(15 days)
No
The description focuses on basic ECG data acquisition, storage, and transmission, with no mention of automated analysis or interpretation using AI/ML. The performance studies compare basic signal characteristics (amplitude and timing) against predicate devices and standards, not the performance of any analytical algorithms.
No.
The device is an Electrocardiographic Event Recorder intended for monitoring, not for treating conditions.
Yes
The device is intended for long-term monitoring of cardiac patients to record ECG data for future transmission and review by medical professionals, which fits the definition of a diagnostic device used to identify the presence or absence of a disease or condition.
No
The device description explicitly states it is a "Electrocardiographic [ECG] Event Recorder" that is "Lightweight and compact," "can operate up for 30 days on two AAA alkaline batteries," and acquires data via "patient leadwires." These are all descriptions of hardware components, not solely software.
Based on the provided information, the Datrix E-Tac EX-1000 Electrocardiographic Event Recorder is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The EX-1000 records and transmits electrical signals from the patient's heart (ECG data) via electrodes placed on the skin. It does not analyze biological specimens taken from the body.
- Intended Use: The intended use is for long-term monitoring of ambulatory cardiac patients experiencing intermittent symptoms associated with cardiac arrhythmia. This involves recording the heart's electrical activity, not analyzing biological samples.
Therefore, the Datrix E-Tac EX-1000 falls under the category of a medical device that monitors physiological signals, but it is not an IVD.
N/A
Intended Use / Indications for Use
The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.
Product codes
DXH
Device Description
The Datrix E-Tac EX-1000 (here simply: EX-1000) Electrocardiographic [ECG] Event Recorder is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Lightweight and compact, the EX-1000 is designed to be as non-intrusive as possible to the patient, and can operate up for 30 days on two AAA alkaline batteries. The patient's ECG data are acquired via patient leadwires (two-lead, one-channel). At the onset of an event, the patient presses the [Record] button to store his or her ECG data in the recorder's flash memory. Events are recorded according to one of four user-selectable memory configurations. Up to two events may be recorded before transmission of the data to a compatible receiving station is required. The patient initiates data transmission via telephone by removing the patient leadwires and pressing the [Send] button, upon which the stored data are transmitted. A physician or other qualified medical professional reviews the transmitted data. Feedback on the EX-1000 recorder status is provided to the user (technician and/or patient) via a multi-colored LED and audible tones.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or other qualified medical professionals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing:
The Datrix E-Tac EX-1000 has been tested and conforms to AAMI/ANSI EC38:1998 Ambulatory Electrocardiographs. It will also be further tested to conform to IEC 60601-1, AAMI / ANSI / IEC 60601-1-2:2001, and ISO 14971.
Predicate Device Performance Comparisons:
Compliance to the ISO 14971 risk assessment requirements was accomplished by demonstrating in-house conformance to safety and reliability standards for acquiring, recording and transmission of known input signals. In addition to testing to AAMI/ANSI EC38:1998, verification, and validation, a predicate comparison test was conducted between the EX-1000 and the listed predicate devices. Performance of each device was evaluated over a range of input amplitudes and frequencies. A total of 24 in-house simulated events were recorded, and subsequently transmitted twice (2 x 24), once each to two separate, commercially available receiving stations (GEMS™ Lite and EKG Speaks™). Reports were printed out from each receiving station, and multiple measurements of each transmitted event were made of 2 key data characteristics: amplitude and timing (frequency).
Key Results:
- All recorders (EX-1000 and predicates) accurately reproduced the timing/frequency of the known input signals with no variance within or between devices.
- For amplitude measurements, all devices performed to requirements and tolerances specified in the AAMI/ANSI EC38:1998 standard.
- Twelve of the 24 combinations of amplitude, frequency, and receiving station combinations tested were input signals for frequencies at 25Hz; the remaining twelve were at 40Hz. All devices showed amplitude attenuation commensurate with their bandwidth specifications.
