MIDMARK IQECG

K103640 · Brentwood Medical Technology Corp. · DPS · Mar 22, 2011 · Cardiovascular

Device Facts

• Record ID: K103640
• Device Name: MIDMARK IQECG
• Applicant: Brentwood Medical Technology Corp.
• Product Code: DPS · Cardiovascular
• Decision Date: Mar 22, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

PC-based 12-lead resting diagnostic electrocardiograph; acquires ECG data via patient surface electrodes; processes data using Midmark IQmanager software on Windows OS; generates measurements and interpretations; provides review/edit functions; stores, archives, and shares reports via network/email; integrates with EMR servers. Used in clinical settings by healthcare professionals. Output allows physicians to review cardiac electrical activity to support clinical decision-making and patient diagnosis.

Clinical Evidence

Bench testing only. The device was tested in accordance with predetermined requirements and procedures, confirming compliance with performance specifications.

Technological Characteristics

PC-based 12-lead resting ECG system; frequency response 0.05Hz-150Hz; sampling rate 500 samples/second; software-based interpretation; connectivity via network/email/EMR integration; Windows-based software platform.

Indications for Use

Indicated for adult and pediatric patients to obtain surface electrocardiograms under physician supervision.

Regulatory Classification

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.

Predicate Devices

• PC-ECG (K955023)

Submission Summary (Full Text)

{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<br>Characteristics | Midmark IQecq | PC-ECG<br>(K955023) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Frequency response<br>bandwidth | 0.05Hz - 150Hz | 0.05Hz-110 Hz |
| ECG signal<br>sampling rate | 500 samples/second | 250<br>samples/second |
| QT Correction<br>(QTc) Measurement | User can select up to 2 from 4 formulas<br>for QTc measurement: Hodges,<br>Bazett, Framingham, or Fridericia.<br>Default QTc value is Hodges formula. | Calculated<br>using Hodges<br>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 [phone] or [phone] 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.