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 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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the DATRIX DR512 Digital ECG Holter Recorder, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" for the device, but rather describes a series of comprehensive tests performed to ensure the device met its "design specifications." Therefore, the "acceptance criteria" below are inferred from the tests conducted, and the "reported device performance" is a summary of the general findings.

Acceptance Criteria (Inferred from testing)	Reported Device Performance
Analog Hardware Verification:
- ECG amplifier frequency response verification	Tested and shown to conform to design specifications.
- ECG amplifier amplification verification	Tested and shown to conform to design specifications.
- ECG amplifier common mode rejection ratio verification	Tested and shown to conform to design specifications.
- Voltage converter functionality	Tested and shown to conform to design specifications.
- Event button circuits functionality	Tested and shown to conform to design specifications.
- Battery polarity detection and handling	Tested and shown to conform to design specifications.
- Visual inspection of all parts	Visual inspection made.
Digital Hardware Verification:
- RAM write-read functionality verification	RAM was functioning, data, address, and control lines were connected correctly, and the microcontroller was functioning.
Firmware Verification:
- Flash disk control	Tested and shown to conform to design specifications.
- A/D conversion and sampling rate accuracy	Tested and shown to conform to design specifications.
- Compression-decompression algorithm functionality and accuracy	Tested with line segment data, calibration signals, and simulated ECG waveforms, conforming to design specifications.
Bench and Subject Testing:	Validated using both bench and subject testing.
Compatibility with Playback Systems:	Independently tested and shown to be compatible with commercially available playback systems.
Response to Improper Use:	Recorder responded appropriately to improper insertion of the flash card, improper termination of recording, improper insertion of the battery, and low battery.
Beep Functionality:	Beeps indicating proper functioning of the recorder were tested.
Environmental Performance:	Environmental tests (temperature, humidity, altitude, shock, EMC) were conducted to verify operating ranges. Results indicated accurate, consistent, and repeatable performance to design specifications.
Overall Performance (Summary from submission):	"Accurate and consistent device, with repeatable performance." "Performed to design specifications, and is suitable for ECG applications with ambulatory patients."
Year 2000 Compliance:	"Will continue to function properly regardless of the date." All time functions based on elapsed time from start of recording. Test devices had no date function or were tested to ensure no effect on quality or safety.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not explicitly state the number of subjects or the specific sample size used for the "subject testing" mentioned. It only refers generally to "subject testing."
Data Provenance: The document does not specify the country of origin of the data. It mentions "subject testing," which is generally prospective, but no further details are provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The study focuses on the technical performance and accuracy of the device itself rather than its diagnostic interpretation by humans.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. The study tested the recorder's technical performance and data recording capabilities, not direct diagnostic output requiring adjudication of human-interpreted results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission describes testing the technical specifications and functionality of the recorder, not evaluating the diagnostic performance of human readers with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

Yes, in effect, a standalone study was performed in terms of the device's technical functionality. The testing detailed (analog and digital hardware verification, firmware testing, compression algorithms, environmental tests) assessed the device's performance purely as a recording instrument, independent of human interpretation or a "human-in-the-loop" for its operation. The device's primary function is to record and store data, which is then processed by a separate "Holter playback system" and reviewed by a physician. The study confirmed the accuracy of this recording and storage.

7. The Type of Ground Truth Used

The "ground truth" for the various tests was primarily based on:
- "Design specifications": The device's performance was measured against its intended technical specifications.
- Known input signals: For example, compression algorithms were tested with "line segment data, calibration signals, and simulated ECG waveforms," where the expected output would be known.
- Expected functional responses: For tests like event button circuits, battery polarity, RAM write-read, and environmental tests, the "ground truth" was whether the device performed as designed and expected under specific conditions.
- Compatibility with existing systems: For playback systems, the ground truth was successful data transfer and processing.

8. The Sample Size for the Training Set

This information is not provided and is likely not applicable in the context of this device. The DR512 is a hardware recorder with firmware, not a machine learning or AI algorithm that requires a "training set" in the typical sense for diagnostic purposes. The firmware and algorithms (e.g., compression) would have been developed and tested against engineering specifications and simulated data during design, rather than "trained" on a dataset.

9. How the Ground Truth for the Training Set Was Established

As a "training set" in the machine learning context is not applicable, the ground truth for any internal development or testing of firmware/algorithms was established based on engineering specifications, mathematical models, and known characteristics of ECG signals and data compression techniques.

Summary

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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 PlaceEscondido, CA 92029
Phone:	(760) 480-8874
Fax:	(760) 480-9474
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

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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

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
RECORDINGDURATION	24 HOURS	24 HOURS	24 HOURS
PHYSICAL
OPERATINGPOSITION	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
ENCLOSUREMATERIAL	Plastic	Plastic	Plastic
ENVIRONMENTAL
OPERATING TEMP	0 to 60 degrees C **	+5 to 45 degrees C	0 to 45 degrees C
OPERATINGHUMIDITY(non condensing)	8% to 95%**	10% to 90%	10% to 90%
OPERATINGALTITUDE	8000 feet	8000 feet	10000 feet
OPERATING SHOCK	26 inch dropin pouch	18 inch dropin 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 INPUTRANGE	5 mV	5 mV	5 mV
INPUT IMPEDANCE	>5 Meg	>5 Meg	>5 Meg
COMMON MODEREJECTION RATIO(60HZ SIGNAL)	60 dB	60 dB	60 dB
POWERREQUIREMENTS
BATTERY	One 9 Volt	One 9 Volt	Two AA
AVERAGEOPERATINGCURRENT	5 mA	5 mA	35 mA
PEAKOPERATINGCURRENT	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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

Carlen Tiller

(Division Sign 510(k) N

Prescription Use
(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).