Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.
Display of reported alarm states produced by such monitoring systems.
Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.
Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waver displays still waveforms.
Provide selected waveform episodes to the host application for printing or inclusion in the patient record.

The Monitoring Waveform Viewer:

Is not a primary or secondary alarm device.
Does not provide a user interface for acknowledging or silencing active alarms.
Does not generate audible or visual (flashing) notifications of active alarms.

The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

Device Description

The Monitoring Waveform Viewer is a software component that includes a system for reviewing snapshots of monitoring data and offers a measurement module with user controlled calipers and magnifier glass.

Medical device data or information system applications may utilize the Monitoring Waveform Viewer software component that includes a stand-alone executable module that functions as a host application. The Monitoring Waveform Viewer is organized as a drawing surface with three areas:

a parameters area located at the bottom of the window, .
a parameter waveform area located at the right and
. a main waveform area.

The parameters area is dedicated to report the values of parameters not associated with displayed waveforms. The parameter waveform area is dedicated to report the values of parameters associated to the displayed waveforms.

The application supports several numerical parameters such as: ECG (electrocardiogram), ART (arterial pressure), PA (pulmonary artery invasive blood pressure), ICP (intracranial pressure), IABP (intra-aotic balloon pump pressure), RR (respiration rate), EtCO2 (end tidal carbon dioxide), SpO2 (oxygen saturation), etc.

The Monitoring Waveform Viewer receives data parameters and waveforms supplied from multi-parameter patient monitoring systems. The Monitoring Waver is able to display alarm states by highlighting the corresponding parameter box. The Monitoring Waveform Viewer operating in near real time mode supports alarm priorities of High Priority, Medium Priority, and Low Priority.

The Monitoring Waveform Viewer allows the user to right-click over any ECG lead or the ECG parameter box to activate a context menu for selecting the ECG gain and displayed leads. The user is able to select a list of active (with data) ECG leads received from the host application. It also allows the user to select gains of 5, 10, 20 and 40mm/mV. The Monitoring Waveform Viewer provides a caliper tool for performance amplitude and interval measurements on the displayed traces. The caliper can be placed anywhere on the waveform display area.

AI/ML Overview

The provided document is a 510(k) notification for the Mortara Monitoring Waveform Viewer, a software component. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria in the typical sense of diagnostic metrics (e.g., sensitivity, specificity).

However, based on the Performance Testing: Software Testing section, we can infer some aspects related to acceptance criteria and the "study" that proves the device meets those criteria.

Here's an attempt to extract the requested information, understanding that this is a software component and not a diagnostic device with traditional performance metrics:

Acceptance Criteria and Device Performance for Mortara Monitoring Waveform Viewer

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a software component for viewing and measuring waveforms, the "acceptance criteria" are related to its functional and performance specifications. Since specific quantitative thresholds are not provided in the document beyond a general statement of compliance, the table below represents the implicit criteria and reported performance.

Acceptance Criteria Category	Specific Criteria (Inferred from device function)	Reported Device Performance
Functional Accuracy	Display data generated by multi-parameter patient monitoring systems continuously.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Functional Accuracy	Display reported alarm states (High, Medium, Low Priority) by highlighting the corresponding parameter box.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Functional Accuracy	Display static waveforms for review of existing data.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Functional Accuracy	Magnification tool correctly enlarges the signal.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Measurement Accuracy	Caliper tool performs accurate horizontal/time and vertical/signal amplitude measurements on displayed traces.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Integration/Compatibility	Provides selected waveform episodes to the host application for printing or inclusion in patient record.	"Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
General Software Quality	Meets all predetermined software specifications and requirements.	"Software for the Mortara Monitoring Waveform Viewer was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification."
Safety - Non-Alarm Device	Does not function as a primary/secondary alarm, acknowledge/silence alarms, or generate audible/visual alarm notifications.	Explicitly stated in "Indications for Use" and "Description" as design constraints. Implicitly confirmed by adherence to design.

