DIGITRAKPLUS HOLTER RECORDER

K993617 · Braemar Corp. · MWJ · Nov 24, 1999 · Cardiovascular

Device Facts

• Record ID: K993617
• Device Name: DIGITRAKPLUS HOLTER RECORDER
• Applicant: Braemar Corp.
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 24, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval

Device Story

DigiTrakPlus is a digital Holter recorder for ambulatory ECG monitoring. Device captures ECG signals via body-surface electrodes; stores data on non-volatile flash memory for up to 48 hours. Unlike its predicate, it lacks on-board ECG analysis; analysis is performed by external Holter Analyzer software. Device features LCD, USB data transfer, and pacemaker detection logic. Used in clinical settings or by patients during daily activities; operated by healthcare professionals or patients. Output is raw ECG data transferred to an analyzer for clinical review. Benefits include patient assessment for cardiac symptoms, therapeutic monitoring, and research. Modification from predicate (Model #1005) includes reduced size/weight, lower power consumption, and removal of on-board analysis.

Clinical Evidence

Bench testing only. Performance of the modified pacemaker detection logic was validated through bench testing to ensure equivalence to the predicate device.

Technological Characteristics

Digital Holter recorder; flash memory storage; USB connectivity; powered by one AA battery. Dimensions: 8.5 x 6.5 x 2 cm; weight: 100 g. Includes LCD and belt clip. Pacemaker detection logic implemented. No on-board ECG analysis software.

Indications for Use

Indicated for patients requiring ambulatory (Holter) ECG monitoring (1-48 hours) for evaluation of arrhythmia, myocardial ischemia, ST segment changes, therapeutic intervention efficacy, post-MI/surgery recovery, pacemaker function, heart rate variability, and QT interval.

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

• Biosensor Model #1005 (K950944)

Reference Devices

• DXP1000 (K990956)

Submission Summary (Full Text)

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NOV 2 4 1999

K993617

### Section 2: 510(k) SUMMARY

- . Substantially Equivalent (SE) To:
Biosensor Model #1005 510(k) # K950944

### Modification Background

The essence of this modification is a change of the digital Holter recorder hardware to a smaller configuration with reduced power consumption and the removal of ECG analysis capabilities from the device. In connection with this modification, the methodology of the pacemaker detection logic has been modified slightly, and its performance validated as reported herein. As a result of this modification, ECG analysis is not a part of this device, but rather is performed by software installed in the Holter Analyzer which is subject to independent 510(k) review, as in the Company's earlier filing (K990956).

The above changes do not affect the intended use of the device or alter the fundamental scientific technology of the device, as is demonstrated on the following pages.

| Attribute | DigiTrakPlus | Model #1005 |
|---------------------------------|----------------------|-----------------------------|
| Storage capacity | Up to 48 hours | 24 hours |
| Memory type | Flash (non-volatile) | Flash (non-volatile) |
| Memory portability | Non-removable | Non-removable |
| On-board ECG analysis | No | Yes |
| Liquid Crystal Display (LCD) | Yes | No |
| Data transfer method | USB port | Bi-directional parallel I/O |
| Pacemaker detection & reporting | Yes | Yes |
| Belt clip | Yes | No |
| Battery | One AA | Four AA |
| Size | 8.5 x 6.5 x 2 cm | 15 x 6 x 2 cm |
| Weight | 100 g | 140 g |

#### . Comparison To The SE Device:

NOTE: Together with this Special 510(k), another Special 510(k) has been filed on a similar device (DXP1000) utilizing alternative hardware which is slightly larger in size. Both devices incorporate the same fundamental scientific technology, and indeed a substantially identical electro-mechanical design. For clarity, the submitter wishes to note to the reviewer that these two devices are essentially the same other than the size and weight characteristics noted.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

Mr. David Norberg Regulatory Affairs Representative Braemar, Inc. 11481 Rupp Drive Burnsville, Minnesota 55337

Re: K993617 DigiTrakPlus Holter Recorder Regulatory Class: II (two) Product Code: MWJ Dated: October 25, 1999 Received: October 26, 1999

Dear Mr. Norberg:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to leqally 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. David Norberg

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

V. Donk Telle

Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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# DigiTrakPlus Holter Recorder

# 510(k) Number: K993617 Indications for Use:

(No change from predicate device)

The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from 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 non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data which provides a powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment.

Ambulatory (Holter) ECG intended use:

The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below.

1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia.

2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients.

3. Evaluation of patients for ST segment changes.

4. Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after M.I. or cardiac surgery.)

5. Clinical and epidemiological research studies.

- 6. Evaluation of patients with pacemakers
- 7. Reporting of time and frequency domain heart rate variability

8. Reporting of QT Interval

**Prescription Use**
(Per 21 CFR 801.109)

Kla Vh Tielh
(Division Sign-Off)

Onnsion of Cardiovascular. Respirat and Neurological Devices 510(k) Number