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.

Device Description

AI/ML Overview

The provided document is a 510(k) Premarket Notification summary for the VentNet Central Monitoring Station. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a dedicated study.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study is not available within this document. The document primarily describes the device's technical specifications and compares them to predicate devices to establish substantial equivalence based on non-clinical performance data.

Here's an analysis of the information that is available, based on the prompt's request:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly present a "table of acceptance criteria and reported device performance" in the way a clinical study would for an AI/medical device. Instead, it lists "Product and Technical Specifications" and "Device Claims" which implicitly serve as performance goals, and then leverages a comparison matrix to predicate devices to argue equivalence. No quantitative "reported device performance" against these specifications from a formal study is detailed.

However, we can infer some "acceptance criteria" from the "Device Claims" and "Product and Technical Specifications" sections. The "reported device performance" is then implicitly demonstrated by stating these specifications and implying they are met, as part of the overall argument for substantial equivalence via non-clinical testing.

Acceptance Criteria (Inferred from Claims/Specifications)	Reported Device Performance (As stated in the document)
Monitoring Capacity (Wireless)	Up to 24 continuous mechanical ventilators
Monitoring Capacity (Hardwire)	Up to 16 continuous mechanical ventilators
Remote Monitoring Features	Displays ventilator settings, alarm status, and physiological patient information
User Interface	Uses graphical user interface conventions, compatible with mouse or touchscreen for ease of learning and operation
Ventilator Compatibility	Compatible with Nellcor Puritan-Bennett 7200 Series Ventilator (host port or DCI) and future compatible ventilators
Automatic Record Keeping	Automatically records ventilator settings and alarm events (up to 1000 records) with time and date stamps; records physiological patient information with alarm events.
Reporting Features	Predefined report formats; archiving data; exporting data to third-party information systems.
Alarm Status Display	Color-coded software buttons for each ventilator, with labels for patient ID and location; ability to investigate specific active alarm codes.
Paging System Integration	Optional configuration with paging systems for remote notification of certain alarm conditions; user-definable alarm message paths and notification conditions (primary/secondary message paths, individual ventilator/alarm conditions).
Security	Passcode protection to restrict access to functions that interrupt monitoring or cause data loss.
Central Station Electrical	115 Vac, 60 Hz, 5 A (maximum) or 230 Vac, 50 Hz, 2.6 A (maximum)
Remote Radio Transceiver Defibrillation Protection	Not damaged by defibrillation, returns to normal operation within 15 seconds.
Computer Hardware	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 Specifications	15 inch or 17 inch diagonal screen, Touchscreen hardware installed, 800 x 600 pixel resolution, 256 colors
Operating Temperature	+10° C to +35° C (+50° F to +95° F)
Operating Relative Humidity	30% RH to 80% RH (noncondensing)
Radio Transceiver Frequencies	Central Transceiver: 902-928 MHz; Remote Transceiver: 902-928 MHz
Radio Transceiver Output Power	Central Transceiver: +20 dBm (100 mW) minimum; Remote Transceiver: +15 dBm nominal, ±2.0 dB
Radio Transceiver FCC Compliance	Spectrum Usage: Spread spectrum (IAW FCC Par. 15.247)
Printer Compatibility	HPGL/2 and PCL5 compatible, minimum 2 MB printer memory.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. The document describes "non-clinical performance data review" based on testing for EMI, software verification/validation, environmental testing, and stress testing. This implies technical testing, not a study with a patient "test set."
Data Provenance: Not applicable for a clinical test set. The data provenance mentioned is related to engineering and software testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of a test set with an associated ground truth established by experts. The device's function is data presentation and alarm relay, not diagnostic interpretation.

4. Adjudication method for the test set:

Not applicable. No clinical 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:

No. This is not an AI diagnostic device. It's a central monitoring station for ventilators. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies standalone system performance was evaluated through "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." However, this refers to the system's technical functionality, not a standalone diagnostic algorithm's performance. The device is explicitly designed to support human staff, not replace them.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The performance data reviewed involved validation of technical specifications and software functionality, not clinical diagnostic accuracy against a ground truth.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning device that would require a "training set" for model development.

9. How the ground truth for the training set was established:

Not applicable. As above, no training set is relevant for this type of device.

Study Proving Acceptance Criteria:

The document states: "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."

