E-TAC EX-1000 ELECTROCARDIOGRAPHIC EVENT RECORDER

{0}------------------------------------------------ 1 - 3 # AUG 1 2 2004 # 510(k) Summary of Safety and Effectiveness | Submitter: | Datrix, Inc.<br>340 State Place<br>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<br>(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<br>reproduction not<br>significantly<br>different or better<br>than all other<br>devices | Amplitude<br>reproduction not<br>significantly<br>different or better<br>than at least one<br>device | Amplitude<br>reproduction<br>significantly<br>different than<br>other devices | Statistic | |---------------------------|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|-----------| | EX-1000 | 20 of 24 cases | 3 of 24 cases | 1 of 24 cases† | p <0.001 | | ER320 | 11 of 24 cases | 13 of 24 cases | 0 of 24 cases | p <0.001 | | ER720 | 9 of 24 cases | 8 of 24 cases | 7 of 24 cases* | p <0.001 | | King of Hearts<br>Express | 6 of 24 cases | 15 of 24 cases | 3 of 24 cases‡ | p <0.001 | † This case occurred for an input signal of 2.0mV and 0.5 Hz with measurements taken from printouts generated by the EKG Speaks™ receiving station software. For the same signal when evaluated using the GEMS™ Lite receiving station, the EX-1000 was substantially equivalent to the King of Hearts Express recorder. See the note (+) below for further explanation. * 5 of these cases were in the high frequency range, and significantly different results may be affected by bandwidth specifications. * all 3 cases were for the low frequency (0.5Hz) measurements taken using the EKG Speaks™ receiving station software. The same effect was not seen with the GEMSTM Lite receiving station. Filtering algorithms used by the EKG Speaks™ program may have affected these results. The Comparison Tables on the following pages provide comparisons of the features and specifications of the EX-1000 device and each of the predicate devices. ## Conclusion The Datrix E-Tac EX-1000 is substantially equivalent to other predicate ambulatory ECG event recorders currently in commercial distribution. {4}------------------------------------------------ | Specification | Datrix E-Tac<br>EX-1000 | Instromedix<br>King of Hearts<br>(From the manual) | Braemar<br>ER 300 series<br>(From the manual) | Braemar<br>ER 700 series | |--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | Intended Use | The Datrix E-Tac EX-1000<br>Electrocardiographic Event<br>Recorder device is intended<br>for long-term monitoring of<br>ambulatory cardiac patients<br>who experience intermittent<br>symptoms associated with<br>cardiac arrhythmia. Upon<br>activation by the patient,<br>ECG data are stored for<br>future transmission via<br>telephone to a receiving<br>station. Data transmission<br>is initiated by the patient<br>and confirmed by the<br>receiving station. Once data The King of Hearts<br>Express® 3X™ cardiac<br>event recorder is a patient-<br>activated device designed<br>for diagnostic evaluation of<br>transient symptoms such as<br>dizziness, palpitations and<br>chest pain. The King of<br>Hearts Express® 3X™ has<br>five minutes of looping<br>ECG memory to capture<br>ECG data both before and<br>after the patient experiences<br>a cardiac symptom. The<br>frequency response is .05 to<br>30Hz The ER300 Series Event<br>Recorders are battery operated,<br>solid state patient activated event<br>recorders designed to recorder<br>infrequent and elusive heart<br>arrhythmias. The recorders offer<br>ten preprogrammed recording<br>options and will operate for a<br>minimum of 7 days with a 9V<br>alkaline battery. To record infrequent and<br>elusive ECG heart<br>arrhythmia data. Once an<br>event is recorded, patients<br>transmit the recorded ECG<br>data over the telephone. Or,<br>as an alternative, the ER700<br>Series allows the ECG data<br>to be transferred directly to<br>a host PC if the patient<br>returns the unit to the clinic. | | | | | Standards<br>Performance | AAMI/ANSI EC38 | unknown | unknown | AAMI/ANSI EC38 | | Safety | IEC60601-1 +A1 +A2 | unknown | unknown | IEC60601-1 +A1 +A2 | | EMC | IEC60601-1-2 | unknown | unknown | IEC60601-1-2 | | Specification | | | | | | Operational<br>Principles<br>Acquire Data: Bandwidth | Datrix E-Tac<br>EX-1000 | Instromedix<br>King of Hearts | Braemar<br>ER 300 series | Braemar<br>ER 700 series | | | .05 - 35 Hz -3db | .05 - 35 Hz -3db | ER300: .5 -35 Hz<br>ER310/320: .05- 30 Hz | .05 - 30 Hz | | Input Impedance | >5M ohm | 2M ohm | 5M ohm | 2M ohm | | Signal Input Range | ±2.5 mV | 2 mV | ±2 mV | ±2mV | | Common Mode<br>Rejection | >60 db | 60 db | Not available | 60 db | | ECG Channels | 1 | 1 | 1 or 2 | ER710 - 1,<br>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)<br>ER310/320: Yes | Yes | | Memory Type | Flash | Microprocessor based | RAM | Flash | | Max. Recording Duration | 360 sec. | 300 sec. | ER300: 270 sec.,<br>ER310: 240 pre/135 post<br>ER 320: 240 pre/100 post | 1 channel: 955 sec.<br>2 channels: 477 sec. | | Maximum # of Events | 2 | 60 | 2 | 120 | | Specification | Datrix E-Tac<br>EX-1000 | Instromedix<br>King of Hearts | Braemar<br>ER 300 series | Braemar<br>ER 700 series | | Operational Principles<br>(continued):<br>Data Transmission: | | | | | | Center Frequency | Transtelephonic (TTP)<br>FM Modulation, FSK<br>1900 Hz | Transtelephonic (TTP)<br>FM Modulation, FSK<br>1900 Hz | Transtelephonic (TTP)<br>FM Modulation<br>1900 Hz | Transtelephonic (TTP)<br>FM Modulation; or<br>download to PC, RS232<br>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<br>leadwires | Insert batteries, insert<br>leadwires | ER300: Insert battery, press<br>[Record] and [Play] buttons at<br>same time<br>ER310/320: Insert battery, press<br>[On/Erase] button | Insert batteries, insert<br>leadwires | | Recording | Press [Record] button | Press [Record] button | ER300: Press [Record] button<br>ER310/320: Press [Play/Record]<br>button | Press [Event/Send] button | | Transmit Data | Remove leadwires, press<br>[Send] button | Remove leadwires<br>1x: press [Send] button<br>3x: press [Send] and<br>[Record] buttons sequence | ER300: Press [Play] button<br>ER310/320: remove leadwires,<br>press [Play/Record] button | Remove leadwires, press<br>[Send] button | | Erase Data | Following transmission or<br>startup, insert leadwires | Following transmission,<br>insert leadwires | ER300: Press [Play] and<br>[Record] buttons together<br>ER310/320: Press [On/Erase] | Following transmission,<br>insert leadwires | | Feedback | LED, audible tones | LCD, audible tones | ER300: audible tones<br>ER310/320: LED, audible tones | LCD, audible tones | | Selectable/programmable | Dipswitches | Insert program key, select<br>using buttons | Various sequence of buttons | Insert program plug, select<br>using buttons | L -【 1l โ {5}------------------------------------------------ 100 - 100 - K042022 לקעים ש . · 8 ・ 1 - 8 {6}------------------------------------------------ KOY2022 70f8 . - 9 1 • 9 {7}------------------------------------------------ | Specification | Datrix E-Tac EX-1000 | Instromedix King of Hearts | Braemar ER 300 series | Braemar ER 700 series | |----------------------------------------|----------------------|----------------------------|--------------------------------------------------------------|--------------------------| | Power<br>Requirements | | | | | | Battery | 2- AAA alkaline | 2- AAA alkaline | 9V alkaline | 2 - AAA alkaline | | Battery Life | 30 days | 7 days | ER300: 30days,<br>ER310/320: 19 days | 7 days | | Physical Specs<br>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<br>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.<br>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<br>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<br>(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 - : ! - 10 {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…