The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.

Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5"display and comes with an optional 2 channel printer.

The Surveyor S12 and S19 are intended for continuous monitoring in both bedside and portable applications and are manufactured in various fixed configurations. A Surveyor S12 or S19 may include the following parameters: 3, 5, or 10 Wire electrocardiography (ECG), 12 lead resting ECG, impedance respiration, non-invasive blood pressure (NIBP), up to two temperatures, functional arterial oxygen saturation (SpO₂), up to four invasive blood pressures (IBP), end-tidal & inspired CO2, and thermal dilution cardiac output.

The Surveyor S12 and S19 may be used as stand-alone monitors near the patient bedside, or during patient transport within a healthcare facility. When connected to the Mortara Surveyor Network, the Surveyor S12 and S19 can be part of a centralized monitoring system managed by the Surveyor Central Station (K131929) which can also send data to the Electronic Health Record. The Surveyor Central displays the aforementioned parameters including audible and visuals alarms.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Not Explicitly Stated for all, but Inferred from Standards)	Reported Device Performance (from Clinical Study for Neonatal NIBP)
Neonatal NIBP Safety & Effectiveness	Compliance with ISO 81060-2:2013 and ISO 14155:2011	Clinical study conducted to demonstrate safety and effectiveness
Other Parameters (ECG, SpO2, etc.)	Compliance with various IEC/ISO standards (e.g., IEC 60601 series, ISO 9919, etc.)	Not explicitly detailed in the provided text

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

The provided text only explicitly mentions a clinical study for the neonatal non-invasive blood pressure (NIBP) readings.

Neonatal NIBP Clinical Study Test Set:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the study was conducted to demonstrate safety and effectiveness for the neonatal patient population, implying prospective data collection specifically for this purpose.

For other parameters (e.g., ECG, SpO2), no specific test set sample sizes or data provenance are detailed. The substantial equivalence relies on compliance with various international standards, which typically involve testing against predefined datasets or clinical scenarios.

3. Number of Experts and Qualifications for Ground Truth Establishment

This information is not provided in the given text for any aspect of the device's evaluation. The clinical study for neonatal NIBP refers to the demonstration of safety and effectiveness, but it does not detail the method for establishing ground truth or the involvement of experts in that process.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted (or at least, not mentioned) for the Mortara Surveyor S12 and S19 Patient Monitor based on the provided text. The submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and compliance with standards, and a single clinical study for one specific parameter (neonatal NIBP).

6. Standalone Performance Study

Yes, a standalone performance study was done for the neonatal Non-Invasive Blood Pressure (NIBP) readings. A clinical study was conducted to demonstrate the safety and effectiveness of these readings. The wording suggests that the device's performance for this specific function was evaluated independently.

For other parameters (like ECG, SpO2, etc.), the document primarily references compliance with various IEC and ISO standards (e.g., IEC 60601 series), which typically involve standalone testing of the algorithm or device's performance against defined benchmarks or simulated signals. The results of these tests, however, are not explicitly provided in the summary.

7. Type of Ground Truth Used

For the neonatal NIBP clinical study, the type of ground truth used is not explicitly stated. However, clinical studies designed to demonstrate safety and effectiveness, as mandated by ISO 81060-2:2013 (which specifies clinical investigation of automated measurement type sphygmomanometers), typically rely on:

Simultaneously obtained reference measurements: Often from an "expert" or gold-standard measurement method (e.g., invasive arterial blood pressure monitoring for NIBP), or highly accurate manual measurements by trained observers using auscultation. The standard sets strict requirements for how these reference measurements are taken and compared.

For other parameters, the ground truth would be established by the respective standards they comply with (e.g., standardized ECG waveforms for arrhythmia detection, calibrated SpO2 simulators, etc.).

8. Sample Size for the Training Set

This information is not provided in the text. The document describes a clinical study for neonatal NIBP for validation/testing, not for training. Given the device's nature as a physiological monitor relying on established algorithms and hardware, it's less likely to involve a "training set" in the machine learning sense for its core functionalities, but rather calibration and verification against known signals or reference measurements during development.

9. How Ground Truth for the Training Set Was Established

As no training set is described or implied in the provided text, information on how its ground truth was established is not applicable/not provided.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of three human profiles facing to the right, stacked on top of each other.

