(159 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard physiological monitoring and data management without mentioning any AI/ML-specific functionalities or training/test data.
No
The device is described as a monitoring system that displays and stores physiological data and waveforms, and generates alarms, for diagnostic purposes by medical professionals. It does not provide any treatment or intervention.
No
This device is a central monitoring station that displays and stores physiological waveforms and vital signs. While the data it provides is used by medical personnel in the diagnosis of patients, the device itself does not perform diagnostic functions. It is a secondary monitoring system that receives data from patient monitors and telemetry systems.
No
The device description explicitly mentions that the system can be supported on a single workstation computer or multiple workstation computers along with a separate optional storage server, and that an antenna network can be installed. This indicates the system includes hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for "monitoring of physiological waveforms, including cardiac and vital signs, for multiple patients within a medical facility." It receives, displays, and stores data from patient monitors and telemetry systems. This is focused on in vivo monitoring of a patient's physiological state, not on analyzing samples in vitro (outside the body).
- Device Description: The description details the system's architecture, how it receives and displays physiological parameters (ECG, pressures, blood pressure, pulse oximetry, etc.), and its functions related to patient monitoring and data management. This aligns with a patient monitoring system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on samples outside the body. The focus is entirely on data acquired directly from the patient.
Therefore, the Mortara Surveyor Central Station system, as described, is a patient monitoring system and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
Intended Use:
The Surveyor Central Station system is intended for monitoring of physiological waveforms, including cardiac and vital signs, for multiple patients within a medical facility. The system can receive, display and store data from multi-parameter patient monitors and/or telemetry systems. The system can support patient monitoring and telemetry monitoring modes simultaneously. Patient monitors can be the Surveyor S12 and S19 patient monitoring systems (K12356) or other compatible patient monitors. Ambulatory telemetry transmitter sources can be the X12+ (K974149) and T12/T12S (K022618) systems or other compatible telemetry transmitters.In palient monitoring mode, the patient monitors will provide primary monitonality while the Surveyor Central Station system provides continuous secondary monitoring of patients including alarm reception and management, display and storage of parameters and waveforms including full-disclosure, automatic and ondemand generation of various printed reports using a network-attached printer.
In telemetry monitoring mode, the Surveyor Central Station will provide primary monitoring of patients including display of values and waveforms, alarm generation and management, data storage, patient management and report printing functionality. Patients are monitored through telemetry, when moving in a defined area, of a variable size depending on system layout. In order to provide proper coverage, an antenna network can be installed according to customer needs.
The data and analysis provided by the Surveyor Central Station is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions.
-
Indications for Use:
The Mortara Surveyor Central Station is indicated for use in adult & pediatric patient populations.- In a clinical setting, by qualified medical properly trained for patient monitoring and use of the . system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
- Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, . Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
- Chest Pain Evaluation. .
- Evaluation of patients with pacemakers. ●
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or ● cardiac surgery )
- . Evaluation of monitored parameters documenting therventions in individual patients or groups of patients.
- Clinical and epidemiological research studies. .
The Surveyor Central System is indicated for use:
- In a clinical setting, by qualified medical professionals, properly trained for patient monitoring . and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
- . Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
- Chest Pain Evaluation. .
- . Evaluation of patients with pacemakers.
- Evaluation of a patient's response after resuming occupational activities (e.g., . after M.I. or cardiac surgery.)
- Evaluation of monitored parameters documenting therapeutic interventions in individual . patients or groups of patients.
- Clinical and epidemiological research studies. .
Product codes
MHX
Device Description
The system architecture of the Surveyor Central Station system is flexible and can be supported on a single workstation computer or multiple workstation computers along with a separate optional storage server. Each workstation can display information for a variable number of patients. Multiple workstations can be combined to expand the system capacity. All data received for all patients is stored and available for review.
Cardiac parameters and functions supported through interface with patient monitors include 3 or 5 lead ECG as well as 12-lead ECG along with interpretation plus continuous monitoring and management of arrhythmia and ST alarms generated by the patient monitor. Cardiac parameters and functions supported through interface with telemetry systems include 12-lead ECG along with interpretation plus continuous monitoring, alaming and management of arrhythmia and ST generated by the Surveyor Central.
Other parameters received from patient monitors or telemetry systems can include invasive pressures, noninvasive blood pressure, pulse oximetry, CO2 capnography, respiration, temperature, cardiac output and hemodynamic calculations including relevant values, indices and waveforms.
