Who is the manufacturer of Surveyor Patient Monitor?

Mortara Instrument, Inc. filed the 510(k) submission for Surveyor Patient Monitor (K173765).

What is the FDA product code for Surveyor Patient Monitor?

MHX. It is classified under 21 CFR 870.1025 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Surveyor Patient Monitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Surveyor Patient Monitor?

Surveyor Patient Monitor (K161517); Philips Intelliview Patient Monitor MX800 (K161531).

Who can help prepare an FDA 510(k) submission like Surveyor Patient Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Surveyor Patient Monitor

K173765 · Mortara Instrument, Inc. · MHX · Sep 4, 2018 · Cardiovascular

Device Facts

Record ID	K173765
Device Name	Surveyor Patient Monitor
Applicant	Mortara Instrument, Inc.
Product Code	MHX · Cardiovascular
Decision Date	Sep 4, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1025
Device Class	Class 2
Attributes	Pediatric

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 The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Device Story

Integrated multi-parameter patient monitor; bedside or transport use; operated by healthcare professionals. Inputs: ECG leads, NIBP cuffs, temperature probes, SpO2 sensors, IBP transducers, CO2 sampling lines. Transforms physiological signals into waveforms, numeric data, and trends; performs arrhythmia and ST-segment analysis via Veritas algorithm. Outputs: color touchscreen display of waveforms/numerics, audible/visual alarms, LED alarm bar, and printer output. Features Wireless LAN and Bedside-to-Bedside (B2B) remote viewing when connected to Surveyor Central Station. Assists clinicians in continuous patient monitoring; facilitates timely clinical intervention through real-time data and alarm notifications.

Clinical Evidence

Bench testing only. Software verification and validation performed per FDA guidance. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-25, IEC 60601-2-27, IEC 60601-2-34, ISO 80601-2-30, ISO 80601-2-55, ISO 80601-2-56, ISO 80601-2-61, and AAMI ANSI EC 57:2012 for arrhythmia and ST-segment algorithm performance.

Technological Characteristics

Multi-parameter monitor with 11.6" (S12) or 18.5" (S19) touchscreen. Power: AC mains or internal Li-ion battery. Connectivity: Wired Ethernet (IEEE 802.3), Wireless LAN, RS-232. Sensing: Oscillometric NIBP, thoracic impedance respiration, pulse oximetry, capnography (non-dispersive infrared), ECG (AM12M module). Software: Veritas algorithm for ECG/arrhythmia/ST-segment analysis. Sterilization: N/A (non-sterile). Standards: IEC 60601 series, ISO 80601 series, IEC 62304, IEC 62366.

Indications for Use

Indicated for adult, adolescent, child, infant, and neonatal patient populations for continuous monitoring of ECG (arrhythmia/ST-segment), respiration (impedance/capnography), NIBP, IBP, temperature, SpO2, CO2, and cardiac output.

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 Patient Monitor (K161517)
Philips Intelliview Patient Monitor MX800 (K161531)

Reference Devices

Surveyor Central Station (K131929)
IntelliVue Information Center (K143057)

