameters, data and alarms are all controlled by the VCOM software. The physiological parameter set defined by the VCOM software has been updated to include the ventilator parameters. As with the predicate device, the distribution of the physiological parameters, data and alarms is controlled by the VCOM software and VitalCom's LAN technology. The V-Link software is also being updated to be capable of transmitting these new ventilator parameters.
Image /page/0/Picture/9 description: The image shows a close-up, black-and-white illustration of a human face. The face is turned slightly to the side, and the features are somewhat distorted or stylized. The image is low resolution, and the details are not very clear.
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1
The typical VCOM monitors up to ten patients using either ambulatory ECG transmitters (V-Pak) or radio transmitters (V-Link) connected to bedside monitors or ventilators. The VitalCom Networked Monitoring™ system may include interactive remote viewing stations (IRVS), and remote viewing stations (RVS) or VCOMs linked using the VitalCom wide area network (WAN) technology (Site-Link). As with the predicate device, multiple central stations (VCOM Hubs) maybe used in the clinical setting and connected via a local area network (LAN).
In summary the new intended use is adding the capability of the VitalCom Networked Monitoring™ system to connect to ventilators and receive, display, monitor, store and distribute patient data and alarms throughout the VCOM network.
1.1.2. INTENDED PATIENT POPULATION
As with the predicate device, the VitalCom Networked Monitoring™ system's ECG and Arrhythmia with ST Segment monitoring capabilities is intended to be used to monitor the adult patient population.
The VitalCom V-Link ventilator connection, is intended to be used to monitor those patients being ventilated by the predicate Puritan-Bennett 7200 series ventilator.
As with the predicate device, the VitalCom Generic V-Link with the Host Protocol is intended to be used to monitor those patients connected to the host device, either bedside monitors or ventilators.
1.1.3. INTENDED ENVIRONMENT OF USE
As with the predicate device, the VitalCom Networked Monitoring™ system and it's associated transmitters are intended to be used in an environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilator.
1.1.4. VERSION 8.0 SOFTWARE RELEASE CLAIMS
- a) As with the predicate device, the VitalCom Networked Monitoring™ system and it's associated transmitters are intended to be used in an environmentally controlled clinical setting that has multiple patients using any combination of ECG leads, bedside monitors, or ventilator.
- b) As with the predicate device, the VitalCom. Networked Monitoring™ system is designed to provide an ongoing, real-time patient monitoring and alarm generation for changes in physiological parameters. When observed on the system or alerted by the system, the clinician can determine whether the event causing the change requires further clinical intervention.
- c) Users of existing VitalCom Networked Monitoring™ systems can option to upgrade their system, to be able to receive, display, monitor, store and distribute patient data and alarms from ventilators.
Image /page/1/Picture/12 description: The image is a blank white square. There are no objects or figures in the image. The image does not contain any text. The image is completely white.
Image /page/1/Picture/13 description: The image shows a close-up of a textured, round object. The object appears to be made of a material with an uneven surface, possibly stone or a similar substance. The texture is characterized by small, irregular bumps and indentations, creating a rough and somewhat grainy appearance. The lighting in the image highlights the texture, casting shadows that accentuate the unevenness of the surface.
2
- d) The Generic V-Link is designed to transmit the VCOM's physiological parameters from other manufacturers devices, whose RS232 digital output has been configured to conform to the V-Link Host Protocol.
- e) VitalCom Networked Monitoring™ systems can be configured to allow multiple VCOM Hubs to share and overview patients' data.
- VitalCom Networked Monitoring™ systems can be configured to serve as the common f) backbone or data repository for physiological information within the VCOM network.
- g) The intended use of the VitalCom wide area network (WAN) connection is to communicate patient data between VitalCom devices utilizing the same Ethernet IEEE 802.3 protocols used in the predicate LAN network. This is intended to provide the means for clinicians from a primary or tertiary care hospital to assist the medical staff at the point of care hospital to over read and interpret physiological waveforms and patient data.
3
COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100
(K942147) | Expanded Features |
|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display | 14" and 17" color analog, RGB high
resolution CRT | 15" and 17" color analog, RGB high
resolution CRT |
| Physical | Mini-tower personal computer 486 or
higher. | Mini-tower personal computer Pentium
or higher. |
| Channels | 8 independent with 2 waveforms per
channel.
