SENTRYSUITE PRODUCT LINE

K122699 · Carefusion Germany 234 GmbH · BTY · Nov 19, 2012 · Anesthesiology

Device Facts

• Record ID: K122699
• Device Name: SENTRYSUITE PRODUCT LINE
• Applicant: Carefusion Germany 234 GmbH
• Product Code: BTY · Anesthesiology
• Decision Date: Nov 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.1890
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

Device Story

SentrySuite Product Line is a software-based system for pulmonary function testing (PFT). It interfaces with hardware modules (MasterScreen Pneumo, IOS, APS Pro, PFT, Body/Diff) to collect respiratory data via mouthpiece, mask, or nasal adapter. The software processes inputs to perform measurements including spirometry, flow-volume, MVV, R-occlusion, impulse oscillometry, bronchial challenge, FRC helium rebreathing, diffusion (single breath/intra-breath), bodyplethysmography, respiratory drive (P0.1), and MIP/MEP. Operated by clinicians in hospitals or physician offices, the system displays results on a computer screen for real-time monitoring, report generation, and data storage. It aids physicians in diagnosing respiratory conditions. The software replaces legacy JLAB software, providing a new graphical interface while maintaining equivalent measurement functionality. It supports workstation and server-based deployment.

Clinical Evidence

Bench testing only. Comparative study of human subjects using predicate JLAB software and new SentrySuite 2.7 software. Statistical analysis (bivariate correlation) performed on key parameters: Diffusion (DLCO, VA, Vin), Bodyplethysmography (TLC, FRCpl, RV, sReff, Reff), Respiratory Drive (P0.1), and PI/PE Max (MIP/MEP). All parameters showed statistically significant correlation (p-values <0.0004) between software versions, meeting pass criteria.

Technological Characteristics

Software-based PFT system operating on high-performance computers/servers. Patient-contact parts: Bormed RG835 MO (single-use mouthpiece), silicone mouthpiece, polyacetal nose clip, EVA nose clip pad. Energy: 100-240V / 50-60Hz. Connectivity: Workstation/Server, online/Vlink/GDT/JINET. Sterilization: Not supplied sterile, not intended for sterilization. Software: SentrySuite 2.7x.

Indications for Use

Indicated for patients 4 years and older capable of cooperating with pulmonary function testing. Used for measurement, data collection, and analysis of lung function parameters to aid in diagnosis of related conditions. Bronchial challenge option requires physician supervision.

Regulatory Classification

Identification

A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.

Predicate Devices

• SentrySuite Product Line (K113813)
• MasterScreen PFT Body (K072061)
• MasterScreen Body / Diff (K936108)

Submission Summary (Full Text)

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# 510(k) Summary

# NOV 1 9 2012

## GENERAL INFORMATION

### Type of Submission 5.1

Traditional 510(k) Submission

Submission date: 08/16/2012

### 5.2 Submitter

Name:

CareFusion Germany 234 GmbH

Address: .

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany: (Regulatory Affairs Specialist) Address:

Elmar Niedermeyer CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany [phone] - 361 [phone] - 62361 [e-mail]

Phone: FAX: E-mail

Contact person in the U.S .: (Official Correspondent) Address

### Carol Emerson

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887 714-919-3342 714-283-8420 [e-mail]

Phone: Fax: E-mail:

{1}------------------------------------------------

### Establishment Registration Number 5.3 9615102

### Common Name or Classification Name 5.4

Calculator, Predicted Values, Pulmonary Function (CFR 868.1890, Product Code BTY) Pulmonary function data calculator (CFR 868.1880, Product Code BZC) Diagnostic Spirometer (CFR 868.1840, Product Code BZG) Volume plethysmograph (CFR 868.1760, Product Code JEH)

#### રે. ર Trade Name

SentrySuite Product Line

#### Device Classification 5.6

This is a Class II device

#### 5.7 Classification Panel

73 Anesthesiology Part 868 Code BTY, BZG, BZC, JEH

### 5.8 Reason for Premarket Notification

--- Modification of legally marketed devices ---Change from previously JLAB software to SentrySuite software for some measurement programs of the device MasterScreen PFT Body K072061

### Legally predicate marketed device 5.9

SentrySuite Product Line MasterScreen PFT Body MasterScreen Body / Diff

K111053 Code BTY, BZC, BZG K072061 Code JEH K936108 Code JEH

#### 5.10 Predicate Device Company

CareFusion Germany 234 GmbH

#### 5.11 Device Description

The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices.

- The SentrySuite software replaces the JLAB software and got a brand-new . graphical surface.
- Measurement can be accomplished under SentrySuite software equivalent . as it was possible under the previously powerful JLAB software

-

CareFusion

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- The results of the tests can be viewed on-line on the computer screen . during the test and can be saved on the computer hard disk for further referral or report generation purposes.
- SentrySuite provides the functionality currently available on the . MasterScreen devices using the JLAB software.
- SentrySuite can be operated on workstations and on servers. .

