(119 days)
No
The summary describes a software update for existing lung function measurement devices, focusing on data collection, analysis of standard PFT parameters, and a new graphical interface. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is used for measurement, data collection, and analysis of lung function to aid in diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the product line is "aiding in the diagnosis of related conditions."
No
The device is described as software that operates on existing hardware (MasterScreen Pneumo, MasterScreen IOS, and APS Pro) and replaces previous software (JLAB). It is not solely software, as it requires specific hardware to function and perform measurements.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that this device performs measurements of lung function (PFT) parameters directly on the patient via a mouthpiece, mask, or nasal adapters. This is a direct physiological measurement, not an analysis of a biological sample.
- The measurements are performed in vivo. The term "In Vitro" means "in glass" or "outside the living organism." This device interacts directly with the patient's respiratory system.
- The device aids in diagnosis based on physiological measurements. While the results aid in diagnosis, they are derived from the patient's physical response and lung mechanics, not from the analysis of a biological specimen like blood, urine, or tissue.
Therefore, this device falls under the category of a medical device that performs physiological measurements, but it is not an IVD.
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.
Product codes
BTY, BZG, BZC
Device Description
The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS and APS Pro 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.
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
Measurements will be performed under the direction of a 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 software was developed according to IEC 62304 (Software life-cycle processes) and IEC 62366 (Usability) standard.
- The risk analysis method used to assess the impact of the new software SentrySuite was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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
K111053
.
510(k) Summary
GENERAL INFORMATION
Type of Submission 5.1
Traditional 510(k) Submission
28/03/2011 Submission date:
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
Phone:
E-mail:
Fax:
/
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
1
| 5.3 | Establishment Registration Number
9615102 |
|------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.4 | Common Name or Classification Name
Calculator, Predicted Values, Pulmonary Function
(CFR 868.1890, Product Code BTY)
Diagnostic Spirometer
(CFR 868.1840, Product Code BZG)
Pulmonary function data calculator
(CFR 868.1880, Product Code BZC) |
| 5.5 | Trade Name
SentrySuite Product line |
| 5.6 | Device Classification
This is a Class II device |
| 5.7 | Classification Panel
73 Anesthesiology Part 868
Code BTY, BZG, BZC |
| 5.8 | Reason for Premarket Notification
--- Modification of legally marketed devices ---
Change from previously JLAB software to SentrySuite software for the
devices MasterScreen Pneumo, MasterScreen IOS, APS Pro |
| 5.9 | Legally predicate marketed device
MasterSreen Pneumo K071753 Code BTY
MasterScreen IOS K954140 Code BZG
APS Pro K001502 Code BZC |
| 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 and APS Pro 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
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 .
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.
Required Components 5.13
- Measuring device MS-Pneumo or MS-IOS or APS Pro .
- . Or Workstation / Server
- Trolley / Stand .
- High performance computer .
- Printer .
- Accessories ●
- SentrySuite software .
- Instruction for Use �
.****
3
Summary Table of Comparison 5.14
Comparison with the predicate devices
| | MasterScreen
IOS
(K954140) | MasterScreen
Pneumo
(K071753) | APS Pro
(K001502) | SentrySuite
Product line |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The MasterScreen IOS is
intended to be used for
measurement and data
collection of lung function
parameters in humans.
The system performs
cooperation-dependent
pulmonary function tests
which include
Spirometry/Flow-
Volume/Resistance
measurements and the
IOS (multifrequent
oscillometry determination)
measurement. Tests can
be easily and quickly
conducted on the basis of
Impulse Oscillometry. The
device is useful in the field
of early diagnosis in every-
day-routine, for clinical
trend observations
as well as for
epidemiologic studies. As
only a minimum of patient
cooperation is required,
Impulse Oscillometry is
also suitable for pediatric
and geriatric studies.
Measurements will be
performed under the
direction of a physician in
the clinic, doctor's office or
hospital.
The MasterScreen IOS is
powered from 100-240 V /
50-60 Hz wall outlets. No
energy is transferred to the
patient. | The Masterscreen Pneumo
is intended to be used for
measurement and data
collection of lung function
parameters. The system
performs cooperation-
dependent flow-volume
measurements. Mostly it
will be used for COPD and
Asthma patients.
Measurements will be
performed under the
direction of a physician in
the clinic, doctor's office or
hospital. It can be utilized
for patients from 4 years on
and older as long as they
can cooperate in the
performance.
The Masterscreen Pneumo
is powered from 100-240V
/ 50-60Hz wall outlets. No
energy is transferred to the
patient. | General
The Aerosol Provocation
System (APSpro) is
intended for specific and
non-specific bronchial
hyperreactivity tests
(provocation tests), as well
as for reversibility tests
using bronchodilatators.
The system is to be used
together with a PC-based
lung-function equipment of
Jaeger together with a
Jaeger compressor to
measure and to display
simultaneously the results
during a patient
reaction. For the D.S.
market only legally
marketed nebulizers which
are also approved by
Jaeger are allowed to be
used with the APS-pro.
Currently only the
SIDESTREAM nebulizer
manufactured by Medic-Aid
Ltd. is approved
(K924123).
