Sentry WEB SmartInterp

K153654 · Carefusion Germany 234 GmbH · DQK · Sep 16, 2016 · Cardiovascular

Device Facts

• Record ID: K153654
• Device Name: Sentry WEB SmartInterp
• Applicant: Carefusion Germany 234 GmbH
• Product Code: DQK · Cardiovascular
• Decision Date: Sep 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Sentry WEB SmartInterp is a web-based medical software application for post-measurement clinical tasks, including re-evaluation, quality grading, and interpretation of cardiopulmonary data. It functions as a standalone version of the evaluation and diagnosis module found in CareFusion's SentrySuite product line. The device receives cardiopulmonary data inputs via network or internet access. It provides clinicians with tools to evaluate and diagnose these readings, supporting workflows in physician offices, hospitals, and multi-site clinical environments. By enabling remote access and centralized data review, it allows physicians to supervise multiple measurement units, optimize post-measurement workflows, and manage data throughput for large clinical teams. The output consists of evaluated and graded cardiopulmonary data, which aids the physician in clinical decision-making. It does not perform primary measurements itself; it relies on the patient population and data parameters established by the connected measuring devices.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed the device meets user needs and design inputs for PFT and CPET, including compliance with ISO 14971 (risk management), EN 62366 (usability), and ISO 62304 (software life cycle). Accuracy testing confirmed the software correctly evaluates data compared to predicate systems.

Technological Characteristics

Web-based software application; operates on workstations, servers, notebooks, or tablets. Connectivity via network/internet. Software life cycle follows ISO 62304. Evaluation algorithms are identical to those in the predicate SentrySuite software. No hardware components; purely software-based diagnostic aid.

Indications for Use

Indicated for use as an aid in the evaluation and diagnosis of previously measured cardiopulmonary data. Patient population is defined by the primary measuring device used to collect the data.

Regulatory Classification

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.

Predicate Devices

• SentrySuite Product Line (K122699)
• Vyntus/SentrySuite Product line (K150810)
• RespiEvents software (K012020)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span style="font-family: Arial, sans-serif;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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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: | [phone] - 361 |
| FAX: | [phone] - 62361 |
| E-mail | [e-mail] |

# 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 [e-mail]

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

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.