This statement indicates that the "study" proving the device meets its (implicitly stated) performance criteria and is "substantially equivalent" involved:

EMI Compatibility and Susceptibility Testing: To ensure the device operates correctly in its intended electromagnetic environment without interference and is not unduly affected by external electromagnetic sources.
Software Verification and Validation: To confirm that the software performs as designed and meets all specified technical and functional requirements. This would involve unit testing, integration testing, system testing, and potentially user acceptance testing.
Environmental Testing: To ensure the device can withstand specified operating and storage conditions (temperature, humidity, etc.).
Stress Testing: To evaluate the system's robustness and stability under extreme or heavy load conditions.
Integration and System Level Testing: To confirm that all components work together correctly as a complete system.

This approach demonstrates meeting technical specifications and equivalency to predicate devices, rather than a clinical performance study with patient data and a diagnostic ground truth.

Summary

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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

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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.

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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.

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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)

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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

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Settling Time < 100 usec Frequency Stability +0.001% Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 62.5 kilobaud (nominal) Antennas Omni-directional Spectrum Usage Spread spectrum (IAW FCC Par. 15.247) CISPR 11 - Class A with exceptions for intentional FCC radiators covered by FCC Part 15, Section 247

Central Transceiver Receiver

Frequency 902 to 928 MHz Frequency Spacing 1 kHz Settling time 100 usec Frequency Stability +0.001% Selectivity 180 kHz (3 dB) nominal 300 kHz (20 dB) nominal Sensitivity: -80 dBm (minimum) in 180 kHz bandwidth for 10 dB SNR Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 133 kilobaud Diversity Full voting, 2 channels Input impedance 2:1 VSWR maximum (50 ohm) Host PC InterfaceMemory-mapped, dual port RAM Antennas Omni-directional

Remote Transceiver Transmitter

Frequency 902 to 928 MHz RF Output Power +15 dBm nominal, ±2.0 dB RF Power Adj. >20 dB range Settling Time <300 usec Frequency Stability +0.001% Modulation Type Direct FM, DDS Synthesized NRZ Modulation Rate 133 kilobaud (nominal) Frame Length: 30 milliseconds Data Rate Instantaneous bandwidth variability CISPR 11 - Class B with exceptions for intentional FCC radiators covered by FCC Part 15, Section 247

Remote Transceiver Receiver

Frequency 902 to 928 MHz Settling time < 300 usec Frequency Stability +0.001%

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Selectivity 180 kHz (3 dB) nominal 300 kHz (20 dB) nominal Sensitivity -90 dBm (minimum) in 180 kHz: bandwidth for 10 dB SNR Spurious Rejection 50 dB nominal Modulation Type 100 kHz deviation NRZ Modulation Rate 133 kilobaud Input impedance 2:1 VSWR maximum (50 ohm)

Laser Printer Minimum Requirements

The VentNet monitoring system supports printers that are both HPGL/2 and PCL5 compatible with a minimum of 2 megabytes of printer memory such as the Hewlett-Packard LaserJet models 4, 4SI, 4L, 5, 5SI, and 5L printers.

Component and System Labels

There are two labels on the rear panel of the central station computer described as follows.

An identification label showing product title, model, and serial numbers plus agency certifications is affixed on the rear panel of the central station computer by the original manufacturer. This label shows certification compliances at the time the computer was purchased from the manufacturer and is applicable to the computer only. This label also facilitates product traceability through the manufacturer's product records system.

Another identification label showing the system model number is affixed on the rear panel of the central station computer by Nellcor Puritan Bennett. This label shows CSA/NRTL/C certification that is applicable to the VentNet monitoring system as a whole. This certification is based on the Canadian Standard for Electromedical Equipment, C22.2, No. 125 and the Underwriters Laboratories Standard for Medical and Dental Equipment, UL544.

