DIGITAL ECG HOLTER RECORDER, MODEL DR512

K982975 · Datrix · MWJ · Nov 10, 1998 · Cardiovascular

Device Facts

• Record ID: K982975
• Device Name: DIGITAL ECG HOLTER RECORDER, MODEL DR512
• Applicant: Datrix
• Product Code: MWJ · Cardiovascular
• Decision Date: Nov 10, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient's daily activity.

Device Story

DR512 is a compact, battery-powered digital Holter recorder for ambulatory ECG monitoring. It collects 3-channel ECG data via 5 or 7 lead wires and silver-chloride electrodes over 24 hours. Device features internal calibration and a patient-activated event marker. Data is stored on digital flash disk media. Used in clinical or home settings; operated by patients under physician prescription. After recording, data is downloaded to a Holter playback system for physician review. Physician analyzes ECG data to identify cardiac abnormalities, aiding clinical decision-making and patient diagnosis. Enclosure includes electromagnetic interference spray coating.

Clinical Evidence

Bench testing only. Verification included analog hardware testing (frequency response, amplification, CMRR), digital hardware RAM write-read tests, and firmware validation (flash disk control, A/D conversion, sampling, compression-decompression). Environmental, shock, and EMC testing performed. Compatibility with playback systems verified. No clinical trial data presented.

Technological Characteristics

3-channel digital Holter recorder. Materials: plastic enclosure with EMI spray. Sensing: 5 or 7 lead wires, silver-chloride electrodes. Power: 9V battery. Connectivity: digital flash disk storage. Bandwidth: 0.05-50 Hz. Resolution: 8-bit. Sampling: 128-512 samples/channel/sec. Firmware-based control for A/D conversion and data compression.

Indications for Use

Indicated for ambulatory patients requiring long-term ECG monitoring to detect normal and abnormal cardiac activity during daily life. Used under physician order.

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

• Datrix XR300 ECG Holter Recorder (K921068)
• Braemar DL700 Digital ECG Holter Recorder (K945130)

Submission Summary (Full Text)

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Jon Barron Inc. dba:

NOV 10 1998

DATRIX®

59
K982975

## APPENDIX A-1

# 510(K) PREMARKET NOTIFICATION SUMMARY OF SAFETY AND EFFECTIVENESS

# 1. SUBMITTER INFORMATION

| Company: | Datrix |
|-----------------|----------------------------------------|
| Address: | 316 State Place<br>Escondido, CA 92029 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Jon Barron |
| Date Prepared: | August 21, 1998 |

# 2. DEVICE INFORMATION

| Trade Name: | DR512 Digital ECG Holter Recorder |
|----------------------|-----------------------------------|
| Common Name: | Ambulatory ECG Recorder |
| Classification Name: | Recorder, Magnetic Tape, Medical |

### 3. PREDICATE DEVICES

| Device | 510(k) No. | Date Cleared |
|-------------------------------------------|------------|----------------|
| Datrix XR300 ECG Holter Recorder | K921068 | March 30, 1992 |
| Braemar DL700 Digital ECG Holter Recorder | K945130 | April 4, 1998 |

### 4. DESCRIPTION

The DR512 is a lightweight, compact, digital Holter recorder designed for ambulatory ECG applications. Three channels of ECG data are collected via a 5 or 7 lead wire set and silver-chloride electrodes. The recorder is battery powered to ensure electrical isolation of

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enclosure coated with an electromagnetic interference spray. The DR512 has internal calibration, and a patient activated event marker button. ECG data are collected for 24 hours.

#### 5. INTENDED USE

The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient's daily activity.

#### 6. SUBSTANTIAL EQUIVALENCE

The DR512 is substantially equivalent to other commercially distributed ECG Holter recorders. The fundamental technical characteristics of the DR512 are similar to those of the predicate devices: all are 3-channel, record for 24 hours, and have similar standards and specifications. The main difference between the XR300 and the DR512 is the storage media. While the analog technology of the XR300 uses a cassette tape to store the data. both the DR512 and DL700 use digital flash disk technology. The technical characteristics of each recorder are summarized in the following chart.

