(499 days)
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.
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).
The provided text describes a premarket notification for the VitalCom Networked Monitoring System, focusing on its expansion to include patient monitoring using ventilators. The document primarily discusses substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the typical format for performance studies.
Based on the provided text, a comprehensive table of acceptance criteria and reported device performance, as well as detailed information on sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for both test and training sets, cannot be fully extracted and thus can only be partially addressed or inferred.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" with corresponding "reported device performance." Instead, it focuses on demonstrating "substantial equivalence" to predicate devices, particularly the VitalCom MPC 1100 (K942147). The "Expanded Features" column in the "Comparison Matrix" can be interpreted as the target performance/capabilities for the new device, which are largely equivalent to, or an enhancement of, the predicate device.
| Characteristic | Acceptance Criteria (Inferred from "Expanded Features") | Reported Device Performance (Inferred from "Non-Clinical & Clinical Performance Data Review") |
|---|---|---|
| General Monitoring Capabilities | Receive, display, monitor, store, and distribute patient data and alarms. | Achieved substantial equivalence to predicate device in these functions. |
| Ventilator Integration | Connect to ventilators (Puritan-Bennett 7200 series) and receive, display, monitor, store, and distribute patient data and alarms. | Achieved substantial equivalence; ventilator parameters are included. |
| Physiological Parameters (Ventilator Specific) | Ventilator Settings, Tidal Volume, Respiratory Rate, Peak Flow, Mode, Oxygen %, PEEP/CPAP, etc. (as listed in comparison matrix). | System updated to include these parameters. Achieved substantial equivalence with predicate in monitoring these. |
| Alarms (Ventilator Specific) | Ventilator-generated alarms (e.g., Hi/Lo Tidal Volume, Respiratory Rate, Airway Pressure, Apnea, Disconnect). | System processes and displays alarms received from the ventilator. Achieved substantial equivalence. |
| Networking | LAN and WAN (Site-Link) connections for sharing and viewing patient data. | Achieved substantial equivalence; WAN capabilities added and validated. |
| Electromagnetic Compatibility (EMI/EMC) | Compliance with EMI compatibility and susceptibility standards. | Testing showed compliance. |
| Software Performance | Verification and validation of system and operating system software performance. | Testing showed compliance. |
| Environmental & Stress Testing | Performance under specified environmental conditions and stress levels. | Testing showed compliance at integration and system levels. |
| Clinical Equivalence | Demonstrated clinical performance comparable to predicate devices. | Study conducted, finding substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions a "study conducted between St. Mark's Hospital and Allen Memorial Hospital" for clinical performance data. However, it does not specify the sample size (number of patients or data points) used in this clinical study.
- Data Provenance: The clinical data was "provided in summary format for the study conducted between St. Mark's Hospital and Allen Memorial Hospital."
- Country of Origin: The hospitals mentioned (St. Mark's Hospital and Allen Memorial Hospital) are typically associated with the United States.
- Retrospective or Prospective: The document does not explicitly state whether the study was retrospective or prospective. Given the context of expanding intended use and conducting a study for substantial equivalence, it could be either, but prospective collection for new features is more common.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide any information regarding the number of experts, their qualifications, or how ground truth was established for the clinical performance data.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This document describes a device that is a central monitoring station, transmitters, and arrhythmia/ST segment analysis, with expanded capabilities to integrate with ventilators. It is a system for monitoring and displaying physiological data and alarms. The document does not mention any AI assistance or a MRMC comparative effectiveness study involving human readers. Therefore, there is no information about effect size of human reader improvement with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The "Non-Clinical Performance Data Review" section mentions "software verification and validation of both the system software performance as well as the operating system software performance." This generally refers to standalone algorithm testing to ensure it functions as designed. The device's primary function includes automated detection and alarm generation. This can be interpreted as standalone performance for the specific algorithms within the system (e.g., arrhythmia detection, ST segment analysis, and processing of ventilator alarms).
7. The Type of Ground Truth Used
For the technical aspects (EMI, software validation, environmental), the ground truth would be established by engineering specifications, industry standards, and validated testing protocols.
For the clinical performance, the document does not explicitly state the type of ground truth used. Given it's a monitoring system, it typically involves:
- Comparison to existing, validated monitoring devices (predicate devices) for accuracy of physiological parameter display and alarm generation.
- Clinical observation and expert interpretation of patient conditions when correlating with device outputs.
8. The Sample Size for the Training Set
The document does not mention a training set or its sample size. This is likely because the device is not presented as an AI/machine learning product that requires distinct training and test sets in the modern sense. It appears to be an upgrade to an existing system, where performance is validated against established medical device standards and predicate device equivalency.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), this information is not applicable or provided.
