Sentry WEB SmartInterp is a medical software which is intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data. Access to data will be realized via network or internet with assigned access rights. Patient population is not assigned as it is defined by the measuring devices itself.

Device Description

Sentry Web SmartInterp is a web application providing support for execution of post-measurement related clinical tasks like re-evaluation, quality grading and interpretation of medical readings. Sentry WEB SmartInterp does not primarily rely on electronic document formats – PDF-like reports – but utilizes modern web technologies to create a rich web-based user experience. Due to its general approach Sentry WEB SmartInterp can serve in many environments as 'the post-measurement' solution - customer-owned or as cloud based software service. Hence, Sentry WEB SmartInterp on one hand extends stand-alone diagnostic systems by running on the measurement system as local post-measurement component. For small labs Sentry WEB SmartInterp enables the attending physician to supervise several measurement units from his office. In mid-sized cardiopulmonary labs Sentry SmartInterp introduces optimized post-measurement workflow WEB capabilities. Finally in sophisticated multi-site setups Sentry WEB SmartInterp supports the channeling of data and creates the throughput required for large clinical teams.

AI/ML Overview

The provided 510(k) summary for the Sentry Web SmartInterp device does not include specific acceptance criteria or a detailed study proving its performance against such criteria in the way typically expected for a diagnostic AI device assessing specific conditions.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. The "acceptance criteria" here are implicitly tied to the performance and safety profiles of the predicate devices.

The study described is primarily a non-clinical performance evaluation focused on software development and safety standards rather than a clinical accuracy study for specific diagnostic outcomes.

Here's an breakdown of the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, AUC values) and consequently does not report device performance against such metrics. The "device performance" in this context refers to its ability to function according to its design and meet various software and safety standards.

Characteristic	Acceptance Criterion (Implicitly based on Predicate Equivalence)	Reported Device Performance
Risk Management	Compliance with ISO 14971	Passed applicable tests and standards
Usability	Compliance with EN 62366	Passed applicable tests and standards
Software Life Cycle	Compliance with ISO 62304	Passed applicable tests and standards
Accuracy Testing	Accuracy of evaluated data (against predicate functionality)	Passed applicable tests and standards
Functional Claims	Meets intended use as described in product labeling	Meets functional claims and intended use
Equivalence	Substantially equivalent to predicate devices	Substantially equivalent to predicate devices

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

The document does not specify a "test set" in the context of a diagnostic performance study (e.g., a set of medical images or patient records used to evaluate diagnostic accuracy). The testing performed was primarily non-clinical verification and validation of the software. Therefore, there's no information on sample size or data provenance related to diagnostic performance.

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

As there was no "test set" for diagnostic performance, there were no experts used to establish ground truth for disease diagnoses. The "ground truth" for the non-clinical testing would refer to the expected behavior and outputs of the software based on its design specifications and standard requirements.

4. Adjudication Method

Not applicable, as no diagnostic performance study involving human interpretation and ground truth adjudication was described.

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

No MRMC study was performed or described. The device is presented as an "aid in the evaluation and diagnosis," similar in function to existing predicate software, rather than a system designed to improve human reader effectiveness in a comparative study.

6. Standalone Performance

A standalone (algorithm only) performance evaluation was implicitly conducted as part of the "Accuracy Testing" and "Summary Discussion of Bench Performance Data." The device (software) was tested to ensure it accurately evaluated data and met design specifications.
The statement "The validation and verification testing confirmed this device meets user needs and design inputs for PFT and CPET" and "Accuracy of evaluated Data" falling under "Non-clinical tests" implies standalone functional testing. However, this is not a standalone diagnostic performance study against clinical ground truth.

7. Type of Ground Truth Used

For the non-clinical tests described, the "ground truth" was internal to the development process:

Design specifications and established standards: For risk management (ISO 14971), usability (EN 62366), and software life cycle (ISO 62304).
Expected data evaluation outputs: For "Accuracy of evaluated Data," implying that the software's calculations and interpretations were compared against expected correct outputs for various cardiopulmonary data. This is more of a functional and computational accuracy check rather than a clinical diagnostic ground truth.

