(106 days)
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.
PHi-Res analysis is a software option for Marquette MAC-series electrocardiographs for high resolution P wave analysis.
The provided document, K972199, details a 510(k) submission for the Signal-Averaged High Resolution P Wave Analysis (PHi-Res) Option. However, it does not contain specific acceptance criteria or an explicit study proving the device meets said criteria in a quantifiable manner as per the requested information. Instead, it relies on general quality assurance measures and substantial equivalence to a predicate device.
Here's an analysis of the information that is available, and what is missing based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Performance Metric | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis is as safe... as the predicate device" |
| Effectiveness | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis is as... effective... as the predicate device" |
| Performance | Not explicitly stated with quantifiable metrics | "demonstrated that PHi-Res analysis... performs as well as the predicate device" |
| P-wave measurement accuracy | Not explicitly stated with quantifiable metrics | "intended to provide only the measurements of the signal averaged P wave." (Implies accuracy is expected to be comparable to predicate) |
| Agreement with predicate device | Not explicitly stated with quantifiable metrics | "employs the same technology as the predicate device," "as safe, as effective, and performs as well as the predicate device" |
Missing Information: The document states that PHi-Res is "as safe, as effective, and performs as well as the predicate device," but it does not provide quantifiable acceptance criteria (e.g., minimum sensitivity, specificity, or error rates) or specific data demonstrating this performance for PHi-Res itself. It relies on the assertion of substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
The document mentions "software testing and field tests," but no details on the size or nature of these tests are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The document refers to the data being used by "qualified personnel" and "competent health professionals," but this relates to the intended use of the device, not the establishment of ground truth for testing.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, this type of study was not reported.
The device provides P-wave measurements and is not intended to provide interpretation or diagnosis. Therefore, a study on human reader improvement with AI assistance would not be applicable to this device's stated function.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Implied, but no specific study or metrics are provided. The device's primary function is to provide automated P-wave measurements. The "software testing" and "field tests" would likely assess this standalone performance against some internal standard or the predicate device, but no details are given.
7. The type of ground truth used
- Type of Ground Truth: Not specified.
Given the reliance on substantial equivalence to the predicate device and the "software testing and field tests," the ground truth likely involved comparing PHi-Res measurements to those from the predicate device or a gold standard ECG measurement technique, but this is not explicitly stated.
8. The sample size for the training set
- Training Set Sample Size: Not applicable/not specified.
The document states the PHi-Res analysis "employs the same technology as the predicate device." There is no indication that this device uses machine learning or AI that would require a separate "training set" in the modern sense. It appears to be a software option based on established signal processing algorithms.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/not specified, as there is no indication of a training set for an AI/ML model.
Summary of Device and Evidence:
The PHi-Res device is a software option for Marquette MAC-series electrocardiographs designed for high-resolution P-wave analysis. Its purpose is to perform signal averaging of the atrial wave and provide its measurements; it explicitly states it is not intended to provide interpretation or diagnosis.
The "study" or evidence provided to support its safety and effectiveness is based on the following:
- Quality Assurance Measures: Requirements specification reviews, code inspections, software testing, and field tests. The results of these measures "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."
- Substantial Equivalence: The submission heavily relies on demonstrating substantial equivalence to a predicate device (Marquette High Resolution ECG Option for MAC-Series Electrocardiographs) by stating it "employs the same technology" and performs "as well as" it.
In conclusion, the document provided is a 510(k) summary focused on demonstrating substantial equivalence through general quality assurance processes rather than a detailed performance study with specific acceptance criteria, sample sizes, and ground truth methodologies that are common in more recent medical device submissions, especially those involving AI/ML.
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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 Systems8200 W. Tower AvenueMilwaukee, WI 53223Telephone: (414) 355-5000FAX: (414) 362-3553 |
|---|---|
| Contact Person: | Kristin Pabst |
| Device: | Trade Name: Signal-Averaged High Resolution P Wave Analysis (PHi-Res) OptionClassification 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. |
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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.
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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.
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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
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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:
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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
§ 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).