Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes software for post-measurement analysis and workflow management of cardiopulmonary data, but there is no mention of AI or ML technologies being used for interpretation or analysis. The "SmartInterp" name is likely a marketing term for enhanced interpretation features, not necessarily AI/ML.

Therapeutic

No
The device is a medical software intended as an aid in evaluation and diagnosis, not to provide therapy directly.

Diagnostic

Yes
The "Intended Use / Indications for Use" states that the software is "intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data."

SaMD (Software as a Medical Device)

Yes

The device is described as a "medical software" and a "web application" that provides post-measurement analysis and interpretation of cardiopulmonary data. The description focuses entirely on the software's functionality and its integration with existing measurement devices, without mentioning any hardware components included with the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, Sentry WEB SmartInterp is not an In Vitro Diagnostic (IVD).

Here's why:

Intended Use: The intended use clearly states it's for the evaluation and diagnosis of already measured cardiopulmonary data. This data is generated by other measuring devices, not by Sentry WEB SmartInterp itself. IVDs are typically used to examine specimens (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis.
Device Description: The description focuses on post-measurement tasks, workflow optimization, and data management. It doesn't describe any process of analyzing biological specimens.
Lack of Specimen Analysis: There is no mention of analyzing any type of biological specimen.
Focus on Data Interpretation: The core function is interpreting data that has already been collected by other devices.

While Sentry WEB SmartInterp is a medical software used in the diagnostic process, it acts as a tool for interpreting data from other diagnostic devices, rather than performing the in vitro diagnostic test itself.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

DQK, BZC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Patient population is not assigned as it is defined by the measuring devices itself.

Intended User / Care Setting

Under the direction of a physician in a hospital environment, physician's office or similar settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical tests conducted for determination of substantial equivalence:

Risk Management (ISO 14971) - The proposed device passes the applicable tests and standards
Usability (EN 62366) - The proposed device passes the applicable tests and standards
Software life cycle (ISO 62304) - The proposed device passes the applicable tests and standards
Accuracy Testing (Accuracy of evaluated Data) - The proposed device passes the applicable tests and standards

Summary Discussion of Bench Performance Data:
The CareFusion Sentry WEB SmartInterp passed all specified test requirements. 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.

Clinical tests conducted for determination of substantial equivalence and/or of clinical information: Clinical testing was not performed with this device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K122699, K150810, K012020

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

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

1

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

2

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)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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:

4

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

5

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

6

5.13 Summary Table of Comparison

| Comparison to predicate devices SentrySuite Product Line K122699 &

Vyntus/SentrySuite Product Line K150810
	SentrySuite
Product Line
K122699	Vyntus/SentrySuite
Product Line
K150810	Sentry WEB
SmartInterp
(new device)
Indication
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 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.	The Vyntus/SentrySuite product line is
intended to be used for measurements, data
collection and analysis of lung function
(PFT) and cardio-pulmonary (CPET)
parameters, aiding in the diagnosis of
related conditions. 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
future reference or report generation
purposes.
The products can be utilized with patients
age 4 years and older as long as they can
cooperate in the performance - no special
limit to patient's sex or height exists.
Measurements will be performed under the
direction of a physician in a hospital
environment, physician's office or similar
setting (professional healthcare facilities). A
qualified physician has to reassess all
Vyntus/SentrySuite measurements. An
interpretation by Vyntus/SentrySuite is only
significant if it is considered in connection
with other clinical findings.
Additional for Vyntus ECG:
The Vyntus ECG is intended for measuring the
surface electro-cardiogram (ECG) of a patient.
The acquired ECG can be recorded and
displayed on the screen or printed on paper.
12-lead ECGs are analyzed automati-cally and
suggestions for the interpretation of the resting
ECG can be made by the soft-ware. ECG
interpretation statements made by the
Vyntus/SentrySuite represent partial qualitative
and quantitative information on the patient's
cardiovascular condition and no therapy or
drugs can be administered based solely on the
interpretation statements. The Vyntus ECG can
be used for non-interpretive applications in
patients age 4 years and older and a weight of
20 kg or higher. The Vyntus ECG is intended to
be used for routine ECG collection, recording
both under resting and stress conditions. The
measure-ment is performed by trained
healthcare professionals under the direction of
a physician in healthcare facilities (e.g. the
doctor's office or hospital). The Vyntus ECG is
not intended for intracranial use. The Vyntus
ECG is not intended for use in an EMS
environment (Emergency Medical Services
Environment). The Vyntus ECG is not intended
for use in home healthcare environments.
Automatic interpretation of the ECG is not
possible for pediatric and adolescent patients
below 16 years of age and for patients with
pacemakers.	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.
Rationale
There is no significant
difference in indication
for use for evaluation
and diagnosis of
patient data from
pulmonary function and
cardio pulmonary
exercise testing. The
evaluation and
diagnosis module of
SentrySuite and Sentry
WEB SmartInterp is
similar and thereby the
proposed device is
substantial equivalent
to the predicate device.
Patient
population	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.	4 years and older and a weight of
20 kg or higher	similar
Rationale

			will be defined by the
measuring device
itself. As the patient
population depends on
the measuring device,
the Sentry WEB
SmartInterp patient
population is identical
to the predicate
SentrySuite devices.
There is no difference
and that is why the
proposed device is
substantial equivalent
to the predicates.
Software	SentrySuite	SentrySuite	Sentry WEB
SmartInterp
(evaluation part of
SentrySuite)

Rationale
The Sentry WEB
SmartInterp software is
as stand-alone version
of the evaluation and
diagnosis module of
the predicate
SentrySuite devices.
There is no new option
or feature in Sentry
WEB SmartInterp
which is not available
in the predicate
SentrySuite devices.
Thereby the proposed
device is substantial
equivalent to the
predicate devices. |
| Performan-
ce (display
of measure-
ments) | Spirometry Flow / Volume MVV R-Oclusion (Airway
Resistance) FRC Helium Rebreathing Real Time Single Breath
Diffusion Intra Breath Diffusion Single Breath Diffusion
CO/He Bodyplethysmography Respiratory Drive P0.1 PI/PE Max (MIP/MEP) Impulse oscillometry Bronchial test Bronchospasm
lysis Broncho provocat-
ion Pulsed
Nebulization Continuous
Nebulization | Spirometry Flow / Volume MVV | similar
(to K122699 &
K150810)

Rationale
The evaluation and
diagnosis module of
Sentry WEB and
SentrySuite is exact
the same. That means,
that only parameters
can be evaluated
which are already
available in the
predicate SentrySuite
devices. There is no
possibility to evaluate
any new parameters as
the evaluation modules
are identical. Thereby
the proposed device is
substantial equivalent
to the predicate
devices. |
| | Breath-by-Breath Indirect Calorimetry Stress & Resting ECG | similar
(to K150810) | |
| Comparison to predicate device RespiEvents Software K012020 | | | |
| | RespiEvents Software
K012020 | Sentry WEB SmartInterp
(new device) | |
| Software
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
Rationale
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
Rationale
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. | |

7

8

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.

9

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
applicable tests and standards
	2. Usability	EN 62366	The proposed device passes the
applicable tests and standards
	3. Software life cycle	ISO 62304	The proposed device passes the
applicable tests and standards
	4. Accuracy Testing	Accuracy of evaluated
Data	The proposed device passes the
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.