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, 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
Bodyplethysmography
Respiratory Drive P0.1
PI/PE Max (MIP/MEP)
Single Breath Diffusion CO/He

AI/ML Overview

The acceptance criteria for the SentrySuite Product Line, specifically for the updated SentrySuite 2.7 software, are based on the statistical correlation of its performance with the predicate JLAB software. The study's objective was to demonstrate substantial equivalence by showing that the new software generates results that are highly correlated with the predicate software.

Here's a breakdown of the requested information:

Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Statistical Correlation (p-value): For each key parameter (DLCO, VA, Vin for Diffusion Single Breath CO/He; TLC, FRCpl, RV, sReff, Reff for Bodyplethysmography; P0.1 for Respiratory Drive; PI/PE Max for PI/PE Max (MIP/MEP)), the one-tail p-value for the bivariate correlation test between the SentrySuite 2.7 software and the predicate JLAB software must be < 0.01.	- Diffusion Single Breath CO/He (DLCO, VA, Vin): p-value < 0.0001 (Pass)- Bodyplethysmography (TLC, FRCpl, RV, sReff, Reff): p-value < 0.0001 (Pass)- Respiratory Drive (P0.1): p-value < 0.0001 (Pass)- PI/PE Max (MIP/MEP): p-value < 0.0004 (Pass)The comparison of the measured values shows a statistically significant correlation between the new SentrySuite 2.7 software and the predicate JLAB software, fulfilling the pass criterion for all measurements and parameters.

Acceptance Criteria

Reported Device Performance

Statistical Correlation (p-value): For each key parameter (DLCO, VA, Vin for Diffusion Single Breath CO/He; TLC, FRCpl, RV, sReff, Reff for Bodyplethysmography; P0.1 for Respiratory Drive; PI/PE Max for PI/PE Max (MIP/MEP)), the one-tail p-value for the bivariate correlation test between the SentrySuite 2.7 software and the predicate JLAB software must be < 0.01.

- Diffusion Single Breath CO/He (DLCO, VA, Vin): p-value < 0.0001 (Pass)- Bodyplethysmography (TLC, FRCpl, RV, sReff, Reff): p-value < 0.0001 (Pass)- Respiratory Drive (P0.1): p-value < 0.0001 (Pass)- PI/PE Max (MIP/MEP): p-value < 0.0004 (Pass)The comparison of the measured values shows a statistically significant correlation between the new SentrySuite 2.7 software and the predicate JLAB software, fulfilling the pass criterion for all measurements and parameters.

Study that Proves the Device Meets Acceptance Criteria:

Sample size used for the test set and the data provenance:
- Sample Size: The document states that "Human subjects were tested," but does not explicitly provide the number of subjects used in the test set.
- Data Provenance: The study was likely conducted by CareFusion Germany 234 GmbH, suggesting data of European origin (Germany). The study involved "human subjects" tested on the devices. It appears to be a prospective study where new data was collected for the purpose of comparing the two software versions on the same subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of study does not involve "ground truth" established by experts in the sense of a diagnostic interpretation task. Instead, the study compares the measurements generated by two software versions (new SentrySuite 2.7 vs. predicate JLAB) on physical measurements from human subjects. The gold standard in this context is the predicate device's established performance, and the "ground truth" for each measurement is effectively the value reported by the predicate JLAB software. There isn't an expert review process for determining the "truth" of a spirometry reading in this comparison.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This was a direct comparison of numerical outputs from two software versions, not an interpretation task requiring adjudication.
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 MRMC comparative effectiveness study was done. This device is a software update for pulmonary function testing equipment, which measures physiological parameters. It is not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, this study is effectively a standalone performance evaluation of the SentrySuite 2.7 software compared to the predicate JLAB software. While both systems are used by humans to perform measurements, the comparison itself focuses on the outputs generated by the software algorithms from the same physical inputs (human subject physiological responses). The study assesses the statistical correlation between these direct algorithmic outputs.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" in this context is the performance of the legally marketed predicate device running the JLAB software. The new SentrySuite 2.7 software is being evaluated for substantial equivalence to the predicate, meaning its outputs should be statistically similar to those of the predicate when given the same inputs.
The sample size for the training set:
- The document describes a comparison study, not the development of a machine learning model, so there is no "training set" in the traditional sense for an AI/ML algorithm. The software is stated to "supersede" previous versions and "replaces" existing software, implying a re-implementation or enhancement of established algorithms, rather than training a de novo AI model.
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/ML algorithm described in this submission. The ground truth for the comparison study is the predicate device's performance.

