ER800 SERIES ECG EVENT RECORDER

K030856 · Braemar Corp. · MWJ · Mar 28, 2003 · Cardiovascular

Device Facts

• Record ID: K030856
• Device Name: ER800 SERIES ECG EVENT RECORDER
• Applicant: Braemar Corp.
• Product Code: MWJ · Cardiovascular
• Decision Date: Mar 28, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.

Device Story

ER800 Series ECG Event Recorder captures cardiac electrical activity via body surface electrodes; stores data in non-volatile flash memory (up to 30-minute looping capacity). Device features on-board arrhythmia and pacemaker detection. Operated by patients in home or ambulatory settings; data transmitted via transtelephonic (TTP) methods to host PC for clinician review. Clinicians use output to evaluate cardiac electrical activity and diagnose arrhythmias. Modification from previous models includes smaller hardware configuration, reduced power consumption (single AA battery, 30-day life), and reinstated arrhythmia/pacemaker analysis functionality. Benefits include improved portability and extended monitoring duration for elusive cardiac events.

Clinical Evidence

Bench testing only. Device performance validated against AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47 standards.

Technological Characteristics

ECG event recorder; non-volatile flash memory; single AA battery power source; transtelephonic (TTP) connectivity. Features on-board arrhythmia and pacemaker detection. Complies with AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47. Form factor includes belt clip.

Indications for Use

Indicated for patients requiring recording of infrequent and elusive ECG heart arrhythmia data. Prescription use only.

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 Model ER700 (K981394)
• Biosensor Model 1005 (K950944)
• Braemar Model DXP1000 (K993618)

Submission Summary (Full Text)

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## SECTION 3. 510(k) SUMMARY

. .

Substantially Equivalent (SE) To: . Ambulatory Devices

Braemar Model ER700 510(k) K981394

MAR 2 8 2003

Biosensor Model 1005 510(k) K950944

Braemar Model DXP1000 510(k) K993618

## Modification Background

The essence of this modification is a change to the recorder hardware to a smaller configuration with reduced power consumption and to reinstate existing arrhythmia functionality to maintain competitiveness with other devices within the domestic marketplace. In connection with the modification the device performance has been validated as reported herein. Note all devices meet the same performance standards of AAMI-EC38, EN60601-1-1, EN60601-1-2, and EN60601-2-47.

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device as is demonstrated in this submission.

| Attribute | ER800 | ER700 | Model 1005 | DXP1000 |
|---------------------------------------|----------------------------------------|----------------------------------------|--------------------------------|---------------------------------|
| Storage capacity | Up to 30 minutes,<br>Looping<br>Memory | Up to 30 minutes,<br>Looping<br>Memory | 1 day, 24 hours | 2 days, 48 hours |
| Memory type | Flash<br>(non-volatile) | Flash<br>(non-volatile) | Flash<br>(non-volatile) | Compact<br>Flash (non-volatile) |
| On-board<br>analysis | Yes | No | Yes | No |
| Liquid Crystal<br>Display (LCD) | No | Yes | No | Yes |
| Data transfer<br>method | TTP<br>Transtelephonic | TTP or RS232<br>Serial | Bi-directional<br>parallel I/O | USB I/O |
| Pacemaker<br>detection &<br>reporting | Yes | No | Yes | Yes |
| Belt clip | Yes | No | No | Yes |
| Battery | One AA | Two AAA | Four AA | Two AA |
| Battery Life | 30 days | 14 days | 24 hours | 48 hours |

## Comparison To The SE Devices: .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2003

Braemar, Inc. c/o Mr. David Norberg Regulatory Affairs Representative 11481 Rupp Drive Burnsville, MN 55337

Re: K030856

Trade Name: ER800 Series ECG Event Recorder Regulation Number: 21 CFR 870.2800 Regulation Name: Medical magnetic tape recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: March 12, 2003 Received: March 18, 2003

Dear Mr. Norberg:

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.

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

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Page 2 - Mr. David Norberg

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/dsma/dsmamain.html

Sincerely vours.

XQeletM

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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## SECTION 4. INDICATIONS FOR USE, INTENDED USE

Indications for Use: (No change from predicate devices)

To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review.

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used noninvasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerful basis for evaluation of these biophysical signals.

Vellath

Prescription Use Only