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

Sample Size: Not explicitly stated. The document mentions "test results." For software testing, the "sample size" would typically refer to the number of test cases executed. This information is not provided.
Data Provenance: Not specified. The testing was conducted internally by Mortara Instrument, Inc. It's likely simulated or recorded patient data was used, but the origin (e.g., country, retrospective/prospective) is not detailed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Number of Experts: Not applicable or not specified. For functional software testing, "ground truth" often refers to the expected output of the software for given inputs, which is derived from the software's specified requirements. There is no mention of external human experts establishing ground truth for evaluating the software's performance on patient data, as this is a viewing and measurement tool, not a diagnostic one. The accuracy of measurements would likely be benchmarked against known values or manual measurements on the displayed data, rather than expert consensus on a clinical outcome.
Qualifications of Experts: Not applicable or not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Since expert consensus on clinical diagnoses is not explicitly used to establish ground truth for this type of device, an adjudication method for conflicting expert opinions is not relevant or described. The "adjudication" in this context would likely be comparing software output to predetermined correct outputs based on specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

MRMC Study: No. The document does not describe an MRMC study. The device is a "viewer" and "measurement tool," not a diagnostic AI intended to assist human readers in interpretation that would typically warrant an MRMC study. The focus is on the software component's ability to accurately display and measure, not on improving human diagnostic accuracy.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Standalone Performance: Yes, in essence. The "Software Testing" and "Performance Testing – Bench" sections describe the device's performance as software. This testing evaluates the algorithm (software component) independently against its predetermined specifications for display, measurement, and functionality. There is no human-in-the-loop performance described beyond the general statement that "The data and analysis provided by the Monitoring Waveform Viewer is reviewed, confirmed, and used by trained medical personnel." The performance tests themselves assess the software's outputs directly.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for this software component would be based on its functional specifications and expected outputs. For display features, it would be whether the waveforms and parameters are displayed correctly and accurately represent the input data. For the caliper tool, ground truth would be the known accurate measurements of simulated or recorded waveforms. This is essentially "specification-based verification" or "expected output" rather than clinical ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

Sample Size: Not applicable. This device is a software component for viewing and measurement; it does not appear to employ machine learning or AI that would require a "training set" in the conventional sense. The software is developed based on deterministic algorithms and rules.

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

How Ground Truth was Established: Not applicable, as there is no "training set" for this type of software component. Its functionality is based on direct programming logic and specifications rather than learning from data.

Summary

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

November 19, 2014

Mortara Instrument, Inc. Ms. Amy Yang Sr. Regulatory Affairs Engineer 7865 N. 86th Street Milwaukee, WI 53224

Re: K141811

Trade/Device Name: Mortara Monitoring Waveform Viewer Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, physiological, patient (with arrhythmia detection or alarms) Regulatory Class: Class II Product Code: MHX Dated: October 2, 2014 Received: October 6, 2014

Dear Ms. Yang:

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

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Page 2 – Ms. Amy Yang

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 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/Resourcesfor You/Industry/default.htm. 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 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.

Melissa A. Torres -S

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) K141811

Device Name Monitoring Waveform Viewer

Indications for Use (Describe)

The Monitoring Waveform Viewer is indicated for use as follows:

The Monitoring Waveform Viewer is a software component utilized within another software application.

The Monitoring Waveform Viewer performs the following:

· Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.

· Display of reported alarm states produced by such monitoring systems.

· Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.

· Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waver displays still waveforms.

· Provide selected waveform episodes to the host application for printing or inclusion in the patient record.

The Monitoring Waveform Viewer:

· Is not a primary or secondary alarm device.
· Does not provide a user interface for acknowledging or silencing active alarms.

· Does not generate audible or visual (flashing) notifications of active alarms.

