(133 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms. The description focuses on standard vital sign monitoring capabilities.
No
The device is described as a patient monitor used for monitoring vital signs, which is a diagnostic function, not a therapeutic intervention.
No
The device is described as a monitor for vital signs, aiding in clinical decisions, but it does not diagnose conditions.
No
The device description explicitly states it is a "modular patient monitor" equipped with an "alphanumeric LCD display," indicating it 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 is to monitor vital signs of patients in the hospital environment. This involves monitoring physiological parameters directly from the patient.
- Device Description: The device monitors parameters like ECG and SpO2, which are measured from the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) in vitro (outside the body) to diagnose or monitor a condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a patient monitor, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The MTS Option for the ESCORT® II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
Product codes (comma separated list FDA assigned to the subject device)
74 DQA
Device Description
The MTS Option for the ESCORT® II Monitor is a modular patient monitor capable of monitoring two parameters simultaneously, including dual-vector ECG and SpO2. The MTS Module is equipped with an alphanumeric LCD display that is capable of displaying vital signs providing the detail needed to aid clinical decisions.
The MTS Patient Monitor can monitor adult and pediatric patients. The appropriate monitoring mode for each patient, ADULT or PED, is selectable. Changing from one mode to another automatically changes all appropriate algorithms, alarm limits and any applicable parameter defaults.
The MTS Module functions through fixed function keys labeled on the front panel.
Factory defaults have been established and installed for all system and physiological monitoring issues (i.e., default ECG lead, initial inflation pressure, etc.). These values may be configured for specific needs.
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 and pediatric patients
Intended User / Care Setting
hospital environment.
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)
The MTS Monitor is designed to meet established standards as follows:
- . Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November, 1993:
- Reviewer Guidance for Computer Controlled Medical Devices ● Undergoing 510(k) Review; Office of Device Evaluation, August, 1991.
- . ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms, 2nd edition
- ASTM F 1415 - 92, Standard Specification for Pulse Oximeters
Tests demonstrating consideration of and mitigation of hazards identified as having potentially arisen as the result of the modifications described were developed. Conformance to product development procedures and plans is assured by application of comprehensive bench testing and product verification and validation studies.
The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
The MTS Patient Monitor is substantially equivalent to the MDE ESCORT® II+ 400 Series Monitor and to the MDE ESCORT® II Series 300 Monitor.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).
0
JUL | 4 1997
MEDICAL DATA ELECTRONICS ESCORT® II MODULAR TELEMETRY SYSTEM 510(k) SUBMISSION 510(K) SUMMARY
1
510(k) Summary
MTS Option for the ESCORT® II Monitor
- Submitter:
Medical Data Electronics 12720 Wentworth Street Arleta, California 91331
| Telephone: | 818.768.6411 |
|---|---|
| Telefacsimile: | 818.768.4197 |
- February 28, 1997 2. Date of Preparation:
-
- Device Name:
| Trade Name: | MTS Option for the ESCORT® II Monitor |
|---|---|
| Common Name: | Portable Patient Monitor |
| Classification Name: | Portable Patient Monitor, consisting of: |
- Cardiac Monitor ●
- Pulse Oximetry .
- Radiofrequency Physiological . Signal Transmitter & Receiver
-
- Substantial Equivalence:
The MTS Patient Monitor is substantially equivalent to the MDE ESCORT® II+ 400 Series Monitor and to the MDE ESCORT® II Series 300 Monitor.
- Description of the Device:
The MTS Option for the ESCORT® II Monitor is a modular patient monitor capable of monitoring two parameters simultaneously, including dual-vector ECG and SpO2. The MTS Module is equipped with an alphanumeric LCD display that is capable of displaying vital signs providing the detail needed to aid clinical decisions.
2
The MTS Patient Monitor can monitor adult and pediatric patients. The appropriate monitoring mode for each patient, ADULT or PED, is selectable. Changing from one mode to another automatically changes all appropriate algorithms, alarm limits and any applicable parameter defaults.
The MTS Module functions through fixed function keys labeled on the front panel.
Factory defaults have been established and installed for all system and physiological monitoring issues (i.e., default ECG lead, initial inflation pressure, etc.). These values may be configured for specific needs.
- Indications for use of the Device:
The MTS Option for the ESCORT® II Monitor is a portable patient monitor intended to be used for monitoring vital signs of critically ill adult and pediatric patients in the hospital environment.
- Summary of the Technological Characteristics of the New Device Compared to the Predicate Device.
The MTS Option for the ESCORT® II Monitor is substantially equivalent to the MDE ESCORT® II Series 300 Monitor and the ESCORT® II+ 400 Series Monitor. The main difference between the ESCORT® with MTS Option Monitor and the current ESCORT® Series Monitors is the addition of a new multiparameter module (MPM) that can be communicate via hardwired or wireless connection. The wireless option will be configured to monitor ECG and oxygen saturation via pulse oximetry.
- Device Testing:
The MTS Monitor is designed to meet established standards as follows:
- . Reviewer Guidance for Premarket Notification Submissions, Anesthesiology and Respiratory Devices Branch; Division of Cardiovascular, Respiratory and Neurological Devices; November, 1993:
- Reviewer Guidance for Computer Controlled Medical Devices ● Undergoing 510(k) Review; Office of Device Evaluation, August, 1991.
- . ANSI/AAMI EC-13: 1992, Cardiac monitors, heart rate meters, and alarms, 2nd edition
- ASTM F 1415 - 92, Standard Specification for Pulse Oximeters
2
3
Tests demonstrating consideration of and mitigation of hazards identified as having potentially arisen as the result of the modifications described were developed. Conformance to product development procedures and plans is assured by application of comprehensive bench testing and product verification and validation studies.
9. Test Conclusions:
The MTS Option for the ESCORT® II Monitor is shown by performance testing to be a safe, effective portable patient monitor. The MTS Monitor is substantially equivalent to the MDE ESCORT® II 300 Series and the MDE ESCORT® II+ 400 Series Monitors.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of an eagle or bird-like figure with three distinct head profiles, suggesting a sense of community or collaboration.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David M. Trueblood Medical Data Electronics, Inc. 12720 Wentworth Street Arleta, California 91331-4329
JUL | 4 1997
Re: K970763 Modular Telemetry System (MTS) Option for the MDE ESCORT® II Monitor Requlatory Class: II (two) Product Code: 74 DQA Dated: June 2, 1997 Received: June 3, 1997
Dear Mr. Trueblood:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
5
Page 2 - Mr. David M. Trueblood
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. -
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of T Page 1
510(k) Number (if known):
MTS Option for the ESCORT II Monitor Device Name:
The MTS Option for the ESCORT II Monitor is a portable Indications for Use: monitor intended to be used for monitoring vital signs ( of critically-ill-adult and pediatric patients in the " hospital environment.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Richard N. Phillips
(Division Sign-C Division of Cardiovas and Neurological De 510(k) Number
Prescription Use
(Per 2.1 CFR 801.109)
OR
Over-the-Counter Use
(Optional Format 1-2-96)