(96 days)
No
The description focuses on data recording, display, and notification based on predefined rules (alarms), without mentioning any learning or adaptive capabilities.
No
The device is described as a remote monitoring system for mechanical ventilators and is not intended to provide therapy or directly treat patients. Its function is to supplement existing ventilator operations, provide alarm notifications, and automate record-keeping.
No
The VentNet system monitors and communicates data from ventilators and records ventilator settings and alarm events. It supplements ventilator operation and automates record keeping, but it does not diagnose medical conditions.
No
The device description explicitly states that the system consists of a "PC based Central Monitoring Station" and "either a hardwire or wireless communication means," indicating the presence of hardware components beyond just software.
Based on the provided information, the VentNet system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- VentNet's Function: The VentNet system monitors and records data directly from mechanical ventilators and potentially patient physiological data communicated from those ventilators. It does not analyze biological specimens.
- Intended Use: The intended use is to supplement the operation of mechanical ventilators, provide remote monitoring, and automate record-keeping. This is related to the management of a patient's respiratory support, not the analysis of biological samples.
Therefore, the VentNet system falls under the category of a medical device used for monitoring and data management in a clinical setting, but not an IVD.
N/A
Intended Use / Indications for Use
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
VentNet's intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.
VentNet's secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
The VentNet is intended to be used in an environmentally controlled hospital and hospital type environment.
The VentNet can be installed as either a hardwire system which can monitor up to sixteen (16) 7200 Series Ventilators or an FCC approved radio system which can monitor up to twenty-four (24) 7200 Series Ventilators. From a VentNet central monitoring station a user can remotely monitor ventilator settings, alarm status, and physiological patient information for up to 24 7200 Series Ventilators. VentNet uses established graphical user interface conventions to improve ease of learning and operation for operators familiar with Windows software applications. The VentNet system can be installed to operate either with a mouse or with a touch screen. VentNet is compatible with Nellcor Puritan-Bennett 7200 Series Ventilator supporting the host port or DCI communications option or with future Nellcor Puritan-Bennett continuous critical care ventilators which support the same communications protocols. VentNet automatically records ventilator settings and ventilator alarm events for monitored ventilators and displays that information in a spreadsheet format for review. VentNet will record the most recent events. up to 1000 records, as they occur. The time and date of settings changes and alarm events are automatically recorded to allow a chronological history. Physiological patient information is recorded along with the alarm events to assist the user in understanding the alarm event. VentNet has predefined report formats allowing the user to print reports of the system configuration, and monitored ventilator information. VentNet also provides means for archiving data and exporting that data to third party information systems. VentNet displays the alarm status of the monitored ventilators which are indicated by color coded software buttons representing each ventilator. Each software button includes labels allowing the user to designate a patient identification and location. The user may further investigate the specific alarm codes which are active at each ventilator. VentNet can optionally be configured to work with paging systems to allow the remote notification of certain alarm conditions. The user can designate where alarm messages are sent and can modify the conditions under which a ventilator alarm will result in a notice being sent. For each ventilator a primary and a secondary message path can be designated. The user can modify the conditions for notification individually for each monitored ventilator, and for each alarm condition of the ventilator. VentNet incorporates passcode protection to restrict access to functions which interrupt ventilator monitoring or might cause the loss of data.
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
VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The determination of substantial equivalence was based on an assessment of nonclinical performance data. The data includes testing for EMI compatibility and susceptability, software verification and validation of both the system software performance as well as the operating system software performance, 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 VentNet is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K942147, K951370, K935846, K942211
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
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
DEC I 8 1998
K963633
PREMARKET NOTIFICATION [510(k)] SUMMARY August 12, 1996
| VitalCom Contact Person: | Mr. Ray Pizinger |
|---|---|
| Trade Name: | VentNet |
| Common Name: | Central Monitoring Station |
| Classification Name: | Monitor, breathing frequency |
| Trade Name: | NSMS-900 |
| Common Name: | Transmitters and Receivers |
| Classification Name: | Transmitters and Receivers, Physiological Signal, Radiofrequency |
| Substantially Equivalent to: | Spacelabs PCMS Monitor, Model 90845 (K913038) |
| Spacelabs Flexport Interface, Model 90436-01 (K903702) |
SUMMARY OF VENTNET
INTENDED USE
9A. PURPOSE AND FUNCTION OF DEVICE
The VentNet system consists of a PC based Central Monitoring Station and either a hardwire or wireless communication means allowing the remote monitoring of up to 24 continuous mechanical ventilators. VentNet further has a means of communication via paging system for the remote notification of alarms or changes in ventilator status. The VentNet automatically records ventifator setting changes and alarm events with patient physiological data from the monitored ventilators. The user may then review this information in a ventilator flowsheet format or print it as pre-formatted reports.
VentNet's intended use is to supplement the operation of dispersed or remotely located mechanical ventilators. VentNet allows the remote monitoring of multiple ventilators from a central station. VentNet displays ventilator settings, ventilator alarm status and physiological patient information as communicated from the monitored mechanical ventilator. VentNet also includes an optional feature which causes automatic notification, via paging system to defined users of certain ventilator alarms. VentNet is not intended to replace on-hand competent medical staff in monitoring for, or responding to ventilator alarms but is intended to support that staff by notifying other respiratory care staff or ventilator specialists in the event of certain alarm conditions.
1
VentNet's secondary intended use is the automation of some of the record keeping and reporting functions performed during mechanical ventilation.
INTENDED PATIENT POPULATION 9B.
The intended population are those patients who are being ventilated by the 7200 Series Ventilator.