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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 StationV-PAK and V-LINK TransmittersArrhythmia and ST Segment |
| Common Name: | Central Monitoring StationTransmitters and ReceiversArrhythmia and ST Segment |
| Classification Name: | Monitors, ElectrocardiographicTransmitters and Receivers, Physiological Signal, RadiofrequencyArrhythmia and ST Segment |
| Substantially Equivalent to: | VCOM Central Monitoring Station (K942147)V-PAK and V-LINK Transmitters (K942147)Arrhythmia and ST Segment (K942147) |
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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.
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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.
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- 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.
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COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100(K942147) | Expanded Features |
|---|---|---|
| Display | 14" and 17" color analog, RGB highresolution CRT | 15" and 17" color analog, RGB highresolution CRT |
| Physical | Mini-tower personal computer 486 orhigher. | Mini-tower personal computer Pentiumor higher. |
| Channels | 8 independent with 2 waveforms perchannel.(16 for remote displays) | 8 independent with 2 waveforms perchannel.(16 for remote displays) |
| Network | LAN Connections | LAN and WAN Connections |
| Display Modes | Up to 8 channels full screen; up to 8channels compressed to top half of screenwith lower half dedicated to detailedpatient view screens or control functions. | Up to 8 channels full screen; up to 8channels compressed to top half ofscreen with lower half dedicated todetailed patient view screens or controlfunctions. |
| Waveforms | ECGPressure (IBP)PlethCO2Resp. | ECGPressure (IBP)PlethCO2Resp. |
| MeasurementOptionsfromBedside Monitorsvia HardwireConnection orTelemetry (RadioLink) | Heart RateAlarmsHi - LoNIBPHi - LoSystolic NIBPHi - LoMean NIBPHi - LoDiastolic NIBPHi - LoNIBP Pulse RateHi - LoSystolic IBPHi - LoMean IBPHi - LoDiastolic IBPHi - LoIBP Pulse RateHi - LoSpO2Hi - LoSpO2 Pulse RateHi - Loend tidal CO2Hi - Loinspired CO2Hi - LoRespirationsHi - LoTemperaturesHi - Lo | Heart RateAlarmsHi - LoNIBPHi - LoSystolic NIBPHi - LoMean NIBPHi - LoDiastolic NIBPHi - LoNIBP Pulse RateHi - LoSystolic IBPHi - LoMean IBPHi - LoDiastolic IBPHi - LoIBP Pulse RateHi - LoSpO2Hi - LoSpO2 Pulse RateHi - Loend tidal CO2Hi - Loinspired CO2Hi - LoRespirationsHi - LoTemperaturesHi - Lo |
| Messages | Status Messages | Status Messages |
| System Alarms | Nurse AlarmLead Off AlarmLow Battery | Nurse AlarmLead Off AlarmLow Battery |
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COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100(K942147) | Expanded Features | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System Alarms | MuscleNo SignalWrong IDEdit | MuscleNo SignalWrong IDEditCheck Patient | ||||||||||||||||
| TrendsRecorder(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 forasystole, ventricular fibrillation,ventricular tachycardia. User selectableresponse for Ventricular Rhythm, RunPVC's, Salvo PVC's, VentricularBigeminy, Ventricular Trigeminy,Couplet, Triplet, SupraventricularTachycardia. | Red prompt and audible alarm forasystole, ventricular fibrillation,ventricular tachycardia. User selectableresponse for Ventricular Rhythm, RunPVC's, Salvo PVC's, VentricularBigeminy, Ventricular Trigeminy,Couplet, Triplet, SupraventricularTachycardia. | ||||||||||||||||
| ST Analysis(Optional) | User selectable ST alarm on ST elevationor 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 232Serial Port RS 422 | Serial Port RS 232Serial 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 or902 - 928 MHz or other FCC approvedfrequency bands for medical telemetry. | ||||||||||||||||
| V-LinkTransmitter(Optional) | FCC approved and digital encoded FM-FSK technique at 174 - 216 MHz.,compatible with specific BedsideMonitors. | FCC approved and digital encoded FM-FSK technique at 174 - 216 MHz orother FCC approved frequency bands,compatible with specific BedsideMonitors and Ventilators. | ||||||||||||||||
| MeasurementOptionsfromVentilatorsvia V-LinkTransmitter | Ventilator Settings Alarms Tidal Volume Setting Lo Exh. Respiratory Rate Hi Peak Flow --- Mode --- Oxygen % --- Plateau --- Sensitivity --- |
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COMPARISON MATRIX
PCI Model 1100 vs. Expanded Features
| Characteristic | PCI Model 1100(K942147) | Expanded Features | |
|---|---|---|---|
| MeasurementOptionsfromVentilatorsvia V-LinkTransmitter | Ventilator SettingsPEEP/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 |
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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.
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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.
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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
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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
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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.
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(*) 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
§ 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).