(267 days)
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.
The Mortara Surveyor S12 and S19 are integrated multi-parameter patient monitors designed to be used by trained medical personnel within healthcare facilities on adult, adolescent, child, infant, and neonatal patient populations.
Surveyor S12 and S19 include color, touch screen displays which present patient demographics, physiological waveforms, numeric data, trends, status condition, with high, medium, and low warning alarms and technical messages. The monitor alerts of patient conditions with audible alarming through a speaker located within the device, visual alarms presented on the graphical user interface, and a visual LED alarm bar indicator on the front of the unit. The monitor provides a dedicated ON/OFF switch with AC power LED indication. Power is provided either from an external power supply connected to mains, or an internal lithium-ion battery. The Surveyor S12 has an 11.6" display and comes with an integrated 2 channel printer, while the Surveyor S19 has at 18.5" display and comes with an optional 2 channel printer.
The 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
The Mortara Surveyor Patient Monitor is a multi-parameter patient monitor that was submitted to the FDA for 510(k) clearance (K173765) as substantially equivalent to its predicate devices, the Surveyor S12 and S19 Patient Monitor v2.0.0 (K161517) and Philips MX800 Patient Monitor (K161531). The new features added were Wireless LAN capability and a Bedside-to-Bedside (B2B) feature that allows remote viewing of monitors when connected to a Surveyor Central Station.
Here's an analysis of the provided information concerning acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a specific table detailing acceptance criteria for performance metrics (e.g., accuracy, sensitivity, specificity) for parameters like ECG, NIBP, SpO2, etc. Instead, it relies on compliance with recognized consensus standards. The "Reported Device Performance" in this context refers to the device's adherence to these standards and the assertion of substantial equivalence based on the technological characteristics being identical or equivalent to the predicate devices and the successful completion of non-clinical software verification and validation.
The "Comparison Matrix to Predicate Device" (Table 12-1) is the closest thing to reported device performance, showing that fundamental parameters and their measurement methods are identical or equivalent to the predicate.
For example, for physiological parameters, the comparison matrix shows:
- NIBP: Measurement Method, Units, and Mode are "Identical" to predicate. Cuff sizes are "Identical".
- Respiration: Measurement Method, Signal origin, and Rate Resolution are "Identical". Bandwidth is "Equivalent" (0.17 to 3.3 Hz for the subject device vs. 0.3 to 2.5 Hz for Predicate 2).
- IBP: Measurement Method and Pressure sources are "Identical". Product Configurations for IBP are "Identical".
- Temperature: Measurement Method and Probe Type are "Identical".
- SpO2: Measurement Method, Algorithm (Mortara SpO2, Nellcor OxiMax), and Parameters are "Identical" to Predicate 1.
- CO2: Method, Sampling configurations, and Measurements are "Identical". Algorithm is "Equivalent" (Veritas for subject device vs. Oridion Microstream for Predicate 2).
- ECG: 12 Lead ECG module and 3/5-wire ECG cable set are "Identical". ECG input impedance is "Equivalent" (>2.5 MOhm at 10 Hz for subject device vs. >2 MOhm for Predicate 2). 3/5 wire ECG lead fail detection is "Identical".
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states that non-clinical software verification and validation testing was conducted. There is no mention of a clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective data) for evaluating the overall device performance for physiological monitoring. The focus of the submission for the new features (Wireless LAN and B2B) is on software validation and compliance with electrical safety and EMC standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Since no clinical test set is described, there's no information about experts establishing ground truth in the context of physiological parameter accuracy or clinical efficacy. The substantial equivalence relies on comparison to predicate devices and adherence to engineering standards.
4. Adjudication Method for the Test Set
As there is no described clinical test set for performance evaluation, there is no adjudication method mentioned for such a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was done or is mentioned in the provided document. The device's clearance is based on substantial equivalence to existing devices and non-clinical testing of new features.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The assessment focused on non-clinical software verification and validation, which can be considered a form of standalone performance evaluation for the software components, particularly for the new Wireless LAN and B2B features, as well as the underlying algorithms for physiological parameters.
