The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of: Non-invasive blood pressure, Impedance respiration, Invasive blood pressure, Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia & ST-segment, 12-Lead resting ECG, Cardiac output. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Description

The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features.

AI/ML Overview

The provided text describes the Mortara Surveyor Patient Monitor (S12 and S19) and aspects of its performance testing for its 510(k) submission. However, it does not include detailed acceptance criteria or the specific study data that would allow for a table of acceptance criteria versus reported device performance. It mainly states that the device "complies with its predetermined specification" and is "substantially equivalent to the predicate device" based on various tests.

Based on the provided document, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This specific table cannot be constructed from the provided text. The document repeatedly states that test results indicated the device "complies with its predetermined specification" for various categories (Software, Electrical Safety, EMC, Bench Performance). It does not, however, spell out what those predetermined specifications (acceptance criteria) were, nor does it provide quantitative performance data to report against those criteria.

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

The document does not specify any sample sizes for test sets. It mentions "Software Testing," "Electrical Safety Testing," "Electromagnetic Compatibility Testing," and "Performance Testing - Bench" but does not detail the number of cases or samples used in these tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned, as no clinical study data is presented.

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

This information is not provided. No clinical study was performed, and therefore, no experts were needed to establish ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set requiring expert ground truth was performed, no adjudication method is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor." This implies the device doesn't involve human interpretation that would be enhanced by AI, making an MRMC study irrelevant in this context.

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

While the device itself is an "algorithm only" in the sense that it's a physiological monitor, the document does not describe a standalone algorithm performance study in the way this question typically implies (e.g., for AI/ML devices). Instead, it refers to "Software Testing" and "Performance Testing - Bench" which validated the device's adherence to its predetermined specifications. No specific performance metrics or studies analogous to those for AI algorithms are detailed.

7. The Type of Ground Truth Used

For the specific testing mentioned (Software, Electrical Safety, EMC, Bench Performance), the ground truth would inherently be based on the device's predetermined specifications and engineering standards. For example, for electrical safety, the "ground truth" is compliance with applicable electrical safety standards. For software, the "ground truth" is that the software performs according to its design requirements. This is not "expert consensus," "pathology," or "outcomes data" as typically thought of in diagnostic imaging or clinical decision support.

8. The Sample Size for the Training Set

No training set is mentioned or applicable in the context of this device's submission description. The described device is a physiological monitor, not an AI/ML-driven device that typically undergoes a "training" phase with data.

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

Not applicable, as no training set is mentioned.

Summary of what is present:

Device Description: The Mortara Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitor for ECG, Respiration, NIBP, Temperature, SpO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG, and cardiac output.
Intended Use: For knowledgeable healthcare professionals in a healthcare facility for continuous monitoring in stationary or portable applications, indicated for adult & pediatric patient populations.
Performance Testing Categories (general statements of compliance):
- Software Testing
- Electrical Safety
- Electromagnetic Compatibility Testing (EMC)
- Performance Testing - Bench (functional, environmental, vibration/shock)
Missing from the document:
- Specific quantitative acceptance criteria.
- Specific quantitative reported device performance data.
- Sample sizes for any tests.
- Data provenance.
- Details on ground truth establishment if clinical data were used (which they weren't for performance).
- MRMC or standalone algorithm studies (as the device is not presented as an AI/ML diagnostic system).

This document mainly focuses on engineering and regulatory compliance as opposed to detailed clinical performance metrics typically found in submissions for AI/ML diagnostic aids.

Summary

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K123556 Page 1 of 3

100 - 100 - 100

Abbreviated 510(k) Notification

MAR 2 2 2013

510(k): Surveyor S12 and S19 Device Summary

Submitter:	Chien Hui (Amy) Yang, Regulatory Affairs EngineerMortara Instrument, Inc.7865 N. 86th StreetMilwaukee, WI 53224
Date:	November 6, 2012
FAX:	(414) 354-4760
Phone:	(414) 354-1600
Contact:	Chien Hui (Amy) Yang (see above)

