Surveyor S4 Mobile Monitor

K160685 · Mortara Instrument, Inc. · MHX · Aug 4, 2016 · Cardiovascular

Device Facts

• Record ID: K160685
• Device Name: Surveyor S4 Mobile Monitor
• Applicant: Mortara Instrument, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Aug 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Surveyor S4 Mobile Monitor is indicated for use: The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own. The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm. The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station. The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure. The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children. The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

Device Story

Surveyor S4 Mobile Monitor is a battery-operated, patient-worn transceiver; communicates via IEEE 802.11 Wi-Fi to Surveyor Central Station (K131929). Inputs: multi-lead ECG (3/4/5 or 12-lead) and SpO2 signals via proprietary cables/sensors. Processing: Mortara VERITAS ECG algorithm for heart rate, ST-segment, and arrhythmia detection (e.g., V-Tach, V-Fib, Asystole); Mortara SpO2 algorithm for pulse rate and oxygen saturation. Output: filtered physiological data packets transmitted to Central Station for alarm processing/annunciation; device has no local alarms. Features touch-sensitive color display for battery, Wi-Fi signal, and waveform visualization. Used in clinical settings by healthcare professionals to facilitate ambulatory patient monitoring. Benefits: enables continuous patient mobility while maintaining diagnostic-quality data acquisition and centralized monitoring.

Clinical Evidence

Bench testing performed for software verification and validation per FDA guidance. Compliance demonstrated with IEC 60601-1, IEC 60601-2-49, IEC 60601-1-2, IEC 60601-2-25, and ANSI/AAMI EC57. Clinical evidence limited to a pulse oximeter study conducted to demonstrate SpO2 compliance with ISO 80601-2-61:2011.

Technological Characteristics

Battery-operated (3 AA or Li-Ion) mobile transceiver. Connectivity: IEEE 802.11g/n Wi-Fi. ECG: 3/4/5-wire or 12-lead diagnostic. SpO2: disposable/clip/SoftTip sensors. Software: Linux derivative, V1.2.0. Standards: IEC 60601-1 (safety), IEC 60601-2-49 (monitoring), IEC 60601-2-25 (ECG), ISO 80601-2-61 (SpO2), ANSI/AAMI EC57 (algorithms).

Indications for Use

Indicated for adults, adolescents, and children requiring ECG and SpO2 monitoring. Used as a mobile radio transceiver for ambulatory patients within a Wi-Fi infrastructure. Prescription use only by healthcare professionals in clinical settings. Not for sole diagnostic use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Surveyor S4 Mobile Monitor (K141020)
• ApexPro Telemetry System (K080251)

Reference Devices

• Surveyor Central Station (K131929)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and 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

August 4, 2016

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

Re: K160685

Trade/Device Name: Surveyor S4 Mobile 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 Dated: June 28, 2016 Received: June 29, 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. Iisting 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.

Munde Jellm
for

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

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# Indications for Use

510(k) Number (if known)

K160685

Device Name Surveyor S4 Mobile Monitor

Indications for Use (Describe)

The Surveyor S4 Mobile Monitor is indicated for use:

· The Surveyor S4 is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals. The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.

- The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm

- The Surveyor S4 can deliver data from a 3/5 lead cable and diagnostic 12-lead ECG data to a receiving Surveyor Central station.
• The Surveyor S4 mobile monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.

· The Surveyor S4 mobile monitor is indicated for use in adults, adolescents and children.

• The Surveyor S4 mobile monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------|--|
| <div> <span>☑</span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | |
| <div> <span>☐</span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |

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Image /page/3/Picture/0 description: The image shows a logo above the text "Traditional 510(k) Notification". The logo is a blue shape that resembles a heart with a flat bottom. The text is in a simple, sans-serif font and is centered below the logo.

# Section 5

# 510(k) Summary Statement

# 1. Submitter

| Mortara Instrument, Inc.<br>7865 North 86th Street | Primary Contact |
|----------------------------------------------------|-------------------------------|
| Milwaukee, WI 53224 | Sarah Weber |
| | Senior Regulatory Affairs |
| | Manager |
| | [e-mail] |
| Telephone [phone]<br>Fax [phone] | Secondary Contact |
| | Margaret Mucha |
| | Director of Global Regulatory |
| | Affairs |
| | [e-mail] |

# 2. Product Names

| Device Trade Name | Surveyor S4 Mobile Monitor |
|--------------------|---------------------------------------------------------------------------------------------------------------|
| Common/ Usual Name | Monitor, Physiological, Patient<br>(With Arrhythmia Detection or<br>Alarms)<br>Oximeter<br>Electrocardiograph |
| Classification | Monitor, Physiological, Patient (With<br>Arrhythmia Detection or Alarms)<br>870.1025<br>MHX |
| | Oximeter<br>870.2700<br>DQA |
| | Electrocardiograph<br>870.2340<br>DPS |

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Image /page/4/Picture/0 description: The image shows a blue heart shape. The heart is formed by two curved lines that meet at the top and bottom. The heart is solid blue, and the background is white. The heart is centered in the image.

