(76 days)
Not Found
No
The summary describes a software update that replaces existing software and maintains equivalent functionality for standard lung function measurements and analysis. There is no mention of AI, ML, or any advanced analytical techniques beyond standard statistical comparison for validation.
No
The device is described as aiding in the diagnosis of lung conditions through measurements and data collection, rather than providing direct treatment or therapy.
Yes
The intended use explicitly states that the product is "aiding in the diagnosis of related conditions" concerning lung function.
No
The device description explicitly states that the software operates "on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT". This indicates that the device is a combination of software and specific hardware components, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions." These measurements are performed directly on the patient via a mouthpiece, mask, or nasal adapters.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility of transfused blood, or to monitor therapeutic measures.
- Nature of Measurements: The measurements performed by the SentrySuite Product line (Spirometry, Flow Volume, etc.) are in vivo measurements, meaning they are taken directly from the living body, not from a specimen outside the body.
Therefore, while the device aids in diagnosis, it does so through direct physiological measurements on the patient, not through the analysis of in vitro specimens.
N/A
Intended Use / Indications for 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.
Product codes
BTY, BZG, BZC, JEH
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
- 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
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
- Printer
- Accessories
- SentrySuite software 2.7x
- Instruction for Use
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
from 4 years on and older
Intended User / Care Setting
Physician in a hospital environment, physician's office or similar settings.
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
Human subjects were tested on the above devices with the predicate JLAB software and also with the new SentrySuite software 2.7. The results obtained with the predicate software JLAB and with the SentrySuite 2.7 software were compared statistically. The bivariate correlation test was chosen to compare the measurements. Beside the correlation coefficient also the one-tail p-value for the test pairs for each selected parameter was calculated. The one-tail p-values were used, as only positive correlation coefficients are judged significant and a requirement for "pass". The pass/fail criterion was defined based on a significant level of 0.01 for the p-value.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The modification for the device was developed in accordance with the CareFusion Design and Development SWI (0301-5001-000-SWI). The risk analysis method used to assess the impact of the SentrySuite software was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.
Non-clinical performance testing for the following measurement programs:
- Diffusion Single Breath CO/He
- Bodyplethysmography
- Respiratory Drive P0.1
- PI/PE Max (MIP/MEP)
Results of compared key parameters:
- Diffusion Single Breath CO/He (DLCO, VA, Vin) p-value
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).
0
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 +49 931 49 72 - 361 +49 931 49 72 - 62361 elmar.niedermeyer@carefusion.com
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 carol.emerson@carefusion.com
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
2
- 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 .
3
. 5 510(k) Summary
- Printer .
- . Accessories
- SentrySuite software 2.7x .
・
.
- Instruction for Use .
5.14 Summary Table of Comparison
| | SentrySuite Product Line
(K113813) | SentrySuite Product Line |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------|
| Indications
for 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. | identical |
| Patient
population | 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. | identical |
| Hardware | APS Pro
• Nebulizer head
• Compressor
• Trolley or Stand with power supply
• Desktop / Notebook
• Accessories
MasterScreen Pneumo
• Trolley or Stand with power supply
• Pneumotach handle
• Desktop / Notebook
• 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
0 | |
| tion | Pulsed Nebulization
0 | |
| | | |
| (measure- | Continuous Nebulization
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 | |
| | | |
| | · Nose clip (material: Polyacetal) | |
| | · Nose clip pad (material: Ethylene Vinyl | |
| | Acetate) | |
| Sterili-
zation | The devices from the SentrySuite
Product Line (APS Pro, MS Pneumo, MS
IOS, MS PFT) along with its accessories
are neither supplied sterile nor intended
to be sterilized | identical |
| Software
Network
options | • Use as Workstation
• Use as Server
• Online connection
• Vlink connection
• GDT connection
• Data integration
• Database handling
• JINET server | Identical |
.
4
.
. .
.
