(219 days)
K954140/A001
Not Found
No
The document describes standard pulmonary function testing methods and data analysis without mentioning AI or ML.
No
The device is described as a diagnostic medical device for lung function testing, intended for measurement and data collection, rather than treatment.
Yes
The "Intended Use / Indications for Use" section states, "The device is useful in the field of early diagnosis in every-day-routine". Additionally, the "Device Description" explicitly calls it a "diagnostically medical device for lung function testing for the early detection of pathological changes".
No
The device description explicitly mentions hardware components like power requirements (100-240 V / 50-60 Hz wall outlets) and describes physical measurements (Spirometry/Flow-Volume/Resistance, Impulse Oscillometry) which require hardware sensors and interfaces.
Based on the provided text, the MasterScreen IOS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices 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 monitor therapeutic measures.
- MasterScreen IOS Function: The MasterScreen IOS directly measures lung function parameters in humans through non-invasive methods like spirometry and oscillometry. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use describes the device as performing "cooperation-dependent pulmonary function tests" and "measurement and data collection of lung function parameters in humans." This is a direct measurement of a physiological function within the body, not an in vitro analysis of a specimen.
Therefore, the MasterScreen IOS falls under the category of a non-invasive diagnostic medical device that measures physiological parameters directly from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
BZG
Device Description
MasterScreen IOS is a diagnostically medical device for lung function testing for the early detection of pathological changes and their onset in the small airways and provides the following advantages:
- Quick and low-cost noninvasive determination of Respiratory Impedance with low technical expenditure
- Differentiation between proximal (central airways) and distal (peripheral airways) pulmonary components
- Sensitive detection and differentiation of extrathoracic changes in the respiratory system
- Save method for differentiation between trapped air or respiratory collapse and obstruction
- Recorded parameters provide valuable information for early diagnosis of pulmonary diseases
- Graphic interpretation of the results on the basis of a simple lung-thorax model
- Airway impedance via complete VC-maneuver allows to answer further clinical questions
- Differentiated determination of bronchial hyper reactivity of both provocation and spasmolysis independent of cooperation.
- Determination of static (VCin, VCex, ... ) and dynamic (FVC, FEV1, FEF50, ... ) lung volumes by the proven Spirometry/Flow-Volume program.
Measurements: - Impulse oscillometry
- Spirometry
- Flow / Volume
- Maximal Voluntary Ventilation (MVV)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lung
Indicated Patient Age Range
pediatric and geriatric studies.
Intended User / Care Setting
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K954140/A001
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).
0
5 510(k) Summary
510(k) Summary
1101873 FEB 1 0 2011
GENERAL INFORMATION
5.1 Type of Submission
Special 510(k) Submission
Submission date: 22/06/2010
5.2 Submitter
Name:
CareFusion Germany 234 GmbH
Address:
Phone:
FAX:
Leibnizstrasse 7 D-97204 Hoechberg Germany
等
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
Contact person in the U.S.: Infficial C
| (Official Correspondent) | Thomas Gutierrez |
|---|---|
| Address | CareFusion |
| Phone: | 714-919-3342 |
| Fax: | 714-283-8420 |
| E-mail: | thomas.gutierrez@carefusion.com |
| 22745 Savi Ranch Road | |
| Yorba Linda, CA 92887 |
1
5 510(k) Summary
- 5.3 Establishment Registration Number 9615102
- 5.4 Common Name or Classification Name Diagnostic Spirometer (CFR 868.1840, Product Code BZG)
- 5.5 Trade Name MasterScreen IOS
- રાદ Device Classification This is a Class II device
5.7 Classification Panel 73 Anesthesiology Part 868 Code BZG
5.8 Reason for Premarket Notification Device modification to an existing CareFusion - device regarding "The New 510(k) Paradigm" -- change from 16 bit software to 32 bit software --
- 5.9 Legally predicate marketed device MasterSreen IOS K954140/A001 Code BZG
- 5.10 Predicate Device Company CareFusion Germany 234 GmbH
5.11 Device Description
MasterScreen IOS is a diagnostically medical device for lung function testing for the early detection of pathological changes and their onset in the small airways and provides the following advantages:
- . Quick and low-cost noninvasive determination of Respiratory Impedance with low technical expenditure
- Differentiation between proximal (central airways) and distal (peripheral . airways) pulmonary components
- . Sensitive detection and differentiation of extrathoracic changes in the respiratory system
- Save method for differentiation between trapped air or respiratory collapse . and obstruction
- Recorded parameters provide valuable information for early diagnosis of . pulmonary diseases
- Graphic interpretation of the results on the basis of a simple lung-thorax . model
- Airway impedance via complete VC-maneuver allows to answer further � clinical questions
2
- . Differentiated determination of bronchial hyper reactivity of both provocation and spasmolysis independent of cooperation.