Trade Name:	Mortara Surveyor Patient Monitor
Common Name:	Patient Physiological Monitor (with Arrhythmia Detection or Alarms)
Classification Name:	Monitor, Physiological Patient (with Arrhythmia Detection or Alarms)
Classification Regulation:	21 CFR §870.1025
Product Code:	MHX

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

	Predicate 510(k) Number	Predicate Manufacturer / Model
Mortara Surveyor Patient MonitorNon-Invasive Blood Pressure component	K090556	Spacelabs Healthcare / élance VitalSigns Monitor
Impedance Respiration component
Invasive Blood Pressure component
Temperature component
Functional Arterial OxygenSaturation component
End-Tidal & Inspired CO2

End-Tidal & Inspired CO2 component

component
ECG Monitoring	K090556	Spacelabs Healthcare / élance VitaSigns Monitor
	K060135	Mortara Instrument, Inc. / SurveyorTelemetry Central Station
12-Lead Resting ECG	K100127	Mortara Instrument, Inc. / ELI 230Electrocardiograph
Cardiac Output	K012226	Schiller / ARGUS PB-1000Monitoring System

© 2012 Mortara Instrument, Inc.

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K123556 Page 2 of 3

Abbreviated 510(k) Notification

Description:

Central Station:

A secure Mortara protocol over an Ethernet connection allows the Mortara Surveyor Patient Monitor to exchange patient information with the Mortara Surveyor Central Station. This allows monitoring of the Surveyor $12/S19 at a central workstation.

Technology Comparison:

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

Intended Use:

The Mortara Surveyor Patient Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthçare facility. It is designed for continuous monitoring in either stationary or portable applications. It is intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output.

Indications for Use:

The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of:

Non-invasive blood pressure .
Impedance respiration
Invasive blood pressure
Temperature ●
Functional arterial oxygen saturation (SpO2)
End-tidal & inspired CO2
ECG monitoring with arrhythmia & ST-segment
12-Lead resting ECG
Cardiac output

The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Performance Testing:

Sterilization Validation:

The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.

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3 of 3

Abbreviated 510(k) Notification

Shelf Life Testing:

The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.

Biocompatibility Testing:

The S12 and S19 patient contacting components use the same materials used on other products that Mortara has used historically and/or has been cleared as substantially equivalent previously.

Software Testing:

Software for the Mortara Surveyor Patient Monitor was designed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.

Electrical Safety:

The Mortara Surveyor Patient Monitor was tested for patient safety in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.

Electromagnetic Compatibility Testing:

The Mortara Surveyor Patient Monitor was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.

Performance Testing - Bench:

The Mortara Surveyor Patient Monitor 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, environmental, and vibration/ shock testing.

Performance Testing - Animal:

Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.

Performance Testing - Clinical:

Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.

Conclusion:

Based upon a comparison of devices and performance testing results, the Mortara Surveyor Patient Monitor is substantially equivalent to the predicate device.

. . . . . .

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 22, 2013

Mortara Instrument, Inc. c/o Ms. Amy Yang 7865 North 86th St. Milwaukee. WI 53224

Re: K123556

Trade/Device Name: Surveyor Patient Monitor

Regulation Number: 21 CFR 870.1025

Regulation Name: Arrhythmia detector and alarm (including ST-segment measurement and alarm)

Regulatory Class: Class II (two)

Product Code: MHX

Dated: February 27, 2013 Received: February 28, 2013

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.

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Page 2 - Ms. Amy Yang

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Owen P. Faris -S

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

Enclosure

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Indications for Use

K123556 510(k) Number (if known):

Mortara Surveyor Patient Monitor · Device Name:

Indications for Use:

The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations.

The Mortara Surveyor Patient Monitor facilitates the monitoring of:

Non-invasive blood pressure ●
Impedance respiration .
Invasive blood pressure .
Temperature ●
Functional arterial oxygen saturation (SpO2) ●
End-tidal & inspired CO2 .
ECG monitoring with arrhythmia & ST-segment ●
12-Lead resting ECG .
Cardiac output .

The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Prescription Use AND/OR × (21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Owen P. Faris -S
2013.03.22
10:42:26'-04'00'

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of

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.