(16 for remote displays) | 8 independent with 2 waveforms per
channel.
(16 for remote displays) |
| Network | LAN Connections | LAN and WAN Connections |
| Display Modes | Up to 8 channels full screen; up to 8
channels compressed to top half of screen
with lower half dedicated to detailed
patient view screens or control functions. | Up to 8 channels full screen; up to 8
channels compressed to top half of
screen with lower half dedicated to
detailed patient view screens or control
functions. |
| Waveforms | ECG
Pressure (IBP)
Pleth
CO2
Resp. | ECG
Pressure (IBP)
Pleth
CO2
Resp. |
| Measurement
Options
from
Bedside Monitors
via Hardwire
Connection or
Telemetry (Radio
Link) | Heart Rate
Alarms
Hi - Lo
NIBP
Hi - Lo
Systolic NIBP
Hi - Lo
Mean NIBP
Hi - Lo
Diastolic NIBP
Hi - Lo
NIBP Pulse Rate
Hi - Lo
Systolic IBP
Hi - Lo
Mean IBP
Hi - Lo
Diastolic IBP
Hi - Lo
IBP Pulse Rate
Hi - Lo
SpO2
Hi - Lo
SpO2 Pulse Rate
Hi - Lo
end tidal CO2
Hi - Lo
inspired CO2
Hi - Lo
Respirations
Hi - Lo
Temperatures
Hi - Lo | Heart Rate
Alarms
Hi - Lo
NIBP
Hi - Lo
Systolic NIBP
Hi - Lo
Mean NIBP
Hi - Lo
Diastolic NIBP
Hi - Lo
NIBP Pulse Rate
Hi - Lo
Systolic IBP
Hi - Lo
Mean IBP
Hi - Lo
Diastolic IBP
Hi - Lo
IBP Pulse Rate
Hi - Lo
SpO2
Hi - Lo
SpO2 Pulse Rate
Hi - Lo
end tidal CO2
Hi - Lo
inspired CO2
Hi - Lo
Respirations
Hi - Lo
Temperatures
Hi - Lo |
| Messages | Status Messages | Status Messages |
| System Alarms | Nurse Alarm
Lead Off Alarm
Low Battery | Nurse Alarm
Lead Off Alarm
Low Battery |
9
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行推
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4
COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100
(K942147) | Expanded Features | | | | | | | | | | | | | | | | |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|
| System Alarms | Muscle
No Signal
Wrong ID
Edit | Muscle
No Signal
Wrong ID
Edit
Check Patient | | | | | | | | | | | | | | | | |
| Trends
Recorder
(Optional) | Graphic trends of all parameters.
Dual channel, thermal array. | Graphic trends of all parameters.
Dual channel, thermal array. | | | | | | | | | | | | | | | | |
| Arrhythmia
(Optional) | Red prompt and audible alarm for
asystole, ventricular fibrillation,
ventricular tachycardia. User selectable
response for Ventricular Rhythm, Run
PVC's, Salvo PVC's, Ventricular
Bigeminy, Ventricular Trigeminy,
Couplet, Triplet, Supraventricular
Tachycardia. | Red prompt and audible alarm for
asystole, ventricular fibrillation,
ventricular tachycardia. User selectable
response for Ventricular Rhythm, Run
PVC's, Salvo PVC's, Ventricular
Bigeminy, Ventricular Trigeminy,
Couplet, Triplet, Supraventricular
Tachycardia. | | | | | | | | | | | | | | | | |
| ST Analysis
(Optional) | User selectable ST alarm on ST elevation
or depression. | User selectable ST alarm on ST elevation or depression. | | | | | | | | | | | | | | | | |
| Full Disclosure
(Optional) | All data for 8 patients. | All data for 8 patients. | | | | | | | | | | | | | | | | |
| Hard Wire
(Optional) | Serial Port RS 232
Serial Port RS 422 | Serial Port RS 232
Serial Port RS 422 | | | | | | | | | | | | | | | | |
| Telemetry
(Optional) | FCC approved and digital encoded FM-
FSK technique at 174 - 216 MHz or 902
- 928 MHz frequencies. | FCC approved and digital encoded FM-
FSK technique at 174 - 216 MHz or
902 - 928 MHz or other FCC approved
frequency bands for medical telemetry. | | | | | | | | | | | | | | | | |
| V-Link
Transmitter
(Optional) | FCC approved and digital encoded FM-
FSK technique at 174 - 216 MHz.,
compatible with specific Bedside
Monitors. | FCC approved and digital encoded FM-
FSK technique at 174 - 216 MHz or
other FCC approved frequency bands,
compatible with specific Bedside
Monitors and Ventilators. | | | | | | | | | | | | | | | | |
| Measurement
Options
from
Ventilators
via V-Link
Transmitter | | Ventilator Settings Alarms Tidal Volume Setting Lo Exh. Respiratory Rate Hi Peak Flow --- Mode --- Oxygen % --- Plateau --- Sensitivity --- | | | | | | | | | | | | | | | | |
Image /page/4/Picture/3 description: The image shows a close-up of a circular object with a textured surface. The object appears to be three-dimensional and has a slightly irregular shape. The texture consists of small, closely packed elements, creating a rough or granular appearance. The lighting in the image is uneven, with some areas appearing brighter than others, which accentuates the texture and contours of the object.
