AFIBALERT ATRIAL FIBRILLATION DETECTOR

K052767 · Lechnologies Research, Inc. · DXH · Jun 23, 2006 · Cardiovascular

Device Facts

• Record ID: K052767
• Device Name: AFIBALERT ATRIAL FIBRILLATION DETECTOR
• Applicant: Lechnologies Research, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Device Story

AfibAlert™ is a cardiac event recorder for patient self-use; stores five 45-second ECG events in solid-state memory. Input: single-channel ECG via thumb electrodes, chest placement, or wrist electrodes. Operation: patient-initiated 45-second recording; internal algorithm analyzes rhythm; LED indicates presence/absence of AF. Output: visual LED indicator; ECG data transmission via telephone or computer to service provider. Clinical utility: early AF detection potentially reduces risk of heart attack and stroke. Healthcare provider uses transmitted ECG data for clinical decision-making.

Clinical Evidence

No clinical data provided. Evidence consists of electrical, mechanical, and software bench testing conducted in accordance with applicable standards to verify device performance and suitability for home use.

Technological Characteristics

Cardiac event recorder; single-channel ECG; solid-state non-volatile memory; LED status indicators; telephone/computer connectivity for data transmission. Powered by internal battery. Designed for home use.

Indications for Use

Indicated for patients diagnosed with or susceptible to atrial fibrillation (AF) who require intermittent heart rhythm monitoring and recording. Includes patients with history of heart bypass, ablation, cardiac abnormality, or those on anti-arrhythmic medication.

Regulatory Classification

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.

Predicate Devices

• King of Hearts Express AF (K020825)
• CG-2211 SelfCheck ECG Transmitter (K012223)
• HeartCard (K010945)

Submission Summary (Full Text)

{0}------------------------------------------------

K052767

JUN 2 3 2006

## SECTION 5: 510(k) Summary

ر.ق. ت

| Submitter: | Lechnologies Research, Inc. |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tim Lohman, President |
| Date Prepared: | September 29, 2005 |
| Trade Name: | The AfibAlert™ Atrial Fibrillation Detector |
| Classification: | Class II<br>21 CFR 870.2920 - Telephone electrocardiograph transmitter and receiver |
| Product Code: | DXH |
| Predicate<br>Device(s): | The subject device is equivalent to the following devices:<br>• The King of Hearts Express AF (K020825), manufactured by Instromedix<br>• The CG-2211 SelfCheck ECG Transmitter (K012223), manufactured by<br>Card Guard Scientific Survival Ltd.<br>• The HeartCard (K010945), manufactured by Instromedix |
| Device Description: | The AfibAlert™ is a cardiac event recorder capable of storing five 45-second<br>events in solid-state non-volatile memory. AfibAlert™ allows patients who have<br>been diagnosed with, or are susceptible to developing atrial fibrillation (AF) to<br>take periodic readings with a computerized rhythm monitor. The system was<br>developed for the patient that has been previously diagnosed with AF, has a<br>history of heart bypass, ablation, or other cardiac abnormality, or is on heart<br>(anti-arrhythmic) medication. In these cases, detecting and determining AF early<br>can potentially reduce the risk of heart attack and stroke.<br><br>The device can record a single channel of ECG data in three ways: (1) via the<br>two thumb electrodes, (2) by placement on the chest, or (3) by applying wrist<br>electrodes. In each case, the patient initiates the recording. The recording takes<br>approximately 45 seconds. Immediately following data acquisition, an internal<br>AF algorithm is used to analyze the patient's rhythm. The appropriate LED<br>(light emitting diode) is illuminated to indicate the presence or absence of AF.<br><br>If AF is indicated, or concerning symptoms are present, the patient makes a<br>telephone call to a service provider as specified by their physician and transmits<br>the ECG data to the receiving personnel. Data can also be transferred by using a<br>computer. |
| Intended Use: | The AfibAlert™ is indicated for self-testing by patients who have been<br>diagnosed with, or are susceptible to developing atrial fibrillation and who would<br>like to monitor and record their heart rhythms on an intermittent basis. |
| Functional and<br>Safety Testing: | Electrical, mechanical, and software testing was conducted and data was<br>collected in accordance with applicable standards to ensure that the device<br>performs according to specifications and to verify that the device is suitable for<br>home use. |
| Conclusion: | Lechnologies Research Inc. considers the AfibAlert™ Atrial Fibrillation<br>Detector to be equivalent to the predicate devices listed above. This conclusion<br>is based upon the devices` similarities in functional design, method of use for<br>self-monitoring, and indications for use. |

-

1 echnologies Research, Inc.

AfibAlert™ 510(k) Premarket Notitication

September 29, 2005 Park 1-1

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the perimeter. Inside the circle is an abstract image of an eagle with three lines representing its wings and a wavy line representing its body.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Lechnologies c/o Ms. Stephanie King Senior Regulatory Consultant 450 Olsen Memorial Highway Minneapolis, MN 55422

Re: K052767

Trade Name: Afibalert Atrial Fibrillation Detector Regulation Number: 21 CFR 870-2920 Regulation Name: Telephone electrocardiograph transmitter and receiver Regulatory Class: II (two) Product Code: DXH Dated: May 25, 2006 Received: May 26, 2006

Dear Ms. King

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. Iisting of devices, good manufacturing practice. Iabeling, 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.

{2}------------------------------------------------

Page 2 - Ms. Stephanie King

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/industry/support/index.html.

Sincerely yours.

B. Harmonia, for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

K052767

## Section 4: Indications for Use Statement

## Device Name: AfibAlert™M

The AfibAlert™ is indicated for self-testing by patients who have been diagnosed with, or are susceptible to developing atrial fibrillation and who would like to monitor and record their heart rhythms on an intermittent basis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C )

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH. Office of Device Evaluation (ODF)

Dhimma

i echt plogico Resemicio p んちゃんな

Resper : 010 Questions : 11 124 - 3

Image /page/3/Picture/13 description: The image shows the handwritten text "Page 1081". The text is written in a cursive style. There is a horizontal line below the text.