(104 days)
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.
The Quantitative Electocardiographic Detector (QED) is a 12-lead resting electrocardiograph. It is a reusable device for acquiring, displaying, and storing the 12-lead electrocardiogram.
This document does not contain the detailed information necessary to complete all sections of your request, particularly regarding specific acceptance criteria, detailed study design, and statistical outcomes. The provided text primarily consists of a 510(k) summary and an FDA clearance letter for the Quantitative Electrocardiographic Detector (QED 1000).
However, I can extract information related to the device's functional and safety testing as an indicator of how it meets requirements.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
| Performance Metric/Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional & Performance Requirements | Device underwent electromagnetic compliance and electrocardiograph standard testing in accordance with EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R) 2001. No specific quantitative performance values (e.g., sensitivity, specificity for detecting specific ECG phenomena) are provided. |
| Electromagnetic Compatibility (EMC) | Compliance with EN 60601-1-2: 2007 |
| Electrocardiograph Standards | Compliance with ANSI/AAMI EC 11: 1999/(R) 2001 |
Missing Information: The document states that the device "met its functional and performance requirements" through testing against specified standards. However, it does not provide specific quantitative acceptance criteria for clinical performance metrics (e.g., accuracy in waveform measurement, arrhythmia detection, etc.) nor does it report specific numerical performance results from these tests beyond stating compliance.
2. Sample size used for the test set and the data provenance
Missing Information: The provided text does not specify a sample size for any test set or the provenance of the data (e.g., country of origin, retrospective or prospective) for performance evaluation. The type of testing mentioned (EMC, DVM standards) typically does not involve patient data in the same way clinical performance studies do.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Missing Information: The document does not mention any experts used to establish ground truth for a test set. The testing described focuses on engineering standards compliance rather than clinical interpretation.
4. Adjudication method for the test set
Missing Information: No information is provided regarding an adjudication method, as no specific test set requiring expert adjudication is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
Missing Information: The document does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study. The QED 1000 is described as a device to "acquire, display, record, and store" ECG signals for review by a user, with a qualified physician over-reading all computer-generated tracings. This implies a human-in-the-loop scenario, but no study comparing human readers with and without AI assistance is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Missing Information: The document does not describe a standalone algorithm performance study. The device is an electrocardiograph that acquires, displays, records, and stores ECG signals, implying its primary function is data capture and presentation for human review, not automated diagnostic interpretation without human oversight. The statement "A qualified physician must over-read all computer-generated tracings" reinforces that it's not a standalone diagnostic device.
7. The type of ground truth used
Missing Information: No specific ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned, as the described testing relates to technical and safety standards rather than clinical diagnostic accuracy against a reference standard.
8. The sample size for the training set
Missing Information: The document does not mention a training set sample size. This device is an electrocardiograph, and the summary focuses on its functionality and compliance with technical standards, not on internal AI/algorithm training which would typically involve a training set.
9. How the ground truth for the training set was established
Missing Information: As no training set is mentioned, there is no information on how its ground truth would have been established.
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JAN 20 2017
Section 5 – 510(k) Summary
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| Submitter: | Dynacardia, Inc.1330 Mountain View Circle, Azusa, California 91702 |
|---|---|
| Contact Person: | Wei-min Brian Chiu, Ph.D., PresidentPhone: (626) 610-1896; Fax: (626) 610-1897Email: brianchiu@dynacardia.com |
| Date Prepared: | August 22, 2009 |
| Trade Name: | Quantitative Electrocardiographic Detector (QED 1000) |
| Classification: | Class IIElectrocardiograph21 CFR §870.2340 |
| Product Code: | DPS |
| Predicate Device(s): | The subject device is equivalent to the following devices:o K080999: "Philips PageWriter"; Philips Medical Systemso K073625: "MAC 5500"; GE Healthcare Systems |
| Device Description: | The Quantitative Electocardiographic Detector (QED) is a 12-lead restingelectrocardiograph. It is a reusable device for acquiring, displaying, andstoring the 12-lead electrocardiogram. |
| Intended Use: | The intended use of the QED 1000 to record 12-lead ECG signals fromadult patients from body surface ECG electrodes. This device canacquire, display, record, and store these ECG signals for review by theuser.The QED 1000 is intended to be used in healthcare facilities by trainedhealthcare professionals. A qualified physician must over-read allcomputer-generated tracings.The QED 1000 is designed for use by a qualified physician to evaluatethe electrocardiogram of adult patients as part of clinical diagnosis. |
| Functional and SafetyTesting: | To verify that device design met its functional and performancerequirements, representative sample of the device underwentelectromagnetic compliance and electrocardiograph standard testing inaccordance with EN 60601-1-2: 2007 and ANSI/AAMI EC 11: 1999/(R)2001. |
| Conclusion: | Dynacardia, Inc. considers the QED 1000 to be equivalent to thepredicate devices listed above. This conclusion is based upon thedevices' similarities in principles of operation, technology, and indicationsfor use. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
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 (800) 638-2041 or (301) 796-7100 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)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W.M.A.
ovascular Devices
wcw
(2010)
§ 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).