E3-80 PORTABLE ECG RECORDER & ANALYZER

K071085 · Micro-Star International Co., Ltd. · MWJ · Oct 3, 2007 · Cardiovascular

Device Facts

• Record ID: K071085
• Device Name: E3-80 PORTABLE ECG RECORDER & ANALYZER
• Applicant: Micro-Star International Co., Ltd.
• Product Code: MWJ · Cardiovascular
• Decision Date: Oct 3, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended 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.

Device Story

E3-80 is a pocket-sized, 3-channel portable ECG recorder; captures ambulatory ECG signals from chest surface for up to 24 hours. Device stores raw ECG data onto removable Secure Digital (SD) disc; no onboard analysis performed. Healthcare practitioners retrieve SD disc and use external PC-based software to analyze recorded ECG data. Intended for ambulatory environment use. Benefits include continuous cardiac monitoring capability for adult patients.

Clinical Evidence

Bench testing only. Performance verified through functional, stability, and user preference testing. Electrical safety and EMC testing conducted per IEC 60601-1 and IEC 60601-1-2. Biocompatibility of electrodes verified per ISO 10993 for short-term skin contact.

Technological Characteristics

3-channel ECG recorder; pocket-sized form factor; battery-powered; removable Secure Digital (SD) storage; PC-based analysis software. Electrical safety/EMC per IEC 60601-1/IEC 60601-1-2. Electrodes biocompatible per ISO 10993.

Indications for Use

Indicated for adult patients requiring up to 24 hours of ambulatory 3-channel ECG signal recording from the chest surface.

Regulatory Classification

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.

Predicate Devices

• Braemar DigiTrak Plus Holter Recorder (K993617)
• Del Mar Lifecard CF Compact Holter Recorder (K001025)

Submission Summary (Full Text)

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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

1. 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 [phone]. 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 [phone] or [phone] 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

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