Compliance with standards such as AAMI ANSI EC 57:2012 Testing And Reporting Performance Results Of Cardiac Rhythm And ST-Segment Measurement Algorithms suggests that the cardiac rhythm and ST-segment measurement algorithms would have undergone standalone testing against reference waveforms, but specific details of this testing (e.g., sample size, specific performance metrics against referenced ground truth) are not provided in this summary.
7. The Type of Ground Truth Used
For the software verification and validation, the ground truth would likely be established through:
- Reference standards and specifications: For electrical safety, EMC, and alarm systems (e.g., IEC 60601 series).
- Internal engineering specifications: For the functionality of the Wireless LAN and B2B features, ensuring they perform as designed.
- Simulated data or known test conditions: For cardiac rhythm and ST-segment measurement algorithms (implied by adherence to AAMI ANSI EC 57:2012), where known arrhythmias or ST-segment changes are used as ground truth.
- Comparison to predicate device performance: The core physiological monitoring components are claimed to be "Identical" or "Equivalent" to already cleared devices, suggesting their performance has a history of acceptable use based on previously established ground truths (though not detailed here).
For the new features (Wireless LAN, B2B), the "ground truth" would be the successful and secure transmission/display of data as specified by the system design.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set or its sample size. This type of information is typically associated with AI/ML-based devices, which is not highlighted as the primary mechanism for the core physiological monitoring functions or the new features of this device.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, no information on how its ground truth was established is available.
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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
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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
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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.
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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
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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
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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 | PediatricAdolescent/Children | Infant/Neonate |
| ECG 3-Lead | ✓ | ✓ | ✓ |
| ECG 5-Lead | ✓ | ✓ | ✓ |
| ECG 12-Lead | ✓ | ✓ | ✓ |
| Resting 12 LeadInterpretation | ✓ | ✓ | ✓ |
| ST Segment Monitoring | ✓ | ✓ | N/A |
| Respiration - Impedance | ✓ | ✓ | ✓ |
| Respiration- Capnography | ✓ | ✓ | ✓ |
| NIBP (Non-Invasive BloodPressure) | ✓ | ✓ | ✓ |
| SpO2- Mortara | ✓ | ✓ | N/A |
| SpO2- Nellcor Oxi-Max | ✓ | ✓ | ✓ |
| CO2 | ✓ | ✓ | ✓ |
| IBP (Invasive Blood | ✓ | ✓ | ✓ |
Parameters by Patient Type
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| 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.
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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.
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Table 12-1 Comparison Matrix to Predicate Device
| PredicateDevice 1(Primary)SurveyorS12 andS19PatientMonitor | PredicateDevice2(Secondary)PhilipsMX800PatientMonitor | Present SubmissionSurveyor S12 and S19Patient Monitor | Changeexplanationfor thesubjectdevice | |
|---|---|---|---|---|
| 510(k) | K161517 | K161531 | Present Submission | |
| BRAND | SurveyorS12/S19 | PhilipsMX800 | Surveyor S12/S19 | |
| COMPANY | MortaraInstrument, Inc. | PhilipsMedicalSystems | Mortara Instrument, Inc. | |
| SoftwareVersion | V2.0.0 | V3.1.0 | ||