Summary

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510(k) Summary

NOV 1 9 2012

GENERAL INFORMATION

Type of Submission 5.1

Traditional 510(k) Submission

Submission date: 08/16/2012

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

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

Phone: Fax: E-mail:

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Establishment Registration Number 5.3 9615102

Common Name or Classification Name 5.4

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) Volume plethysmograph (CFR 868.1760, Product Code JEH)

રે. ર Trade Name

SentrySuite Product Line

Device Classification 5.6

This is a Class II device

5.7 Classification Panel

73 Anesthesiology Part 868 Code BTY, BZG, BZC, JEH

5.8 Reason for Premarket Notification

--- Modification of legally marketed devices ---Change from previously JLAB software to SentrySuite software for some measurement programs of the device MasterScreen PFT Body K072061

Legally predicate marketed device 5.9

SentrySuite Product Line MasterScreen PFT Body MasterScreen Body / Diff

K111053 Code BTY, BZC, BZG K072061 Code JEH K936108 Code JEH

5.10 Predicate Device Company

CareFusion Germany 234 GmbH

5.11 Device Description

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

CareFusion

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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 .
FRC Helium Rebreathing .
. Real Time Single Breath Diffusion
Intra Breath Diffusion .
Bodyplethysmography .
. Respiratory Drive P0.1
PI/PE Max (MIP/MEP) .
Single Breath Diffusion CO/He .

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.

5.13 Required Components

Measuring device MS-Pneumo or MS-IOS or APS Pro or MS-PFT or MS-. PFT Body or MS Body Diff
Or Workstation / Server ●
Trolley / Stand .
High performance computer .

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. 5 510(k) Summary

Printer .
. Accessories
SentrySuite software 2.7x .

・

Instruction for Use .

5.14 Summary Table of Comparison

	SentrySuite Product Line(K113813)	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• Accessories	identical

	MasterScreen IOS
	· Trolley or Stand with power supply

	· Pneumotach handle
	· Desktop / Notebook

	· Accessories


	MasterScreen PFT / PFT Body
	· Trolley with power supply

	· Analyzer box (gas)
	• Pneumotach handle
	· Body Box

	· Desktop / Notebook
	· Accessories

Software	SentrySuite Software (version 2.5)	SentrySuite Software (version 2.7x)

	APS Pro
Perfor-	· Bronchial test
mance	o Bronchospasmolysis

specifica-	Bronchoprovocation0
tion	Pulsed Nebulization0

(measure-	Continuous Nebulizationo
ment
programs)	MasterScreen Pneumo

	· Spirometry
	· Incentive Spirometry

	· Flow / Volume
	• MVV
	· R-Occlusion (Airway Resistance)

	MasterScreen IOS
		identical
	· Spirometry
	· Incentive Spirometry

	· Flow / Volume
	• MVV
	· Impulse oscillometry

	MasterScreen PFT / PFT Body
	· Spirometry

	· Incentive Spirometry
	· Flow / Volume
	• MVV

	· R-Occlusion (Airway Resistance)
	· FRC Helium Rebreathing

	· Real Time Single Breath Diffusion
	· Intra Breath Diffusion

Energy	100 - 240V / 50 - 60Hz
type		identical

Patient	· Single Use mouthpiece (material:

contacting	Bormed RG835 MO)	identical
parts	· Silicone mouthpiece

	· Nose clip (material: Polyacetal)
	· Nose clip pad (material: Ethylene Vinyl
	Acetate)
Sterili-zation	The devices from the SentrySuiteProduct Line (APS Pro, MS Pneumo, MSIOS, MS PFT) along with its accessoriesare neither supplied sterile nor intendedto be sterilized	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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. .