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
- Intended User: qualified medical personnel properly trained for patient monitoring and use of the system.
- Care Setting: medical facility, Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers.
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)
Software testing: Software for the Mortara Surveyor Central Station was designed and developed according to a robust software development process, and was rigorously verfied and validated. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification.
Electrical Safety: The Mortara Surveyor Central Station was evaluated for patient safety in accordance with applicable Standards.
Electromagnetic Compatibility Testing: The Mortara Surveyor Central Station was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification.
Bench Performance Testing: The Mortara Surveyor Central Station 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.
Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.
Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.
Conclusion: Based upon a comparison of devices and performance testing results, the Mortara Surveyor Central Station 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.
0
Image /page/0/Picture/0 description: The image shows the text "K131929 - 510(k) Summary" in bold font. Below this text, the text "Page 1 of 3" is shown. This indicates that the image is likely the first page of a document summarizing a 510(k) submission with the identifier K131929. The document appears to be 3 pages long.
Abbreviated 510(k) Notification
510(k): Surveyor Central Station System Device Summary
Submitter:
Date: November 26, 2013
| Amy Yang, Regulatory Affairs Engineer |
|---|
| Mortara Instrument, Inc. |
| 7865 N. 86th Street |
| Milwaukee, WI 53224 |
| FAX: | (414) 354-4760 |
|---|---|
| Phone: | (414) 354-1600 |
| Contact: | Amy Yang (see above) |
| Trade Name: | Mortara Surveyor Central Station |
|---|---|
| Common Name: | Central Station |
| Classification Name: | Monitor, Physiological, Patient (with Arrhythmia Detection or Alarms) |
| Classification Description: | Arrhythmia detector and alarm (including ST-segment measurement and alarm) |
| Classification Regulation: | 21 CFR §870.1025 |
| Product Code: | MHX |
DEC 0 3 2013#### Legally marketed devices to which S.E. is claimed:
| Mortara Surveyor Central Station | Predicate 510(k) Number | Predicate Manufacturer / Model |
|---|---|---|
| Patient Monitoring | K060135 | Mortara Instrument, Inc. / Surveyor |
| Telemetry Central Station | ||
| Electrocardiograph | K082946 | Mortara Instrument, Inc. / ELI 350 |
| Electrocardiograph |
Description:
The system architecture of the Surveyor Central Station system is flexible and can be supported on a single workstation computer or multiple workstation computers along with a separate optional storage server. Each workstation can display information for a variable number of patients. Multiple workstations can be combined to expand the system capacity. All data received for all patients is stored and available for review.
Cardiac parameters and functions supported through interface with patient monitors include 3 or 5 lead ECG as well as 12-lead ECG along with interpretation plus continuous monitoring and management of arrhythmia and ST alarms generated by the patient monitor. Cardiac parameters and functions supported through interface with telemetry systems include 12-lead ECG along with interpretation plus continuous monitoring, alaming and management of arrhythmia and ST generated by the Surveyor Central.
Other parameters received from patient monitors or telemetry systems can include invasive pressures, noninvasive blood pressure, pulse oximetry, CO2 capnography, respiration, temperature, cardiac output and hemodynamic calculations including relevant values, indices and waveforms.
1
Image /page/1/Picture/0 description: The image shows a black and white graphic of a heart shape. The heart is formed by two curved lines meeting at a point at the bottom and curving inward at the top. The heart is surrounded by a black border, which is thicker at the top and thinner at the bottom. The heart is white, and the background is black.
Abbreviated 510(k) Notification
Technology Comparison:
The Mortara Surveyor utilizes the same or similar technology for each parameter as utilized by the predicate devices.
Intended Use:
The Surveyor Central Station system is intended for monitoring of physiological waveforms, including cardiac and vital signs, for multiple patients within a medical facility. The system can receive, display and store data from multi-parameter patient monitors and/or telemetry systems. The system can support patient monitoring and telemetry monitoring modes simultaneously. Patient monitors can be the Surveyor S12 and S19 patient monitoring systems (K12356) or other compatible patient monitors. Ambulatory telemetry transmitter sources can be the X12+ (K974149) and T12/T12S (K022618) systems or other compatible telemetry transmitters.
In palient monitoring mode, the patient monitors will provide primary monitonality while the Surveyor Central Station system provides continuous secondary monitoring of patients including alarm reception and management, display and storage of parameters and waveforms including full-disclosure, automatic and ondemand generation of various printed reports using a network-attached printer.