- Determination of static (VCin, VCex, ... ) and dynamic (FVC, FEV1, FEF50, . ...) lung volumes by the proven Spirometry/Flow-Volume program.
Measurements:
- . Impulse oscillometry
- . Spirometry
- . Flow / Volume
- Maximal Voluntary Ventilation (MVV) .
5.12 Intended Use Statement
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.
5.13 Required Components
- IOS measuring unit including impulse generator, flow and pressure . sensor
- Trollev / Stand .
- . High performance personal computer / Notebook
- . Printer
- Acquisition interface .
- . Acquisition software
- Accessories .
- Instruction for Use .
3
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·
: 上
.
.
5.14 Summary Table of Comparison
| | MasterScreen IOS
(K954140) | MasterScreen IOS
with 32 bit software |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 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. | identical |
| Patient
population | MasterScreen IOS can be used for
pediatric and geriatric studies. | identical |
| Hardware | IOS head Trolley or Stand with power supply Pneumotach handle Desktop / Notebook Accessories | identical |
| Software | JLAB 4.x
16 bit version | JLAB 5.x
32 bit version |
| Performance
specification
(measurement
programs) | Impulse scillometry Spirometry Flow / Volume Maximal Voluntary Ventilation (MVV) | identical |
| Energy type | 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) | identical |
| Sterilization | The MasterScreen IOS along with
its accessories is neither supplied
sterile nor intended to be sterilized | identical |
| Fundamental
scientific
Technology | multifrequent oscillometry
technique (IOS head) / pressure to
flow conversion technique
(pneumotach handle) | identical |
·
,
.
: ·
.
:
. , '
4
Discussion to the table above:
The insignificant difference to the MasterScreen IOS K954140/A001 is:
- The JLAB Software changes from 16 bit version to 32 bit version .
5.15 Summary of Device Testing
The following practices were followed and monitored for development of the MasterScreen IOS with 32 bit JLAB software:
- The modification for the above device was developed in accordance . with the Cardinal Health development standard operating procedures (000490 09 - Design Control).
- The software was developed according to IEC 62304 (Software life-. cycle processes) and IEC 60601-1-6 (Usability) standard.
- The risk analysis method used to assess the impact of MasterScreen . IOS with 32 bit software was a Failure Modes and Effects Analysis (FMEA).
5.16 Conclusions
Based on the above, CareFusion Germany 234 GmbH concludes that the MasterScreen IOS with the 32 bit JLAB software is substantially equivalent to legally marketed predicate device and is safe and effective for its intended use, and performs at least as well as the predicate device.
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Elmar Niedermeyer Regulatory affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 97204 Hoechberg GERMANY
FEB 10 201
Re: K101873
Trade/Device Name: MasterScreen IOS Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BZG Dated: February 2, 2011 Received: February 7, 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 liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If 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.
6
Page 2 - Mr. Niedermever
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 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 (QS) 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/CDRHQffices/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.htm 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.
Wh for
Anthony 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
7
Indications for Use
510(k) Number (if known): K
Device Name:
MasterScreen IOS
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 cause 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 geriation 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.
Prescription Use × (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Schick
(Division Sign-Uff) (Division Sigil-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion Devices Division of Ansothers - 3.
Infection Control, Dental Devices
510(k) Number: K101873
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