(201 days)
Marquette 12SL Analysis Program
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard ECG analysis measurements without mentioning adaptive algorithms or learning.
No
The device provides measurements (QT interval dispersion and T wave complexity) from ECGs but explicitly states it is "not intended to produce any interpretation of those measurements or diagnosis." It is an analysis tool for health professionals to use in conjunction with other clinical information, not a direct therapeutic intervention.
Yes
Explanation: The device performs "analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity," which are measurements used for evaluating a patient's condition, thus fitting the definition of a diagnostic device. While it states it does not produce interpretations or diagnoses directly, it provides measurements "intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment," indicating its role in the diagnostic process.
Yes
The device description explicitly states that the "QT Guard Analysis System is a software program". There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, the QT Guard Analysis System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The QT Guard Analysis System analyzes ECG signals, which are electrical measurements of the heart's activity, not biological samples like blood, urine, or tissue.
- The intended use describes analysis of ECG data. The description clearly states it analyzes "simultaneously acquired 12-lead ECG".
- There is no mention of analyzing biological samples. The entire description focuses on processing and measuring aspects of the ECG waveform.
Therefore, the QT Guard Analysis System falls under the category of a medical device that analyzes physiological signals, not an IVD.
N/A
Intended Use / Indications for Use
QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals.
QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.
QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis.
The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
QT Guard Analysis System is intended for adult patient populations.
Product codes (comma separated list FDA assigned to the subject device)
74 LOS
Device Description
QT Guard Analysis System is a software program for measuring the QT interval dispersion and T wave complexity from simultaneously acquired 12-lead ECG.
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 patient populations
Intended User / Care Setting
competent health professionals / hospital or clinic 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 following quality assurance measures were applied: to the development of PHi-Res analysis. Requirements specification reviews, code inspections, software testing and laboratory tests of the QT Guard analysis.
The results of these measurements demonstrated that QT Guard analysis is as safe, as effective, and performs as well as the predicate device, Marquette 12SL analysis program.
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.
Marquette 12SL Analysis Program
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
N/A
0
OCT 6 1998
K981024
SECTION 2 - SUMMARY AND CERTIFICATION
2.1 510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter: | Marquette Medical Systems
8200 W. Tower Avenue
Milwaukee, WI 53223
Telephone: (414) 355-5000
FAX: (414) 362-3553 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: QT Dispersion and T wave Analysis
System (QT Guard Analysis System)
Classification Name: Computer, diagnostic, programmable |
| Predicate Device: | Marquette 12SL Analysis Program |
| Device Description: | QT Guard Analysis System is a software program for
measuring the QT interval dispersion and T wave complexity from
simultaneously acquired 12-lead ECG. |
| Intended Use: | QT Guard Analysis System is intended to be used in a hospital
or clinic environment by competent health professionals |
| | ♦ QT Guard Analysis System is intended to perform the analysis
of simultaneously acquired 12-lead ECG for obtaining the
measurements of QT interval dispersion and T wave complexity. |
| | ♦ QT-Guard Analysis System is intended to provide only the
measurements of the QT dispersion and T wave complexity and it
is not intended to produce any interpretation of those
measurements or diagnosis. |
| | ♦ The QT dispersion & T wave complexity measurements
produced by QT-Guard Analysis System are intended to
be used by qualified personnel in evaluating the patient in
conjunction with patient's clinical history, symptoms, other
diagnostic tests, as well as the professional's clinical judgment. |
| | ♦ QT Guard Analysis System is intended for adult patient
populations. |
| Technology: | QT Guard Analysis System employs technology similar to that
used in the predicate device. |
1
Performance:
The following quality assurance measures were applied: to the development of PHi-Res analysis. Requirements specification reviews, code inspections, software testing and laboratory tests of the QT Guard analysis.
The results of these measurements demonstrated that QT Guard analysis is as safe, as effective, and performs as well as the predicate device, Marquette 12SL analysis program.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 6 1998
Ms. Kristin Pabst Marquette Medical Systems, Inc. 8200 West Tower Avenue Milwaukee, WI 53223
Re : K981024 QT Dispersion and T Wave Analysis Program (QT-Guard Analysis System) Regulatory Class: III (three) Product Code: 74 LOS July 15, 1998 Dated: Received: July 16, 1998
Dear Ms. Pabst:
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 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). 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 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 regulatory action. In addition TPDA 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.
3
Page 2 - Ms. Kristin Pabst
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 regulation (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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 11 - INTENDED USE STATEMENT
510(k) Number (if known): Unknown - 510(k) filed March 18, 1998
Device Name: QT Dispersion and T wave Analysis Program (QT Guard Analysis System)
Indications For Use:
QT Guard Analysis System is intended to be used in a hospital or clinic environment by competent health professionals.
QT Guard Analysis System is intended to perform the analysis of simultaneously acquired 12-lead ECG for obtaining the measurements of QT interval dispersion and T wave complexity.
QT-Guard Analysis Program is intended to provide only the measurements of the QT dispersion and T wave complexity and is not intended to produce any interpretation of those measurements or diagnosis.
The QT dispersion and T wave complexity measurements produced by QT Guard Analysis System are intended to be used by qualified personnel in evaluating the patient in conjunction with patient's clinical history, symptoms, other diagnostic tests, as well as the professional's clinical judgment.
QT Guard Analysis System is intended for adult patient populations.
Rucuptim Use ✓
Mark Krainer
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number __