(106 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on signal processing for P wave analysis, not AI/ML interpretation.
No.
The device is for P wave analysis and does not provide interpretation or diagnosis, which are key characteristics of a therapeutic device. It is for measurement and evaluation, not treatment.
No
Explanation: The description explicitly states that "PHi-Res analysis is only intended to provide the measurements of the signal averaged P wave and is not intended to provide any interpretation of those measurements or any kind of diagnosis." It further clarifies that the measurements 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," indicating it's a tool to aid diagnosis rather than performing it itself.
No
The device is described as a "software option for Marquette MAC-series electrocardiographs". This indicates that the software is an add-on or feature for existing hardware (the MAC-series electrocardiographs), and is not a standalone software-only medical device.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The description clearly states that PHi-Res is a software option for analyzing the surface electrocardiogram (ECG), which is a measurement of electrical activity on the body, not a sample taken from the body (like blood, urine, or tissue).
- The intended use is for analyzing electrical signals. The focus is on recording and analyzing low amplitude/high frequency components of the surface electrocardiogram for P wave analysis. This is a physiological measurement, not an analysis of a biological sample.
Therefore, PHi-Res falls under the category of a medical device that analyzes physiological signals, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
PHi-Res analysis is intended to be used in a hospital or clinic environment by competent health professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis.
- PHi-Res analysis is intended to perform signal averaging of the atrial wave (P wave) from high-resolution ECG by P wave triggering method and analyzing the averaged P wave for its measurements.
- PHi-Res analysis is intended to provide only the measurements of the signal averaged P wave. PHi-Res is not intended to produce any interpretation of those measurements or any kind of diagnosis.
- The signal averaged P wave measurements produced by PHi-Res 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 judgement.
- PHi-Res is intended for patient populations including adult and pediatric.
Product codes (comma separated list FDA assigned to the subject device)
74 DPS
Device Description
PHi-Res analysis is a software option for Marquette MAC-series electrocardiographs for high resolution P wave analysis.
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.
Intended User / Care Setting
hospital or clinic environment by competent health professionals
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)
Requirements specification reviews, code inspections, software testing and field tests of the PHi-Res analysis. The results of these measurements demonstrated that PHi-Res analysis is as safe, as effective, and performs as well as the predicate device, Marquette High Resolution Option for MAC-Series Electrocardiographs.
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 High Resolution ECG Option for MAC-Series Electrocardiographs
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
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).
0
SEP 25 1007
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: Signal-Averaged High Resolution P Wave Analysis (PHi-Res) Option
Classification Name: Computer, diagnostic, programmable |
| Predicate Device: | Marquette High Resolution ECG Option for MAC-Series Electrocardiographs |
| Device Description: | PHi-Res analysis is a software option for Marquette MAC-series electrocardiographs for high resolution P wave analysis. |
| Intended Use: | PHi-Res analysis is intended to be used in a hospital or clinic environment by competent health professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis.
PHi-Res analysis is intended to perform signal averaging of the atrial wave (P wave) from high-resolution ECG by P wave triggering method and analyzing the averaged P wave for its measurements.PHi-Res analysis is intended to provide only the measurements of the signal averaged P wave. PHi-Res is not intended to produce any interpretation of those measurements or any kind of diagnosis.The signal averaged P wave measurements produced by PHi-Res 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 judgement.PHi-Res is intended for patient populations including adult and pediatric. |
| Technology: | PHi-Res analysis employs the same technology as the predicate device. |
1
The following quality assurance measures were applied:
Requirements specification reviews, code inspections, software testing and field tests of the PHi-Res analysis.
The results of these measurements demonstrated that PHi-Res analysis is as safe, as effective, and performs as well as the predicate device, Marquette High Resolution Option for MAC-Series Electrocardiographs.
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized eagle with three lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 2 5 1997
Ms. Kristin Pabst Marquette Medical Systems 8200 West Tower Avenue Milwaukee, Wisconsin 53223
Re: K972199 Signal-Averaged High Resolution P Wave Analysis (PHi-Res, Software Version 1A) for MAC-Series ECG only Regulatory Class: II (two) Product Code: 74 DPS Dated: June 10, 1997 Received: June 11, 1997
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 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, Druq, 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, 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.
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 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. 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
4
SECTION 11 - INTENDED USE STATEMENT
☐ 510(k) Number (if known): Unknown - 510(k) filed May 30, 1997 K972199
Device Name: Signal-Averaged High Resolution P Wave Analysis (PHi-Res)
Indications For Use:
'مرس
PHi-Res is a software option for Marquette ECG analysis systems for high resolution P wave analysis. PHi-Res is intended to be used in a hospital or clinic environment by health care professionals for recording low amplitude/high frequency components of the surface electrocardiogram for P wave analysis.
PHi-Res analysis is only intended to provide the measurements of the signal averaged P wave and is not intended to provide any interpretation of those measurements or any kind of diagnosis. The P wave measurements provided by PHi-Res analysis 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.
PHi-Res is intended for patient populations including adult and pediatric.
At A. Gatti.
Prescription Use
(Per 21 CFR 801. 109)
000034
510(k) Notification "P wave Analysis" - June 10, 1997