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| SPECIFICATION | DATRIX DR512 | DATRIX XR300 | BRAEMAR DL700 * |
|-------------------------------------------------|--------------------------|--------------------------|---------------------|
| FUNCTIONAL | | | |
| ECG CHANNELS | 3 | 3 | 3 |
| RESOLUTION | 8 BIT | ANALOG | 8 BIT |
| SAMPLE RATE | 128 TO 512/CHAN/SEC | ANALOG | 128 TO 140/CHAN/SEC |
| RECORDING<br>DURATION | 24 HOURS | 24 HOURS | 24 HOURS |
| PHYSICAL | | | |
| OPERATING<br>POSITION | ANY | ANY | ANY |
| SIZE (in) | 4.94 x 2.75 x .94 | 6 x 3.5 x 1.12 | 6 x 3.5 x .95 |
| WEIGHT | 4 ounces | 13 ounces | 10 ounces |
| ENCLOSURE<br>MATERIAL | Plastic | Plastic | Plastic |
| ENVIRONMENTAL | | | |
| OPERATING TEMP | 0 to 60 degrees C ** | +5 to 45 degrees C | 0 to 45 degrees C |
| OPERATING<br>HUMIDITY<br>(non condensing) | 8% to 95%** | 10% to 90% | 10% to 90% |
| OPERATING<br>ALTITUDE | 8000 feet | 8000 feet | 10000 feet |
| OPERATING SHOCK | 26 inch drop<br>in pouch | 18 inch drop<br>in pouch | 3 inch drop |
| | | | |
| SPECIFICATION | DATRIX DR512 | DATRIX XR300 | BRAEMAR DL700 * |
| ELECTRICAL | | | |
| BANDWIDTH | .05 to 50 Hz | .05 to 100 Hz (-3dB) | .05 to 50 Hz |
| SIGNAL INPUT<br>RANGE | 5 mV | 5 mV | 5 mV |
| INPUT IMPEDANCE | >5 Meg | >5 Meg | >5 Meg |
| COMMON MODE<br>REJECTION RATIO<br>(60HZ SIGNAL) | 60 dB | 60 dB | 60 dB |
| POWER<br>REQUIREMENTS | | | |
| BATTERY | One 9 Volt | One 9 Volt | Two AA |
| AVERAGE<br>OPERATING<br>CURRENT | 5 mA | 5 mA | 35 mA |
| PEAK<br>OPERATING<br>CURRENT | 55 mA | 5 mA | 330 mA |

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* Specifications taken from manufacturer's specification sheet

** Limited by flash card specifications

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### 7. PERFORMANCE DATA

The DR512 digital ECG Holter recorder has been tested and shown to conform to design specifications. Verification of the analog hardware was comprised of testing the ECG amplifier frequency response, amplification, and common mode rejection ratio, as well as the voltage converter, event button circuits, and battery polarity. Visual inspection of all parts was also made. A RAM write-read test of the digital hardware was conducted using an emulator to verify that the RAM was functioning, the RAM data, address, and control lines were connected correctly, and that the microcontroller was functioning. The recorder firmware was tested for flash disk control, A/D conversion and sampling rate, compression-decompression. The compression algorithms were tested with line segment data, calibration signals, and simulated ECG waveforms. The recorder was validated using both bench and subject testing. The recorder was also independently tested and shown to be compatible with commercially available playback systems.

Extensive troubleshooting was conducted to ensure that the recorder responded appropriately to improper use of the recorder . These tests included improper insertion of the flash card, improper termination of recording, improper insertion of the battery, and low battery. The beeps indicating proper functioning of the recorder were also tested.

Environmental tests were conducted to verify the operating ranges for temperature. humidity, and altitude. Shock and EMC testing were also conducted.

Results of all testing indicated that the DR512 digital Holter recorder is an accurate and consistent device, with repeatable performance. The recorder has been shown to perform to design specifications, and is suitable for ECG applications with ambulatory patients.

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### APPENDIX 2

# YEAR 2000 STATEMENT

The DR512 will continue to function properly regardless of the date. All time functions of the DR512 are based on elapsed time from the start of recording. All of the devices used to test the DR512 have no date function, or have been tested to ensure that there is no effect on the quality or safety of the device.

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Image /page/6/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wing. The eagle faces right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV | 0 |998

Mr. Jon Barron DATRIX 316 State Place Escondido, CA 92029

K982975 Re : Digital ECG Holter Recorder Requlatory Class: II (two) Product Code: MWJ Dated: Auqust 21, 1998 Received: August 26, 1998

Dear Mr. Barron:

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 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). 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 regulations affecting your device can be found in the Code of Federal Requlations, 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 regulation 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 provísions, or other Federal laws or regulations.

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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, 2 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 2.0 STATEMENT OF INTENDED USE

The DR512 digital Holter recorder is intended for the recording and storage of long-term ECG data collected from ambulatory patients. The recorder is used under the order of a physician, who reviews the data after downloading and processing by a Holter playback system. The physician determines the presence of normal and abnormal ECG data during the events of the patient's daily activity.

Carlen Tiller

(Division Sign 510(k) N

Prescription Use
(Per 21 CFR 801.109)