Related Devices

K132026 — V SERIES MONITORING SYSTEM, 12.1 DCU/V12 AND 21.0 DCU/V21 · Mindray DS USA, Inc. · Dec 20, 2013
K090172 — STAR 55 MODEL 100 · Larsen & Toubro Limited · Jun 5, 2009
K122253 — PROCARE MONITOR B20 · Ge Medical Systems China Co., Ltd. · Mar 22, 2013
K032749 — BEDSIDE MONITOR, MODEL OPV-1500 · Nihon Kohden America, Inc. · Sep 16, 2003
K151512 — Star 60 · Skanray Technologies Private Limited · Feb 14, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. September 4, 2018 Mortara Instrument, Inc. Manisha Gokuli Regulatory Affairs Manager 7865 North 86th Street Milwaukee, Wisconsin 53224 #### Re: K173765 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 Product Code: MHX, DQA, DPS, MLD, DSB, MSX, DSI, DSJ Dated: December 7, 2017 Received: December 11, 2017 Dear Manisha Gokuli: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Image /page/1/Picture/6 description: The image shows the name "Arielle Drummond -S" in a large, sans-serif font. The text is black and appears to be centered on a white background. The letters are clear and easy to read, with consistent spacing between them. for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) #### K173765 #### 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 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 The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text 'K173765' at the top. Below the text is a blue heart shape. The heart is formed by two curved lines meeting at a point at the bottom and a rounded top. # Section 5 # 510(k) Summary ### 1. Submitter ### Date: 10/17/2017 Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, WI 53224 Telephone 414-354-1600 Fax 414-354-4760 Primary Contact Manisha Gokuli Regulatory Affairs Manager Manisha.Gokuli@mortara.com Secondary Contact Mark Elliott VP Global RA/QA Mark.Elliott@mortara.com ### 2. Product Names Device Trade Name Common/ Usual Name Classification Surveyor Patient Monitor Patient Physiological Monitor (with Arrhythmia Detection or Alarms) Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) 870.1025 MHX Oximeter 870.2700 DQA Electrocardiograph 870.2340 DPS {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the text "K173765" above a blue heart shape. The heart shape is formed by two curved lines meeting at a point at the bottom and curving outwards at the top. The heart is solid blue, and the background is white. The text is in black and is located in the top left corner of the image. Monitor, ST Segment with Alarm 870.1025 MLD Alarm, Blood Pressure 870.1100 DSJ Plethysmograph, Impedance 870.2770 DSB System, Network and Communication, Physiological Monitors 870.2300 MSX Detector and Alarm, Arrhythmia 870.1025 DSI #### 3. Predicate Device to which this is Substantially Equivalent | Predicate Device | Name | 510(k) Number | |------------------|-------------------------------------------|---------------| | Primary | Surveyor Patient Monitor | K161517 | | Secondary | Philips Intelliview Patient Monitor MX800 | K161531 | 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 July 26, 2016, Z-2328-2016. #### 4. Device Description 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the text 'K173765' at the top left corner. Below the text is a blue shape that resembles a stylized heart or an 'M' shape. The heart shape is created by a white space within the blue area, giving it a cutout appearance. 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 Survevor 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, noninvasive 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 Survevor Network, the Survevor 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. The new Surveyor S12, S19, V3.0.1 has added Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station | | Patient Types | | | |---------------------------------------|---------------|----------------------------------|----------------| | Parameters | Adult | Pediatric Adolescent/Children | Infant/Neonate | | ECG 3-Lead | ✓ | ✓ | ✓ | | ECG 5-Lead | ✓ | ✓ | ✓ | | ECG 12-Lead | ✓ | ✓ | ✓ | | Resting 12 Lead Interpretation | ✓ | ✓ | ✓ | | ST Segment Monitoring | ✓ | ✓ | N/A | | Respiration - Impedance | ✓ | ✓ | ✓ | | Respiration- Capnography | ✓ | ✓ | ✓ | | NIBP (Non-Invasive Blood Pressure) | ✓ | ✓ | ✓ | | SpO2- Mortara | ✓ | ✓ | N/A | | SpO2- Nellcor Oxi-Max | ✓ | ✓ | ✓ | | CO2 | ✓ | ✓ | ✓ | | IBP (Invasive Blood | ✓ | ✓ | ✓ | #### Parameters by Patient Type {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the text 'K173765' above a blue graphic. The graphic is a square with a heart-shaped cutout in the center. The heart shape is white, contrasting with the blue square. | Pressure) | | | | |---------------------|---|---|-----| | Cardiac Output | ✓ | ✓ | N/A | | Temperature | ✓ | ✓ | ✓ | | Arrhythmia Basic | ✓ | ✓ | ✓ | | Arrhythmia Extended | ✓ | ✓ | ✓ | ### 5. Intended Use Indications for 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: - V Non-invasive blood pressure - > Impedance respiration - Invasive blood pressure > - > Temperature - > Functional arterial oxygen saturation (SpO2) - V End-tidal & inspired CO2 - > ECG monitoring with arrhythmia - V 12-Lead resting ECG The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the number K173765 at the top left corner. Below the number is a blue heart shape. The heart shape is formed by two curved lines that meet at a point at the bottom and two curved lines that meet at a point at the top. #### 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 v2.0.0 (K161517) and Philips MX800 Patient Monitor (K161531). 