Surveyor S2

K182297 · Mortara Instrument, Inc. · DRG · Jan 24, 2019 · Cardiovascular

Device Facts

• Record ID: K182297
• Device Name: Surveyor S2
• Applicant: Mortara Instrument, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Jan 24, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Surveyor S2 is indicated for use: · The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals. · The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit. · The Surveyor S2 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 S2 is indicated for use to acquire and output electrocardiographic data. · The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.

Device Story

Patient-worn, battery-powered telemetry transmitter; acquires 3-lead ECG signals via 4-wire lead cables; transmits waveforms and status to external monitoring node via Wi-Fi (IEEE 802.11 a/b/g/n, 2.4/5GHz). Device features 2.8'' capacitive touch screen for status/waveform visualization. Used in clinical facilities/pharmacology units by healthcare professionals. Data processed at monitoring node; output includes ECG waveforms, heart rate, and demographic data. Benefits include ambulatory monitoring within antenna network range. Device reduces size/weight and improves battery life compared to predicate.

Clinical Evidence

No clinical data. Bench testing only, including software verification/validation, unit/integration/system testing, electrical/electromagnetic safety (IEC 60601 series), and wireless coexistence testing.

Technological Characteristics

Battery-powered telemetry transmitter; 2.8'' capacitive touch screen; 3-lead ECG acquisition (500 samples/sec, 2.5 µV LSB); IEEE 802.11 a/b/g/n (2.4/5GHz) connectivity. Complies with IEC 60601-1, 60601-1-2, 60601-2-27, ISO 10993, IEC 62304, ISO 14971. Software lifecycle per IEC 62304.

Indications for Use

Indicated for adult, adolescent, and pediatric patients requiring ECG monitoring. Prescription use only in clinical settings by healthcare professionals. Not for sole diagnostic use.

Regulatory Classification

Identification

A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.

Predicate Devices

• Surveyor S4 Mobile Monitor (K141020)

Submission Summary (Full Text)

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January 24, 2019

Mortara Instrument, Inc. Marco Manduchi OA/RA Manager 7865 North 86th Street Milwaukee, Wisconsin 53224

Re: K182297

Trade/Device Name: Surveyor S2 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG Dated: December 20, 2018 Received: December 26, 2018

Dear Marco Manduchi:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Jessica E. Paulsen -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) K182297

Device Name Surveyor S2

| Indications for Use (Describe) | |
|--------------------------------|--|
|--------------------------------|--|

The Surveyor S2 is indicated for use:

· The Surveyor S2 is indicated for use in adult, adolescents, and children patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.

· The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.

· The Surveyor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.

· The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering realtime acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows a white heart shape with a blue background at the top. Below the heart shape, the text "Traditional 510(k) Premarket Notification" is displayed. The text is in a simple, sans-serif font and is left-aligned. The image appears to be a logo or header for a document related to medical device regulation.

# 510(k) Summary

[As described in 21 CFR 807.92]

| Submitted by: | Mortara Instrument, Inc.<br>7865 North 86th Street<br>Milwaukee, WI 53224<br>U.S.A. |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person<br>Primary Contact: | Marco Manduchi<br>Regulatory Affairs Manager<br>Phone: +39 - 0512987821<br>[e-mail] |
| Secondary Contact: | Mark Elliott<br>VP Global RA/QA<br>Phone: [phone]<br>[e-mail] |
| Date Prepared: | July 31, 2018 |
| Trade Name: | Surveyor S2 |
| Common Name | Transmitters and receivers, physiological<br>signal, radiofrequency |
| Classification<br>Reference: | Class II, Transmitters and receivers,<br>physiological signal, radiofrequency (21<br>CFR 870.2910, Product code DRG) |
| Predicate device: | Surveyor S4 Mobile Monitor<br>510(k) Number: K141020<br>Transmitters and receivers, physiological<br>signal, radiofrequency, 21 CFR 870.2910<br>Class II, DRG |

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# Device Description

The Surveyor S2 is a patient-worn, battery-powered telemetry transmitter. The Surveyor S2 is intended to acquire ECG signals and transmits waveforms and corresponding status to a receiving S2 Communication Library. The S2 Communication Library, to be integrated in an external monitoring node for processing, exposes an API to obtain ECG signals and push session status, parameters and demographic information to the S2.

The ECG acquired signals are transmitted through the S2 communication Library to the Monitoring Node for further processing, presentation, storage, etc via the hospital/clinic wireless and wired network infrastructure. The Surveyor S2 is designed to be used within the existing network IT infrastructure.

The Surveyor S2 has a 2.8'' color display with a capacitive touch sensitive screen, allowing for operational conveniences such as a battery level indicator, Wi-Fi Signal Strength and on-demand visual indication of the status of its connection to the monitoring node. The Surveyor S2 acquires and sends signals to the monitoring node where ECG signal processing and monitoring occurs. The Surveyor S2 displays ECG derived parameters (Heart Rate) and demographic data and monitoring state as received from the monitoring node through the S2 Communication Library.

