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.

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.

Measurements:
Spiormetry
Flow Volume
Maximal Voluntary Ventilation (MVV)
Incentive Spirometry
R-Occlusion
Impulse oscillometry
Bronchial test

AI/ML Overview

Carefusion Germany 234 GmbH's SentrySuite Product line is a software modification that replaces the JLAB software for existing hardware (MasterScreen Pneumo, MasterScreen IOS, APS Pro) used for pulmonary function testing. The 510(k) submission (K111053) focused on demonstrating substantial equivalence to the predicate devices with the JLAB software.

No specific acceptance criteria or a dedicated study demonstrating the device meets acceptance criteria are explicitly detailed in the provided K111053 summary.

However, the submission outlines the general approach taken to ensure the new software performs at least as well as the predicate devices, focusing on the equivalence of its functionality and adherence to relevant standards.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not include a table of explicit acceptance criteria with quantitative performance metrics for the SentrySuite Product line. Instead, it states that the SentrySuite software provides the functionality currently available on the MasterScreen devices using the JLAB software and that "The measurement programs for the medical applications for each device remain the same."

The declaration of substantial equivalence implies that the SentrySuite software is expected to maintain the performance characteristics of the predicate devices. The performance specifications listed in the comparison table (3) under the "Perfor-mance specifica-tion (measure-ment programs)" indicate the types of measurements the device can perform, which are "identical" to the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The 510(k) summary does not specify a sample size for a test set or data provenance in direct relation to evaluating the performance of the SentrySuite software against acceptance criteria. The focus of this 510(k) appears to be on the software change, and the demonstration of equivalence is primarily based on the functional identity of the measurement programs and adherence to software development and risk management standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This information is not applicable and not provided in the context of this 510(k) submission. The device is a pulmonary function testing system that measures parameters. The "ground truth" for such devices typically comes from established calibration standards and physiological measurements, not expert interpretation of results for diagnostic accuracy in the way an imaging AI might.

4. Adjudication Method for the Test Set

This information is not applicable and not provided for the reasons stated above.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not conducted and is not relevant for this type of device. The SentrySuite Product line is a measurement and data collection system, not an AI diagnostic tool requiring human reader interpretation with or without AI assistance.

6. Standalone Performance Study

While not explicitly called a "standalone performance study" in the common sense of AI algorithm evaluation, the software was developed according to:

CareFusion Design and Development SWI (0301-5001-000-SWI)
IEC 62304 (Software life-cycle processes)
IEC 62366 (Usability) standard

This indicates internal verification and validation activities specific to the software's functionality, safety, and usability. The summary states: "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." This suggests that the internal testing aimed to confirm that the new software performs measurements equivalently to the old software, effectively serving as a standalone evaluation of the new software's capabilities.

7. Type of Ground Truth Used

The concept of "ground truth" as pathology or outcomes data is not directly applicable here. For pulmonary function devices, the "ground truth" would relate to the accuracy and precision of the measurements obtained (e.g., spirometry, flow volume, MVV) against recognized calibration standards or accepted physiological models. The submission implies that the measurement programs being "identical" to the predicate devices' programs means they adhere to the same established physiological measurement principles and accuracy.

8. Sample Size for the Training Set

There is no mention of a training set sample size. This device is a software update for a measurement system, not a machine learning or AI model that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no indication of a training set being used for this software modification. The software's functionality is based on established algorithms for pulmonary function measurements, not on learned patterns from a dataset.

Summary of the Study and Evidence for Equivalence:

The primary "study" and evidence presented in K111053 to demonstrate the device meets acceptance criteria (implied as being equivalent in function and safety to the predicate devices) are through:

Comparison to Predicate Devices: A detailed comparison table (3) is provided, highlighting that the "SentrySuite Product line" has identical indications for use, patient population, hardware, performance specifications (measurement programs), energy type, patient-contacting parts, sterilization, and software network options compared to the predicate devices, except for the software name itself (SentrySuite replaces JLAB).
Software Development Standards: Adherence to established software development and usability standards (IEC 62304, IEC 62366) and the company's internal design and development procedures (CareFusion Design and Development SWI).
Risk Analysis: A Failure Modes and Effects Analysis (FMEA) according to ISO 14971 was performed to assess the impact of the new software.
Claim of Functional Equivalence: The submission explicitly states: "Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software." and "The measurement programs for the medical applications for each device remain the same."

