DIGITAL AMBULATORY ECG (HOLTER) RECORDER

K031074 · Datrix · MWJ · Oct 15, 2003 · Cardiovascular

Device Facts

• Record ID: K031074
• Device Name: DIGITAL AMBULATORY ECG (HOLTER) RECORDER
• Applicant: Datrix
• Product Code: MWJ · Cardiovascular
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2800
• Device Class: Class 2

Intended Use

The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. 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 as well as pacemaker pulses during the events of the patient's daily activity.

Device Story

VX3 is a compact, digital Holter recorder for ambulatory ECG monitoring. It captures ECG signals via leadwires; stores data on removable compact flashcards; supports 2 or 3-channel configurations. Features include an LCD for leadwire verification/status, optional keypad, and optional pacemaker pulse detection. Operated by patients in ambulatory settings under physician order; data is subsequently downloaded to a Holter playback system for physician review. Physician uses processed output to diagnose cardiac arrhythmias and evaluate pacemaker function. Benefits include continuous cardiac monitoring during daily activities to capture transient events.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technical specifications, including electrical performance (bandwidth, CMRR, input impedance), environmental testing (shock, temperature, humidity), and functional feature comparison.

Technological Characteristics

Materials: ABS 94-V0 plastic enclosure. Sensing: ECG leadwire input, >5MΩ impedance, >60dB CMRR. Energy: 2 AA or one 9V battery. Dimensions: 4.46 x 2.75 x 1.02 inches. Connectivity: Removable compact flashcard for data transfer. Processing: 8 or 10-bit resolution, 128-512 samples/sec/channel. Bandwidth: 0.05Hz to 60Hz. Pacemaker detection: Optional signal detection.

Indications for Use

Indicated for ambulatory patients requiring ECG data recording, including those with implanted pacemakers, to assist physicians in identifying normal/abnormal ECG activity and pacemaker pulses during daily life.

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 DR512 digital Holter recorder (K982975)
• Braemar DXP1000 digital Holter recorder (K993618)

Submission Summary (Full Text)

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Jon Barron Inc. dba

# OCT 1 5 2003

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## 510(K) PREMARKET NOTIFCATION SUMMAR Y

| Company: | Datrix |
|-----------------|----------------------------------------|
| Address: | 340 State Place<br>Escondido, CA 92029 |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Lauren Luhmann |

Date Prepared: April 2, 2003

VX3 Series Digital Holter Recorder Trade Name: Ambulatory ECG Recorder Common Name: Classification Name: Electrocardiograph, Ambulatory (Without Analysis) (CFR 870:2800)

## Description

The VX3 is a lightweight, compact, digital Holter recorder designed for the recording of ECG data collected from ambulatory patients. A derivative of the Datrix DR512 digital Holter recorder, the VX3 has enhanced features, including an LCD to verify leadwire hookup and display recorder status and error messages, optional keypad for selection of various options, and optional pacemaker pulse detection. Various channel and lead configurations are accommodated by using the appropriate leadwire set without additional recorder reconfiguration. Data are recorded on industry standard compact flashcards for subsequent download and to a Holter playback system. Sampling rates are factory programmable to accommodate compatibility with various OEM Holter playback systems.

### Intended Use

The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. 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 as well as pacemaker pulses during the events of the patient's daily activity.

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KOBIC74

#### Jon Barron Inc. dba

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## Predicate Device Comparison

The VX3 is substantially equivalent to other commercially distributed ECG Holter recorders. The following chart compares the VX3 with its predecessor device (Datrix DR512 digital Holter recorder (510(k): K982975), and another predicate device, (Braemar DXP1000 digital Holter recorder (510(k): K993618) with pacemaker pulse detection).

