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.

Device Description

The SentrySuite Product line when operating on the existing hardware for MasterScreen Pneumo, MasterScreen IOS, APS Pro and MasterScreen PFT will be as functional as the existing version of JLAB software for all the available measuring programs and options for these devices.

The SentrySuite software replaces the JLAB software and got a brand-new graphical surface.
Measurement can be accomplished under SentrySuite software equivalent as it was possible under the previously powerful JLAB software
The results of the tests can be viewed on-line on the computer screen during the test and can be saved on the computer hard disk for further referral or report generation purposes.
SentrySuite provides the functionality currently available on the MasterScreen devices using the JLAB software.
SentrySuite can be operated on workstations and on servers.

Measurements:

Spiormetry
Flow Volume
Maximal Voluntary Ventilation (MVV)
Incentive Spirometry
R-Occlusion
Impulse oscillometry
Bronchial test
FRC Helium Rebreathing
Real Time Single Breath Diffusion
Intra Breath Diffusion

AI/ML Overview

The provided text is a 510(k) summary for the SentrySuite Product Line, which is a software for lung function measurements. It describes the device, its intended use, and its comparison to predicate devices, but does not contain information about acceptance criteria or a specific study proving the device meets those criteria, as typically understood in the context of clinical performance evaluation with metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily by highlighting that the updated SentrySuite software (version 2.5) replaces an older version (2.3) and incorporates the functionality of another predicate device (MasterScreen PFT K072061). The "Summary of Device Testing" section mentions adherence to development standards (CareFusion Design and Development SWI, IEC 62304, IEC 62366) and risk analysis (ISO 14971 FMEA), but these are related to software development and validation processes, not performance evaluation against specific clinical acceptance criteria.

Therefore, many of the requested details cannot be extracted directly from this document.

Here's what can be gathered and what is missing:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on device modifications and substantial equivalence to predicates, not on specific performance metrics or acceptance criteria for those metrics. The performance is implied to be "identical" or "equivalent" to the predicate devices.

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

Sample size for test set: This information is not provided.
Data provenance: This information is not provided. The document does not describe any specific clinical or performance test data.

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

This information is not provided as there is no description of a clinical or performance test that would require expert-established ground truth.

4. Adjudication method for the test set:

This information is not provided as there is no description of a clinical or performance test that would require adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

This information is not provided. The document does not describe any MRMC study or any study involving human readers with or without AI assistance.

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

The device is a "PFT data calculator" and "pulmonary function data calculator," which implies an algorithm-only function. However, no standalone performance study results, in terms of specific metrics, are presented. The "performance specification" listed in the tables refers to the types of measurements the device can perform (e.g., Spirometry, Flow/Volume), not performance metrics like accuracy or reliability.

7. The type of ground truth used:

This information is not provided because specific performance testing against ground truth is not detailed in this submission.

8. The sample size for the training set:

This information is not provided. The document describes software development and changes, but does not mention any machine learning or AI models that would require training data.

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

This information is not provided.

Summary of what the document DOES provide regarding "testing":

The "Summary of Device Testing" (Section 5.15) states that:

The device modification was developed in accordance with 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) standards.
Risk analysis was performed using FMEA according to ISO 14971.

These are process-oriented validations and risk management activities, typically required for software medical devices, rather than clinical performance studies demonstrating accuracy, sensitivity, or specificity against specific acceptance criteria. The conclusion (Section 5.16) is based on "substantial equivalence" to predicate devices, implying that since the new software maintains identical functionality and performance specifications to previously cleared devices, it is considered safe and effective.

Summary

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MAY 1 0 2012

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KIJ3813

510(k) Summary

GENERAL INFORMATION

5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 12/12/2011

5.2 Submitter

Name:

CareFusion Germany 234 GmbH

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

(Regulatory Affairs Specialist) Elmar Niedermeyer Address: CareFusion Germany 234 GmbH Leibnizstrasse 7, 97204 Hoechberg Germany Phone: +49 931 49 72 - 361 +49 931 49 72 - 62361 FAX: E-mail elmar.niedermeyer@carefusion.com

Contact person in the U.S .:

(Official Correspondent)

Carol Emerson

Address

CareFusion 22745 Savi Ranch Parkway Yorba Linda, CA 92887

Phone: Fax: E-mail:

714-919-3342 714-283-8420 carol emerson@carefusion.com

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5.3 Establishment Registration Number 9615102

5.4 Common Name or Classification Name

Calculator, Predicted Values, Pulmonary Function (CFR 868.1890, Product Code BTY) Pulmonary function data calculator (CFR 868.1880, Product Code BZC) Diagnostic Spirometer (CFR 868.1840, Product Code BZG)

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 device MasterScreen PFT K072061 by adding it to the SentrySuite Product Line.

5.9 Legally predicate marketed device

SentrySuite Product Line K111053 Code BTY, BZC, BZG MasterScreen PFT K072061 Code JEH

5.10 Predicate Device Company

CareFusion Germany 234 GmbH

Device Description 5.11

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.

