(1162 days)
No
The summary describes a system for reviewing and analyzing stored ECG data, focusing on graphical presentation and trend analysis. There is no mention of AI, ML, or any algorithms that would typically fall under those categories for interpretation or analysis beyond basic data display and measurement. The performance studies focus on data integrity, not algorithmic performance.
No
The device is intended for the retrospective review and analysis of stored ECG data to assist clinicians in detecting changes in a patient's physiological condition. It does not directly treat or diagnose a condition, but rather provides information to support clinical decision-making.
Yes
The device "retrospectively review/analyze stored ECG data" and helps "detect changes in a patients physiological condition", which are functions associated with diagnostic devices. While it is an adjunct, it clearly serves a diagnostic purpose by enabling clinicians to analyze medical data for patient assessment.
Yes
The device is described as "specially developed software" that utilizes a "PC based operating system" to view and present data captured by a separate hardware device (ELI 100/STM). The description focuses solely on the software's function of displaying and analyzing existing data, without mentioning any hardware components included with the ST Review Station itself.
Based on the provided information, the ST Review Station is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The ST Review Station analyzes ECG data, which is electrical activity measured from the body's surface, not a biological specimen like blood, urine, or tissue.
- The intended use is retrospective review and analysis of stored ECG data. This is a post-acquisition analysis of physiological signals, not a test performed on a biological sample to diagnose a condition.
- The device description explicitly states it's an adjunct to an electrocardiograph. Electrocardiographs are devices that measure electrical activity of the heart, not IVDs.
Therefore, the ST Review Station falls under the category of a medical device that processes and displays physiological data, not an IVD.
N/A
Intended Use / Indications for Use
The ST Review Station is intended to allow Physicians and/or Clinical personnel from ER. Cath Lab, ICU, and other related settings to retrospectively review/analyze stored ECG data. By being able review/analyze ECG trends, including ST segment measurements, Clinicians and/or Physicians have access to information to assist in their ability to detect changes in a patients physiological condition and therefore enabling them to respond accordingly to a patients medical needs.
Product codes
DXJ
Device Description
The ST Review Station is an adjunct to the ELI 100/STM Electrocardingraph (12-I.ead Diagnostic Electrocardiograph) to provide rapidly responsive trend data originating from the ELI 100/STM Electrocardiouraph and associated patient population. The ST Review Station utilizes a PC based operating system with specially developed software that provides for the means to graphically view and/or present the ECG data captured and stored by the ELI 100/STM (legally marketed predicate device - K895232), including ST segment measurements.
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
Not Found
Intended User / Care Setting
Physicians and/or Clinical personnel from ER. Cath Lab, ICU, and other related settings
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)
To ensure that the ST Review Station did not alter the integrity of the ECG data and ST segment measurements received and stored from the ELI 100/STM, the ST Review Station was subjected to verification and validation practices appropriate to determine that it is safety and effective for its intended use.
The verification and validation tests performed demonstrated that the ECG data and ST segment measurements received and stored by the ST Review Station maintained their integrity as obtained from the ELI 100/STM. Therefore, supporting the determination of substantial equivalence while demonstrating its safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2450 Medical cathode-ray tube display.
(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).
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P. 02
K941 2685
ST Review Station 510(k) Summary
AUG 12 1997
Submitter: Address:
Telephone/Fax:
Contact: Prepared: Mortara Instrument, Inc. 7865 North 86dt Street Milwaukee, WI 53224
(414) 354-1600/354-4760 Regulatory Affairs Manager or Director August 8, 1997
Proprietary Name: Common/Classification Name: Predicate Device:
ST Review Station ST Segment Display FILI IIII/STM and ST Central Station
New Device Description:
The ST Review Station is an adjunct to the ELI 100/STM Electrocardingraph (12-I.ead Diagnostic Electrocardiograph) to provide rapidly responsive trend data originating from the ELI 100/STM Electrocardiouraph and associated patient population. The ST Review Station utilizes a PC based operating system with specially developed software that provides for the means to graphically view and/or present the ECG data captured and stored by the ELI 100/STM (legally marketed predicate device - K895232), including ST segment measurements.
Intended Use:
The ST Review Station is intended to allow Physicians and/or Clinical personnel from ER. Cath Lab, ICU, and other related settings to retrospectively review/analyze stored ECG data. By being able review/analyze ECG trends, including ST segment measurements, Clinicians and/or Physicians have access to information to assist in their ability to detect changes in a patients physiological condition and therefore enabling them to respond accordingly to a patients medical needs.