Traditional 510(k) Notification Note: There are no previous submissions for this device

### 3. Predicate Device to which this is Substantially Equivalent

| Surveyor S4 Mobile Monitor | K141020 |
|----------------------------|---------|
| ApexPro Telemetry System | K080251 |

The primary predicate device is Surveyor S4 Mobile Monitor, K141020.

The S4 predicate device has not been subject to a design-related recall. The ApexPro predicate device does has not been under recall since 2011, Z-1522-2011.

#### 4. Device Description

The Surveyor™ S4 Mobile Monitor is a battery operated patient worn transceiver that communicates via IEEE 802.11 Wi-Fi technology to the Surveyor™ Central Station (K131929) which is the primary monitoring display and alarm source.

The Surveyor S4 transmitter has a touch sensitive, color display allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and Surveyor Central Station slot information. The Surveyor S4 can display physiological waveforms, measured parameters, demographic data and other status information. The Surveyor S4 acquires, filters, and processes ECG or ECG and SpO2 parameters and sends filtered signals and parameters to the Surveyor Central Station where alarm processing and annunciation occurs.

The Surveyor Central is designed to communicate with the Surveyor S4 within a healthcare facilities Wi-Fi network infrastructure. The Surveyor Central provides primary monitoring of telemetry patients when used with the Surveyor S4. The central station displays numeric values, waveforms, alarm generation and management, data storage, individualized patient management, report generation and printing functionality.

The Surveyor S4 provides continuous data acquisition which can be visualized on the S4 itself for the following parameters:

- o Electrocardiography (ECG) including heart rate and ECG waveforms
- · Saturation percentage of peripheral oxygen (SpO2), including SpO2 plethysmogram waveform, pulse rate, and signal quality index.
- o No alarm status or processing information of ECG or SpO2 is shown on the Surveyor S4 device.

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Image /page/5/Picture/0 description: The image shows a white heart shape inside of a blue square. The heart shape is formed by two curved lines that meet at the bottom and form a point at the top. The blue square provides a background for the heart shape, making it stand out. The logo is simple and clean, with a focus on the heart shape.

Traditional 510(k) Notification

- o The Surveyor S4 processes Heart rate, ST segment deviation and arrhythmias, by utilizing Mortara VERITAS™ ECG algorithm and sends ECG data packets, including arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole to the Surveyor Central Station for alarm processing and annunciation.
- o The Surveyor S4 utilizes proprietary ECG lead cables available in AHA or IEC, snap or clip, 3-Lead, 5-Lead, and diagnostic 12 Lead configurations.

#### SpO2

- o The Surveyor S4 processes SpO2 percentage, pulse rate and signal quality through the Mortara SpO2 algorithm and sends data packets for SpO2 to the Surveyor Central Station for alarm processing and annunciation.
- o Multiple SpO2 sensor styles allow connection of adults, adolescents, and children. SpO2 sensors are specified for use with the Surveyor S4 and available through Mortara Instrument.

#### 5. Intended Use

The Surveyor S4 Mobile Monitor is indicated for use:

·The Surveyor S4 Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG and SpO2 signals.

The Mortara Surveyor S4 mobile monitor facilitates the monitoring of ECG and SpO2 parameters when used in conjunction with alarm annunciating devices such as the Surveyor Central Station for telemetric monitoring; however, the Surveyor S4 has no alarming capabilities of its own.

- · The Surveyor S4 processes Heart Rate, ST segment deviation and arrhythmias such as, but not limited to, Ventricular Tachycardia, Ventricular Fibrillation, and Asystole by utilizing Mortara VERITAS™ ECG algorithm.
- · The Surveyor S4 can deliver data from a 3/5-lead cable and_diagnostic 12-lead ECG data to a receiving Surveyor Central_station
- The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure.

ECG

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Image /page/6/Picture/0 description: The image shows a logo with a heart shape in the center, formed by two curved lines. The heart is white, and the background is blue. Below the logo, the text "Traditional 510(k) Notification" is written in a simple, sans-serif font. The text is black and appears to be centered beneath the logo.

· The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children.

· The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare or clinical setting. It is not intended as a sole means of diagnosis.

## 6. Technological Characteristics

The Surveyor S4 Mobile Monitor employs the same functional scientific technology as its predicate device Surveyor S4 Mobile Monitor (K141020). It is a prescription device designed to acquire and transmit diagnostic quality ECG in a clinical setting while allowing the patient to be ambulatory. The Surveyor S4 Mobile Monitor is suitable for use as a telemetry solution within centralized ECG monitoring systems or other clinical settings for patients connected to telemetry transceivers

The Surveyor S4 Mobile Monitor is designed to work with ECG when used with a compatible multi-parameter Telemetry Central Station System such as the Mortara Surveyor Central Station (K131929) and other compatible receiving devices.

