(123 days)
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard physiological monitoring parameters and features.
No.
The device is described as a patient monitor that facilitates the monitoring of various vital signs and physiological parameters, but it does not treat or alleviate a medical condition.
Yes
The device is a patient monitor that facilitates the monitoring of various physiological parameters (e.g., blood pressure, ECG, SpO2), which are used by healthcare professionals to assess a patient's health status and make diagnostic decisions.
No
The device description explicitly states it is a "portable patient monitor" with different sized viewing areas (11.6" and 18.5"), indicating it is a physical hardware device, not software only.
Based on the provided text, the Mortara Surveyor Patient Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device facilitates the monitoring of various physiological parameters (blood pressure, respiration, ECG, SpO2, CO2, temperature, cardiac output) in patients. This is direct patient monitoring, not testing of samples in vitro (outside the body).
- Device Description: The description reinforces that it's a portable patient monitor used by clinicians for monitoring these same physiological parameters.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances within those samples
- Providing information for diagnosis, screening, or monitoring of disease based on sample analysis.
The device is a patient monitor, which is a different category of medical device than an IVD.
N/A
Intended Use / Indications for Use
The Mortara Surveyor Patient Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthcare facility. It is designed for continuous monitoring in either stationary or portable applications. It is intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output.
The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of:
- 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 a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Product codes
MHX
Device Description
The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features. See the Product Specification for identified models and monitoring features.
A secure Mortara protocol over an Ethernet connection allows the Mortara Surveyor Patient Monitor to exchange patient information with the Mortara Surveyor Central Station. This allows monitoring of the Surveyor S12/S19 at a central workstation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult & pediatric patient populations
Intended User / Care Setting
knowledgeable healthcare professionals within a healthcare facility.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
Sterilization Validation: The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.
Shelf Life Testing: The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.
Biocompatibility Testing: The S12 and S19 patient contacting components use the same materials used on other products that Mortara has used historically and/or has been cleared as substantially equivalent previously.
Software Testing: Software for the Mortara Surveyor Patient Monitor was designed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Electrical Safety: The Mortara Surveyor Patient Monitor was tested for patient safety in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Electromagnetic Compatibility Testing: The Mortara Surveyor Patient Monitor was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Performance Testing - Bench: The Mortara Surveyor Patient Monitor was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and vibration/ shock testing.
Performance Testing - Animal: Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.
Performance Testing - Clinical: Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.
Conclusion: Based upon a comparison of devices and performance testing results, the Mortara Surveyor Patient Monitor is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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K123556 Page 1 of 3
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100 - 100 - 100
Abbreviated 510(k) Notification
.
.
:
MAR 2 2 2013
510(k): Surveyor S12 and S19 Device Summary
.
| Submitter: | Chien Hui (Amy) Yang, Regulatory Affairs Engineer
Mortara Instrument, Inc.
7865 N. 86th Street
Milwaukee, WI 53224 |
|------------|-----------------------------------------------------------------------------------------------------------------------------|
| Date: | November 6, 2012 |
| FAX: | (414) 354-4760 |
| Phone: | (414) 354-1600 |
| Contact: | Chien Hui (Amy) Yang (see above) |
| Trade Name: | Mortara Surveyor Patient Monitor |
|---|---|
| Common Name: | Patient Physiological Monitor (with Arrhythmia Detection or Alarms) |
| Classification Name: | Monitor, Physiological Patient (with Arrhythmia Detection or Alarms) |
| Classification Regulation: | 21 CFR §870.1025 |
| Product Code: | MHX |
Legally marketed devices to which S.E. is claimed:
| Predicate 510(k) Number | Predicate Manufacturer / Model | |
|---|---|---|
| Mortara Surveyor Patient Monitor | ||
| Non-Invasive Blood Pressure component | K090556 | Spacelabs Healthcare / élance Vital |
| Signs Monitor | ||
| Impedance Respiration component | ||
| Invasive Blood Pressure component | ||
| Temperature component | ||
| Functional Arterial Oxygen | ||
| Saturation component | ||
| End-Tidal & Inspired CO2 |
End-Tidal & Inspired CO2 component
| component | ||
|---|---|---|
| ECG Monitoring | K090556 | Spacelabs Healthcare / élance Vita |
| Signs Monitor | ||
| K060135 | Mortara Instrument, Inc. / Surveyor | |
| Telemetry Central Station | ||
| 12-Lead Resting ECG | K100127 | Mortara Instrument, Inc. / ELI 230 |
| Electrocardiograph | ||
| Cardiac Output | K012226 | Schiller / ARGUS PB-1000 |
| Monitoring System |
© 2012 Mortara Instrument, Inc.