Comparison to Predicate Devices:
See Attached Table (Attachment 1)
Non-Clinical Performance Data:
To ensure that the ST Review Station did not alter the integrity of the ECG data and ST segment measurements received and stored from the ELI 100/STM, the ST Review Station was subjected to verification and validation practices appropriate to determine that it is safety and effective for its intended use.
Performance Data Conclusion:
The verification and validation tests performed demonstrated that the ECG data and ST segment muasurements received and stored by the ST Review Station maintained their integrity as obtained from the ELI 100/STM. Therefore, supporting the determination of substantial equivalence while demonstrating its safety and effectiveness.
1
ST Review Station 510(k) Summary
Attachment 1
Tabular Comparison of Predicate Device's
| Features | ELI 100/STM
(K895232)
Predicate Device | ST Central Station
(K922927)
Predicate Device | ST Review Station
(K942685)
Premarket
Notification |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Computer Based
System | No -- 12-lead EKG that
provides continuous
and simultaneous
monitoring of the ST
segment | Yes -- Central display
of ECG data in real-
time for up to 8 patients
acquired from the ELI
100/STM | Yes -- Allows for the
review and storage of
ST monitoring sessions
from the ELI 100/STM |
| Color Monitor Display | No -- LCD display | Yes | Yes |
| Receives 12-lead EKG
Data from
Electrocardiograph | No -- 12-lead EKG
with continuous ST
segment monitoring | Yes | Yes |
| Displays ST Segment
Changes | No -- Only prints 12-
lead ST segment
changes | Yes -- Optional 2-hour
ST trend for the
displayed ECO lead | Yes -- Displays entire
ST trends and
templates from ELI
100/STM monitoring
session |
| Storage of 12-lead ST
Segment Monitoring | Yes -- 900 to 1800
ECG's, Stores a single
patient's continuous 12-
lead ST segment
monitoring session | No | Yes -- 25,000 to 37,000
Allows for the storage
and review of multiple
patient ST segment
monitoring sessions |
| Displays 12-lead ECG | No -- Print only | Yes -- Continuous
display of real-time
ECG data on up to 8
patient's (Can display
either median beat
ECG, ST trends, or HR
trends) | Yes -- Allows for the
review of entire
monitoring sessions
stored median beat
ECG, ST trends, and
HR trends for a selected
patient record |
| Automatic Template
Update | Yes -- Compares
successive 12-lead
EKG to updated
template for detection
of significant ST
segment changes | No | No |
| Display of Scanning
and Serial Comparison | No -- Print of serial
comparison | No | Yes -- Allows for the
review of averaged
stored ST complexes
using superimposition
scanning and serial
comparison |
2
| ST Review Station |
|---|
| 510(k) Summary |
.
| Features | ELI 100/STM
(K895232) Predicate
Device | ST Central Station
(K922927) Predicate
Device | ST Review Station
(K942685) Premarket
Notification |
|-------------------------------------------------------|----------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Display and Printing of
Trends and Graphic
Data | No -- Print of ST trends | Yes -- Can display the
most recent 2-hours of
either the HR or ST
trends received from
the ELI 100/STM and
the most recent 2-hours
of both HR and ST
trends of the displayed
ECG can be printed | Yes -- Can display and
print a 3D color image
of ST segment changes
for all 12-leads along
with HR and ST trends
from a patient's entire
ELI 100/STM
monitoring session |
| User Defined Alarms | Yes -- One lead and
two lead ST segment
alarm thresholds | Yes -- High and Low
HR alarms and ST
segment alarm
thresholds as
established at the ELI
100/STM | No |
| 12-Lead ECG Printouts | Yes -- 4 inch format | Yes -- 8.5 x 11 inch
format | Yes -- 8.5 x 11 inch
format |
| Patient Information | Name and ID # | Name and Room # --
(Name originates from
the ELI 100/STM) | Name -- (Name
originates from the ELI
100/STM) |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
Mr. Scott J. Pease Mortara Instrument, Inc. 7865 North 86th Street Milwaukee, Wisconsin 53224
AUG 1 2 1997
Re: K942685 ST Review Station Regulatory Class: II (two) Product Code: 74 DXJ May 13, 1997 Dated: Received: May 16, 1997 :
Dear Mr. Pease:
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 Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. 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 regulatory 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.
4
Page 2 - Mr. Scott J. Pease
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 regulation 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. Callahon
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health