Essentially, the document argues that because the new software performs the same functions using the same measurement programs on the same hardware as the legally marketed predicate devices, and was developed under stringent quality and risk management standards, it is substantially equivalent and thus meets the implicit acceptance criteria of being safe and effective for its intended use, performing at least as well as the predicate devices.

Summary

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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

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5.3	Establishment Registration Number9615102
5.4	Common Name or Classification NameCalculator, 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 NameSentrySuite Product line
5.6	Device ClassificationThis is a Class II device
5.7	Classification Panel73 Anesthesiology Part 868Code BTY, BZG, BZC
5.8	Reason for Premarket Notification--- Modification of legally marketed devices ---Change from previously JLAB software to SentrySuite software for thedevices MasterScreen Pneumo, MasterScreen IOS, APS Pro
5.9	Legally predicate marketed deviceMasterSreen Pneumo K071753 Code BTYMasterScreen IOS K954140 Code BZGAPS Pro K001502 Code BZC
5.10	Predicate Device CompanyCareFusion Germany 234 GmbH
5.11	Device DescriptionThe SentrySuite Product line when operating on the existing hardware forMasterScreen Pneumo, MasterScreen IOS and APS Pro will be as functionalas 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

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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 .

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 �

.****

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Summary Table of Comparison 5.14

