(99 days)
Not Found
No
The document mentions "interpretation" but does not explicitly state or imply the use of AI/ML for this function. There are no mentions of AI, DNN, ML, training sets, or test sets.
No
The device is described as a diagnostic electrocardiograph used to obtain and interpret ECG data, not to treat a condition.
Yes
The device description explicitly states, "The Midmark IQecg is a PC based 12-lead resting diagnostic electrocardiograph with interpretation and data storage capabilities." This indicates its primary function is diagnostic.
No
The device description explicitly states it is a "PC based 12-lead resting diagnostic electrocardiograph," which includes hardware components for acquiring ECG data.
Based on the provided information, the Midmark IQecg is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. The "in vitro" part means "in glass" or "in the lab," referring to tests performed outside the living organism.
- Midmark IQecg Function: The Midmark IQecg obtains electrocardiograms directly from the human body surface. This is a non-invasive procedure performed on the patient, not on a specimen taken from the patient.
- Intended Use: The intended use is to "obtain electrocardiograms from the adult and pediatric human body surface," which is a direct measurement of electrical activity of the heart in vivo.
Therefore, the Midmark IQecg falls under the category of a diagnostic medical device that performs measurements directly on the patient, rather than an IVD device that analyzes specimens.
N/A
Intended Use / 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 non-invasive, painless, without direct risk to the patient and is reproducible.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human body surface
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
Physician
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 Midmark IQecg was tested in accordance with requirements and procedures, and test results indicated that the device complies with the predetermined requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Premarket Notification, Midmark, IQecg
5. 510(k) Summary
Image /page/0/Picture/3 description: The image shows the word "MIDMARK" in a bold, sans-serif font. The word is white and is set against a dark, textured background. The background appears to be a combination of black and white pixels, giving it a grainy or speckled appearance. There is a dark horizontal line above the word, and the overall image has a slightly distressed or aged look.
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:
| Technological
Characteristics | Midmark IQecq | PC-ECG
(K955023) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Frequency response
bandwidth | 0.05Hz - 150Hz | 0.05Hz-110 Hz |
| ECG signal
sampling rate | 500 samples/second | 250
samples/second |
| QT Correction
(QTc) Measurement | User can select up to 2 from 4 formulas
for QTc measurement: Hodges,
Bazett, Framingham, or Fridericia.
Default QTc value is Hodges formula. | Calculated
using Hodges
formula |
1
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.
2
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.
3
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
4
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.