#### 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 &<br>Vyntus/SentrySuite Product Line K150810 | | | |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SentrySuite<br>Product Line<br>K122699 | Vyntus/SentrySuite<br>Product Line<br>K150810 | Sentry WEB<br>SmartInterp<br>(new device) |
| Indication<br>for Use | The SentrySuite Product line is intended<br>to be used for measurements, data<br>collection and analysis of lung function<br>(PFT) parameters, aiding in the diagnosis<br>of related conditions. All the<br>measurements are performed via a<br>mouthpiece, a mask or nasal adapters.<br>The results of the test can be viewed on-<br>line with the help of a computer screen<br>and can be printed after the test. The test<br>results can be saved for further referral or<br>report generation purposes. Use of the<br>Option Bronchial Challenge requires the<br>supervision of a physician familiar with<br>emergency medicine.<br>The products can be utilized for patients<br>from 4 years on and older as long as they<br>can cooperate in the performance - no<br>special limit to patient's sex or height.<br>Measurements will be performed under<br>the direction of a physician in a hospital<br>environment, physician's office or similar<br>settings. | The Vyntus/SentrySuite product line is<br>intended to be used for measurements, data<br>collection and analysis of lung function<br>(PFT) and cardio-pulmonary (CPET)<br>parameters, aiding in the diagnosis of<br>related conditions. The results of the test<br>can be viewed online with the help of a<br>computer screen and can be printed after<br>the test. The test results can be saved for<br>future reference or report generation<br>purposes.<br>The products can be utilized with patients<br>age 4 years and older as long as they can<br>cooperate in the performance - no special<br>limit to patient's sex or height exists.<br>Measurements will be performed under the<br>direction of a physician in a hospital<br>environment, physician's office or similar<br>setting (professional healthcare facilities). A<br>qualified physician has to reassess all<br>Vyntus/SentrySuite measurements. An<br>interpretation by Vyntus/SentrySuite is only<br>significant if it is considered in connection<br>with other clinical findings.<br>Additional for Vyntus ECG:<br>The Vyntus ECG is intended for measuring the<br>surface electro-cardiogram (ECG) of a patient.<br>The acquired ECG can be recorded and<br>displayed on the screen or printed on paper.<br>12-lead ECGs are analyzed automati-cally and<br>suggestions for the interpretation of the resting<br>ECG can be made by the soft-ware. ECG<br>interpretation statements made by the<br>Vyntus/SentrySuite represent partial qualitative<br>and quantitative information on the patient's<br>cardiovascular condition and no therapy or<br>drugs can be administered based solely on the<br>interpretation statements. The Vyntus ECG can<br>be used for non-interpretive applications in<br>patients age 4 years and older and a weight of<br>20 kg or higher. The Vyntus ECG is intended to<br>be used for routine ECG collection, recording<br>both under resting and stress conditions. The<br>measure-ment is performed by trained<br>healthcare professionals under the direction of<br>a physician in healthcare facilities (e.g. the<br>doctor's office or hospital). The Vyntus ECG is<br>not intended for intracranial use. The Vyntus<br>ECG is not intended for use in an EMS<br>environment (Emergency Medical Services<br>Environment). The Vyntus ECG is not intended<br>for use in home healthcare environments.<br>Automatic interpretation of the ECG is not<br>possible for pediatric and adolescent patients<br>below 16 years of age and for patients with<br>pacemakers. | Sentry WEB<br>SmartInterp is a<br>medical software which<br>is intended to be used<br>as an aid in the<br>evaluation and<br>diagnosis of already<br>measured<br>cardiopulmonary data.<br>Access to data will be<br>realized via network or<br>internet with assigned<br>access rights. Patient<br>population is not<br>assigned as it is<br>defined by the<br>measuring devices<br>itself.<br>Rationale<br>There is no significant<br>difference in indication<br>for use for evaluation<br>and diagnosis of<br>patient data from<br>pulmonary function and<br>cardio pulmonary<br>exercise testing. The<br>evaluation and<br>diagnosis module of<br>SentrySuite and Sentry<br>WEB SmartInterp is<br>similar and thereby the<br>proposed device is<br>substantial equivalent<br>to the predicate device. |
| Patient<br>population | The products can be utilized for<br>patients from 4 years on and older<br>as long as they can cooperate in<br>the performance - no special limit<br>to patient's sex or height. | 4 years and older and a weight of<br>20 kg or higher | similar<br>Rationale |
| | | | |
| | | | will be defined by the<br>measuring device<br>itself. As the patient<br>population depends on<br>the measuring device,<br>the Sentry WEB<br>SmartInterp patient<br>population is identical<br>to the predicate<br>SentrySuite devices.<br>There is no difference<br>and that is why the<br>proposed device is<br>substantial equivalent<br>to the predicates. |
| Software | SentrySuite | SentrySuite | Sentry WEB<br>SmartInterp<br>(evaluation part of<br>SentrySuite)<br><br><b>Rationale</b><br>The Sentry WEB<br>SmartInterp software is<br>as stand-alone version<br>of the evaluation and<br>diagnosis module of<br>the predicate<br>SentrySuite devices.<br>There is no new option<br>or feature in Sentry<br>WEB SmartInterp<br>which is not available<br>in the predicate<br>SentrySuite devices.<br>Thereby the proposed<br>device is substantial<br>equivalent to the<br>predicate devices. |
| Performan-<br>ce (display<br>of measure-<br>ments) | Spirometry Flow / Volume MVV R-Oclusion (Airway<br>Resistance) FRC Helium Rebreathing Real Time Single Breath<br>Diffusion Intra Breath Diffusion Single Breath Diffusion<br>CO/He Bodyplethysmography Respiratory Drive P0.1 PI/PE Max (MIP/MEP) Impulse oscillometry Bronchial test Bronchospasm<br>lysis Broncho provocat-<br>ion Pulsed<br>Nebulization Continuous<br>Nebulization | Spirometry Flow / Volume MVV | <b>similar</b><br>(to K122699 &<br>K150810)<br><br><b>Rationale</b><br>The evaluation and<br>diagnosis module of<br>Sentry WEB and<br>SentrySuite is exact<br>the same. That means,<br>that only parameters<br>can be evaluated<br>which are already<br>available in the<br>predicate SentrySuite<br>devices. There is no<br>possibility to evaluate<br>any new parameters as<br>the evaluation modules<br>are identical. Thereby<br>the proposed device is<br>substantial equivalent<br>to the predicate<br>devices. |
| | Breath-by-Breath Indirect Calorimetry Stress & Resting ECG | similar<br>(to K150810) | |
| Comparison to predicate device RespiEvents Software K012020 | | | |
| | RespiEvents Software<br>K012020 | Sentry WEB SmartInterp<br>(new device) | |
| Software<br>characteristics | 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 | Similar<br><b>Rationale</b><br>The 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 | Similar<br><b>Rationale</b><br>Both 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 the<br>applicable tests and standards |
| | 2. Usability | EN 62366 | The proposed device passes the<br>applicable tests and standards |
| | 3. Software life cycle | ISO 62304 | The proposed device passes the<br>applicable tests and standards |
| | 4. Accuracy Testing | Accuracy of evaluated<br>Data | The proposed device passes the<br>applicable 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.