The Surveyor S4 Mobile Monitor was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. The Surveyor S4 Mobile Monitor is substantially equivalent to The Surveyor S4 Mobile Monitor (Predicate K141020) with the following technological differences:

- . Added 3/4/5 lead ECG
- Added shielded 3/4/5- wire ECG patient cable ●
- Added SpO2 functionality ●
- Added SpO2 sensor with optional extender cable .

| 510(k) | K080251 | K141020 | Present Submission | Change<br>explanation |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| BRAND | ApexPro | Surveyor S4 Mobile<br>Monitor (Primary) | Surveyor S4 Mobile<br>Monitor | |
| COMPANY | GE Medical<br>Systems<br>Information<br>Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | |
| Software<br>Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)<br>Number | K080251 | K141020 | Present Application | |
| Indications for<br>Use | The ApexPro<br>Telemetry<br>System is | The Surveyor S4 Mobile<br>Monitor is indicated for<br>use: | The Surveyor S4 Mobile<br>Monitor is indicated for use:<br>• The Surveyor S4 | |
| | | | | Equivalent.<br>Indications revised |
| 510(k) | K080251 | K141020 | Present Submission | Change explanation |
| BRAND | ApexPro | Surveyor S4 Mobile Monitor (Primary) | Surveyor S4 Mobile Monitor | |
| COMPANY | GE Medical Systems Information Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | |
| Software Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K) Number | K080251 | K141020 | Present Application | |
| | intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are | The Surveyor S4 Mobile Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor S4 Mobile Monitor facilitates the monitoring of ECG signals. The Surveyor S4 Mobile Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. The Surveyor S4 Mobile Monitor is indicated for use in a clinical setting by a physician, or by trained personnel acting on the orders of a licensed physician. It is not intended as a sole means of diagnosis. The Surveyor S4 Mobile Monitor is indicated for use to acquire and output electrocardiographic data. The Surveyor S4 Mobile Monitor is indicated for use as a | Mobile Monitor is indicated for use to acquire, analyze and output multi-lead ECG, SpO2 and other physiological signals. The Mortara Surveyor S4 Mobile Monitor facilitates the real-time monitoring of clinical parameters when used in conjunction with alarm annunciating devices such as a Central Station for telemetric monitoring. The Surveyor S4 can deliver diagnostic 12-lead ECG data to a receiving station. The Surveyor S4 Mobile Monitor is indicated for use as a mobile radio transceiver, allowing the patient to be ambulatory within the range of a Wi-Fi information infrastructure. The Surveyor S4 Mobile Monitor is indicated for use in adults, adolescents and children. The Surveyor S4 Mobile Monitor is a prescription device intended to | for clarity and to provide patient population categories in accordance with FDA guidance "Providing Information about Pediatric Uses of Medical Devices - Guidance for Industry and Food and Drug Administration Staff" dated May 1, 2014. Added SpO2 functionality. |
| 510(k) | K080251 | K141020 | Present Submission | |
| BRAND | ApexPro | Surveyor S4 Mobile<br>Monitor (Primary) | Surveyor S4 Mobile<br>Monitor | |
| COMPANY | GE Medical<br>Systems<br>Information<br>Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Change<br>explanation |
| Software<br>Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)<br>Number | K080251 | K141020 | Present Application | |
| | typically<br>deployed in<br>sub-acute<br>care areas in<br>hospitals or<br>clinical sites<br>where patient<br>mobility can<br>enhance the<br>effectiveness<br>of the medical<br>procedures<br>administered.<br>The<br>physiological<br>parameters<br>monitored<br>include ECG,<br>noninvasive<br>blood<br>pressure,<br>non-invasive<br>temperature<br>and SpO2.<br>The ApexPro<br>Telemetry<br>System is<br>intended to<br>provide ECG<br>data<br>via Ethernet<br>to the<br>computer<br>platform for<br>processing.<br>The<br>ApexPro<br>Telemetry<br>System is<br>also intended<br>to provide<br>physiologic<br>data over the<br>Unity Network<br>to clinical<br>information<br>systems for<br>display. | radiofrequency<br>physiological<br>signal<br>transceiver,<br>receiving and<br>delivering real-<br>time acquisition<br>and transmission<br>of simultaneous<br>electrocardiograp<br>hic data, while<br>allowing the<br>patient to be<br>ambulatory<br>within the range<br>of the antenna<br>network.<br>The Mortara Li-Ion<br>Battery Charger is<br>intended for charging<br>only the Mortara<br>Rechargeable Li-Ion<br>battery pack. | be used by<br>knowledgeable<br>healthcare<br>professionals<br>within a healthcare<br>or clinical setting.<br>It is not intended<br>as a sole means<br>of diagnosis. | |
| 510(k) | K080251 | K141020 | Present Submission | |
| BRAND | ApexPro | Surveyor S4 Mobile<br>Monitor (Primary) | Surveyor S4 Mobile<br>Monitor | |
| COMPANY | GE Medical<br>Systems<br>Information<br>Technologies | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Change<br>explanation |
| Software<br>Version | Proprietary | V1.00 | V1.2.0 | |
| 510 (K)<br>Number | K080251 | K141020 | Present Application |…