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9E. COMPARISON MATRIX

VentNet vs. Spacelabs PCMS and VitalCom Model 1100 NOTE: THE 7200 VENTILATOR CONNECTS TO THE SPACELABS PCMS VIA THE FLEXPORT INTERFACE (90436-01)

Characteristic	VentNetCentral Monitoring Station	Spacelabs Patient CareManagement System (PCMS)(K913038)	VitalCom Model 1100Central Monitoring Station(K942147)
Display	SVGA Color Monitor with and withouttouchscreen	SVGA Color Monitor with andwithout touchscreen	SVGA Color Monitor with andwithout touchscreen
Channels	Up to 24 Patients (wireless)Up to 16 Patients (hardwire)	Access of up to 16 Patients (telemetry orhardwire)	8 independent with 2 waveforms perchannel; (16 for remote displays)
Hardware	PC based, Pentium, 75 MHz or higher,16 MB RAM, 1.2 GB HD	CPU based 80486, 50 MHz,48 MB RAM, 700 MB HD	Mini-tower personal computer 486 orhigher.
Hardwire Interface	RS232 or RS422 Interface	Spacelabs Flexport Interface (K903702)	RS232
Radio TransmitterInterface (wireless)	1. Remote Transceiver- Frequency 903 - 920 MHz- Output 50 mW (Max)2. Central Transceiver- Frequency 903 - 922 MHz- Output 500 mW (Max)	Not Provided	Multiple, Applicable option:1. Remote Transceiver- Frequency 903 - 920 MHz- Output 50 mW (Max)2. Central Transceiver- Frequency 903 - 922 MHz- Output 500 mW (Max)
Software OperatingSystem	Microsoft Window 3.11	unknown	VRTX
Ventilator Settings	Provided by the 7200 Series Ventilator	Provided by the 7200 Series Ventilator	not applicable
Patient Data	Provided by the 7200 Series Ventilator	Provided by the 7200 Series Ventilator	not applicable
Ventilator AlarmSettings	Provided by the 7200 Series Ventilator	High/Low Limits Adjustable at theBedside Monitor, a remote location andat the Central Monitor	not applicable
Individual patient realtime alarm status	Status of the ventilator alarms for aselected patient as provided by the 7200series ventilator.	Patient displayed statusin the patient block	ECG, Arrhythmia, and BedsideMonitor alarm status for individualpatients
Paging	User selectable for each patient, either nopage, autopage to one number, or manualpage to a preset number. VentNet uses ahospital paging system using the standardTAP protocol	Not provided	(Optional) Paging via user prompt tohospital paging system, including Zonepaging.
Characteristic	VentNetCentral Monitoring Station	Spacelabs Patient CareManagement System (PCMS)(K913038)	VitalCom Model 1100Central Monitoring Station(K942147)
Tabular Trends	Future Options	Tabular trends include both settings andmonitored patient data	ST and others if available from theBedside
Graphical Trends	Future Options	Graphical trends of tidal volume andrespiratory rate	Pressure (NIBP), and Pleth and othersif available from the Bedside
Waveforms	Future Options	Pressure and Flow waveforms areavailable if the ventilator provides them	ECG, Pressure (NIBP), and Pleth andothers if available from the Bedside
Reports	Multiple available, user selectableintervals, automatic print on alarms, andmanual requests	User selectable intervals, automatic printon alarms, and manual requests	Multiple available, user selectableintervals, automatic print on alarms,and manual requests
VentilationCalculations	As provided by the 7200 SeriesVentilator	Calculations for minute volume,dynamic & static compliance, dead spacevolume, dead space to tidal volumeratio, and alveolar ventilation	not applicable
Logs	Alarm, ventilator setting changes, andpatient monitoring status	Events Logs	Events Logs

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9F. TECHNOLOGICAL CHARACTERISTIC REVIEW

The VentNet Central Monitoring Station is substantially equivalent to the Spacelabs PCMS Monitor, Model 90845 (K913038) with the use of the Spacelabs Flexport Interface, Model 90436-01(K903702). The VentNet uses a pentium based personal computer and offers both a hardwire interface and a wireless interface (radio transceivers). This technology is equivalent to the VitalCom Model 1100 systems provided to other manufacturers for communication from bedside monitors to a centralized monitoring station which was determined substantially equivalent in 1995 (K942147). VentNet also utilizes Microsoft Windows 3.11 as it's operating system which is currently being utilized through out the monitoring industry in a variety of products, including the Zymed Central Station Monitor System, Model T8010 (K951370), the Acuity Central Monitor (K935846) and the VMAX Pulmanary / Medabolic System, (K942211).

9G. NON-CLINICAL PERFORMANCE DATA REVIEW

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.

Regulation Number and Section

§ 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).