| Indications forUse | The MortaraSurveyor PatientMonitor isindicated for usein adult,adolescents andchildren patientpopulations forthe monitoring ofthe followingparameters:• Non-invasiveblood pressure• Impedancerespiration | The PhilipsMX800 isindicated forAdult,Pediatric orNeonatal) forthemonitoring ofthe followingparameters:• Non-invasivebloodpressure• Impedancerespiration• Invasiveblood | The Mortara SurveyorPatient Monitor isindicated for use in adult,adolescents and childrenpatient populations for themonitoring of the followingparameters:• Non-invasive bloodpressure• Impedancerespiration• Invasive bloodpressure• Temperature• Functional arterialoxygen saturation(SpO2)• End-tidal & inspiredCO2• ECG monitoring witharrhythmia & ST- | Added |
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| • Invasivebloodpressure | • pressure• Temperature• Functionalarterialoxygensaturation(SpO₂)• End-tidal &inspiredCO₂ (withMMSextension)• ECGmonitoring witharrhythmia &ST-segment• Cardiacoutput | • segment• 12-Lead resting ECG• Cardiac outputThe Mortara SurveyorPatient Monitor isindicated for use in infantsand neonatal patientpopulations for themonitoring of the followingparameters:• ion-invasive bloodpressure• Impedance respiration• Invasive blood pressure• Temperature• Functional arterialoxygen saturation(SpO₂) End-tidal &inspired CO₂• ECG monitoring witharrhythmiaThe 'Bed 2 Bedcommunication' featureallows remote viewing ofmonitors when connectedto a Surveyor CentralStation.The Mortara SurveyorPatient Monitor is aprescription deviceintended to be used byhealthcare professionalsin all areas of a healthcarefacility. |
|---|---|---|
| neonatal patientpopulations forthe monitoring ofthe followingparameters:Non-invasivebloodpressure Impedancerespiration Invasivebloodpressure Temperature Functionalarterialoxygensaturation(SpO₂)End-tidal &inspired CO₂ ECGmonitoringwitharrhythmia 12-Leadresting |
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| gECGTheMortaraSurveyorPatientMonitor is aprescriptiondeviceintended tobeusedbyhealthcareprofessionals in allareasof ahealthcarefacility. | ||
|---|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -- | -- |
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| BedsidetoBedside(B2B)Feature | None | Bed-to-bedoverviewprovidesclinicianswith anoverview ofall the patientbeds in theircare(Reference:Philips_IntelliVue_MX800Technical_Datasheet). | The 'Bed to Bedcommunication' featureallows remote viewing ofmonitors when connectedto a Surveyor CentralStation. The RemoteView and Notificationfeatures are enabled on aUnit by Unit basis. | Added |
|---|---|---|---|---|
| Viewingthe OtherBedWindow | NA | The otherBed Windowlets you viewa subset ofthewaveformand numericinformationfrom anotherbed on thesamenetwork –ReferencePage 125Instructionsfor USE453564417561(Eng) | The 'Bed to Bedcommunication' feature ifenabled, allows remoteviewing of other patientmonitor limited informationwhen connected to aSurveyor Central Station. | Added |
| Alarmoccurrence atanotherBed | NA | The other Bedwindow can beconfigured to pop-upautomatically whenan alarm occurs atanother Bed. This automaticpop-up can betemporarily disabled. | When the 'Bed to Bedcommunication' feature isenabled and the AlarmNotification is set to ON, itallows the notification ofalarm at another bed inB2B window. | Added |
| Accessing remotepatient limitedinformation | NA | Overview BAR nextto the Monitor'sown Bed Label To Open the OtherBed Window,select the requiredbed label or patientname in the AlarmStatus OverviewBar If you are in a UnitGroup with manybeds, the 'MYPatients windowmay open for you toselect the bed | Touching the RemoteView button displays theSetup Remote Viewmenu and the Bed list.The user can select anybed on the list to openthe Remote view for theBed. | Added |
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| ConnectsHospitalIntranettoretrieveotherPatientinformation/data | NA | Yes | Yes | Equivalent |
|---|---|---|---|---|
| Processor Board | Z1 | Z2 | Equivalent | |
| Networkinterface,wired | IEEE 802.3Ethernet,10/100 Mbps | IEEE 802.3Ethernet,100 Mbps | IEEE 802.3 Ethernet,10/100 Mbps | Identical |
| Networkinterface,wireless | None | IEEE802.11a/b/g2.4 GHz and5 GHz Band | Wireless LAN | Added |