Comparison with the predicate devices

	MasterScreenIOS(K954140)	MasterScreenPneumo(K071753)	APS Pro(K001502)	SentrySuiteProduct line
Indicationsfor Use	The MasterScreen IOS isintended to be used formeasurement and datacollection of lung functionparameters in humans.The system performscooperation-dependentpulmonary function testswhich includeSpirometry/Flow-Volume/Resistancemeasurements and theIOS (multifrequentoscillometry determination)measurement. Tests canbe easily and quicklyconducted on the basis ofImpulse Oscillometry. Thedevice is useful in the fieldof early diagnosis in every-day-routine, for clinicaltrend observationsas well as forepidemiologic studies. Asonly a minimum of patientcooperation is required,Impulse Oscillometry isalso suitable for pediatricand geriatric studies.Measurements will beperformed under thedirection of a physician inthe clinic, doctor's office orhospital.The MasterScreen IOS ispowered from 100-240 V /50-60 Hz wall outlets. Noenergy is transferred to thepatient.	The Masterscreen Pneumois intended to be used formeasurement and datacollection of lung functionparameters. The systemperforms cooperation-dependent flow-volumemeasurements. Mostly itwill be used for COPD andAsthma patients.Measurements will beperformed under thedirection of a physician inthe clinic, doctor's office orhospital. It can be utilizedfor patients from 4 years onand older as long as theycan cooperate in theperformance.The Masterscreen Pneumois powered from 100-240V/ 50-60Hz wall outlets. Noenergy is transferred to thepatient.	GeneralThe Aerosol ProvocationSystem (APSpro) isintended for specific andnon-specific bronchialhyperreactivity tests(provocation tests), as wellas for reversibility testsusing bronchodilatators.The system is to be usedtogether with a PC-basedlung-function equipment ofJaeger together with aJaeger compressor tomeasure and to displaysimultaneously the resultsduring a patientreaction. For the D.S.market only legallymarketed nebulizers whichare also approved byJaeger are allowed to beused with the APS-pro.Currently only theSIDESTREAM nebulizermanufactured by Medic-AidLtd. is approved(K924123).Place of useThe system is only to beused in-door. The requiredambient conditions are• Temperature: +10 to+40°C• Relative humidity: 30% to75%• Barometric pressure: 700to 1060 mBarPatient groupsThe system is to be usedfor testing patients from 4years upwards. Tests withthe APSpro are to beperformed by the order ofa physician only. Duringthe tests trained personalmust be available.	The SentrySuite Productline is intended to be usedfor measurements, datacollection and analysis oflung function (PFT)parameters, aiding in thediagnosis of relatedconditions. All themeasurements areperformed via amouthpiece, a mask ornasal adapters. Theresults of the test can beviewed on-line with thehelp of a computer screenand can be printed afterthe test. The test resultscan be saved for furtherreferral or reportgeneration purposes. Useof the Option BronchialChallenge requires thesupervision of a physicianfamiliar with emergencymedicine.The products can beutilized for patients from 4years on and older aslong as they cancooperate in theperformance - no speciallimit to patient's sex orheight.Measurements will beperformed under thedirection of a physician ina hospital environment,physician's office orsimilar settings.
Patientpopulation	MasterScreen IOScan be used forpediatric and geriatricstudies.	It can be utilized forpatients from 4 yearson and older as longas they cancooperate in theperformance.	The system is to beused for testingpatients from 4 yearsupwards.	The products can beutilized for patientsfrom 4 years on andolder as long as theycan cooperate in theperformance - nospecial limit topatient's sex orheight.
Hardware	• IOS head• Trolley or Standwith power supply• Pneumotachhandle• Desktop /Notebook• Accessories	• Trolley or Standwith power supply• Pneumotachhandle• Desktop /Notebook• Accessories	• Nubulizer head• Compressor• Trolley or Standwith power supply• Desktop /Notebook• Accessories	identical
Software	JLAB Software	JLAB Software	JLAB Software	SentrySuiteSoftware
Perfor-mancespecifica-tion(measure-mentprograms)	• Impulseoscillometry• Spirometry• Flow / Volume• Maximal VoluntaryVentilation (MVV)• IncentiveSpirometry	• R-Occlusion• Spirometry• Flow / Volume• Maximal VoluntaryVentilation (MVV)• IncentiveSpirometry	• Bronchial testo Bronchospas-molysiso Bronchoprovo-cationo PulsedNebulizationo ContinuousNebulization	identical
Energytype	100 - 240V / 50 -60Hz	100 - 240V / 50 -60Hz	100 - 240V / 50 -60Hz	identical
Patientcontactingparts(	• Single Usemouthpiece(material: BormedRG835 MO)• Siliconemouthpiece• Nose clip(material:Polyacetal)• Nose clip pad(material: EthyleneVinyl Acetate)	• Single Usemouthpiece(material: BormedRG835 MO)• Siliconemouthpiece• Nose clip(material:Polyacetal)• Nose clip pad(material: EthyleneVinyl Acetate)	• Single Usemouthpiece(material: BormedRG835 MO)• Siliconemouthpiece• Nose clip(material:Polyacetal)• Nose clip pad(material: EthyleneVinyl Acetate)	identical
Sterili-zation	The MasterScreenIOS along with itsaccessories isneither suppliedsterile nor intendedto be sterilized	The MasterScreenPneumo along withits accessories isneither suppliedsterile nor intendedto be sterilized	The APS Pro alongwith its accessories isneither suppliedsterile nor intendedto be sterilized	identical
SoftwareNetworkoptions	• Use asWorkstation• Use as Server• Online connection• Vlink connection• GDT connection• Data integration• Database handling	• Use asWorkstation• Use as Server• Online connection• Vlink connection• GDT connection• Data integration• Database handling	• Use asWorkstation• Use as Server• Online connection• Vlink connection• GDT connection• Data integration• Database handling	Identical

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5 510(k) Summary

్లో ప్రా

. .

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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.

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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.

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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

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Indications for Use

510(k) Number (if known): K111053

Device Name:

SentrySuite Product Line

Indications for Use:

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:

Page 1 of

Regulation Number and Section

§ 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).