Measurements:

- Spiormetry .
- Flow Volume .
- Maximal Voluntary Ventilation (MVV) .
- Incentive Spirometry .
- R-Occlusion .
- . Impulse oscillometry
- Bronchial test .
- FRC Helium Rebreathing .
- . Real Time Single Breath Diffusion
- Intra Breath Diffusion .
- Bodyplethysmography .
- . Respiratory Drive P0.1
- PI/PE Max (MIP/MEP) .
- Single Breath Diffusion CO/He .

#### 5.12 Intended Use Statement

The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes.

Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine.

The products can be utilized for patients from 4 years on and older as long as they can cooperate in the performance - no special limit to patient's sex or height.

Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

### 5.13 Required Components

- Measuring device MS-Pneumo or MS-IOS or APS Pro or MS-PFT or MS-. PFT Body or MS Body Diff
- Or Workstation / Server ●
- Trolley / Stand .
- High performance computer .

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## . 5 510(k) Summary

- Printer .
- . Accessories
- SentrySuite software 2.7x .

・

.

- Instruction for Use .
# 5.14 Summary Table of Comparison

| | SentrySuite Product Line<br>(K113813) | SentrySuite Product Line |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Indications<br>for Use | The SentrySuite Product line is intended to<br>be used for measurements, data collection<br>and analysis of lung function (PFT)<br>parameters, aiding in the diagnosis of<br>related conditions. All the measurements<br>are performed via a mouthpiece, a mask or<br>nasal adapters. The results of the test can<br>be viewed on-line with the help of a<br>computer screen and can be printed after<br>the test. The test results can be saved for<br>further referral or report generation<br>purposes. Use of the Option Bronchial<br>Challenge requires the supervision of a<br>physician familiar with emergency<br>medicine.<br>The products can be utilized for patients<br>from 4 years on and older as long as they<br>can cooperate in the performance - no<br>special limit to patient's sex or height.<br>Measurements will be performed under the<br>direction of a physician in a hospital<br>environment, physician's office or similar<br>settings. | identical |
| Patient<br>population | The products can be utilized for patients<br>from 4 years on and older as long as they<br>can cooperate in the performance - no<br>special limit to patient's sex or height. | identical |
| Hardware | APS Pro<br>• Nebulizer head<br>• Compressor<br>• Trolley or Stand with power supply<br>• Desktop / Notebook<br>• Accessories<br>MasterScreen Pneumo<br>• Trolley or Stand with power supply<br>• Pneumotach handle<br>• Desktop / Notebook<br>• Accessories | identical |
| | | |
| | MasterScreen IOS | |
| | · Trolley or Stand with power supply | |
| | | |
| | · Pneumotach handle | |
| | · Desktop / Notebook | |
| | | |
| | · Accessories | |
| | | |
| | | |
| | MasterScreen PFT / PFT Body | |
| | · Trolley with power supply | |
| | | |
| | · Analyzer box (gas) | |
| | • Pneumotach handle | |
| | · Body Box | |
| | | |
| | · Desktop / Notebook | |
| | · Accessories | |
| | | |
| Software | SentrySuite Software (version 2.5) | SentrySuite Software (version 2.7x) |
| | | |
| | APS Pro | |
| Perfor- | · Bronchial test | |
| mance | o Bronchospasmolysis | |
| | | |
| specifica- | Bronchoprovocation<br>0 | |
| tion | Pulsed Nebulization<br>0 | |
| | | |
| (measure- | Continuous Nebulization<br>o | |
| ment | | |
| programs) | MasterScreen Pneumo | |
| | | |
| | · Spirometry | |
| | · Incentive Spirometry | |
| | | |
| | · Flow / Volume | |
| | • MVV | |
| | · R-Occlusion (Airway Resistance) | |
| | | |
| | MasterScreen IOS | |
| | | identical |
| | · Spirometry | |
| | · Incentive Spirometry | |
| | | |
| | · Flow / Volume | |
| | • MVV | |
| | · Impulse oscillometry | |
| | | |
| | MasterScreen PFT / PFT Body | |
| | · Spirometry | |
| | | |
| | · Incentive Spirometry | |
| | · Flow / Volume | |
| | • MVV | |
| | | |
| | · R-Occlusion (Airway Resistance) | |
| | · FRC Helium Rebreathing | |
| | | |
| | · Real Time Single Breath Diffusion | |
| | · Intra Breath Diffusion | |
| | | |
| Energy | 100 - 240V / 50 - 60Hz | |
| type | | identical |
| | | |
| Patient | · Single Use mouthpiece (material: | |
| | | |
| contacting | Bormed RG835 MO) | identical |
| parts | · Silicone mouthpiece | |
| |…