QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)

K093172 · Dynacardia, Inc. · DPS · Jan 20, 2010 · Cardiovascular

Device Facts

• Record ID: K093172
• Device Name: QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000)
• Applicant: Dynacardia, Inc.
• Product Code: DPS · Cardiovascular
• Decision Date: Jan 20, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

The intended use of the QED 1000 is to record 12-lead ECG signals from adult patients from body surface ECG electrodes. This device can acquire, display, record, and store these ECG signals for review by the user. The QED 1000 is intended to be used in healthcare facilities by trained healthcare professionals. A qualified physician must over-read all computer-generated tracings. The QED 1000 is designed for use by a qualified physician to evaluate the electrocardiogram of adult patients as part of clinical diagnosis.

Device Story

QED 1000 is a 12-lead resting electrocardiograph; acquires, displays, records, and stores ECG signals from body surface electrodes. Used in healthcare facilities by trained professionals; qualified physician must over-read all computer-generated tracings to support clinical diagnosis. Device provides visual output of ECG tracings for physician review; aids in cardiac assessment and clinical decision-making.

Clinical Evidence

Bench testing only. Device underwent electromagnetic compliance and electrocardiograph standard testing per EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R) 2001.

Technological Characteristics

12-lead resting electrocardiograph; acquires, displays, and stores ECG signals. Complies with EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R) 2001 standards.

Indications for Use

Indicated for recording 12-lead ECG signals in adult patients for clinical diagnostic evaluation by a qualified physician in healthcare facilities.

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

• Philips PageWriter (K080999)
• MAC 5500 (K073625)

Submission Summary (Full Text)

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JAN 20 2017

## Section 5 – 510(k) Summary

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| Submitter: | Dynacardia, Inc.<br>1330 Mountain View Circle, Azusa, California 91702 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wei-min Brian Chiu, Ph.D., President<br>Phone: [phone]; Fax: [phone]<br>Email: [e-mail] |
| Date Prepared: | August 22, 2009 |
| Trade Name: | Quantitative Electrocardiographic Detector (QED 1000) |
| Classification: | Class II<br>Electrocardiograph<br>21 CFR §870.2340 |
| Product Code: | DPS |
| Predicate Device(s): | The subject device is equivalent to the following devices:<br>o K080999: "Philips PageWriter"; Philips Medical Systems<br>o K073625: "MAC 5500"; GE Healthcare Systems |
| Device Description: | The Quantitative Electocardiographic Detector (QED) is a 12-lead resting<br>electrocardiograph. It is a reusable device for acquiring, displaying, and<br>storing the 12-lead electrocardiogram. |
| Intended Use: | The intended use of the QED 1000 to record 12-lead ECG signals from<br>adult patients from body surface ECG electrodes. This device can<br>acquire, display, record, and store these ECG signals for review by the<br>user.<br>The QED 1000 is intended to be used in healthcare facilities by trained<br>healthcare professionals. A qualified physician must over-read all<br>computer-generated tracings.<br>The QED 1000 is designed for use by a qualified physician to evaluate<br>the electrocardiogram of adult patients as part of clinical diagnosis. |
| Functional and Safety<br>Testing: | To verify that device design met its functional and performance<br>requirements, representative sample of the device underwent<br>electromagnetic compliance and electrocardiograph standard testing in<br>accordance with EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R)<br>2001. |
| Conclusion: | Dynacardia, Inc. considers the QED 1000 to be equivalent to the<br>predicate devices listed above. This conclusion is based upon the<br>devices' similarities in principles of operation, technology, and indications<br>for use. |

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K093172

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Dynacardia, Inc. c/o Mr. Morten Simon Christensen Underwriters Laboratories Inc. 455 E. Trimble Road San Jose, CA 95131

JAN 2 0 2010

Re: K093172

> Trade/Device Name: Quantitative Electrocardiographic Detector (QED 1000) Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II (Two) Product Code: DPS Dated: January 4, 2010 Received: January 5, 2010

Dear Mr. Christensen:

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 Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. 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. Ilsting 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. Morten Simon Christensen

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.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

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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## K093172

## Section 4 - Indications for Use Statement

Device Name: Quantitative Electrocardiographic Detector (QED 1000)

Intended Use:

The intended use of the QED 1000 is to record 12-lead ECG signals from adult patients from body surface ECG electrodes. This device can acquire, display, record, and store these ECG signals for review by the user.

The QED 1000 is intended to be used in healthcare facilities by trained healthcare. professionals. A qualified physician must over-read all computer-generated tracings.

The QED 1000 is designed for use by a qualified physician to evaluate the electrocardiogram of adult patients as part of clinical diagnosis.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.A.

ovascular Devices

**510(k) Number** K092911
K093172

wcw
(2010)