| Networksystemcompatibility | Mortara SurveyorNetwork | TheintegratedPC(iPC) allowsaccess torelevantpatientinformationresiding onthe hospital'sintranet.(Reference:Datasheet) | Mortara Surveyor Network | Identical |
| Serialinterface | RS-232 | IEEE 1073-3.2-2000ConnectorsRJ45 (8 pin) | RS-232 | Identical |
| TargetPopulation | Adult,adolescents,children, infantsand neonatalpatientpopulations | Adult,pediatric,neonatal | Adult, adolescents,children, infants andneonatal patientpopulations | Identical |
| Operating Modes | ContinuousMonitoring | ContinuousMonitoring | Continuous monitoring | Identical |
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| 12 LeadECG | ECG acquisitionmodulemodel AM12Mwith snap endlead set | X1 multimeasurement module for12-lead ECG | ECG acquisition modulemodel AM12M with snapend lead set | Identical |
|---|---|---|---|---|
| ECGcable setfor3/5-wireapplications | Integrated cablesand trunk cablewith detachablelead sets(including forNeonatalapplications). | X1 multimeasurement module for3/5 wire ECG | Integrated cables andtrunk cable withdetachable lead sets(including for Neonatalapplications). | ldentical |
| ECGinputimpedanсе | >2.5 MOhm at 10Hz | >2 MOhmRA-LL leads(Resp)>5 MOhm atall otherleads (at 10Hz includingpatientcable) | >2.5 MOhm at 10 Hz | Equivalent |
| 3/5 wireECGlead faildetection | Active electrode:<100 nAReferenceelectrode: <900nA | Activeelectrode:<100 nAReferenceelectrode:<900 nA | Active electrode: <100 nAReference electrode:<900 nA | Identical |
| AlarmLevels | High, medium,low; visuallycolor-coded &audible, complieswith IEC 60601-1-8 | High,mediumvisuallycolor-coded& audible | High, medium, low;visually color-coded &audible, complies with IEC60601-1-8 | ldentical |
| Alarm onoff canbe donebymanualcontrolon thedevice orremotely | Alarm on theDevice can besilenced only onthe device orfrom SurveyorCentral | Alarm on/offcan be doneon the deviceonly | Alarm on the Device canbe silenced only on thedevice or from SurveyorCentral | ldentical |
| Response tocontrols: | Power on/off ison the Device | Power on/offis on theDevice | Power on/off is on theDevice | Identical |
| Trending | Up to 72 hours ofparameterinformation,available in1/5/15/60/240min. averagedintervals | 8 hours trenddata at 1-minuteresolution inmodule X1,24 hours inmodule X2 | Up to 72 hours ofparameter information,available in 1/5/15/60/240min. averaged intervals | Identical |
| CompatibleSystems | Surveyor CentralStation(K131929) | IntelliVueInformationCenter(K143057) | Surveyor Central Station(K131929) | Identical |
| MeasurementMethod | Oscillometric | Oscillometric | Oscillometric | Identical |
| MeasurementUnits | mmHg | mmHg | mmHg | Identical |
| MeasurementMode | 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, SmallAdult,Pediatric,Infant | Neonate, Infant, Child,Small Adult, RegularAdult, Large Adult, Thigh | Identical |
| Measurementmethod | Thoracicimpedanceplethysmography | Thoracicimpedanceplethysmography | Thoracic impedanceplethysmography | Identical |
| Input | 3 or 5-Lead ECGcable | 3, 5, 6 or 10-lead ECGCable | 3 or 5-Lead ECG cable | Identical |
| RespirationSignal | Measuredbetween the RAand LLelectrodes | Measuredbetween theRA and LLelectrodes | Measured between theRA and LL electrodes | Identical |
| RespirationRateResolution | 1 bpm (breathsper minute) | 1 bpm(breaths perminute) | 1 bpm (breaths perminute) | 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 |
| Measurementmethod | Directmeasurement ofarterial or venouspressure viatransducer | Directmeasurement of arterial orvenouspressure viatransducer | Direct measurement ofarterial or venouspressure via transducer | Identical |
| Pressuresources | ART, CVP, ICP,LA, P1, P2, P3,P4, PAWP, RA,PA, UAP, UVP | ABP,ART,Ao,CVP,ICP,LAP,P,PAP,RAP,UAP,UVP | ART, CVP, ICP, LA, P1,P2, P3, P4, PAWP, RA,PA, UAP, UVP | Identical |
| ProductConfigurationswith IBP | Marketedconfigurationsinclude 2 IBPchannels, 4 IBPchannels, and noIBP channels. | 2 x IBPchannels.Additionalchannelsmay beaddedthrough | Marketed configurationsinclude 2 IBP channels,4 IBP channels, and noIBP channels. | Identical |