- Two in-house, three-factor ANOVA evaluations were performed separately on amplitude data from each of the receiving stations. Results and statistical analyses indicated that performance of the Datrix EX-1000 was substantially equivalent or better than the three predicate devices with regards to amplitude reproduction in nearly all combinations of input amplitudes, input frequencies, and receiving stations (total of 24 cases).
Performance Table summary: - EX-1000: Amplitude reproduction not significantly different or better than all other devices in 20 of 24 cases; not significantly different or better than at least one device in 3 of 24 cases; significantly different than other devices in 1 of 24 cases (p
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).
0
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AUG 1 2 2004
510(k) Summary of Safety and Effectiveness
| Submitter: | Datrix, Inc.
340 State Place
Escondido, CA 92029 USA |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Phone: | (760) 480-8874 |
| Fax: | (760) 480-9474 |
| Contact: | Lauren Luhmann, Quality Assurance Manager |
| Date Prepared: | July 15, 2004 |
| Trade Name: | E-Tac EX-1000 Electrocardiographic Event Recorder |
| Common Name: | Ambulatory ECG Event Recorder |
| Classification Name: | Telephone electrocardiographic transmitter and receiver
(class 2 device; 21 CFR 870.2920; product code: DXH) |
| Predicate Devices: | |
Predicate Devices
- Instromedix King of Hearts Express 3x [K920984] .
- Braemar ER300 series (ER300, ER310, ER320) [K923930] .
- Braemar ER700 series (ER710 and ER720) [K981394] .
Indications for Use
The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder device is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Upon activation by the patient, ECG data are stored for future transmission via telephone to a receiving station. Data transmission is initiated by the patient and confirmed by the receiving station. Once data are transmitted, they are immediately available for review solely by a physician or other qualified medical professionals.
Description
The Datrix E-Tac EX-1000 (here simply: EX-1000) Electrocardiographic [ECG] Event Recorder is intended for long-term monitoring of ambulatory cardiac patients who experience intermittent symptoms associated with cardiac arrhythmia. Lightweight and compact, the EX-1000 is designed to be as non-intrusive as possible to the patient, and can operate up for 30 days on two AAA alkaline batteries. The patient's ECG data are acquired via patient leadwires (two-lead, one-channel). At the onset of an event, the patient presses the [Record] button to store his or her ECG data in the recorder's flash memory. Events are recorded according to one of four user-selectable memory configurations. Up to two events may be recorded before transmission of the data to a compatible receiving station is required. The patient initiates data transmission via telephone by removing the patient leadwires and pressing the [Send] button, upon which the stored data are transmitted. A physician or other qualified medical professional reviews the transmitted data. Feedback on the EX-1000 recorder status is provided to the user (technician and/or patient) via a multi-colored LED and audible tones.
1
Standards/Guidance Documents
- AAMI/ANSI EC38:1998 Ambulatory Electrocardiographs .
- IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements . for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03
- AAMI / ANSI / IEC 60601-1-2:2001, Medical Electrical Equipment Part 1-. 2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- ISO 14971, "Medical devices --- Application of risk management to medical . devices" (December 15, 2000)
- Partially Applicable: Cardiac Monitor Guidance (including Cardiotachometer . and Rate Alarm); Final, Version 1.0, November 5, 1998.
- Guidance for the Content of Premarket Submissions for Software Contained . in Medical Devices; Final, May 29, 1998.
- Medical Device Use-Safety: Incorporating Human Factors Engineering into . Risk Management, July 18, 2000.
Operational Principle(s)
The operational principles for the EX-1000 are as follows: ECG data are acquired via patient leadwires, sampled with an analog/digital converter, and subsequently saved to the flash memory. Stored ECG data are transmitted to a compatible receiving station utilizing FM Modulation and Frequency Shift Keying techniques. Transmission characteristics include carrier center frequency, carrier deviation, and transmission speeds commensurate with the predicate devices, which ensure compatibility with many commercially available receiving stations.