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

January 11, 2017

Mortara Instrument, Inc. Sarah Weber Senior Regulatory Affairs Manager 7865 North 86th Street Milwaukee. Wisconsin 53224

Re: K161517 Trade/Device Name: Surveyor S12 and S19 Patient Monitor Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MHX, DQA, DPS, MLD, DSJ, DSB, MSX, DSI Dated: September 27, 2016 Received: September 28, 2016

Dear Sarah Weber:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

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

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

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

Sincerely yours.

Mude 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)

K161517

Device Name Surveyor S12 and S19 Patient Monitor

Indications for Use (Describe)

The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents, and children patient populations for the following paramaters:

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 indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:

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

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

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

|X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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Section 5 510(k) Summary Statement

1. Submitter

Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224

Primary Contact

Sarah Weber Senior Regulatory Affairs Manager sarah.weber@mortara.com

Telephone 414-354-1600 Fax 414-354-4760

Secondary Contact

Mark Elliott VP of QARA mark.elliott@mortara.com

2. Product Names

Device Trade Name	Surveyor S12 and S19 PatientMonitor
Common/ Usual Name	Patient Physiological Monitor(with Arrhythmia Detection orAlarms)
Classification	Monitor, Physiological, Patient(with Arrhythmia Detection orAlarms)870.1025MHX
	Oximeter
	870.2700

DQA

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Electrocardiograph 870.2340 DPS

Monitor, ST Segment with Alarm 870.1025 MLD

Alarm, Blood Pressure 870.1100 DSJ

Plethysmograph, Impedance 870.277 DSB

System, Network and Communication, Physiological Monitors 870.23 MSX

Arrhythmia detector and alarm (incl. ST-segment measurement & alarm) DSI / 870.1025

Note: There are no previous submissions for this device

3. Predicate Device to which this is Substantially Equivalent

Surveyor S12 and S19 Patient Monitor	K123556
Intellivue Patient Monitor Model MX800	K102562

The S12/S19 was last recalled in 2014, Z-0110-2015. There are no open recalls for the S12/S19 Patient Monitor.

The Intellivue Patient Monitor Model MX800 was last recalled in 2012, Z-1134-2012.

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4. Device Description

	Patient Types
Parameter	Adult	Pediatric	Neonate
		Adolescent/Child/Infant
ECG 3-Lead	✓	✓	✓
ECG 5-Lead	✓	✓	✓
ECG 12-Lead	✓	✓	✓
Resting 12 LeadInterpretation	✓	✓	✓
ST Segment Monitoring	✓	✓	N/A
Respiration - Impedance	✓	✓	✓
Respiration- Capnography	✓	✓	✓

Parameters by Patient Type

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NIBP (Non-Invasive BloodPressure)	✓	✓	✓
SpO2- Mortara	✓	✓	N/A
SpO2- Nellcor Oxi-Max	✓	✓	✓
CO2	✓	✓	✓
IBP (Invasive Blood Pressure)	✓	✓	✓
Cardiac Output	✓	✓	N/A
Temperature	✓	✓	✓
Arrhythmia Basic	✓	✓	✓
Arrhythmia Extended	✓	✓	✓

5. Intended Use

The Mortara Surveyor Patient Monitor is indicated for use in adult, adolescents and children patient populations for the monitoring of the following parameters:

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 indicated for use in infants and neonatal patient populations for the monitoring of the following parameters:

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

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

6. Technological characteristics

The Surveyor S12 and S19 Patient Monitor employs the same functional scientific technology as its predicate devices Surveyor S12 and S19 Patient Monitor (K123556), and Philips Intellivue Patient Monitor Model MX800 (102562). At a high level, the devices provide continuous monitoring for ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output.

Surveyor S12 and S19 Patient Monitor was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. Surveyor S12 and S19 Patient Monitor is substantially equivalent to Surveyor S12 and S19 Patient Monitor (Predicate K123556) with the following technological differences:

Added Neonates to the target population
Modifications were made to the AM12 ●
Added 10-Wire Snap Ends leads for AM12 ●
Adjusted display of alarm priority level on Arrhythmia settings page ●
Improved impedance resistor and capacitor value changes ●
Added ECG Trunk Cables o
Software update to allow printing of displayed trends upon request of 0 user
o Improved tolerance when using 3/5-wire ECG with high impedance electrodes
Added a product configuration without Invasive Blood Pressure ●
Software correction of technical error message when the NIBP ● port/hose is occluded
Improve recovery from standby of the communication with central ● station
Communication to third party software through the serial port o

A full comparison matrix of functionality is located in Section 12, Substantial Equivalence Discussion.

