(169 days)
The E3-80 device is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment.
The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.
The E3-80 ECG device is designed to be a portable recorder of electrocardiograms. The device has a storage function in which the recorded signals are automatically stored in a removable storage disc for trained healthcare practitioners to perform further analysis using PC-based software.
The E3-80 ECG device is a light-weight, pocket-size portable recorder of three channel electrocardiograms. The device has adequate battery life and recording capability for continuous recording of the ambulatory ECG signals for up to 24 hours. The recorded signals are automatically stored in a removable Secure Digital (SD) disc for trained healthcare practitioners to perform further analysis using PC-based software.
The provided text focuses on the 510(k) premarket notification for the E3-80 Portable ECG Recorder. It describes the device, its intended use, and its technological characteristics. However, the text does not contain information about specific acceptance criteria for device performance, a study detailing device performance against such criteria, sample sizes for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.
The document states that "Various bench and user preference tests were performed to ensure that the E3-80 Portable ECG Recorder meets all functional, performance, and stability requirements for its intended use." It also mentions electrical safety, EMC, and biocompatibility testing according to relevant IEC and ISO standards. However, it does not elaborate on the specific performance metrics or the results of these tests in a way that would allow for the creation of the requested table or answer the specific questions about clinical study methodology.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth.
- Adjudication method.
- MRMC comparative effectiveness study details.
- Standalone algorithm performance details.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
The provided text primarily focuses on regulatory approval and substantial equivalence to predicate devices, rather than detailed performance and validation study results.
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Image /page/0/Picture/0 description: The image shows the logo for MSI, which stands for Micro-Star International. The logo consists of two parts: a stylized symbol on the left and the text "MSI MICRO-STAR INTERNATIONAL" on the right. The symbol features a square with the letters "MSI" inside, surrounded by four arrow-like shapes pointing outwards. The text is written in a bold, sans-serif font, with "MSI" in a larger size than "MICRO-STAR INTERNATIONAL".
Micro-Star International Co., Ltd. Pre-market Notification for E3-80 Portable ECG Recorder
071085
Pg. 1 of 2
E3-80 Portable ECG Recorder
OCT 3 * 2007
510(k) Summary of Safety and Effectiveness
- Submitter
Micro-Star International Co., Ltd. No. 69, Li-De Street, Jung-He City Taipei Hsien, 235 Taiwan (ROC)
| Contact: | Album D. Tsai, Regulatory Affairs Representative |
|---|---|
| Phone: | 011-8862-3234-5599 ext. 1056 |
| Fax: | 011-8862-2227-1644 |
2. Name of Device
| Trade Name: | E3-80 Portable ECG Recorder |
|---|---|
| Common/Usual Name: | ECG Recorder |
| Classification: | 21CFR 870.2800 |
| Medical Magnetic Tape Recorder | |
| Product Code: | MWJ |
| Electrocardiograph, Ambulatory (Without Analysis) |
3. Predicate Device
| Trade Name | 510(k) Number | Decision Date |
|---|---|---|
| Braemar DigiTrak Plus Holter Recorder | K993617 | 11/24/1999 |
| Del Mar Lifecard CF Compact Holter Recorder | K001025 | 04/19/2000 |
4. Device Description
The E3-80 ECG device is designed to be a portable recorder of electrocardiograms. The device has a storage function in which the recorded signals are automatically stored in a removable storage disc for trained healthcare practitioners to perform further analysis using PC-based software.
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Image /page/1/Picture/0 description: The image shows the MSI logo. The logo consists of a square with the letters "MSI" inside, and four lines extending from the square. To the right of the square are the letters "MSI" in large font, and below that is the text "MICRO-STAR INTERNATIONAL".
5. Indications for Use
The E3-80 device is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment.
The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.
6. Technological Characteristics
The E3-80 ECG device is a light-weight, pocket-size portable recorder of three channel electrocardiograms. The device has adequate battery life and recording capability for continuous recording of the ambulatory ECG signals for up to 24 hours. The recorded signals are automatically stored in a removable Secure Digital (SD) disc for trained healthcare practitioners to perform further analysis using PC-based software.
7. Performance Summary
Various bench and user preference tests were performed to ensure that the E3-80 Portable ECG Recorder meets all functional, performance, and stability requirements for its intended use. The electrical safety and EMC requirements were tested by independent labs in accordance with the requirements specified in IEC 60601-1 and IEC 60601-1-2. Biocompatibility of the electrodes were tested according to ISO 10993 guidelines for "short-term exposure, skin contact devices".
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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the name of the department.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Micro-Star International Co., LTD. c/o Mr. Album Tsai Research Center No. 69. Li-De Street Jung-He City, Taipei Hsien 235 Taiwan (R.O.C.)
2007 01.1 3
Re: K071085
Trade/Device Name: E3-80 Portable ECG Recorder & Analyzer Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II Product Code: MWJ Dated: September 20, 2007 Received: September 24, 2007
Dear Mr. Album Tsai:
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, 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 such 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. Album Tsai
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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Bhimima for
Bram D. Zuckerman, MD Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K071085
Device Name: E3-80 Portable ECG Recorder
Indications For Use:
The E3-80 is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment.
The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.
Prescription Use X = (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
B. Bymma
Division of Cardiovascular Devices 510(k) Numb
Page 1 of 1 _
§ 870.2800 Medical magnetic tape recorder.
(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).