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5 510(k) Summary

SentrySuite provides the functionality currently available on the . MasterScreen devices using the JLAB software.
SentrySuite can be operated on workstations and on servers. .

Measurements:

. Spiormetry
Flow Volume .
Maximal Voluntary Ventilation (MVV) .
Incentive Spirometry .
R-Occlusion .
. Impulse oscillometry
Bronchial test ●
. FRC Helium Rebreathing
Real Time Single Breath Diffusion .
Intra Breath Diffusion .

Intended Use Statement 5.12

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 MS-PFT .
Or Workstation / Server .
Trolley / Stand .
High performance computer .
Printer .
Accessories .
SentrySuite software 2.5 .
Instruction for Use .

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5.14 Summary Table of Comparison

A) Comparison to predicate device SentrySuite Product Line 510(k) # K111053

	SentrySuite Product Line(K111053)	SentrySuite Product Line
Indicationsfor Use	The SentrySuite Product line is intended tobe used for measurements, data collectionand analysis of lung function (PFT)parameters, aiding in the diagnosis ofrelated conditions. All the measurementsare performed via a mouthpiece, a mask ornasal adapters. The results of the test canbe viewed on-line with the help of acomputer screen and can be printed afterthe test. The test results can be saved forfurther referral or report generationpurposes. Use of the Option BronchialChallenge requires the supervision of aphysician familiar with emergencymedicine.The products can be utilized for patientsfrom 4 years on and older as long as theycan cooperate in the performance - nospecial limit to patient's sex or height.Measurements will be performed under thedirection of a physician in a hospitalenvironment, physician's office or similarsettings.	identical
Patientpopulation	The products can be utilized for patientsfrom 4 years on and older as long as theycan cooperate in the performance - nospecial limit to patient's sex or height.	identical
Hardware	APS Pro· Nebulizer head· Compressor· Trolley or Stand with power supply· Desktop / Notebook· AccessoriesMasterScreen Pneumo· Trolley or Stand with power supply· Pneumotach handle• Desktop / Notebook· AccessoriesMasterScreen IOS· Trolley or Stand with power supply· Pneumotach handle· Desktop / Notebook· Accessories	identical
Software	SentrySuite Software (version 2.3)	SentrySuite Software (version 2.5)
Perfor-mancespecifica-tion(measure-mentprograms)	APS Pro• Bronchial test• Bronchospasmolysis• Bronchoprovocation• Pulsed Nebulization• Continuous NebulizationMasterScreen Pneumo• Spirometry• Incentive Spirometry• Flow / Volume• MVV• R-Occlusion (Airway Resistance)MasterScreen IOS• Spirometry• Incentive Spirometry• Flow / Volume• MVV• Impulse oscillometry	identical
Energytype	100 - 240V / 50 - 60Hz	identical
Patientcontactingparts	• Single Use mouthpiece (material:Bormed RG835 MO)• Silicone mouthpiece• Nose clip (material: Polyacetal)• Nose clip pad (material: Ethylene VinylAcetate)	identical
Sterili-zation	The devices from the SentrySuiteProduct Line (APS Pro, MS Pneumo, MSIOS) along with its accessories areneither supplied sterile nor intended to besterilized	identical
SoftwareNetworkoptions	• Use as Workstation• Use as Server• Online connection• Vlink connection• GDT connection• Data integration• Database handling• JINET server	Identical

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B} Comparison to predicate device MasterScreen PFT 510(k) # K072061
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

	New feature comparison
	MasterScreen PFT(K072061)	SentrySuite Product Line
Perfor-mancespecifica-tion(measure-mentprograms)	MasterScreen PFT• Spirometry• Incentive Spirometry• Flow / Volume• MVV• R-Occlusion (Airway Resistance)• FRC Helium Rebreathing• Real Time Single Breath Diffusion• Intra Breath Diffusion	Identical
Hardware	• Trolley with power supply• Analyzer box (gas)• Pneumotach handle• Desktop / Notebook• Accessories	Identical
Software	JLAB Software 5.x	SentrySuite Software (version 2.5)

Discussion to the two tables above:

The insignificant difference from the SentrySuite Product Line with 510(k) K111053 to the extended SentrySuite Product Line is:

The SentrySuite software with version 2.3 will be superseded by the . SentrySuite software with version 2.5. The measurement programs for the medical applications for APS Pro, MasterScreen Pneumo and MasterScreen IOS remain thereby untouched.
The device MasterScreen PFT K072061 with the measurement programs . from the table "B" above will be added to the SentrySuite Product Line under the SentrySuite software version 2.5.

In Summary: The SentrySuite Product Line K111053 with software SentrySuite 2.3 will be expanded with the measurements "FRC Helium Rebreathing, Real Time Single Breath Diffusion and Intrabreath Diffusion" and the software version is the SentrySuite 2.5.

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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 SentrySuite . software was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.

5.16 Conclusions

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/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle in flight, with three curved lines representing the wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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 Hoechberg GERMANY 97204

MAY 1 0 2012

Re: K113813

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: April 23, 2012 Received: April 26, 2012

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. Niedermeyer

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/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.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 vours.

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): K

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 × (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)

L. Selmer

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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).