There was no clinical ground truth (e.g., pathology, clinical outcomes, expert consensus on diagnoses) used in the reported testing.

8. Sample Size for the Training Set

The document does not mention any "training set," which is typically associated with machine learning or AI models. Given the device's description as an "evaluation software" that relies on web technologies and mirrors existing functionalities of predicate devices, it's unlikely to be a machine learning model requiring a distinct training set in the conventional sense. It appears to be a rule-based or algorithmic system that processes and displays data.

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

Not applicable, as no training set was mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2016

Carefusion Germany 234 Gmbh Elmar Niedermeyer Regulatory Affairs Leibnizstrasse 7 D-97204 Hoechberg Germany

Re: K153654

Trade/Device Name: Sentry Web SmartInterp Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, BZC Dated: August 12, 2016 Received: August 15, 2016

Dear Elmar 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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Muda Jellman
for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K153654

Device Name Sentry WEB SmartInterp

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

GENERAL INFORMATION

5.1 Type of Submission

Traditional 510(k) Submission

Submission date: 15/12/2015

5.2 Submitter

Name:

CareFusion Germany 234 GmbH

Address:

Leibnizstrasse 7 D-97204 Hoechberg Germany

Contact person in Germany:

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

Contact person in the U.S.:

(U.S. Agent) Address

Sharon Nichols

CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 847-3628107 312 9490823 sharon.nichols@carefusion.com

Phone: Fax: E-mail:

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5.3 Establishment Registration Number 9615102

5.4 Common Name or Classification Name

Programmable Diagnostic Computer (CFR 870.1425, Product Code DQK) Pulmonary function data calculator (CFR 868.1880, Product Code BZC)

5.5 Trade Name Sentry WEB SmartInterp

5.6 Device Classification

This is a Class II device

5.7 Classification Panel

74 Cardiovascular Part 870 (Primary) Code DQK 73 Anesthesiology Part 868 (Secondary) Code BZC

5.8 Reason for Premarket Notification

. New device (evaluation software)

5.9 Legally predicate marketed device

SentrySuite Product Line K122699 Code BTY, BZG, BZC, JEH (CareFusion Germany 234 GmbH)
Vyntus/SentrySuite Product line K150810 Code BZC, DPS ● (CareFusion Germany 234 GmbH)
RespiEvents software K012020 Code DQK ● (Non-Invasive Monitoring Systems Inc.)

5.10 Device Description

Sentry Web SmartInterp is a web application providing support for execution of post-measurement related clinical tasks like re-evaluation, quality grading and interpretation of medical readings.

Sentry WEB SmartInterp does not primarily rely on electronic document formats – PDF-like reports – but utilizes modern web technologies to create a rich web-based user experience.

Due to its general approach Sentry WEB SmartInterp can serve in many environments as 'the post-measurement' solution - customer-owned or as cloud based software service. Hence, Sentry WEB SmartInterp on one hand

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extends stand-alone diagnostic systems by running on the measurement system as local post-measurement component. For small labs Sentry WEB SmartInterp enables the attending physician to supervise several measurement units from his office. In mid-sized cardiopulmonary labs Sentry SmartInterp introduces optimized post-measurement workflow WEB capabilities. Finally in sophisticated multi-site setups Sentry WEB SmartInterp supports the channeling of data and creates the throughput required for large clinical teams.

5.11 Intended Use Statement

5.12 Required Components

Workstation / Server / Notebook / Tablet
. Sentry WEB SmartInterp software
Instruction for Use

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5.13 Summary Table of Comparison

