(1162 days)
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.
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.
The provided document is a 510(k) summary for the ST Review Station, a device that reviews and stores ECG data and ST segment measurements. However, it does not contain specific acceptance criteria or a detailed study proving the device meets those criteria through quantitative performance metrics.
Instead, the document primarily focuses on establishing "substantial equivalence" of the ST Review Station to predicate devices (ELI 100/STM and ST Central Station) by comparing features. The "Performance Data Conclusion" section makes a general statement about verification and validation but lacks the specific details requested in the prompt.
Therefore, I cannot provide the detailed information for all your requested points. Below is a summary based on the available information:
ST Review Station Study Information
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided document, explicit quantitative acceptance criteria and their corresponding reported device performance metrics are NOT available.
The document states: "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."
And concludes: "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."
This indicates that integrity of data was the primary performance requirement, but no specific numerical targets or results are presented.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified.
- Data Provenance: The document implies that the device receives and stores data "from the ELI 100/STM." The ELI 100/STM itself is an "Electrocardiograph (12-Lead Diagnostic Electrocardiograph)." This suggests the data is clinical ECG data, but details like country of origin or whether it was retrospective or prospective are not provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- Given the nature of the device (review and storage of existing data), the "ground truth" likely refers to the "integrity" of the data as passed through the system. This implies a comparison against the original data from the ELI 100/STM, rather than a clinical interpretation by experts for the purpose of algorithm evaluation.
4. Adjudication Method for the Test Set
- Not specified. (Likely not applicable in the sense of clinical adjudication, since the focus is on data integrity, not diagnostic accuracy.)
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not done. The device's intended use is to "retrospectively review/analyze stored ECG data" and "assist in their ability to detect changes in a patients physiological condition." It is not described as an AI/CAD device that provides interpretations or assists human readers in a diagnostic task in a way that would warrant an MRMC study comparing human readers with and without AI assistance. The focus is on data display and storage capabilities.
6. Standalone Performance Study
- Yes, in the sense that the system's ability to maintain data integrity was assessed. The "verification and validation practices" were likely conducted on the software and hardware system itself. However, it's not a standalone diagnostic algorithm performance study in the typical AI/CAD sense. The device's primary function is to accurately process, display, and store data from another device (ELI 100/STM).
7. Type of Ground Truth Used
- Data integrity against the source device (ELI 100/STM). The ground truth would be the original ECG data and ST segment measurements as recorded by the ELI 100/STM. The study would verify that the ST Review Station accurately received, stored, and displayed this data without alteration.
8. Sample Size for the Training Set
- Not applicable. The ST Review Station is described as a software-based system for viewing and storing ECG data, not a machine learning or AI-based device that would require a "training set" in the context of developing an algorithm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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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.
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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)PremarketNotification |
|---|---|---|---|
| Computer BasedSystem | No -- 12-lead EKG thatprovides continuousand simultaneousmonitoring of the STsegment | Yes -- Central displayof ECG data in real-time for up to 8 patientsacquired from the ELI100/STM | Yes -- Allows for thereview and storage ofST monitoring sessionsfrom the ELI 100/STM |
| Color Monitor Display | No -- LCD display | Yes | Yes |
| Receives 12-lead EKGData fromElectrocardiograph | No -- 12-lead EKGwith continuous STsegment monitoring | Yes | Yes |
| Displays ST SegmentChanges | No -- Only prints 12-lead ST segmentchanges | Yes -- Optional 2-hourST trend for thedisplayed ECO lead | Yes -- Displays entireST trends andtemplates from ELI100/STM monitoringsession |
| Storage of 12-lead STSegment Monitoring | Yes -- 900 to 1800ECG's, Stores a singlepatient's continuous 12-lead ST segmentmonitoring session | No | Yes -- 25,000 to 37,000Allows for the storageand review of multiplepatient ST segmentmonitoring sessions |
| Displays 12-lead ECG | No -- Print only | Yes -- Continuousdisplay of real-timeECG data on up to 8patient's (Can displayeither median beatECG, ST trends, or HRtrends) | Yes -- Allows for thereview of entiremonitoring sessionsstored median beatECG, ST trends, andHR trends for a selectedpatient record |
| Automatic TemplateUpdate | Yes -- Comparessuccessive 12-leadEKG to updatedtemplate for detectionof significant STsegment changes | No | No |
| Display of Scanningand Serial Comparison | No -- Print of serialcomparison | No | Yes -- Allows for thereview of averagedstored ST complexesusing superimpositionscanning and serialcomparison |
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| ST Review Station |
|---|
| 510(k) Summary |
.
| Features | ELI 100/STM(K895232) PredicateDevice | ST Central Station(K922927) PredicateDevice | ST Review Station(K942685) PremarketNotification |
|---|---|---|---|
| Display and Printing ofTrends and GraphicData | No -- Print of ST trends | Yes -- Can display themost recent 2-hours ofeither the HR or STtrends received fromthe ELI 100/STM andthe most recent 2-hoursof both HR and STtrends of the displayedECG can be printed | Yes -- Can display andprint a 3D color imageof ST segment changesfor all 12-leads alongwith HR and ST trendsfrom a patient's entireELI 100/STMmonitoring session |
| User Defined Alarms | Yes -- One lead andtwo lead ST segmentalarm thresholds | Yes -- High and LowHR alarms and STsegment alarmthresholds asestablished at the ELI100/STM | No |
| 12-Lead ECG Printouts | Yes -- 4 inch format | Yes -- 8.5 x 11 inchformat | Yes -- 8.5 x 11 inchformat |
| Patient Information | Name and ID # | Name and Room # --(Name originates fromthe ELI 100/STM) | Name -- (Nameoriginates from the ELI100/STM) |
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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.
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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
§ 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).