© 2012 Mortara Instrument, Inc.
.
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K123556 Page 2 of 3
Abbreviated 510(k) Notification
Description:
The Mortara Instrument, Inc. Surveyor Patient Monitoring System (S12 and S19) is a portable patient monitors intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output. Models within the Mortara Surveyor family come in two different sized viewing areas (11.6" and 18.5") and offer selected monitoring features. See the Product Specification for identified models and monitoring features.
Central Station:
A secure Mortara protocol over an Ethernet connection allows the Mortara Surveyor Patient Monitor to exchange patient information with the Mortara Surveyor Central Station. This allows monitoring of the Surveyor $12/S19 at a central workstation.
Technology Comparison:
The Mortara Surveyor utilizes the same or similar technology for each parameter as utilized by the predicate devices.
Intended Use:
The Mortara Surveyor Patient Monitor is a prescription device intended to be used by knowledgeable healthcare professionals within a healthçare facility. It is designed for continuous monitoring in either stationary or portable applications. It is intended to be used by clinicians and medical qualified personnel for monitoring ECG, Respiration, NIBP, Temperature, SPO2, Invasive Blood Pressure, End-Tidal & Inspired CO2, 12-lead resting ECG and cardiac output.
Indications for Use:
The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations. The Mortara Surveyor Patient Monitor facilitates the monitoring of:
- 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 a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Performance Testing:
Sterilization Validation:
The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.
2
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3 of 3
Abbreviated 510(k) Notification
Shelf Life Testing:
The Mortara Surveyor Patient Monitor is not sterilizable, and therefore this section does not apply to the monitor itself.
Biocompatibility Testing:
The S12 and S19 patient contacting components use the same materials used on other products that Mortara has used historically and/or has been cleared as substantially equivalent previously.
Software Testing:
Software for the Mortara Surveyor Patient Monitor was designed according to a robust software development process, and was rigorously verified and validated. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Electrical Safety:
The Mortara Surveyor Patient Monitor was tested for patient safety in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Electromagnetic Compatibility Testing:
The Mortara Surveyor Patient Monitor was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Patient Monitor complies with its predetermined specification.
Performance Testing - Bench:
The Mortara Surveyor Patient Monitor was tested in accordance with internal requirements and procedures, and test results indicated that the device complies with the predetermined requirements. This testing includes performance and functional, environmental, and vibration/ shock testing.
Performance Testing - Animal:
Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.
Performance Testing - Clinical:
Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Patient Monitor.
Conclusion:
Based upon a comparison of devices and performance testing results, the Mortara Surveyor Patient Monitor is substantially equivalent to the predicate device.
© 2012 Mortara Instrument, Inc.
. . . . . .
3
Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 22, 2013
Mortara Instrument, Inc. c/o Ms. Amy Yang 7865 North 86th St. Milwaukee. WI 53224
,
Re: K123556
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 (two)
Product Code: MHX
Dated: February 27, 2013 Received: February 28, 2013
Dear Ms. Yang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Amy Yang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
Bram D. Zuckerman, M.D. for · . Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K123556 510(k) Number (if known):
Mortara Surveyor Patient Monitor · Device Name:
Indications for Use:
The Mortara Surveyor Patient Monitor is indicated for use in adult & pediatric patient populations.
The Mortara Surveyor Patient Monitor facilitates the monitoring of:
- 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 a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Prescription Use AND/OR × (21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Owen P. Faris -S
2013.03.22
10:42:26'-04'00'
Concurrence of CDRH, Office of Device Evaluation (ODE)
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