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.

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) .

AI/ML Overview

This document (CareFusion Germany 234 GmbH 510(k) Summary for MasterScreen IOS) is a 510(k) submission for a device modification, specifically an upgrade of the software from a 16-bit to a 32-bit version. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (MasterScreen IOS K954140/A001) rather than presenting a performance study against specific acceptance criteria for a new device.

Therefore, many of the requested criteria for describing an acceptance study are not applicable or not explicitly detailed in this type of submission for a software upgrade.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics for the modified device. The core of this submission is to demonstrate that the new 32-bit software version performs identically to the predicate device, not that it meets new or updated performance specifications. The "Performance specification (measurement programs)" row in the summary table (Section 5.14) states "identical" for the modified device compared to the predicate, implying no change in fundamental performance.

Acceptance Criteria Category	Acceptance Criteria (Not explicitly stated as criteria, but implied by the submission)	Reported Device Performance (as stated in the document)
Software Functionality	Device performs all functions of the predicate device (Impulse oscillometry, Spirometry, Flow/Volume, MVV) with 32-bit software.	"The JLAB Software changes from 16 bit version to 32 bit version." "Performance specification (measurement programs) identical"
Intended Use	Device maintains the same intended use as the predicate device.	"Indications for Use identical"
Patient Population	Device is suitable for the same patient population as the predicate device.	"Patient population identical"
Safety and Effectiveness	Device is safe and effective for its intended use, and performs at least as well as the predicate device.	"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."

2. Sample size used for the test set and the data provenance:

Sample size: Not specified. The submission does not detail a formal clinical or performance test study with a defined sample size for the modified device.
Data provenance: Not applicable. There is no mention of country of origin or whether the data was retrospective or prospective, as no such performance data is presented. The submission focuses on internal development and risk analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There is no mention of experts or ground truth establishment for a test set. This type of submission relies on technical verification and validation of software changes against the predicate's established performance, rather than re-establishing clinical ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No adjudication method is described as there isn't a performance test set requiring expert review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device (a diagnostic spirometer with software for lung function testing) is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies. Its function is to measure physiological parameters directly.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document implies that the device operates as a standalone system (algorithm only) in terms of its core measurement functions. However, the software itself is not the subject of a standalone performance study in the sense of demonstrating a new algorithm's diagnostic accuracy. The submission asserts the identical performance of the updated software version compared to the predicate. The "algorithm" here (the 32-bit JLAB software) is stated to perform the same measurement programs as the 16-bit version.

7. The type of ground truth used:

Not explicitly stated. For a software upgrade of an existing device, the "ground truth" implicitly refers to the verified and validated performance of the predicate device (MasterScreen IOS K954140/A001) as understood by relevant standards and clinical expectations for spirometry and oscillometry. The submission aims to show that the new software does not alter this established performance.

8. The sample size for the training set:

Not applicable. This is a software upgrade for a diagnostic measurement device, not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned or implied.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in the 510(k) is not a conventional clinical or performance study. Instead, it is a verification and validation process for a software modification.

Objective: To demonstrate that the MasterScreen IOS with the new 32-bit JLAB software is substantially equivalent to the predicate device (MasterScreen IOS K954140/A001) and performs at least as well.
Methodology:
- Development of the modification according to Cardinal Health's standard operating procedures (Design Control).
- Software development following IEC 62304 (Software life-cycle processes) and IEC 60601-1-6 (Usability) standards.
- Risk analysis using Failure Modes and Effects Analysis (FMEA) to assess the impact of the 32-bit software.
Results (Conclusion): "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."

In essence, the submission relies on demonstrating that changing the software from 16-bit to 32-bit, while maintaining identical indications for use, patient population, hardware, performance specifications (measurement programs), energy type, patient contacting parts, sterilization methods, and fundamental scientific technology, does not adversely affect the device's safety or effectiveness compared to the predicate. The "study" is the internal design control, software development, and risk analysis documented to support this claim.

Summary

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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:

E-mail

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

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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

. 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

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. 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

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 .

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5.14 Summary Table of Comparison

	MasterScreen IOS(K954140)	MasterScreen IOSwith 32 bit software
Indicationsfor Use	The MasterScreen IOS is intended to beused for measurement and data collectionof lung function parameters in humans.The system performs cooperation-dependent pulmonary function tests whichinclude Spirometry/Flow-Volume/Resistance measurements andthe IOS (multifrequent oscillometrydetermination) measurement. Tests canbe easily and quickly conducted on thebasis of Impulse Oscillometry. The deviceis useful in the field of early diagnosis inevery-day-routine, for clinical trendobservationsas well as for epidemiologic studies. Asonly a minimum of patient cooperation isrequired, Impulse Oscillometry is alsosuitable for pediatric and geriatric studies.Measurements will be performed underthe direction of a physician in the clinic,doctor's office or hospital.The MasterScreen IOS is powered from100-240 V / 50-60 Hz wall outlets. Noenergy is transferred to the patient.	identical
Patientpopulation	MasterScreen IOS can be used forpediatric and geriatric studies.	identical
Hardware	IOS head Trolley or Stand with power supply Pneumotach handle Desktop / Notebook Accessories	identical
Software	JLAB 4.x16 bit version	JLAB 5.x32 bit version
Performancespecification(measurementprograms)	Impulse scillometry Spirometry Flow / Volume Maximal Voluntary Ventilation (MVV)	identical
Energy type	100 - 240V / 50 - 60Hz	identical
Patientcontactingparts	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 withits accessories is neither suppliedsterile nor intended to be sterilized	identical
FundamentalscientificTechnology	multifrequent oscillometrytechnique (IOS head) / pressure toflow conversion technique(pneumotach handle)	identical

: ·

. , '

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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.

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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.

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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

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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

Page 1 of

Regulation Number and Section

§ 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).