In telemetry monitoring mode, the Surveyor Central Station will provide primary monitoring of patients including display of values and waveforms, alarm generation and management, data storage, patient management and report printing functionality. Patients are monitored through telemetry, when moving in a defined area, of a variable size depending on system layout. In order to provide proper coverage, an antenna network can be installed according to customer needs.
The data and analysis provided by the Surveyor Central Station is reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various conditions.
Indications for Use:
The Mortara Surveyor Central Station is indicated for use in adult & pediatric patient populations.
- In a clinical setting, by qualified medical properly trained for patient monitoring and use of the . system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
- Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, . Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
- Chest Pain Evaluation. .
- Evaluation of patients with pacemakers. ●
- Evaluation of a patient's response after resuming occupational activities (e.g., after M.I. or ● cardiac surgery )
- . Evaluation of monitored parameters documenting therventions in individual patients or groups of patients.
- Clinical and epidemiological research studies. .
2
Image /page/2/Picture/0 description: The image shows a white heart shape inside of a black square. The heart is symmetrical and has a rounded top and a pointed bottom. The black square is solid and has sharp corners. The image is simple and graphic.
Abbreviated 510(k) Notification
Performance Testing:
Sterilization Validation:
The Mortara Surveyor Central Station is not sterilizable, and therefore this section does not apply to the monitor itself.
Shelf Life Testing:
The Mortara Surveyor Central Station is not sterilizable, and therefore this section does not apply to the monitor itself.
Biocompatibility Testing:
The electrodes, transmitter and monitor housing and patient cable are parts of the system that come in contact with the patient. These component devices have been previously tested in their own right for other submissions and found to be acceptable. However, the Surveyor Central Station itself does not involve direct / indirect patient contact.
Software Testing:
Software for the Mortara Surveyor Central Station was designed and developed according to a robust software development process, and was rigorously verfied and validated. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification.
Electrical Safety:
The Mortara Surveyor Central Station was evaluated for patient safety in accordance with applicable Standards.
Electromagnetic Compatibility Testing:
The Mortara Surveyor Central Station was tested for EMC in accordance with applicable Standards. Test results indicated that the Mortara Surveyor Central Station complies with its predetermined specification.
Performance Testing - Bench:
The Mortara Surveyor Central Station 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.
Performance Testing - Animal:
Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.
Performance Testing - Clinical:
Clinical performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the Mortara Surveyor Central Station.
Conclusion:
Based upon a comparison of devices and performance testing results, the Mortara Surveyor Central Station is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its body, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 3, 2013
Mortara Instrument, Inc. % Amy Yang, BSBE, MBA, RAC Senior Regulatory Affairs Engineer 7865 North 86th St. Milwaukee, WI 53224 US
Re: K131929
Trade/Device Name: Surveyor Central Station Regulation Number: 21 CFR 870.1025 Regulation Name: Monitor, Physiological, Patient (With Arrhythmia Detection Or Alams) Regulatory Class: Class II Product Code: MHX Dated: October 18, 2013 Received: October 21, 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 - 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (2) CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Owen Paris -S
for
:
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
K131929 510(k) Number (if known):_
Device Name: Mortara Surveyor Central System
Indications for Use:
The Surveyor Central System is indicated for use:
- In a clinical setting, by qualified medical professionals, properly trained for patient monitoring . and use of the system. Continuous analysis is provided for all patients. The personnel must be experienced in cardiovascular problematic situations and emergency procedures or pathologies related to cardiac involvements.
- . Centralized monitoring through a network of patients in Coronary Care Units, Intensive Care Units, Ambulatory Care Units (Telemetry Units), Step-Down Units, Operating Rooms, Emergency Departments and Surgical Centers. Evaluation of adult and pediatric patients with symptoms suggesting arrhythmia. Detected arrhythmias create an audiovisual alarm according to the alarm profile.
- Chest Pain Evaluation. .
- . Evaluation of patients with pacemakers.
- Evaluation of a patient's response after resuming occupational activities (e.g., . after M.I. or cardiac surgery.)
- Evaluation of monitored parameters documenting therapeutic interventions in individual . patients or groups of patients.
- Clinical and epidemiological research studies. .
AND/OR Prescription Use X (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)
Image /page/5/Picture/16 description: The image shows a signature and a digitally signed FDA logo. The signature is illegible. The FDA logo includes the text "Digitally signed by Faris -5 Date: 2013.12.03 14:09:22 -05'00'".
Concurrence of CDRH, Office of Device Evaluation (ODE)
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