| Specification | Datrix VX3 | Datrix DR512 | Braemar DXP1000* |
|---------------------------|------------------------------------------------|------------------------------------------------|-------------------------------------------------|
| Functional | | | |
| ECG Channels | 2 or 3 | 2 or 3 | 2 or 3 |
| Resolution | 8 or 10 bit<br>(programmable) | 8 bit | 12-bit sampling/ 10-bit<br>recording |
| Sample Rate | 128 to 512 per<br>channel/sec,<br>programmable | 128 to 512 per<br>channel/sec,<br>programmable | 256 samples per second |
| Recording Duration | 24 or 48 hours,<br>programmable | 24 hours | 24 or 48 hours |
| Memory Type | Non-volatile flash | Non-volatile flash | Non-volatile flash |
| Data Transfer | Removable flashcard | Removable flashcard | USB interface |
| Liquid Crystal Display | Yes | No | Yes |
| Keypad | Yes, optional | No | Yes |
| Pacemaker Pulse Detection | Yes, optional | No | Yes |
| Physical | | | |
| Dimensions | 4.46 x 2.75 x 1.02 in.<br>(113 x 70 x 26) mm | 4.94 x 2.75 x 0.94 in. | 2.75 x 4.37 x .80 in.<br>(69.9 x 111 x 20.3) mm |
| Weight | 4oz. w/out batteries | 4oz. w/out batteries | 5oz.(141 gm) w/batteries |
| Enclosure Material | plastic | plastic | plastic/water resistant |
| Enclosure flammability | ABS 94-V0 | ABS 94-IIB | not available |
| Operating Position | Any | Any | Any |

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<03107 >

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Jon Barron Inc. dba

. .

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| Specification | Datrix VX3 | Datrix DR512 | Braemar DXP1000* |
|------------------------------------------------------|---------------------------------|--------------------------------|--------------------------------|
| Environmental | | | |
| Operating Temperature | 0 to 45°C, (32-113°F) | 0 to 60°C | 0 to 45°C, (32 to 113°F) |
| Non-operating Temperature | -20 to 65°C (-4 -149°F) | -20 to 65°C (-4 to 149°F) | -20 to 65°C (-4 to 149°F) |
| Operating Humidity | 10% to 95%(non-<br>condensing) | 8% to 95% | 10% to 95%(non-<br>condensing) |
| Non-operating Humidity | 5% to 95% (non-<br>condensing) | 5% to 95% (non-<br>condensing) | 5% to 95% (non-<br>condensing) |
| Operating Altitude/Pressure | 700 - 1060 millibars | 8000 ft. | not available |
| Operating Shock | 1 meter drop | 26 inch drop in<br>pouch | not available |
| Electrical | | | |
| Bandwidth | 0.05Hz to 60Hz @-3dB | 0.05Hz to 50Hz | 0.05Hz to 60Hz @-3dB |
| Signal Input Range | ±2.5 mV 8 bit<br>±5.0 mV 10 Bit | 5mV | not available |
| Input Impedence | > 5MΩ | >5MΩ | not available |
| Common Mode Rejection<br>Ratio (CMMR) | > 60dB | 60 dB | not available |
| Power Requirements | | | |
| Battery | 2 AA or one 9 Volt | One 9 Volt | 2 AA or 2 NiMH |
| Average Operating Current<br>(varies with flashcard) | 5 mA @ 9V<br>5-40 mA @ 3V | 5 mA | not available |
| Peak Operating Current<br>(varies with flashcard) | 55 mA @ 9V<br>250 mA @ 3V | 55 mA | not available |

* Specifications taken from manufacturer's specification sheet

40535

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Datrix c/o Ms. Lauren M. Luhmann Quality Assurance Manager 340 State Place Escondido, CA 92029

## Re: K031074

Trade Name: Digital Ambulatory ECG Holter Recorder Model VX3 and VX3i Regulation Number: 21 CFR 870.2800 Regulation Name: Medical Magnetic Tape Recorder Regulatory Class: Class II (two) Product Code: MWJ Dated: July 18, 2003 Received: July 21, 2003

Dear Ms. Luhmann:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle. The eagle is depicted with its wings spread, and its head facing to the left.

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Page 2 – Ms. Lauren M. Luhmann

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Ulegan mayn
C. R. B. Zukerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## STATEMENT OF INDICATIONS FOR USE

The VX3 digital Holter recorder is intended for the recording of ECG data collected from ambulatory patients. The recorder can collect data in the presence of implanted pacemaker pulses, and can detect and record the occurrence of signals characteristic of pacemaker pulses. 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 as well as pacemaker pulses during the events of the patient's daily activity.

MMe May
(Division Sign Off)

510(k) Number K031074