·
5
1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
| B) Comparision to predicate device MasterScreen PFT K072061 | ||
|---|---|---|
| MasterScreen PFT | ||
| (K072061) | SentrySuite Product Line | |
| Performance | ||
| specification | ||
| (measurement | ||
| programs) | MasterScreen PFT | |
| • Spirometry | ||
| • Incentive Spirometry | ||
| • Flow / Volume | ||
| • MVV | ||
| • R-Occlusion (Airway Resistance) | ||
| • FRC Helium Rebreathing | ||
| • Real Time Single Breath Diffusion | ||
| • Intra Breath Diffusion | ||
| • Diffusion Single Breath CO/He | ||
| • Bodyplethysmography | ||
| • Respiratory Drive P0.1 | ||
| • PI/PE Max (MIP/MEP) | Identical | |
| Hardware | MasterScreen PFT | |
| • Trolley with power supply | ||
| • Analyzer box (gas) | ||
| • Pneumotach handle | ||
| • Body Box | ||
| • Desktop / Notebook | ||
| • Accessories | Identical | |
| Software | MasterScreen PFT | |
| JLAB Software 5.x | SentrySuite Software (version 2.7x) |
・
.
.
.
.
:
6
| | MasterScreen Body Diff
(K936108) | SentrySuite Product Line |
|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| Perfor-
mance
specifica-
tion
(measure-
ment
programs) | MasterScreen Body / Body Diff
• Spirometry
• Incentive Spirometry
• Flow / Volume
• MVV
• R-Occlusion (Airway Resistance)
• Bodyplethysmography
• Respiratory Drive P0.1
• PI/PE Max (MIP/MEP)
• Single Breath Diffusion CO/He | Identical |
| Hardware | MasterScreen Body / Body Diff
• Trolley with power supply
• Pneumotach handle
• Body Box (with or without Analyzer box)
• Desktop / Notebook
• Accessories | Identical |
| Software | MasterScreen Body / Body Diff
JLAB Software 5.x | SentrySuite Software (version 2.7) |
Discussion to the two tables above:
The insignificant difference from the SentrySuite Product Line with 510(k) K113813 to the extended SentrySuite Product Line is:
- The SentrySuite software with version 2.5 will be superseded by the . SentrySuite software with version 2.7. The existing measurement programs for the medical applications for APS Pro, MasterScreen Pneumo, MasterScreen IOS and MasterScreen PFT remain thereby untouched.
- The measurements in bold printed characters of MasterScreen PFT . K072061 of table "B" above will be added to the SentrySuite Product Line with the SentrySuite software version 2.7.
In Summary: The SentrySuite Product Line K113813 with software SentrySuite 2.5 will be expanded with the measurements "Diffusion Single Breath CO/He, bodyplethysmograpy, respiratory drive P0.1 and PI/PE Max (MIP/MEP)" and the software version will be the SentrySuite 2.7.
7
Summary of Device Testing 5.15
The following practices were followed and monitored for development of the SentrySuite Product Line:
- The modification for the above device was developed in accordance . with the CareFusion Design and Development SWI (0301-5001-000-SWI).
- The risk analysis method used to assess the impact of the SentrySuite . software was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.
Summary detail of the non-clinical performance testing for the following measurement programs:
- Diffusion Single Breath CO/He .
- Bodyplethysmography .
- Respiratory Drive P0.1 .
- PI/PE Max (MIP/MEP) .
Human subjects were tested on the above devices with the predicate JLAB software and also with the new SentrySuite software 2.7.
The results obtained with the predicate software JLAB and with the SentrySuite 2.7 software were compared statistically. The bivariate correlation test was chosen to compare the measurements. Beside the correlation coefficient also the one-tail p-value for the test pairs for each selected parameter was calculated. The one-tail p-values were used, as only positive correlation coefficients are judged significant and a requirement for "pass". The passifail criterion was defined based on a significant level of 0.01 for the p-value.
Results of compared key parameters:
- Diffusion Single Breath CO/He (DLCO, VA, Vin) p-value