The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

Type of Use (Select one or both, as applicable)

Description Use (Part 91 CFR 901 Subpart D)	Over-The-Counter Use (91 CFR 901 Subpart C)
☒	☐

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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Abbreviated 510(k) Notification

510(k): Mortara Monitoring Waveform Viewer Summary K141811

Submitter:

Date: November 18, 2014

Amy Yang, Sr. Regulatory Affairs Engineer
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224
FAX:	(414) 354-4760
Phone:	(414) 354-1600
Contact:	Amy Yang (see above)
Trade Name:	Mortara Monitoring Waveform View

Trade Name:	Mortara Monitoring Waveform Viewer
Common Name:	Monitoring Waveform Viewer
Classification Name:	Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms)
Classification Description:	Arrhythmia detector and alarm (including ST-segment measurement and alarm)
Classification Regulation:	21 CFR §870.1025
Product Code:	MHX

Legally marketed devices to which S.E. is claimed:

Mortara Monitoring WaveformViewer	Predicate 510(k) Number	Predicate Manufacturer / Model
Surveyor Central Station	K131929	Mortara Instrument, Inc. / SurveyorCentral Station

Description:

a parameters area located at the bottom of the window, .
a parameter waveform area located at the right and
. a main waveform area.

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Abbreviated 510(k) Notification

Further description and details concerning use of the Monitoring Waveform Viewer can be found in:

Tab 2 Device Description, Monitoring Waveform Viewer Block Diagram .
. Tab 12 Proposed Labeling documents, Monitoring Waveform Viewer product brochure, Monitoring Waveform Viewer User Manual.

Technology Comparison:

The Mortara Monitoring Waver utilizes the same or similar technology for each parameter as utilized by the predicate devices.

Intended Use:

The Monitoring Waveform Viewer is a software component intended to be utilized within another software application. The software component can continuously receive and display data generated by multiparameter patient monitoring systems in near real time, display reported alarm states, display static waveforms for review of existing data, and perform measurements with the support of a caliper tool.

The Monitoring Waveform Viewer software component is not intended to be used as an alarm device. The data and analysis provided by the Monitoring Waveform Viewer is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions.

Indications for Use:

The Monitoring Waveform Viewer is indicated for use as follows: The Monitoring Waveform Viewer is a software component utilized within another software application.

The Monitoring Waveform Viewer performs the following:

Display of data generated by multi-parameter patient monitoring systems continuously producing waveforms and parameters.
. Display of reported alarm states produced by such monitoring systems.
. Display of static waveforms for review of existing data, with the possibility to activate a magnification tool. The magnification tool will enlarge the signal located under the magnification icon.
. Perform measurements with the support of a caliper tool (providing horizontal/time measurements and vertical/signal amplitude measurements). The caliper tool can be activated when the Monitoring Waveform Viewer displays still waveforms.
. Provide selected waveform episodes to the host application for printing or inclusion in the patient record.

The Monitoring Waveform Viewer:

Is not a primary or secondary alarm device. .
. Does not provide a user interface for acknowledging or silencing active alarms.
. Does not generate audible or visual (flashing) notifications of active alarms.

The Monitoring Waveform Viewer does not provide any support for implementing an application that is part of an alarm system.

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Abbreviated 510(k) Notification

Performance Testing:

Sterilization Validation - The Mortara Monitoring Waveform Viewer is not sterilized or sterilizable, and therefore this section does not apply to the Waveform Viewer itself.

Shelf Life Testing – The Mortara Monitoring Waveform Viewer is not sterilizable, and therefore this section does not apply to the Waveform Viewer itself.

Biocompatibility Testing - The Moritoring Waveform Viewer is software only, and therefore this section does not apply to the Waveform Viewer itself.

Software Testing - Software for the Mortara Monitoring Waveform Viewer was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Monitoring Waver complies with its predetermined specification.

Electrical Safety - The Mortara Monitoring Waver is software only, and therefore this section does not apply to the Waveform Viewer itself.

Electromagnetic Compatibility Testing - The Mortara Monitoring Waveform Viewer is software only, and therefore this section does not apply to the Waveform Viewer itself.

Performance Testing – Bench – The Mortara Monitoring Waveform Viewer was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional.

Performance Testing – Animal – Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Monitoring Waveform Viewer.

Performance Testing – Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Monitoring Waveform Viewer.

Conclusion - The results of these activities demonstrate that the Mortara Monitoring Waver is as safe, as effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.