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 v3.1.0 was designed and manufactured by Mortara Instrument according to 21 CFR Part 820. Surveyor S12 and S19 Patient Monitor v3.1.0 is substantially equivalent to Surveyor S12 and S19 Patient Monitor v2.0.0 (Primary Predicate K161517), which is in commercial distribution, except for the following new features that were added: - Wireless LAN capability . - Bedside-to-Bedside (B2B) Feature: The 'Bed to Bed . communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. A second predicate device used for this submission is Philips MX800 Patient Monitor (K161531), and has a feature 'Bed-to-bed overview', that provides clinicians with an overview of all the patient beds in their care. This feature is similar to the 'Bedsideto-Bedside (B2B) Feature' that is in the submitted device. A full comparison matrix of functionality is located in Section 12, Substantial Equivalence Discussion and is shown below. #### Comparison Matrix For detailed comparisons refer to the Table 12-1. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the text "K173765" above a blue and white heart-shaped logo. The logo is a stylized heart shape with a flat bottom and rounded top. The heart is white, and the background is blue. The text is black and located in the upper left corner of the image. # Table 12-1 Comparison Matrix to Predicate Device | | Predicate Device 1 (Primary) Surveyor S12 and S19 Patient Monitor | Predicate Device 2 (Secondary) Philips MX800 Patient Monitor | Present Submission Surveyor S12 and S19 Patient Monitor | Change explanation for the subject device | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------| | 510(k) | K161517 | K161531 | Present Submission | | | BRAND | Surveyor S12/S19 | Philips MX800 | Surveyor S12/S19 | | | COMPANY | Mortara Instrument, Inc. | Philips Medical Systems | Mortara Instrument, Inc. | | | Software Version | V2.0.0 | | V3.1.0 | | | Indications for 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 | The Philips MX800 is indicated for Adult, Pediatric or Neonatal) for the monitoring of the following parameters: • Non-invasive blood pressure • Impedance respiration • Invasive blood | 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- | Added | {10}------------------------------------------------ Image /page/10/Picture/0 description: The image shows the text "K173765" at the top left corner. Below the text is a blue heart shape. The heart is formed by two curved lines that meet at a point at the bottom and curve upwards to form the top of the heart. | • Invasive blood pressure | • pressure • Temperature • Functional arterial oxygen saturation (SpO₂) • End-tidal & inspired CO₂ (with MMS extension) • ECG monitoring with arrhythmia & ST-segment • Cardiac output | • 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: • ion-invasive blood pressure • Impedance respiration • Invasive blood pressure • Temperature • Functional arterial oxygen saturation (SpO₂) End-tidal & inspired CO₂ • ECG monitoring with arrhythmia The 'Bed 2 Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility. | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | | | {11}------------------------------------------------ Image /page/11/Picture/0 description: The image shows a logo with the text "K173765" above it. The logo is a blue square with a white heart shape cut out of the center. The heart shape is formed by two curved lines that meet at a point at the bottom and two curved lines that meet at a point at the top. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the text "K173765" above a blue logo. The logo is a blue square with a white heart shape cut out of the center. The heart shape is symmetrical and takes up most of the space within the square. | g ECG The Mortar a Surve yor Patien t Monit or is a prescr iption device intend ed to be used by health care profes sional s in all areas of a health care facility . | | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the text "K173765" at the top left corner. Below the text is a blue heart shape. The heart is formed by a blue outline with the inside of the heart being white. | Bedside to Bedside (B2B) Feature | None | Bed-to-bed overview provides clinicians with an overview of all the patient beds in their care (Reference: Philips_Intelli Vue_MX800 Technical_ Datasheet). | The 'Bed to Bed communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. The