The Surveyor S2 provides continuous data acquisition which can be visualized on the S2 itself for the ECG waveforms.

The Surveyor S2 utilizes ECG lead cables available in AHA or IEC, snap or clip, 4-wire Lead. ECG data delivered is 3-leads, lossless compressed, 2.5 µV LSB at 500 samples per second.

ECG data is augmented with electrode fail markers, lead identifications, hardware detected pacemaker spikes.

### Indication for use

The Surveyor S2 is indicated for use:

- The Surveyor S2 is indicated for use in adult, adolescents, and children ● patient populations. The Surveyor S2 facilitates the monitoring of ECG signals.
- o The Surveyor S2 is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility or clinical pharmacology unit.

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Image /page/5/Picture/0 description: The image shows a white heart shape against a blue background. The heart is centered and fills most of the frame. The blue background surrounds the heart, creating a simple and clean design.

- . The Survevor S2 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 S2 is indicated for use to acquire and output electrocardiographic data.
- . The Surveyor S2 is indicated for use as a radiofrequency physiological signal transceiver, receiving and delivering real-time acquisition and transmission of simultaneous electrocardiographic data, while allowing the patient to be ambulatory within the range of the antenna network.

# Technological Characteristics

The Survevor S2 employs the same functional scientific technology as its predicate device Surveyor S4 (K141020). It is a prescription device designed to acquire and transmit ECG in a clinical setting while allowing the patient to be ambulatory. The Surveyor S2 is suitable for use as a telemetry solution within centralized ECG monitoring node systems or other clinical settings for patients connected to telemetry transceivers.

The Surveyor S2 is designed and manufactured by Mortara Instrument according to 21 CFR Part 820. Surveyor S2 is substantially equivalent to Surveyor S4 (Predicate K141020) with the following technological differences:

- Surveyor S2 is designed to communicate with a S2 communication Library . a C++ software library intended to provide a consistent, tested and reusable interface for integrating the S2 Wi-Fi telemetry transmitter into a monitoring node.
- . S2 and S4 has a different WLAN module, but both use a Wi-Fi network interface. Surveyor S4 supports only IEEE 802.11 b/g/n at 2.4 GHz band whereas S2 supports IEEE 802.11 a/b/g/n on 2.4GHz and 5GHz band.
- . Surveyor S2 supports 4-wire lead

Moreover, modifications were made to the Surveyor S2 to provide the same functionality of the predicate device Surveyor S4 in a smaller size, to reduce the weight of the device, to improve the battery duration and to improve the touch screen responsiveness.

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Image /page/6/Picture/0 description: The image shows a logo with a white heart shape inside a blue square. Below the logo, the text "Special 510(k) Premarket Notification" is displayed. The text is in a simple, sans-serif font and is left-aligned. The image appears to be a title or heading for a document related to medical device regulations.