Place of use
The system is only to be
used in-door. The required
ambient conditions are
• Temperature: +10 to
+40°C
• Relative humidity: 30% to
75%
• Barometric pressure: 700
to 1060 mBar
Patient groups
The system is to be used
for testing patients from 4
years upwards. Tests with
the APSpro are to be
performed by the order of
a physician only. During
the tests trained personal
must be available. | 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. |
| Patient
population | MasterScreen IOS
can be used for
pediatric and geriatric
studies. | It can be utilized for
patients from 4 years
on and older as long
as they can
cooperate in the
performance. | The system is to be
used for testing
patients from 4 years
upwards. | 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. |
| Hardware | • IOS head
• Trolley or Stand
with power supply
• Pneumotach
handle
• Desktop /
Notebook
• Accessories | • Trolley or Stand
with power supply
• Pneumotach
handle
• Desktop /
Notebook
• Accessories | • Nubulizer head
• Compressor
• Trolley or Stand
with power supply
• Desktop /
Notebook
• Accessories | identical |
| Software | JLAB Software | JLAB Software | JLAB Software | SentrySuite
Software |
| Perfor-
mance
specifica-
tion
(measure-
ment
programs) | • Impulse
oscillometry
• Spirometry
• Flow / Volume
• Maximal Voluntary
Ventilation (MVV)
• Incentive
Spirometry | • R-Occlusion
• Spirometry
• Flow / Volume
• Maximal Voluntary
Ventilation (MVV)
• Incentive
Spirometry | • Bronchial test
o Bronchospas-
molysis
o Bronchoprovo-
cation
o Pulsed
Nebulization
o Continuous
Nebulization | identical |
| Energy
type | 100 - 240V / 50 -
60Hz | 100 - 240V / 50 -
60Hz | 100 - 240V / 50 -
60Hz | identical |
| Patient
contacting
parts
( | • Single Use
mouthpiece
(material: Bormed
RG835 MO)
• Silicone
mouthpiece
• Nose clip
(material:
Polyacetal)
• Nose clip pad
(material: Ethylene
Vinyl Acetate) | • Single Use
mouthpiece
(material: Bormed
RG835 MO)
• Silicone
mouthpiece
• Nose clip
(material:
Polyacetal)
• Nose clip pad
(material: Ethylene
Vinyl Acetate) | • Single Use
mouthpiece
(material: Bormed
RG835 MO)
• Silicone
mouthpiece
• Nose clip
(material:
Polyacetal)
• Nose clip pad
(material: Ethylene
Vinyl Acetate) | identical |
| Sterili-
zation | The MasterScreen
IOS along with its
accessories is
neither supplied
sterile nor intended
to be sterilized | The MasterScreen
Pneumo along with
its accessories is
neither supplied
sterile nor intended
to be sterilized | The APS Pro along
with its accessories is
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 | • Use as
Workstation
• Use as Server
• Online connection
• Vlink connection
• GDT connection
• Data integration
• Database handling | • Use as
Workstation
• Use as Server
• Online connection
• Vlink connection
• GDT connection
• Data integration
• Database handling | Identical |
.
.
--••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••
.
4
5 510(k) Summary
్లో ప్రా
..
·
. .
:
5
Discussion to the table above:
The insignificant difference from the SentrySuite Product line to the devices MasterScreen lOS K954140, MasterScreen Pneumo K071753 and-APS-Pro K001502 is:
- The JLAB software will be superseded by the new SentrySuite � software. The measurement programs for the medical applications for each device remain the same.
5.15 Summary of Device Testing
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 software was developed according to IEC 62304 (Software life-. cycle processes) and IEC 62366 (Usability) standard.
- The risk analysis method used to assess the impact of the new software . SentrySuite was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.
Conclusions 5.16
Based on the above. CareFusion Germany 234 GmbH concludes that the SentrySuite Product line with the SentrySuite software is substantially equivalent to the legally marketed predicate devices and is safe and effective for its intended use, and performs at least as well as the predicate devices.
6
Image /page/6/Picture/1 description: The image contains a logo for the Department of Health & Human Services USA. The logo features the department's seal, which includes an abstract symbol consisting of three stylized human figures or shapes connected by curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the seal.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Carefusion Germany 234 GmbH Mr. Elmar Niedermeyer Regulatory Affairs Specialist Leibnizstrasse 7 Hoechberg, Bavaria Germany 97204
AUG 1 2 2011
Re: K111053
Trade/Device Name: SentrySuite Product Line Regulation Number: 21 CFR 868.1890 Regulation Name: Predictive Pulmonary-Function Value Calculator Regulatory Class: II Product Code: BTY, BZC, BZG Dated: July 28, 2011 Received: August 1, 2011
Dear Mr. Niedermeyer: ·
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract fiability warranties. We remind you, however, that device labeling must be truthful and not misleading.
ff your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 – Mr. Niedermeyer
Please be advised that FDA's issuance of a substantial equivalence determination does notmean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.html for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510(k) Number (if known): K111053
Device Name:
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 online 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
oncurrence of CDRH, Office of Device Evaluation (ODE)
Nungesser for L. Schultheiss
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KII1052 510(k) Number:
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