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5
COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100
(K942147) | Expanded Features | |
|----------------------------------------------------------------------------|-----------------------------|----------------------------------|---------|
| Measurement
Options
from
Ventilators
via V-Link
Transmitter | | Ventilator Settings
PEEP/CPAP | Lo |
| | | Support Pressure | --- |
| | | Waveform | --- |
| | | Automatic Sigh | --- |
| | | I:E Ratio | Hi |
| | | Minute Volume | Lo Exh. |
| | | Spont. Min. Volume | --- |
| | | Peak Airway Pressure | Hi |
| | | Mean Airway Pressure | --- |
| | | Plateau Pressure | --- |
| | | Inspiratory Pressure | Lo |
| | | Inspiratory Time | --- |
| | | Nebulizer Status | --- |
| | | 100% O2 Suction | --- |
| | | Sigh Volume | --- |
| | | Sigh HP Limit | Hi |
| | | Sigh Rate | --- |
| | | Multiple Sighs | --- |
| | | SPO2 | Hi-Lo |
| | | Pulse Rate | Hi-Lo |
| | | Airway Pressure | Alarm |
| | | Disconnect | --- |
| Status Messages | | Apnea | Alarm |
| | | Alarm Silence | --- |
| | | Exhalation Valve Leak | |
| | | Low Pressure Air Inlet | |
| | | Low Pressure O2 Inlet | |
| | | Safety Valve Open | |
| | | Apnea Ventilation | |
| | | Plateau Time | |
| | | Inhaled Tidal Volume | |
| | | Compliance | |
Image /page/5/Picture/5 description: The image shows a black and white drawing of a circle. The circle is not perfectly round and has some irregularities in its shape. There are some dark spots and shading on the surface of the circle, giving it a textured appearance. The background is white.
11
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(1)
6
TECHNOLOGICAL CHARACTERISTIC REVIEW
The VitalCom Networked Monitoring™ system with the expanded intended use is substantially equivalent to the VitalCom MPC 1100 (K942147) and, for use with ventilators, Spacelabs' PCMS Monitor, Model 90845 (K913038) with Flexport Interface (K903702). The VCOM uses a pentium based personal computer and offers a wireless interface (radio transmitters and receivers). This technology is equivalent to the 486 based pcrsonal computer and arc exactly the same transmitters and receivers contained in the VitalCom MPC 1100 (K942147).
NON-CLINICAL PERFORMANCE DATA REVIEW
I'he determination of substantial equivalence was based on an assessment of non-clinical performance data. The data includes testing for EMI compatibility and susceptibility, software verification and validation of both the system software performance as well as the operating system software pcrformance, environmental testing and stress testing both at the integration level and the system level. The conclusion drawn from a review of the data indicates that the VitalCom Networked Monitoring™ system, 7200 Ventilator V-I.ink, and Generic V-Link are substantially cquivalent to the predicate devices.
CLINICAL PERFORMANCE DATA REVIEW
The determination of substantial equivalence was also based on an assessment of clinical performance data, which was provided in summary format for the study conducted between St. Mark's Hospital and Allen Memorial Hospital.
7
、
Image /page/7/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo is a stylized image of a human figure with outstretched arms, representing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
. . . .