Remote View and Notification features are enabled on a Unit by Unit basis. | Added | |----------------------------------------------------|------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------| | Viewing the Other Bed Window | NA | The other Bed Window lets you view a subset of the waveform and numeric information from another bed on the same network – Reference Page 125 Instructions for USE 4535644175 61(Eng) | The 'Bed to Bed communication' feature if enabled, allows remote viewing of other patient monitor limited information when connected to a Surveyor Central Station. | Added | | Alarm occurrence at another Bed | NA | The other Bed window can be configured to pop-up automatically when an alarm occurs at another Bed. This automatic pop-up can be temporarily disabled. | When the 'Bed to Bed communication' feature is enabled and the Alarm Notification is set to ON, it allows the notification of alarm at another bed in B2B window. | Added | | Accessing remote patient limited information | NA | Overview BAR next to the Monitor's own Bed Label To Open the Other Bed Window, select the required bed label or patient name in the Alarm Status Overview Bar If you are in a Unit Group with many beds, the 'MY Patients window may open for you to select the bed | Touching the Remote View button displays the Setup Remote View menu and the Bed list. The user can select any bed on the list to open the Remote view for the Bed. | Added | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows a blue logo with the text "K173765" above it. The logo is a stylized heart shape, with the top of the heart formed by a curved line and the bottom of the heart formed by two angled lines. The heart is white, and the background is blue. The text is black and is located in the top left corner of the image. {15}------------------------------------------------ Image /page/15/Picture/0 description: The image shows the text 'K173765' above a blue logo. The logo is a square with a heart-shaped cutout in the center. The heart is white, and the square is blue. | Connect s Hospital Intranet to retrieve other Patient informati on/data | NA | Yes | Yes | Equivalent | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------------| | Processo r Board | Z1 | | Z2 | Equivalent | | Network interface, wired | IEEE 802.3 Ethernet, 10/100 Mbps | IEEE 802.3 Ethernet, 100 Mbps | IEEE 802.3 Ethernet, 10/100 Mbps | Identical | | Network interface, wireless | None | IEEE 802.11a/b/g 2.4 GHz and 5 GHz Band | Wireless LAN | Added | | Network system compatib ility | Mortara Surveyor Network | The integrated PC (iPC) allows access to relevant patient information residing on the hospital's intranet. (Reference: Datasheet) | Mortara Surveyor Network | Identical | | Serial interface | RS-232 | IEEE 1073- 3.2-2000 Connectors RJ45 (8 pin) | RS-232 | Identical | | Target Populatio n | Adult, adolescents, children, infants and neonatal patient populations | Adult, pediatric, neonatal | Adult, adolescents, children, infants and neonatal patient populations | Identical | | Operatin g Modes | Continuous Monitoring | Continuous Monitoring | Continuous monitoring | Identical | {16}------------------------------------------------ Image /page/16/Picture/0 description: The image shows a blue logo with the text "K173765" above it. The logo is a stylized heart shape formed by two angled lines meeting at the bottom and curving inward to create the top of the heart. The heart shape is cut out of a blue square, creating a negative space effect. | 12 Lead ECG | ECG acquisition module model AM12M with snap end lead set | X1 multi measuremen t module for 12-lead ECG | ECG acquisition module model AM12M with snap end lead set | Identical | |----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------| | ECG cable set for 3/5-wire applicati ons | Integrated cables and trunk cable with detachable lead sets (including for Neonatal applications). | X1 multi measuremen t module for 3/5 wire ECG | Integrated cables and trunk cable with detachable lead sets (including for Neonatal applications). | ldentical | | ECG input impedan се | >2.5 MOhm at 10 Hz | >2 MOhm RA-LL leads (Resp) >5 MOhm at all other leads (at 10 Hz including patient cable) | >2.5 MOhm at 10 Hz | Equivalent | | 3/5 wire ECG lead fail detection | Active electrode: <100 nA Reference electrode: <900 nA | Active electrode: <100 nA Reference electrode: <900 nA | Active electrode: <100 nA Reference electrode: <900 nA | Identical | | Alarm Levels | High, medium, low; visually color-coded & audible, complies with IEC 60601- 1-8 | High, medium visually color-coded & audible | High, medium, low; visually color-coded & audible, complies with IEC 60601-1-8 | ldentical | | Alarm on off can be done by manual control on the device or remotely | Alarm on the Device can be silenced only on the device or from Surveyor Central | Alarm on/off can be done on the device only | Alarm on the Device can be silenced only on the