HEARTRAK AF

K071130 · Universal Medical, Inc. · DXH · May 14, 2008 · Cardiovascular

Device Facts

• Record ID: K071130
• Device Name: HEARTRAK AF
• Applicant: Universal Medical, Inc.
• Product Code: DXH · Cardiovascular
• Decision Date: May 14, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2920
• Device Class: Class 2

Intended Use

Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines. Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.

Device Story

Hand-held, portable, externally applied cardiac event recorder; used by patients at home. Device captures ECG signals; converts signals into audio tones for transmission over standard telephone lines to a receiving center at a hospital or physician's office. Physician/staff at receiving center listen to/process audio output to review cardiac rhythm. Device includes an added firmware module for atrial fibrillation detection. Does not deliver energy, administer drugs, or provide automated diagnostic conclusions. Benefits include remote cardiac rhythm monitoring without requiring patient presence in clinic.

Clinical Evidence

Bench testing only. Atrial fibrillation detection module validated using annotated MIT-BIH AFIB database, MIT-BIH Arrhythmia database (Series 100 and 200), and MIT Wave Form Data Base (WFDB) software. Testing performed in compliance with ANSI/AAMI EC38:1998, IEC 60601-1, IEC 61000-4, ANSI/AAMI EC57:1998/R2003, and AAMI ECAR (1987) protocols.

Technological Characteristics

Hand-held, portable, externally applied cardiac event recorder. Identical materials and design to predicate. Energy source: battery (implied). Connectivity: transtelephonic audio transmission. Firmware: includes arrhythmia and atrial fibrillation detection module. Standards: ANSI/AAMI EC38:1998, IEC 60601-1, IEC 61000-4, ANSI/AAMI EC57:1998/R2003.

Indications for Use

Indicated for patients requiring transtelephonic cardiac event recording. Device is a hand-held, portable, externally applied recorder used by patients at home to transmit ECG signals via telephone to a receiving center at a hospital or physician's office. Not a diagnostic tool; does not deliver energy or drugs.

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

• Heartrak Smart AT (K033451)

Submission Summary (Full Text)

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K071130 R /3

MAY 1 4 2008

## "510(k) Summary" As Required By 21 CFR Section 807.92(c)

#### Applicant's Name: Universal Medical Incorporated 275 Phillips Blvd, Ewing, New Jersey 08618 Phone [phone] Fax [phone]

Establishment Registration Number: 2248680

Contact Person:

Steven Adamsky

Date:

09-19-2007

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K071130

p.2/3

### Proprietary Name: Heartrak Smart AF (K071130)

Classification Name: Telephone Hlectrocardiograph Transmitter and Receiver 21 CFR 870.2920.

Predicate Devices: Heartrak Smart AT (K033451)

#### Device Description:

Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use.

#### Intended Use:

Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder, which is intended for transtelephonic use.

#### Indication for Use:

Heartrak Smart AF is a hand-held, portable, externally applied transtelephonic cardiac event recorder device, which is intended for transtelephonic use. Patient calls a receiving center at the hospital or physicians office from the patient's home to play back the recording. Heartrak Smart AF converts ECG signals into audio tones which are transmitted over the telephone lines. Heartrak Smart AF does not deliver any energy. administer any drugs, or controls a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.

#### Technological Characteristics:

All of the technological characteristics are identical to the predicate device, including design, material, and energy source. A module to better detect Atrial Fibrillation was added to the Heartrak Smart AT (predicate device) firmware to develop the Heartrak Smart AF (subject device). The Heartrak Smart AT device and Heartrak Smart AF device are otherwise identical in materials and technology.

#### Substantial Equivalence:

The Heartrak Smart AF is substantially equivalent to the predicate device, Heartrak Smart AT. The safety and effectiveness of this device is substantially equivalent to the predicate device. There are no known contradictions for use of this type of device. All of the features in this device present a non-significant risk to the user. The Substantial Equivalence Table is presented in the submission, Section 12 Substantial Equivalence Discussion.

A module to better detect Atrial Fibrillation was added to the Heartrak Smart AT (predicate device) firmware to develop the Heartrak Smart AF (subject device). The Heartrak Smart AT device and Heartrak Smart AF device are otherwise identical in materials and technology.

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# 17130 3/3

#### Conclusions Based on Tests Submitted:

All testing performed on the Heartrak Smart AF device was derived from the risk assessment that evaluated the effects of the addition of the atrial fibrillation detection module to the existing Heartrak Smart AT arrhythmia detection firmware. Heartrak Smart AF testing included environmental and software validation testing and device testing,

The atrial fibrillation detection module was tested, using available annotated MIT-BIH AFIB databasc and MIT-BIH Arrhythmia database (Series 100 and Series 200), which are annotated ECG databases, and the MIT Wave Form Data Base (WFDB) software to derive performance statistics for Heart Smart AF. Testing was performed in compliance with standard cvaluation protocols. These protocols have been adopted as parts of the ANSI/AAMI EC38:1998; IEC 60601-1; IEC 61000-4, and ANSI/AAMI EC57:1998/R2003 recommendations for testing cardiac rhythm and reporting the results of those tests. They include earlier evaluation protocols developed for an AAMI Recommended Practice, Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms (AAMI ECAR, 1987).

The subject device, Heartrak Smart AF, has indications for use the same as the predicate device, Heartrak Smart AT. The testing included in our submission in Section 18 Performance Testing - Live Patient/Field Test and Bench Test demonstrates that there are no differences in the technological characteristics of the subject device and the predicate device; therefore there are no new issues of safety or effectiveness. Heartrak Smart AF is substantially equivalent to the predicate device, Heartrak Smart AT.

#### Promotional Material:

Instructional manual, labeling.

#### Address for Manufacturing Site:

Heartrak Smart AF will be manufactured by Universal Medical, Inc. at its offices at 275 Phillips Boulevard, Ewing, New Jersey 08618.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2008

Universal Medical, Inc. c/o Mr. Steven Adamsky Executive Vice President 275 Philips Blvd. Ewing, NJ 08618

Re: K071130

Heartrak Smart AF Regulation Number: 21 CFR 870.2920 Regulation Name: Telephone Electrocardiograph Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DXH Dated: April 24, 2008 Received: April 25, 2008

Dear Mr. Adamsky:

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.

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Page 2 - Mr. Steven Adamsky

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Prem P. Zukerman, M.D.

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

Enclosure

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Image /page/5/Picture/0 description: The image is a logo for Universal Medical Incorporated, a Mednet company. The logo features a stylized letter "U" with a star at the top, enclosed within a circle. The words "UNIVERSAL MEDICAL" are stacked above the word "INCORPORATED", and the phrase "A MEDNET COMPANY" is at the bottom of the logo.

#### UNIVERSAL MEDICAL INCORPORATED

275 Phillips Blvd, Ewing, NJ 08618 [phone] Fax [phone]

# Indications for Use

510(k) Number (if known): K071130

Device Name: Heartrak Smart AF

Indications for Use:

Heartrak Smart AF is a hand-held, portable, externally applied, cardiac event recorder that is intended for transtelephonic use. Patient calls a receiving center at the hospital or physician's office from the patient's home to play back the recording. Heartrak Smart AF converts electrocardiogram (ECG) signals into audio tones which are transmitted over the telephone lines.

Heartrak Smart AF does not deliver any energy, administer any drugs, or control a patient's life. Heartrak Smart AF is not a diagnostic tool and performs no diagnostic functions.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

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| Division of Cardiovascular Devices |
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| 510(k) Number | k071130 |
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