Comparison to predicate devices SentrySuite Product Line K122699 &Vyntus/SentrySuite Product Line K150810
	SentrySuiteProduct LineK122699	Vyntus/SentrySuiteProduct LineK150810	Sentry WEBSmartInterp(new device)
Indicationfor Use	The SentrySuite Product line is intendedto be used for measurements, datacollection and analysis of lung function(PFT) parameters, aiding in the diagnosisof related conditions. All themeasurements are performed via amouthpiece, a mask or nasal adapters.The results of the test can be viewed on-line with the help of a computer screenand can be printed after the test. The testresults can be saved for further referral orreport generation purposes. Use of theOption Bronchial Challenge requires thesupervision of a physician familiar withemergency medicine.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 underthe direction of a physician in a hospitalenvironment, physician's office or similarsettings.	The Vyntus/SentrySuite product line isintended to be used for measurements, datacollection and analysis of lung function(PFT) and cardio-pulmonary (CPET)parameters, aiding in the diagnosis ofrelated conditions. The results of the testcan be viewed online with the help of acomputer screen and can be printed afterthe test. The test results can be saved forfuture reference or report generationpurposes.The products can be utilized with patientsage 4 years and older as long as they cancooperate in the performance - no speciallimit to patient's sex or height exists.Measurements will be performed under thedirection of a physician in a hospitalenvironment, physician's office or similarsetting (professional healthcare facilities). Aqualified physician has to reassess allVyntus/SentrySuite measurements. Aninterpretation by Vyntus/SentrySuite is onlysignificant if it is considered in connectionwith other clinical findings.Additional for Vyntus ECG:The Vyntus ECG is intended for measuring thesurface electro-cardiogram (ECG) of a patient.The acquired ECG can be recorded anddisplayed on the screen or printed on paper.12-lead ECGs are analyzed automati-cally andsuggestions for the interpretation of the restingECG can be made by the soft-ware. ECGinterpretation statements made by theVyntus/SentrySuite represent partial qualitativeand quantitative information on the patient'scardiovascular condition and no therapy ordrugs can be administered based solely on theinterpretation statements. The Vyntus ECG canbe used for non-interpretive applications inpatients age 4 years and older and a weight of20 kg or higher. The Vyntus ECG is intended tobe used for routine ECG collection, recordingboth under resting and stress conditions. Themeasure-ment is performed by trainedhealthcare professionals under the direction ofa physician in healthcare facilities (e.g. thedoctor's office or hospital). The Vyntus ECG isnot intended for intracranial use. The VyntusECG is not intended for use in an EMSenvironment (Emergency Medical ServicesEnvironment). The Vyntus ECG is not intendedfor use in home healthcare environments.Automatic interpretation of the ECG is notpossible for pediatric and adolescent patientsbelow 16 years of age and for patients withpacemakers.	Sentry WEBSmartInterp is amedical software whichis intended to be usedas an aid in theevaluation anddiagnosis of alreadymeasuredcardiopulmonary data.Access to data will berealized via network orinternet with assignedaccess rights. Patientpopulation is notassigned as it isdefined by themeasuring devicesitself.RationaleThere is no significantdifference in indicationfor use for evaluationand diagnosis ofpatient data frompulmonary function andcardio pulmonaryexercise testing. Theevaluation anddiagnosis module ofSentrySuite and SentryWEB SmartInterp issimilar and thereby theproposed device issubstantial equivalentto the predicate device.
Patientpopulation	The products can be utilized forpatients from 4 years on and olderas long as they can cooperate inthe performance - no special limitto patient's sex or height.	4 years and older and a weight of20 kg or higher	similarRationale