System Descriptions
- Modes of Operation: 1 .
- Monitoring mode- ECG data continuously acquired and written to flash . memory in a loop. The size of the looping memory varies according to one of four selectable memory configurations.
- Recording mode when the patient presses the [Record] button, data are . stored in flash memory until transmitted.
- Transmission mode data are transmitted via telephone to a compatible . receiving station
- Software Software pertaining to the EX-1000 consists of the firmware 2. instructions to the microcontroller for managing the different functions of the recorder. The firmware is considered to be of "minor level" of concern as evaluated using the FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Final" (May 29, 1998). Software
2
Documentation was provided in the submission commensurate with this evaluation. The firmware was designed, documented, and validated in accordance with required device Design Controls [i.e., 21 CFR 820.30]. Risks associated with the firmware were analyzed in accordance with FDA's Guidance "Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management" (July 18, 2000), and ISO 14971, "Medical devices -- Application of risk management to medical devices" (December 15, 2000).
Performance Testing
In addition to thorough verification and validation testing, the Datrix E-Tac EX-1000 has been tested and conforms to the following recognized performance standard for safety and effectiveness:
-
AAMVANSI EC38:1998 Ambulatory Electrocardiographs .
By the time of marketing, the Datrix E-Tac EX-1000 has and will have been further tested to conform to the following recognized safety standards: -
IEC 60601-1. Medical Electrical Equipment Part 1: General Requirements . for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995-03
-
AAMI / ANSI / IEC 60601-1-2:2001, Medical Electrical Equipment Part 1-. 2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
-
ISO 14971, "Medical devices Application of risk management to medical . devices" (December 15, 2000)
Predicate Device Performance Comparisons
Compliance to the ISO 14971 risk assessment requirements was accomplished by demonstrating in-house conformance to safety and reliability standards for acquiring, recording and transmission of known input signals. In addition to testing to AAMI/ANSI EC38:1998, verification, and validation, a predicate comparison test was conducted between the EX-1000 and the listed predicate devices. Performance of each device was evaluated over a range of input amplitudes and frequencies. A total of 24 in-house simulated events were recorded, and subsequently transmitted twice (2 x 24), once each to two separate, commercially available receiving stations (GEMS™ Lite and EKG Speaks TM). Reports were printed out from each receiving station, and multiple measurements of each transmitted event were made of 2 key data characteristics: amplitude and timing (frequency). Results are summarized as follows:
- . All recorders (EX-1000 and predicates) accurately reproduced the timing/frequency of the known input signals with no variance within or between devices.
- . For amplitude measurements, all devices performed to requirements and tolerances specified in the AAMI/ANSI EC38:1998 standard.
3
- Twelve of the 24 combinations of amplitude, frequency, and receiving station . combinations tested were input signals for frequencies at 25Hz; the remaining twelve were at 40Hz. All devices showed amplitude attenuation commensurate with their bandwidth specifications.
Two in-house, three-factor ANOVA evaluations were performed separately on amplitude data from each of the receiving stations. Results and statistical analyses indicated that performance of the Datrix EX-1000 was substantially equivalent or better than the three predicate devices with regards to amplitude reproduction in nearly all combinations of input amplitudes, input frequencies, and receiving stations (total of 24 cases). The following Performance Table summarizes these statistical results:
| Device | Amplitude
reproduction not
significantly
different or better
than all other
devices | Amplitude
reproduction not
significantly
different or better
than at least one
device | Amplitude
reproduction
significantly
different than
other devices | Statistic |
|---------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------|
| EX-1000 | 20 of 24 cases | 3 of 24 cases | 1 of 24 cases† | p 5M ohm | 2M ohm | 5M ohm | 2M ohm |
| Signal Input Range | ±2.5 mV | 2 mV | ±2 mV | ±2mV |
| Common Mode
Rejection | >60 db | 60 db | Not available | 60 db |
| ECG Channels | 1 | 1 | 1 or 2 | ER710 - 1,
ER720 - 2 |
| Digitize Data: | | | | |
| Resolution | 8 bit | $15.6 \mu V$ | 8 bit | 8 bit |
| Sample Rate | 128 samples/sec | 218 Hz | 120/sec. | 120/sec. |
| Record Data | | | | |
| Looping memory | Yes | Yes | ER300: No (post)
ER310/320: Yes | Yes |
| Memory Type | Flash | Microprocessor based | RAM | Flash |
| Max. Recording Duration | 360 sec. | 300 sec. | ER300: 270 sec.,
ER310: 240 pre/135 post
ER 320: 240 pre/100 post | 1 channel: 955 sec.