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1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

	B) Comparision to predicate device MasterScreen PFT K072061
	MasterScreen PFT(K072061)	SentrySuite Product Line
Performancespecification(measurementprograms)	MasterScreen PFT• Spirometry• Incentive Spirometry• Flow / Volume• MVV• R-Occlusion (Airway Resistance)• FRC Helium Rebreathing• Real Time Single Breath Diffusion• Intra Breath Diffusion• Diffusion Single Breath CO/He• Bodyplethysmography• Respiratory Drive P0.1• PI/PE Max (MIP/MEP)	Identical
Hardware	MasterScreen PFT• Trolley with power supply• Analyzer box (gas)• Pneumotach handle• Body Box• Desktop / Notebook• Accessories	Identical
Software	MasterScreen PFTJLAB Software 5.x	SentrySuite Software (version 2.7x)

・

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	MasterScreen Body Diff(K936108)	SentrySuite Product Line
Perfor-mancespecifica-tion(measure-mentprograms)	MasterScreen Body / Body Diff• Spirometry• Incentive Spirometry• Flow / Volume• MVV• R-Occlusion (Airway Resistance)• Bodyplethysmography• Respiratory Drive P0.1• PI/PE Max (MIP/MEP)• Single Breath Diffusion CO/He	Identical
Hardware	MasterScreen Body / Body Diff• Trolley with power supply• Pneumotach handle• Body Box (with or without Analyzer box)• Desktop / Notebook• Accessories	Identical
Software	MasterScreen Body / Body DiffJLAB Software 5.x	SentrySuite Software (version 2.7)

Discussion to the two tables above:

The insignificant difference from the SentrySuite Product Line with 510(k) K113813 to the extended SentrySuite Product Line is:

The SentrySuite software with version 2.5 will be superseded by the . SentrySuite software with version 2.7. The existing measurement programs for the medical applications for APS Pro, MasterScreen Pneumo, MasterScreen IOS and MasterScreen PFT remain thereby untouched.
The measurements in bold printed characters of MasterScreen PFT . K072061 of table "B" above will be added to the SentrySuite Product Line with the SentrySuite software version 2.7.

In Summary: The SentrySuite Product Line K113813 with software SentrySuite 2.5 will be expanded with the measurements "Diffusion Single Breath CO/He, bodyplethysmograpy, respiratory drive P0.1 and PI/PE Max (MIP/MEP)" and the software version will be the SentrySuite 2.7.

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Summary of Device Testing 5.15

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 risk analysis method used to assess the impact of the SentrySuite . software was a Failure Modes and Effects Analysis (FMEA) according standard ISO 14971.

Summary detail of the non-clinical performance testing for the following measurement programs:

Diffusion Single Breath CO/He .
Bodyplethysmography .
Respiratory Drive P0.1 .
PI/PE Max (MIP/MEP) .

Human subjects were tested on the above devices with the predicate JLAB software and also with the new SentrySuite software 2.7.

The results obtained with the predicate software JLAB and with the SentrySuite 2.7 software were compared statistically. The bivariate correlation test was chosen to compare the measurements. Beside the correlation coefficient also the one-tail p-value for the test pairs for each selected parameter was calculated. The one-tail p-values were used, as only positive correlation coefficients are judged significant and a requirement for "pass". The passifail criterion was defined based on a significant level of 0.01 for the p-value.

Results of compared key parameters:

Diffusion Single Breath CO/He (DLCO, VA, Vin) p-value <0.0001 / pass A
Bodyplethysmography (TLC, FRCpl, RV, sReff, Reff) s

A Respiratory Drive (P0.1) PI/PE Max (MIP/MEP)

p-value <0,0001 / pass p-value <0.0001 / pass p-value <0,0004 / pass

The comparison of the measured values of the subjects shows statistically significant correlation between the new SentrySuite 2.7 software and the predicate software JLAB. The pass criterion was fulfilled by all

measurements and parameters.

This performance testing demonstrates that the subject device is as safe and effective as the predicate device and meets the intended uses.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue

Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Public Health Service

November 19, 2012

Mr. Elmar Niedermeyer Regulatory Affairs Specialist CareFusion Germany 234 GmbH Leibnizstrasse 7 Hoechberg Bavaria, Germany 97204

Re: K122699

Trade/Device Name: SentrySuite Product Line Regulation Number: 21 CFR 868.1840 Regulation Name: Diagnostic Spirometer Regulatory Class: II Product Code: BTY, BZG, BZC, JEH Dated: August 24, 2012 Received: September 4, 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.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml 15809.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.

Cortley Birther --

DN: c=US, o=U.S. Government, · ou=HHS.ou=FDA.ou=People. cn=Anthony D. Watson, 0.9.2342.19200300.100.1.1=1300 092402

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and

Dental Devices

Office of Device Evaluation

Center for Devices and

Radiological Health

Enclosure

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Indications for Use

K | 22 699 510(k) Number (if known):

Device Name:

SentrySuite Product Line

Indications for Use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

2012.11.19 Susan Runner DDS, MA -13:57:15 -05'00'

(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).