			will be defined by themeasuring deviceitself. As the patientpopulation depends onthe measuring device,the Sentry WEBSmartInterp patientpopulation is identicalto the predicateSentrySuite devices.There is no differenceand that is why theproposed device issubstantial equivalentto the predicates.
Software	SentrySuite	SentrySuite	Sentry WEBSmartInterp(evaluation part ofSentrySuite)RationaleThe Sentry WEBSmartInterp software isas stand-alone versionof the evaluation anddiagnosis module ofthe predicateSentrySuite devices.There is no new optionor feature in SentryWEB SmartInterpwhich is not availablein the predicateSentrySuite devices.Thereby the proposeddevice is substantialequivalent to thepredicate devices.
Performan-ce (displayof measure-ments)	Spirometry Flow / Volume MVV R-Oclusion (AirwayResistance) FRC Helium Rebreathing Real Time Single BreathDiffusion Intra Breath Diffusion Single Breath DiffusionCO/He Bodyplethysmography Respiratory Drive P0.1 PI/PE Max (MIP/MEP) Impulse oscillometry Bronchial test Bronchospasmlysis Broncho provocat-ion PulsedNebulization ContinuousNebulization	Spirometry Flow / Volume MVV	similar(to K122699 &K150810)RationaleThe evaluation anddiagnosis module ofSentry WEB andSentrySuite is exactthe same. That means,that only parameterscan be evaluatedwhich are alreadyavailable in thepredicate SentrySuitedevices. There is nopossibility to evaluateany new parameters asthe evaluation modulesare identical. Therebythe proposed device issubstantial equivalentto the predicatedevices.
	Breath-by-Breath Indirect Calorimetry Stress & Resting ECG	similar(to K150810)
Comparison to predicate device RespiEvents Software K012020
	RespiEvents SoftwareK012020	Sentry WEB SmartInterp(new device)
Softwarecharacteristics	Displays recorded signals from measuring device Logging already measured values Aid in identifying and classifying measured data Provides analysis of already captured data Evaluating measured physiological data	SimilarRationaleThe Both software can display signals from measuring devices, logging already measured values, add in identifying and classifying measured data, provide analysis of captured data and evaluate measured physiological data. Thereby the proposed software is substantial equivalent to the predicate software.
Intended use	Software running on a computer intended for analyzing and displaying of already measured data	SimilarRationaleBoth medical software are for running on a computer intended for analyzing and displaying of already measured data. Thereby the proposed software is substantial equivalent to the predicate software.

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Summary of technological characteristics compared to the predicate devices to the table above:

The Indication for Use for Sentry WEB SmartInterp is similar to the . predicate devices. It is for evaluating and diagnosis of Cardio Pulmonary data. The SentrySuite software package consists of all these possibilities. . The patient population for the SentrySuite is similar to the patient population of Sentry WEB SmartInterp as the patient population of Sentry WEB SmartInterp depends on the SentrySuite measuring device. . The Sentry WEB SmartInterp software is similar to the SentrySuite evaluation and diagnosis module as all the Sentry WEB SmartInterp options are available in the predicate SentrySuite software. . The displayed measurement parameters which can be evaluated are all present in the predicate devices under the software SentrySuite. The software Characteristics of Sentry WEB SmartInterp and the predicate ● RespiEvents software are similar.
- . The intended use of Sentry WEB SmartInterp and the predicate RespiEvents is similar.

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5.14 Summary of Device Testing

1. Non-clinical tests conducted for determination of substantial equivalence:

	Characteristic	Standard/Test	Results Summary
	1. Risk Management	ISO 14971	The proposed device passes theapplicable tests and standards
	2. Usability	EN 62366	The proposed device passes theapplicable tests and standards
	3. Software life cycle	ISO 62304	The proposed device passes theapplicable tests and standards
	4. Accuracy Testing	Accuracy of evaluatedData	The proposed device passes theapplicable tests and standards
Summary Discussion of Bench Performance Data
The CareFusion Sentry WEB SmartIntern passed all specified test requirements

SmartInterp passed all specified test requiren entry vv The validation and verification testing confirmed this device meets user needs and design inputs for PFT and CPET.

Testing also confirmed physical attributes and device performance meet the requirements of the standards listed in the performance testing summary above. These standards address risk management, usability and software life cycle. All testing which have been performed demonstrate substantial equivalence to the predicate devices.

2. Clinical tests conducted for determination of substantial equivalence and/or of clinical information:

Clinical Performance Data/Information:

Clinical testing was not performed with this device.

3. Conclusion drawn from non-clinical and clinical data:

The Carefusion Sentry WEB SmartInterp meets the functional claims and intended use as described in the product labeling. The Sentry WEB SmartInterp is substantially equivalent to the predicate device described in the submission.

5.15 Conclusion

Based on the modifications above, CareFusion concludes that the Sentry WEB SmartInterp software is substantially equivalent to the legally marketed predicate software devices and as safe as effective as the predicates.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).