9C. INTENDED ENVIRONMENT OF USE
The VentNet is intended to be used in an environmentally controlled hospital and hospital type environment.
9D. DEVICE CLAIMS
9D1. ADVERTISING CLAIMS
- 9D1.1) VentNet can be installed as either a hardwire system which can monitor up to sixteen (16) 7200 Series Ventilators or an FCC approved radio system which can monitor up to twenty-four (24) 7200 Series Ventilators.
- 9D1.2) From a VentNet central monitoring station a user can remotely monitor ventilator settings, alarm status, and physiological patient information for up to 24 7200 Series Ventilators.
- 9D1.3) VentNet uses established graphical user interface conventions to improve ease of learning and operation for operators familiar with Windows software applications. The VentNet system can be installed to operate either with a mouse or with a touch screen.
- 9D1.4) VentNet is compatible with Nellcor Puritan-Bennett 7200 Series Ventilator supporting the host port or DCI communications option or with future Nellcor Puritan-Bennett continuous critical care ventilators which support the same communications protocols.
- 9D1.5) VentNet automatically records ventilator settings and ventilator alarm events for monitored ventilators and displays that information in a spreadsheet format for review. VentNet will record the most recent events. up to 1000 records, as they occur. The time and date of settings changes and alarm events are automatically recorded to allow a chronological history. Physiological patient information is recorded along with the alarm events to assist the user in understanding the alarm event.
2
- 9D1.6) VentNet has predefined report formats allowing the user to print reports of the system configuration, and monitored ventilator information. VentNet also provides means for archiving data and exporting that data to third party information systems.
- 9D1.7) VentNet displays the alarm status of the monitored ventilators which are indicated by color coded software buttons representing each ventilator. Each software button includes labels allowing the user to designate a patient identification and location. The user may further investigate the specific alarm codes which are active at each ventilator.
- 9D1.8) VentNet can optionally be configured to work with paging systems to allow the remote notification of certain alarm conditions. The user can designate where alarm messages are sent and can modify the conditions under which a ventilator alarm will result in a notice being sent. For each ventilator a primary and a secondary message path can be designated. The user can modify the conditions for notification individually for each monitored ventilator, and for each alarm condition of the ventilator.
- VentNet incorporates passcode protection to restrict access to functions which 9D1.9) interrupt ventilator monitoring or might cause the loss of data.
9D2. PRODUCT AND TECHNICAL SPECIFICATIONS
92D.2.1 Central Station Compliance
- 9D.2.2 Electrical
- 9D.2.3 Physical Characteristics
- 9D.2.4 Environmental
- 9D.2.5 Operational Characteristics
- 9D.2.7 Radio-Link Transceivers Operational Characteristics
- 9D.2.8 Laser Printer Requirements
- 9D.2.9 Component and System Labels
9D.2.10 Central Station Compliance
This section contains specifications for components of the central station and the bedside station remote radio transceiver. Requirements for the facility provided laser printer are also provided.
3
9D.2.11 Electrical Characteristics
Central Station External AC Input Voltage/Current
115 Vac, 60 Hz, 5 A (maximum) or 230 Vac, 50 Hz, 2.6 A (maximum)
Remote Radio Transceiver Defibrillation Protection
The remote radio transceiver shall not be damaged by defibrillation and shall return to normal operation within 15 seconds of defibrillation.
9D.2.12 Physical Characteristics
Dimensions
Computer:
21 cm (8.3 in.) x 40.6 cm (16 in.) x 46 cm (18.1 in.)
Monitor:
38.2 cm (15 in.) or 43.2 cm (17 in.) diagonal screen
Uninterruptible Power Supply:
15.0 cm (6.0 in) x 9.0 cm (3.4 in.) x 33.0 cm (13.1 in)
Bedside Station Radio Transceiver
12.5 cm (4.92 in.) x 6.7 cm (2.64 in.) x 3.0 cm (1.18 in.)
Weight
Computer
29.5 kg (65 lbs) Monitor 13.8 kg (30 lbs, 7 oz) Uninterruptible Power Supply
8.2 kg (18 lbs)
Bedside Station Radio Transceiver
0.18 kg (6.6 oz)
9D.2.13 Environmental
Temperature
Operating
+10° C to +35° C (+50° F to +95° F)
Shipping/Storage (In sealed shipping container) -40° C to +70° C (-40° F to +158° F)
4
Relative Humidity
Operating
30% RH to 80% RH (noncondensing)
Shipping/Storage (In sealed shipping container) 95% (maximum)
Central Station Ventilation and Cabling Requirements
All components of the central station should have a minimum of 1.5 inches clearance around top, sides, back, and front for ventilation. No central station component should be installed in an enclosed cabinet. A minimum of 4 inches is required behind the computer to accommodate cabling.
9D.2.14 Operational Characteristics
Computer
Pentium-100 MHz 16 MB RAM 1 GB Hard Drive 3.5-inch Floppy Drive Hercules Dynamite Video Board Serial Mouse 101-key Keyboard
Monitor
15 inch or 17 inch diagonal screen Touchscreen hardware installed 800 x 600 pixel resolution 256 colors
9D.2.15 Hard-wired Interface Characteristics
Selectable EIA-232 or EIA-422 RJ45 interface connector at central station 9-pin D-connector at the bedside station
Radio-Link Transceivers Characteristics
Central Transceiver Transmitter
Frequency 902 to 928 MHz RF Output Power +20 dBm (100 mW) minimum RF Power Adj. >20 dB range
5
Settling Time 20 dB range Settling Time