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7. Determination of Substantial Equivalence – Non-clinical

Software verification and validation testing was conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content for Premarket Submissions for Software Contained in Medical Devices" and "Off-the-Shelf Software Use in Medical Devices."

S12/S19 was designed and tested for compliance with the applicable clauses of the following standards:

UL 60601-1 Issued: 2003/04/25 Ed: 1 Rev: 2006/04/26 Medical ● Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1: 2005 Ed:3 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance; Corr. 1: 2006, Corr. 2: 2007
IEC 60601-1-4 Issued 2000/04/01 Ed 1.1 Medical electrical systems -● Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-1-6 Issued: 2006/12/08 2nd Ed. Medical electrical ● equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366 Issued: 2007/10/18 Ed. 1 Medical Devices Application Of . Usability Engineering To Medical Devices
IEC 60601-1-8 Issued: 2006/10/25 Ed: 2 Medical Elec. Equip. Part 1-. 8: General Req. for Basic Safety & Essential Perf. - Collateral Standard: General Req., Tests & Guidance for Alarm Systems in Medical Elec. Equip. & Medical Elec. Systems
. IEC 60601-2-27 Issue:2011/03/30 Ed:3 Medical electrical equipment -Part 2-27: Particular requirements for the safety, including essential performance, of electrocardiographic monitoring equipment
. IEC 60601-1-4 Issued 2000/04/01 Ed 1.1 Medical electrical systems -Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems
IEC 60601-2-30 Issued:1995/01/01 Ed:1 Medical Electrical Equipment . - Part 2: Particular Requirements for the Safety of Automatic Cycling Indirect Blood Pressure Monitoring Equipment-First Edition
IEC 80601-2-30 Issued: 2009/01/28 Ed: 1 Medical Electrical Equipment . - Part 2-30: Particular Requirements for the Basic Safety and Essential

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Performance of Automated Non-Invasive Sphygmomanometers; Corr. 1: 2010

IEC 60601-2-34 Issue:2011/05/19 Ed:3 Medical Electrical Equipment . Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment
IEC 60601-2-49 Issued:2011/02/25 Ed:2 Medical Electrical Equipment ● - Part 2-49: Particular Requirements for the Safety of Multifunction Patient Monitoring Equipment
ISO 80601-2-55 Issued: 2011/12/15 Ed:1 Medical electrical equipment ● - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors
ISO 80601-2-56 Issue:2009/10/01 Ed:1 Medical Electrical Equipment -● Part 2-56: Particular Requirements for the Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement
ISO 80601-2-61 Issued: 2011/04/01 Ed:1 Medical Electrical Equipment . - Part 2-61: Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment
ISO 9919 Issued:2005/03/15 Medical electrical equipment Particular . requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
IEC 60601-2-25:2011 Ed. 2.0, Medical Electrical Equipment. Part 2-25: . Particular requirements for the basic safety and essential requirements of electrocardiographs
IEC 60601-1-2: 2007 Medical Electrical Equipment Part 1-2: General . requirements for safety- Collateral standard: Electromagnetic Compatibility
IEC 62304:2006 Medical device software Software life cycle process ●
ANSI/AAMI/ISO EC57:1998/(R)2008 Testing and reporting ● performance results of cardiac rhythm and ST-segment measurement algorithms
ANSI/AAMI/ISO 81060-2:2013, Noninvasive sphygmomanometers . Part 2: Clinical investigation of automated measurement type

8. Determination of Substantial Equivalence – Clinical

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Traditional 510(k) Notification

A clinical study was conducted to demonstrate the safety and effectiveness of Non-Invasive Blood Pressure readings for the neonatal patient population, per ISO 81060-2:2013 and ISO 14155:2011.

9. Conclusion

The Surveyor S12 and S19 Patient Monitor includes Non-Invasive Blood Pressure for the neonatal patient population.

Mortara Instrument, Inc. considers the Surveyor S12 and S19 Patient Monitor to be as safe, as effective and performance is substantially equivalent to the predicate devices.

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.