2 channels: 477 sec. |
| Maximum # of Events | 2 | 60 | 2 | 120 |
| Specification | Datrix E-Tac
EX-1000 | Instromedix
King of Hearts | Braemar
ER 300 series | Braemar
ER 700 series |
| Operational Principles
(continued):
Data Transmission: | | | | |
| Center Frequency | Transtelephonic (TTP)
FM Modulation, FSK
1900 Hz | Transtelephonic (TTP)
FM Modulation, FSK
1900 Hz | Transtelephonic (TTP)
FM Modulation
1900 Hz | Transtelephonic (TTP)
FM Modulation; or
download to PC, RS232
1900 Hz |
| Deviation | 100 Hz/mV | 100 Hz/mV | 100 Hz/mV | 100 Hz/mV |
| Transmission Speed | 1x or 3x | 1x or 3x | 1x | 1x or 3x |
| User Interface | | | | |
| Start recorder | Insert batteries, insert
leadwires | Insert batteries, insert
leadwires | ER300: Insert battery, press
[Record] and [Play] buttons at
same time
ER310/320: Insert battery, press
[On/Erase] button | Insert batteries, insert
leadwires |
| Recording | Press [Record] button | Press [Record] button | ER300: Press [Record] button
ER310/320: Press [Play/Record]
button | Press [Event/Send] button |
| Transmit Data | Remove leadwires, press
[Send] button | Remove leadwires
1x: press [Send] button
3x: press [Send] and
[Record] buttons sequence | ER300: Press [Play] button
ER310/320: remove leadwires,
press [Play/Record] button | Remove leadwires, press
[Send] button |
| Erase Data | Following transmission or
startup, insert leadwires | Following transmission,
insert leadwires | ER300: Press [Play] and
[Record] buttons together
ER310/320: Press [On/Erase] | Following transmission,
insert leadwires |
| Feedback | LED, audible tones | LCD, audible tones | ER300: audible tones
ER310/320: LED, audible tones | LCD, audible tones |
| Selectable/programmable | Dipswitches | Insert program key, select
using buttons | Various sequence of buttons | Insert program plug, select
using buttons |
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| Specification | Datrix E-Tac EX-1000 | Instromedix King of Hearts | Braemar ER 300 series | Braemar ER 700 series |
|---|---|---|---|---|
| Power | ||||
| Requirements | ||||
| Battery | 2- AAA alkaline | 2- AAA alkaline | 9V alkaline | 2 - AAA alkaline |
| Battery Life | 30 days | 7 days | ER300: 30days, | |
| ER310/320: 19 days | 7 days | |||
| Physical Specs | ||||
| Dimension, inches | 2.5 x 1.6 x 0.57 | 3.38 x 2.13 x 0.65 | ER 300: 4.15 x 2.39 x 1.06 | |
| ER 310/320: 4.15 x 2.39 x 0.86 | 3.5 x 2.125 x .65 | |||
| Weight (w/batteries) | 1.5 oz. | 3.5 oz. | ER 300: 5.6 oz. | |
| ER 310/320: 3 oz. | 3.5 oz. | |||
| Color | Black | Black | Black | Black |
| Enclosure | ABS, IPX0 | Not available | Molded Plastic (UL94V-0) | Molded Plastic (UL94V-0) |
| Environmental | ||||
| Operating Temp. | 0-45° C | 10-40°C | 0-45° C | 0-45° C |
| Storage Temp. | -20-65° C | -10-+60°C | -20-+65° C | -20-+65° C |
| Operating Humidity | ||||
| (non-condensing) | 5-95% | 10-95% | 10-95% | 10-95% |
| Non-operating Humidity | 5-95% | Not available | 5-95% | 5-95% |
亿042022 8 of B
10
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8
Image /page/8/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with outstretched wings, rendered in black. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the top portion of the logo.