| Measurementmethod | Direct,continuous | Direct,continuous | Direct, continuous | Identical |
| ProbeType | 400-seriestemperaturesensor with ¼inch phone plug | 400-seriestemperaturesensor with¼ inchphone plug | 400-series temperaturesensor with ¼ inch phoneplug | Identical |
| MeasurementMethod | Pulse oximetry,optical | Pulseoximetry,optical | Pulse oximetry, optical | Identical |
| Measurementalgorithm | Mortara SpO2,Nellcor OxiMax | Philips,Nellcor,Masimo | Mortara SpO2, NellcorOxiMax | Identical |
| Parameters | % SpO2, pulserate,plethysmogram | % SpO2,pulse rate,plethysmogram,perfusionvalue | % SpO2, pulse rate,plethysmogram | Identical |
| Method | Capnography,non-dispersiveinfraredspectroscopy,continuous | Capnography, non-dispersiveinfraredspectroscopy, continuous | Capnography, non-dispersive infraredspectroscopy, continuous | Identical |
| Algorithm | Veritas | OridionMicrostream | Veritas | Equivalent |
| Samplingconfigurations | Sidestream | Mainstream,sidestream,microstream | Sidestream | Identical |
| Measurements | End-tidalCO2 (EtCO2),FractionalInspiredCO2 (FiCO2),RespirationRate (RR-CO2),IntegratedPulmonaryIndex (IPI) | CO2waveform,End TodalCO2(etCO2),InspiredMinimumCO2(iMCO2),airwayrespirationrate (awRR),IntegratedPulmonaryIndex (IPI), | End-tidal CO2 (EtCO2),Fractional InspiredCO2 (FiCO2), RespirationRate (RR-CO2), IntegratedPulmonary 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 |
| Inputmethods | Touchscreen | Touchscreen | Touchscreen | Identical |
| Powersources | Mains AC,100-240 V,50/60 Hz; orinternal battery | Mains AC,100-240 V,50/60 Hz; oruserreplaceableinternalbattery | Mains AC, 100-240 V,50/60 Hz; or internalbattery | Identical |
| BatteryType | Internal lithium-ion rechargeable | Internallithium-ionrechargeable | Internal lithium-ionrechargeable | Identical |
| Degreeofprotection | Type CF appliedparts | Type CFapplied parts | Type BF and CF appliedparts | Identical |
| Intendedoperatingenvironment | Temp: +32 to+104 °FHumidity: 15 to90% | 0 to 40 °C(32 to 104°F)0 to 35°C (32Operating15% to 95%RelativeHumidity(RH) (noncondensing)Storage 5%to 95%RelativeHumidity(RH) (noncondensing) | Temp: +32 to +104 °FHumidity: 15 to 90% | Identical |
| Mode ofoperation | Continuous | Continuous | Continuous | Identical |
| IngressProtection | IPX1 (drip-proof) | IPX1 | IPX1 | Identical |
| UserInterfaceSelectionOptions | N/A | N/A | • Ability to selectdetection leads• Ability to select QRSamplitude threshold | Added |
| Datalogging | Veritas QRSlabels onBedside Monitordata storage | N/A | Veritas QRS labels onBedside Monitor datastorage or connectedSurveyor Central Systemdata storage | Added |
| PacemakerDetection | Pacemakerdetectionselectable fromBedside Monitor | N/A | Pacemaker detectionselectable from BedsideMonitor or connectedSurveyor Central System | Added |
| STAnalysis | Partial support ofST Analysisfeatures onconnectedSurveyor CentralSystem | N/A | Full support of STAnalysis features onconnected SurveyorCentral System | Added |
| TrendReports | Trend reportsavailable onBedside Monitor | N/A | Trend reports available onBedside Monitor orconnected SurveyorCentral System | Added |
| Demographic dataediting | N/A | N/A | Demographic data can beupdated through serialcommunication | Added |
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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.
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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.
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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.
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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.
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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:
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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.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.