# Device Comparison Table:

| Predicate Device and Subject Device Comparison | | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Predicate device | Subject device | Change explanation |
| Device | Surveyor S4 | Surveyor S2 | Model Number |
| COMPANY | Mortara Instrument, Inc. | Mortara Instrument, Inc. | Same |
| 510(k) number | K141020 | N/A | N/A |
| Software Version | V1.00 | V1.0.0 | Since the device has a different<br>model number has been created a<br>new software version. |
| Product Code | DRG | DRG | Same |
| Classification Name | Class II Transmitters and<br>receivers, physiological<br>signal, radiofrequency | Class II Transmitters and<br>receivers, physiological<br>signal, radiofrequency | Same |
| Regulation Number | 21 CFR 870.2910 | 21 CFR 870.2910 | Same |
| Intended use | The Surveyor S4 is<br>indicated for use:<br>The Surveyor S4 is<br>indicated for use in adult &<br>pediatric patient<br>populations.<br>The Surveyor S4<br>facilitates the monitoring<br>of ECG signals.<br>The Surveyor S4 is a<br>prescription device<br>intended to be used by<br>knowledgeable healthcare<br>professionals within a<br>healthcare facility or<br>clinical pharmacology unit.<br>The Surveyor S4 is<br>indicated for use in a<br>clinical setting by a<br>physician, or by trained<br>personnel acting on the<br>orders of a licensed<br>physician. It is not<br>intended as a sole means<br>of diagnosis.<br>The Surveyor S4 is<br>indicated for use to<br>acquire and output<br>electrocardiographic data.<br>The Surveyor S4 is<br>indicated for use as a | The Surveyor S2 is<br>indicated for use:<br>The Surveyor S2 is<br>indicated for use in adult,<br>adolescents, and children<br>patient populations.<br>The Surveyor S2 facilitates<br>the monitoring of ECG<br>signals.<br>The Surveyor S2 is a<br>prescription device intended<br>to be used by<br>knowledgeable healthcare<br>professionals within a<br>healthcare facility or clinical<br>pharmacology unit.<br>The Surveyor S2 is<br>indicated for use in a clinical<br>setting by a physician, or by<br>trained personnel acting on<br>the orders of a licensed<br>physician. It is not intended<br>as a sole means of<br>diagnosis.<br>The Surveyor S2 is<br>indicated for use to acquire<br>and output<br>electrocardiographic data.<br>The Surveyor S2 is<br>indicated for use as a<br>radiofrequency physiological | Same<br>Surveyor S2 indications for use have<br>been revised for clarity to provide<br>patient population categories in<br>accordance with FDA guidance<br>"Providing Information about<br>Pediatric Uses of Medical Devices -<br>Guidance for Industry and Food and<br>Drug Administration Staff" dated May<br>1, 2014.<br>Surveyor S2 is not provided with a<br>specific Mortara li-on battery<br>Charger. Surveyor S2 use a OEM<br>battery recharger. The new battery<br>charger has been tested for safety by<br>the supplier and to demonstrate<br>proper charging across each<br>charging port as well as<br>demonstrating proper LED functions<br>for the charger. |
| Characteristic | Predicate device | Subject device | Change explanation |
| radiofrequency<br>physiological signal<br>transceiver, receiving and<br>delivering real-time<br>acquisition and<br>transmission of<br>simultaneous<br>electrocardiographic data,<br>while allowing the patient<br>to be ambulatory within<br>the range of the antenna<br>network.<br><br>The Mortara Li-Ion Battery<br>Charger is intended for<br>charging only the Mortara<br>Rechargeable Li-Ion<br>battery pack. | signal transceiver, receiving<br>and delivering real-time<br>acquisition and transmission<br>of simultaneous<br>electrocardiographic data,<br>while allowing the patient to<br>be ambulatory within the<br>range of the antenna<br>network. | | |
| Standard<br>Compliance | IEC 60601-1:2005<br>IEC 60601-1-2:2007<br>IEC 60601-2-27:2011<br>IEC 60601-1-6:2010<br>IEC 62366:2007-10<br>ISO10993-1:2009<br>ISO10993-5: 2009<br>ISO10993-10: 2010<br>EN 62304:2006<br>ISO 14971:2007 | IEC 60601-1:2005 Ed 3.1<br>IEC 60601-1-2:2014 Ed 4.0<br>IEC 60601-2-27:2011 Ed<br>3.0<br>IEC 60601-1-6:2010 Ed 3.1<br>IEC 62366:2014 Ed.1.1<br>ISO 10993-1:2009 Ed 4<br>ISO 10993-5:2009 Ed 3<br>ISO 10993-10:2010 Ed 3<br>IEC 62304:2006 Ed 1,<br>ISO 14971:2007 Ed 2. | Equivalent, Surveyor S2 has been<br>designed in conformity with the<br>same standard of the predicate<br>Surveyor S4. Surveyor S2 follow<br>the new version of the IEC 60601-<br>1-2. |
| Network Interface<br>and Frequency<br>Transmission | Digital/Wireless network<br>interface per<br>IEEE 802.11 b/g/n 2.4<br>GHz band | Digital/Wireless network<br>interface per<br>IEEE 802.11a/g/n, 2.4 or<br>5GHz bands | S2 use the same network interface<br>of S4. S2 differently from S4 use<br>also 5Ghz Frequency<br>Transmission. This new feature<br>has been tested in the V&V<br>documentation. |
| Characteristic | Predicate device | Subject device | Change explanation |
| Target Population | Adults, pediatrics | Adults, adolescents, children | Equivalent.<br>Subject device includes a subset of the Adults to Children population of the predicate device.<br><br>Revised 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. |
| Where used | Health care facilities | Health care facilities | Same |
| ECG | 12-lead diagnostic ECG | 3-lead ECG | Equivalent, S2 uses the a 3-lead ECG, this function has been cleared in the K160685. Moreover, Surveyor S2 functionality with 3-lead ECG has been tested in the system V&V. |
| Patient Cable | LeadForm 10-wire ECG | Shielded 4-wire ECG | Equivalent, S2 uses the a 4-wire ECG cable, this cable has been cleared in the K160685. Moreover, Surveyor S2 functionality with 4-wires ECG cable has been tested in the system V&V. |
| ECG Sampling Rate | 500 Samples/sec | 500 samples/sec | Same |
| Graphic Display | Yes | Yes | Equivalent |
| Touch screen | Resistive Touch screen | Capacitive touch screen | Equivalent, this modification improves the responsiveness of the device, and allow the Surveyor S2 do not be calibrated. Capacitive touch screen responsiveness has been tested in the hardware verification. |
| Display Size | 4" | 2,8" | Equivalent, this modification reduces the dimension of the device. |
| Predicate Device and Subject Device Comparison | | | |
| Characteristic | Predicate device…