(99 days)
The Midmark IQecg is indicated for use, under the supervision of a Physician, to obtain electrocardiograms from the adult and pediatric human body surface. The process of taking an electrocardiogram is non-invasive, painless, without direct risk to the patient and is reproducible.
The Midmark IQecg is a PC based 12-lead resting diagnostic electrocardiograph with interpretation and data storage capabilities. Together with the Midmark IQmanager software running on Microsoft Windows operating systems, the IQecg device can acquire 12-lead ECG (electrocardiogram) data, generate ECG measurement and interpretation results, provide review/edit functions to modify the measurement and interpretation results, store the ECG data and report in a database, archive the ECG reports for future reference and share the ECG reports with other physicians via network or email. The IQecg can also be connected to servers and electronic medical records.
The provided document is a 510(k) Pre-market Notification for the Midmark IQecg, a resting diagnostic electrocardiograph. It details the device description, technological comparison to a predicate device, intended use, and general performance testing. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study proving the device meets those criteria, or the methodology typically associated with AI/ML device studies (e.g., ground truth establishment, sample sizes for training/test sets, expert adjudication, MRMC studies).
The document is a regulatory submission for a traditional medical device, not an AI/ML powered device, which would typically involve different types of performance testing and reporting for its interpretative algorithms. The "interpretation" provided by the IQecg is likely based on established, rule-based algorithms for ECG analysis, rather than a machine learning model.
Therefore, many of the requested data points (like sample sizes for test/training sets, detailed ground truth establishment, expert adjudication, MRMC studies, or standalone performance for an AI algorithm) are not explicitly available or applicable in this document.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "The Midmark IQecg was tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements." However, the specific acceptance criteria and detailed quantitative performance metrics are not provided in this summary. The comparison focuses on technological characteristics rather than clinical performance metrics or specific algorithm accuracy.
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Not provided in detail. General statement: "complies with the predetermined requirements." | Frequency response bandwidth: 0.05Hz - 150Hz |
| ECG signal sampling rate: 500 samples/second | |
| QTc Measurement: User selects up to 2 from 4 formulas (Hodges, Bazett, Framingham, Fridericia). Default is Hodges. | |
| "as safe and performs as effectively as the predicate device." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "Performance Testing" was conducted, but details are absent.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. For this type of traditional ECG device with established interpretation algorithms, ground truth for performance testing is typically based on standardized databases or reference ECG recordings with known arrhythmias/morphologies, rather than expert consensus on individual cases for algorithm validation as would be common for new AI/ML systems.
4. Adjudication method for the test set
Not applicable/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
Not applicable. This device predates the widespread use of sophisticated AI for ECG interpretation requiring such studies in regulatory submissions. The interpretation component is likely based on established, rule-based algorithms, not a novel AI model that would assist human readers in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as having "interpretation results." While the performance of this interpretation algorithm was likely assessed, the specifics of this "standalone" performance testing (e.g., metrics like sensitivity, specificity for various conditions) are not detailed in the provided summary. The comparison focuses on hardware specifications and QTc calculation methods, implying that the interpretation algorithm itself is substantially equivalent to the predicate.
7. The type of ground truth used
Not specified. For ECG interpretation algorithms, ground truth often comes from:
- Standardized ECG databases (e.g., MIT-BIH Arrhythmia Database).
- Clinically adjudicated ECGs (though details of adjudication would be needed).
- Correlation with other diagnostic tests or clinical outcomes.
Given this is a traditional ECG device, it's highly probable it relies on established benchmarks.
8. The sample size for the training set
Not applicable/Not specified. For traditional rule-based algorithms, there isn't a "training set" in the machine learning sense. If the interpretation component involved statistical models, the data used to develop them is not mentioned.
9. How the ground truth for the training set was established
Not applicable/Not specified, as it's not an AI/ML device with a training set.
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Premarket Notification, Midmark, IQecg
5. 510(k) Summary
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MAR 2 2 2011
Midmark Diagnostics Group
Submitter: Midmark Diagnostics Group
Trade Names: Midmark IQecq
Common Name: Electrocardiograph
Classification Name: Electrocardiograph
Classification Regulation: 21 CFR 870.2340
Product Code: DPS
Device Description:
The Midmark IQecg is a PC based 12-lead resting diagnostic electrocardiograph with interpretation and data storage capabilities. Together with the Midmark IQmanager software running on Microsoft Windows operating systems, the IQecg device can acquire 12-lead ECG (electrocardiogram) data, generate ECG measurement and interpretation results, provide review/edit functions to modify the measurement and interpretation results, store the ECG data and report in a database, archive the ECG reports for future reference and share the ECG reports with other physicians via network or email. The IQecg can also be connected to servers and electronic medical records.
Technology Comparison:
The Midmark IQecg utilizes the same or similar technology for each parameter as utilized by the predicate device PC-ECG (K955023). This 510(k) is primarily being submitted for these changes:
| TechnologicalCharacteristics | Midmark IQecq | PC-ECG(K955023) |
|---|---|---|
| Frequency responsebandwidth | 0.05Hz - 150Hz | 0.05Hz-110 Hz |
| ECG signalsampling rate | 500 samples/second | 250samples/second |
| QT Correction(QTc) Measurement | User can select up to 2 from 4 formulasfor QTc measurement: Hodges,Bazett, Framingham, or Fridericia.Default QTc value is Hodges formula. | Calculatedusing Hodgesformula |
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Premarket Notification, Midmark, IQecg
Intended Use:
The Midmark IQecg is indicated for use, under the supervision of a Physician, to obtain electrocardiograms from the adult and pediatric human body surface. The process of taking an electrocardiogram is non-invasive, painless, without direct risk to the patient and is reproducible.
Performance Testing:
The Midmark IQecg was tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements.
Conclusion:
Based upon a comparison of devices and performance testing results, the Midmark IQecg is as safe and performs as effectively as the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Brentwood Medical Technology Corp. Midmark Diagnostics Group c/o Mr. Greg Holland Regulatory Regulatory Specialists, Inc. 3722 Ave. Sausalito Irvine, CA 92606
MAR 2 2 2011
Re: K103640
Trade/Device Name: Midmark IQecg Electrocardiograph Regulation Number: 21 CFR 870.2430 Regulation Name: Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS Dated: December 7, 2010 Received: December 13, 2010
Dear Mr. Holland:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 Amendmante devices that have been reclassified in accordance with the provisions of the Federal Food, Or to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Greg Holland
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
J.H. Hiller
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification, Midmark, IQecg
4. Indications for Use Statement Indications for Use
510(k) Number: _ Klo 3640
Device Name: Midmark IQecg
Indications for Use:
The Midmark IQecg is indicated for use, under the supervision of a Physician, to obtain electrocardiograms from the adult and pediatric human body surface. The process of taking an electrocardiogram is noninvasive, painless, without direct risk to the patient and is reproducible.
× Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) e============================================================================================================================================================================
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stitt Stitt for B Zuckerman
(Division Sign-Off) 3/22/2011
Division of Cardiovascular Devices
510(k) Number K103640
Page 1 of 1
REGULATORY SPECIALISTS, INC.
§ 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).