INFRASONICS ADULT VENTILATOR TRENDING OPTION

K964543 · Nellcor Puritan Bennett, Inc. · CBK · Feb 14, 1997 · Anesthesiology

Device Facts

• Record ID: K964543
• Device Name: INFRASONICS ADULT VENTILATOR TRENDING OPTION
• Applicant: Nellcor Puritan Bennett, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Feb 14, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2

Intended Use

This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.

Device Story

Trending Option is a hardware/firmware upgrade for the Adult Star Ventilator. It samples ventilator data to provide 72-hour trending of 54 parameters; stores patient data (name, weight, blood gas); and captures real-time pressure, flow, and volume waveforms/loops for recall and comparison. Used in clinical settings by healthcare providers to track patient status and ventilator performance. Output displayed on existing ventilator CRT; allows cursor-based analysis of trends and hardcopy printing. Provides monitoring only; no direct control of ventilator function. Benefits include improved longitudinal data visualization and retrospective comparison of patient respiratory status.

Clinical Evidence

Bench testing only. Includes environmental testing (EMC, vibration, shock, temperature, humidity) and system-level design validation to verify correct implementation of performance specifications and regression testing to ensure compatibility with existing ventilator options.

Technological Characteristics

Hardware upgrade consisting of a printed circuit board with battery-backed 256K RAM. Firmware stored in EPROMs. Integrates with existing Adult Star Ventilator CRT for graphical display. Provides periodic data sampling and storage. No specific material standards or connectivity protocols (e.g., DICOM) cited.

Indications for Use

Indicated for use with the Adult Star Ventilator to track 54 patient and ventilator parameters over 72 hours, display real-time waveforms, and store patient data for clinical monitoring.

Regulatory Classification

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.

Predicate Devices

• Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200®ae ventilator
• Bird Products Corp. Graphic Monitor

Reference Devices

• Adult Star Ventilator (K872466)
• Pressure Control (K911804)
• Flow Triggering (K954724)
• Remote Alarm (K943106)
• Lung Mechanics (K905272)
• Pediatric and Compliance Compensations (K922654)

Submission Summary (Full Text)

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FEB 14 1997
K964543

# 510(k) Summary

Submitter's Name: Nellcor Puritan Bennett Inc.

Address: 4280 Hacienda Drive
Pleasanton, CA 94588

Phone: [phone]

Contact Name: Albert Paul

Date of Summary: October 31, 1996

Trade Name: Trending Option for the Infrasonics Adult Star Ventilator

Common Name: Adult Ventilator

Classification: Continuous Ventilator (21 CFR 868.5895)
Class II

Predicate Device: Puritan Bennett Graphics 2.0 option for the Puritan-Bennett 7200®ae ventilator
Bird Products Corp. Graphic Monitor

Description of Device: Trending Option is a software and hardware modification to the Adult Star Ventilator (K872466). It adds three features: 72 hour trending of ventilator and patient monitored parameters, storage of Patient Data, and Save and Recall of real time waveforms. This option requires both software and hardware upgrades. The software, or firmware, is retained in EPROM's. The hardware upgrade consists of a print circuit board with battery backed up 256K RAM. A label is added to the front of the ventilator indicating that this option has been installed. This option is designed to function with all available options for the Adult Star Ventilator.

Intended Use: This product is to be used only in conjunction with the Adult Star Model ventilator. It provides a monitoring function only and therefore has no direct interaction with ventilator function. The Trending option will periodically sample ventilator data to be used as trended parameters. This option is intended for the operator to track a total of 54 patient and ventilator parameters over a maximum time period of 72 hours. Three trended parameters can be displayed simultaneously. A cursor can then be used scan the trended dated to determine the time and magnitude of a particular occurrence or change in a monitored function. In addition, Patient data such as name, weight, clinician

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identification, and blood gas test data can be manually inputted. The Trending option allows real-time pressure, flow, and volume waveforms to be saved and recalled for comparison to subsequent waveforms. Pressure/Volume and Flow/Volume loops can also be saved and recalled for subsequent comparisons. A hardcopy print out can be made of all saved and trended data.

## Statement of Similarities and/or Differences With Marketed Devices:

The Infrasonics Trending option is a software and hardware upgrade to the Infrasonics Adult Star ventilator. The graphical display of trended parameters are shown on the existing Adult Star CRT. The Trending option is similar to the Puritan Bennett Graphics 2.0 option and the Bird Products Graphics Monitor. The Puritan Bennett Graphics 2.0 option requires a 7200*ae ventilator and an optional 7202 Display. The Bird Graphics monitor is an optional display for the Bird infant and adult ventilators. The Puritan Bennett and the Bird Graphics monitor acquire and display data in a similar manner as the Infrasonics Trending option. All designs use the same general principles and incorporate similar technologies, materials, energy sources, and components.

The primary function of all three products is to acquire ventilator data through an electronic means and store that data for later retrieval. The technological characteristics of the devices are the same and raise no new questions of safety and effectiveness. It is concluded that the Trending Option is substantially equivalent to the Puritan-Bennett and Bird products.

## Functionality with Available Options

The Trending Option for the Adult Star Ventilator is to be used in conjunction with or without other available options. The following is a list of the options and the 510(k) number associated with them:

| Product or Option to the Adult Star | 510(k) number |
| --- | --- |
| Adult Star Ventilator | K872466 |
| Pressure Control | K911804 |
| Flow Triggering | K954724 |
| Remote Alarm | K943106 |
| Lung Mechanics | K905272 |
| Pediatric and Compliance Compensations | K922654 |

It is possible, for example, for a ventilator to be configured with Trending and Pressure Control, or Trending, Pressure Control, and Flow Triggering. System testing was conducted to show the There is no limitation on the combinations that are available. The Trending option is independent of the other options.

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Summary of Testing:

The following environmental test were conducted on the Adult Star Ventilator with the Trending Hardware installed.

| Test Description | Results |
| --- | --- |
| Powerline Conducted Emissions | Passed |
| Radiated Emission Measurements | Passed |
| Radiated E-Field Susceptibility | Passed |
| Electrostatic Discharge Susceptibility | Passed |
| AC Voltage Fluctuation | Passed |
| AC Voltage Dropout | Passed |
| Slow Sag and Surges | Passed |
| Fast Transient Burst | Passed |
| Fast Surges | Passed |
| Magnetic Fields Emissions | Passed |
| Conducted Electromagnetic Energy | Passed |
| Magnetic Field Immunity | Passed |
| Quasi-Static Electromagnetic Field | Passed |
| Sinusoidal Vibration | Passed |
| Random Vibration | Passed |
| Shock | Passed |
| High temperature | Passed |
| Low Temperature | Passed |
| Humidity | Passed |

System Level Tests

The following system level tests were performed to validation the design of this option:

| Test | Description |
| --- | --- |
| Design Validation for the Trending Option | Validates that the Design and Performance Specification has been correctly implemented. |
| Design Validation of Options Selection | Verifies that all available options for the Adult Star can be correctly selected. |
| Generic Testing (Includes specific testing for all available options: | A regression level to verify that function of the basic ventilator and available options still perform as required with the Trending Option Installed. |