device or from Surveyor Central | ldentical | | Respons e to controls: | Power on/off is on the Device | Power on/off is on the Device | Power on/off is on the Device | Identical | | Trending | Up to 72 hours of parameter information, available in 1/5/15/60/240 min. averaged intervals | 8 hours trend data at 1- minute resolution in module X1, 24 hours in module X2 | Up to 72 hours of parameter information, available in 1/5/15/60/240 min. averaged intervals | Identical | | Compatible Systems | Surveyor Central Station (K131929) | IntelliVue Information Center (K143057) | Surveyor Central Station (K131929) | Identical | | Measurement Method | Oscillometric | Oscillometric | Oscillometric | Identical | | Measurement Units | mmHg | mmHg | mmHg | Identical | | Measurement Mode | Auto or manual | Auto or manual | Auto or manual | Identical | | Cuff Size | Infant, Child, Small Adult, Regular Adult, Large Adult, Thigh | Adult (thigh), Large Adult, Adult, Small Adult, Pediatric, Infant | Neonate, Infant, Child, Small Adult, Regular Adult, Large Adult, Thigh | Identical | | Measurement method | Thoracic impedance plethysmography | Thoracic impedance plethysmography | Thoracic impedance plethysmography | Identical | | Input | 3 or 5-Lead ECG cable | 3, 5, 6 or 10- lead ECG Cable | 3 or 5-Lead ECG cable | Identical | | Respiration Signal | Measured between the RA and LL electrodes | Measured between the RA and LL electrodes | Measured between the RA and LL electrodes | Identical | | Respiration Rate Resolution | 1 bpm (breaths per minute) | 1 bpm (breaths per minute) | 1 bpm (breaths per minute) | Identical | | Bandwidth | 0.17 to 3.3 Hz (-3dB) | 0.3 to 2.5 Hz (-6 dB) | 0.17 to 3.3 Hz (-3dB) | Equivalent | | Measure ment method | Direct measurement of arterial or venous pressure via transducer | Direct measuremen t of arterial or venous pressure via transducer | Direct measurement of arterial or venous pressure via transducer | Identical | | Pressure sources | ART, CVP, ICP, LA, P1, P2, P3, P4, PAWP, RA, PA, UAP, UVP | ABP,ART,Ao ,CVP,ICP,LA P,P,PAP,RA P,UAP,UVP | ART, CVP, ICP, LA, P1, P2, P3, P4, PAWP, RA, PA, UAP, UVP | Identical | | Product Configur ations with IBP | Marketed configurations include 2 IBP channels, 4 IBP channels, and no IBP channels. | 2 x IBP channels. Additional channels may be added through | Marketed configurations include 2 IBP channels, 4 IBP channels, and no IBP channels. | Identical | | Measure ment method | Direct, continuous | Direct, continuous | Direct, continuous | Identical | | Probe Type | 400-series temperature sensor with ¼ inch phone plug | 400-series temperature sensor with ¼ inch phone plug | 400-series temperature sensor with ¼ inch phone plug | Identical | | Measure ment Method | Pulse oximetry, optical | Pulse oximetry, optical | Pulse oximetry, optical | Identical | | Measure ment algorithm | Mortara SpO2, Nellcor OxiMax | Philips, Nellcor, Masimo | Mortara SpO2, Nellcor OxiMax | Identical | | Paramet ers | % SpO2, pulse rate, plethysmogram | % SpO2, pulse rate, plethysmogram, perfusion value | % SpO2, pulse rate, plethysmogram | Identical | | Method | Capnography, non-dispersive infrared spectroscopy, continuous | Capnograph y, non- dispersive infrared spectroscopy , continuous | Capnography, non- dispersive infrared spectroscopy, continuous | Identical | | Algorith m | Veritas | Oridion Microstream | Veritas | Equivalent | | Sampling configura tions | Sidestream | Mainstream, sidestream, microstream | Sidestream | Identical | | Measure ments | End-tidal CO2 (EtCO2), Fractional Inspired CO2 (FiCO2), Respiration Rate (RR-CO2), Integrated Pulmonary Index (IPI) | CO2 waveform, End Todal CO2 (etCO2), Inspired Minimum CO2 (iMCO2), airway respiration rate (awRR), Integrated Pulmonary Index (IPI), | End-tidal CO2 (EtCO2), Fractional Inspired CO2 (FiCO2), Respiration Rate (RR-CO2), Integrated Pulmonary Index (IPI) | Identical | | Type | Color LCD | Color LCD | Color LCD | Identical | | Size | S12: 11.6" S19: 18.5" | 19" | S12: 11.6" S19: 18.5" | Identical | | Input methods | Touchscreen | Touchscreen | Touchscreen | Identical | | Power sources | Mains AC, 100-240 V, 50/60 Hz; or internal battery | Mains AC, 100-240 V, 50/60 Hz; or user replaceable internal battery | Mains AC, 100-240 V, 50/60 Hz; or internal battery | Identical | | Battery Type | Internal lithium- ion rechargeable | Internal lithium-ion rechargeable | Internal lithium-ion rechargeable | Identical | | Degree of protectio n | Type CF applied parts | Type CF applied parts | Type BF and CF applied parts | Identical | | Intended operating environm ent | Temp: +32 to +104 °F Humidity: 15 to 90% | 0 to 40 °C (32 to 104 °F) 0 to 35°C (32 Operating 15% to 95% Relative Humidity (RH) (non condensing) Storage 5% to 95% Relative Humidity (RH) (non condensing) | Temp: +32 to +104 °F Humidity: 15 to 90% | Identical | | Mode of operation | Continuous | Continuous | Continuous | Identical | | Ingress Protectio n | IPX1 (drip-proof) | IPX1 | IPX1 | Identical | | User Interface Selection Options | N/A | N/A | • Ability to select detection leads • Ability to select QRS amplitude threshold | Added | | Data logging | Veritas QRS labels on Bedside Monitor data storage | N/A | Veritas QRS labels on Bedside Monitor data storage or connected Surveyor Central System data storage | Added | | Pacemak er Detectio n | Pacemaker detection selectable from Bedside Monitor | N/A | Pacemaker detection selectable from Bedside Monitor or connected Surveyor Central System | Added | | ST Analysis | Partial support of ST Analysis features on connected Surveyor Central System | N/A | Full support of ST Analysis features on connected Surveyor Central System | Added | | Trend Reports | Trend reports available on Bedside Monitor | N/A | Trend reports available on Bedside Monitor or connected Surveyor Central System | Added | | Demogra phic data editing | N/A | N/A | Demographic data can be updated through serial communication | Added | {17}------------------------------------------------ Image /page/17/Picture/0 description: The image shows a logo with the text "K173765" above it. The logo is a blue square with a white heart shape cut out of the center. The heart shape is formed by two curved lines that meet at a point at the bottom and a rounded top. {18}------------------------------------------------ Image /page/18/Picture/0 description: The image shows a blue heart shape with a white interior. The heart is stylized and has a modern look. The text "K173765" is located in the upper left corner of the image. {19}------------------------------------------------ Image /page/19/Picture/0 description: The image shows a logo with the text "K173765" above it. The logo is a blue square with a white heart shape cut out of the center. The heart shape is formed by two curved lines that meet at a point at the bottom. {20}------------------------------------------------ Image /page/20/Picture/0 description: The image shows the text 'K173765' above a blue logo. The logo is a square with a heart-shaped cutout in the center. The heart is white, and the square is blue. {21}------------------------------------------------ Image /page/21/Picture/0 description: The image shows the text 'K173765' at the top left corner. Below the text is a blue heart shape. The heart is formed by two curved lines meeting at a point at the bottom and two curves at the top. #### 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: {22}------------------------------------------------ Image /page/22/Picture/0 description: The image shows the text 'K173765' in the upper left corner. Below the text is a blue symbol that resembles a heart shape within a square. The heart shape is formed by the white space inside the blue square. IEC 60601-1:2005 Ed:3 Medical electrical equipment Part 1: General requirements for basic safety and essential performance IEC 60601-1-2:2007 Medical Electrical Equipment – Part 1-2: General requirements for safety - Collateral Standard: Electromagnetic Compatibility IEC 60601-1-8:2006 Medical Electrical Equipment -- Part 1-8: General requirements for basic safety and essential performance -- Collateral standard: General requirements, tests and quidance for alarm systems in medical electrical equipment and medical electrical systems IEC 60601-2-25 Edition 2.0 2011-10: Medical Electrical Equipment - Part 2-25: Particular Requirements For The Basic Safety And Essential Performance Of Electrocardiographs IEC 60601-2-27:2011 Ed:3 Medical Electrical Equipment PT. 2: Particular Requirements for the Safety, including essential performance, of Electrocardiographic Monitoring Equipment IEC 60601-2-34:2011 Ed:3 Medical Electrical Equipment Part 2-34: Particular Requirements for the Safety, Including Essential Performance, of Invasive Blood Pressure Monitoring Equipment IEC 62366:2007 Medical Devices -- Application of usability engineering to medical devices ISO 80601-2-30:2009 Ed: 1.1 Medical Electrical Equipment - Part 2-30: Particular Requirements for the Basic Safety and Essential Performance of Automated Non-Invasive Sphygmomanometers; Corr. 1: 2010 ISO 80601-2-55:2011 Medical electrical equipment Particular requirements for the basic safety and essential performance of respiratory gas monitors ISO 80601-2-56:2009 - Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement ISO 80601-2-61:2011 - Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment AAMI ANSI EC 57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms IEC 62304:2006; Medical device software -- Software life cycle processes #### 8. Conclusion The new/submitted Surveyor S12 and S19 Patient Monitor has added - Wireless LAN capability ● - Bedside-to-Bedside (B2B) Feature: The 'Bed to Bed . communication' feature allows remote viewing of monitors when connected to a Surveyor Central Station. Mortara Instrument, Inc. considers the Surveyor S12 and S19 Patient Monitor performance to be substantially equivalent to the predicate devices.