NOV - 6 1997
Mr. Raymond M. Pizinger Vitalcom Inc. 15222 Del Amo Avenue Tustin, California 92680
Re: K962473 VitalCom Networked Monitoring™ System Requlatory Class: III (three) Product Code: 74 MSX Dated: August 15, 1997 Received: August 18, 1997
Dear Mr. Pizinger:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
8
Paqe 2 - Mr. Raymond M. Pizinger
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neuroloqical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
9
K962473 510(k) Number (if known):
VitalCom Networked Monitoring™ System Device Name:
Indications for Use:
The indications for use of the VitalCom Networked Monitoring™ system (VCOM, IRVS/RVS) are:
Monitoring of Recognized Conditions
An environmentally controlled clinical settings that has multiple patients using any combination of ECG leads, bedside monitors or Nellcor Puritan Bennett (NPB) 7200 series ventilators.
Hospital areas that have the capability of installing hardwire paths to the VitalCom's Central Monitoring Station (VCOM) from the rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
Clinical areas that have the capability of installing 174-216 MHz radio systems (or alternate frequency bands approved by the FCC) to communicate via RF. The information from the ECG leads, bedside monitors or NPB 7200 series ventilators is transferred via an RF transmitter to the Central Monitoring Station (VCOM),
The Target Population
Those patients who are connected through the VitalCom Networked Monitoring™ system via ambulatory ECG transmitters, bedside monitors or NPB 7200 series ventilators.
Important Limitations
Each VitalCom Network Monitoring™ system can monitor up to a maximum of 10 patients per Central Monitoring Station (VCOM) and 200 patients per VitalCom Networked Monitoring™ system.
The VitalCom Central Monitoring Station (VCOM) is to be installed at the point of care locations that have the capability of installing hardwire paths to a VCOM from rooms or areas where bedside monitors or NPB 7200 series ventilators operate.
If employing wide area networking technology, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated telephone lines and commercially available interface hardware.
The VitalCom Networked Monitoring™ system is not for use in the home.
The Central Monitoring Station (VCOM), is only used at the point of care location and is capable of operating independently of any IRVS/RVS connections.
- Indicates changes made during the submission review.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Christy Foreman for AAC
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
10
VitalCom ﺮ
Intended Use Summary:
The intended use of VitalComs Networked Monitoring System is monitoring of adult (ambulatory and bedside) patients vital signs including ECG and Archythmia with ST Segment monitoring and Alarms (which is identical to its predicate system, K942147). The intended use of VitalCom Networked Monitoring System has been expanded to monitor those patients being ventilated by the predicate Nellcor Puritan-Bennett 7200 series ventilator or other compatible ventilators, For ventilator patients, the alarms are processed at and by the ventilator unit and the central monitor simply displays the alarms received from the ventilator. The VitalCom Central Monitoring Station (VCOM) is intended to be used with bedside monitors or ventilators, but will only recognize that have been validated by VitalCom as compatible.
The VitalCom Networked Monitoring System is intended to be used within an environmentallycontrolled hospital or clinical sctting by qualified personnel who are acting on the orders of a physician and trained in the use of the equipment; in which, multiple central stations (VCOM hulss) are commented via a local area network (identical to its predicate system, K942147). The network communication has been expanded to provide the means for clinicians from a supplementary care (primary or tertiary care) hospital to assist the medical staff at the point of care hospital to over read and interpret physiological waveforms and patient data using VitalComs proprietary WAN (wide area network) technology (SiteLink). The VCOM is used only at the noint of care location and is capable of operating independently of any IRVS (interactive remote view station) and RVS (remote view station) connections.
If employing SiteLink patient monitoring, the communication between the VCOM, at the point of care location, and the IRVS/RVS, at the supplementary care location, is facilitated by dedicated tclephone lines and interface hardware with an established set of (*) policies and procedures between the two sites.
The primary responsibility for monitoring and care of the patients resides with the point of care facility. As with all monitors, the system cannot replace skilled nursing care and proper surveillance.
The VitalCom Networked Monitoring System is not intended for use in the home.
文章出要要要要要并并
(*) Sitel ink Operations Manual should include but not limited to the following information:
· timely cmergency notification of personnel
- · loss of WAN communications link between two sites (e.g., loss of phone line)
- admitting patients to be monitored
- · temporary removal of patients from monitoring
- · discharging patient from monitoring
- · routine reporting of patient parameters
NOV - 6 1997