AUG 1 2 2004
Datrix, Inc. c/o Alfredo J. Quattrone, Ph.D., D.A.B.T. California Department of Health Services Food and Drug Branch Medical Device Safety Section, MS 7602 1500 Capitol Avenue Sacramento, CA 95814
Re: K042022
Trade Name: Datrix E-Tac EX-1000 ECG Event Recorder Regulation Number: 21 CFR 870.2920 Regulation Name: DXH Regulatory Class: II (two) Regulatory Class: It (viro)
Product Code: Telephone Electrocardiograph Transmitter and Receiver Dated: August 6, 2004 Received: August 9, 2004
Dear Dr. Quattrone:
We have reviewed your Section 510(k) premarket notification of intent to market the device indication we nave reviewed your Section 910(x) premaired is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate 10 tuse stated in the enclosure) to regarry manates of the Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food Frya commerce prof to hay 28, 1776, the enaontance with the provisions of the Federal Food. Drug, devices that have been recatismed in accessfroval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval appli and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The Y ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (SCP above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of Pourist concerning your device in the Federal Register.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
9
Page 2 – Alfredo J. Quattrone, Ph.D., D.A.B.T.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualice of a substition requirements of the Act
that FDA has made a determination that your device of a caleral accepcios. You must that FDA has made a delefinitiation that your acrises by other Federal agencies. You must a or any Federal statules and regulations duminstered of end limited to: registration and listing (21
comply with all the Act's requirements, including, but not limited to: req comply with all the Act s requirements, more and course requirements as set CFR Part 807); labeling (21 CFR Part 801); good manager (20); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR 1000 (2) CFR 1000 1050 forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 100-1050.
product radiation control provisions (Sections 531-542 of the Action S product radiation control provisions (Sections our device as described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a le I his letter will anow you to begin maneling your avvel equivalence of your device to a legally premarket notification. The PDA miding of backanda experies and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your act (301) 594-4646. Also, please note the regulation entitled, contact the Office of Compilance as (s st ) it ) it (21CFR Part 807.97) you may obtain. "Misbranding by reference to premation on your responsibilities under the Act may be obtained from the Other general information on your responsional and Consumer 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,
Niel R.P. Ogden
Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
10
Statement of Indications for Use
| 510(k) Number: | K042022 |
|---|---|
| Device Name: | Datrix E-Tac EX-1000 Electrocardiographic Event Recorder |
| Indications for Use: | The Datrix E-Tac EX-1000 Electrocardiographic Event Recorder |
| device is intended for long-term monitoring of ambulatory | |
| cardiac patients who experience intermittent symptoms | |
| associated with cardiac arrhythmia. Upon activation by the | |
| patient, ECG data are stored for future transmission via | |
| telephone to a receiving station. Data transmission is initiated | |
| by the patient and confirmed by the receiving station. Once | |
| data are transmitted, they are immediately available for review | |
| solely by a physician or other qualified medical professionals. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescriptive Use _ X
OR Over-The-counter Use
(Per 21 CFR 801.109)
Nail R. Ogden for 302
היישוב להיירה ל
510(k) Number K042022