HEARTTRENDS

K012825 · Lev-El, Ltd. · DQK · Mar 19, 2002 · Cardiovascular

Device Facts

• Record ID: K012825
• Device Name: HEARTTRENDS
• Applicant: Lev-El, Ltd.
• Product Code: DQK · Cardiovascular
• Decision Date: Mar 19, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.

Device Story

HeartTrends™ is a software-based diagnostic tool for analyzing prerecorded ambulatory ECG data. It processes up to 3 channels of ECG input to calculate and report Heart Rate Variability (HRV) using a Multipole Parameter Weighted (MPW) method. The software operates on a physical-mathematical description of complex time series to generate multiple parameters (multipoles) that characterize HRV. It is intended for use by qualified clinicians to review, edit, and assess HRV measurements. The output provides clinicians with summarized HRV data to assist in clinical decision-making regarding patient heart health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based programmable diagnostic computer. Utilizes a physical-mathematical algorithm for MPW HRV analysis. Complies with cGMP/QSR, ISO 9001 (1994), EN 46002 (1996), EN 60601-1-4 (1997), and EN 1441 (1998) standards.

Indications for Use

Indicated for the analysis, summary, and reporting of up to 3 channels of prerecorded ambulatory ECG data and up to 5 channels of Multipole Parameter Weighted (MPW) Heart Rate Variability (HRV) for clinical assessment.

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

• Biosensor The Treason Ambulatory (Holter) Recording System (K950944)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a drawing of a heart with an electrocardiogram (ECG) line running through it. The heart is drawn in a simple, slightly rough style, and the ECG line is jagged and uneven. The drawing is done in black on a white background, giving it a stark, graphic look. The overall impression is one of love and health, or perhaps a reminder of the importance of heart health.

510(k) Summary Lev-El, Ltd.'s HeartTrends™ 510(k) Number K012825

MAR 1 9 2002

# Applicant's Name:

Lev-El, Ltd. P.O.B 3 Ariel Israel 44837

## Contact Person:

Avner Ben-Harush Lev-El, Ltd. P.O.B 3 Ariel Israel 44837 Telephone: [phone] Fax: [phone]

## Date Prepared:

15 August 2001

# Trade Name:

HeartTrends™

## Classification Name:

Programmable Diagnostic Computer

## Classification:

The FDA has classified Programmable Diagnostic Computer devices as class II device (product code DQK) and it is reviewed by the Cardiovascular Advisory Committee.

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#### Predicate Devices:

The HeartTrends™ is substantially equivalent to the Biosensor The Treason Ambulatory (Holter) Recording System cleared under K950944.

# Performance Standards:

The HeartTrends ™ complies with the following standards and regulations: cGMP/QSR, MDD 93/42 EEC (1993), ISO 9001 (1994), EN 46002 (1996), EN 60601-1-4 (1997), EN 1441 (1998).

#### Indication for Use:

The HeartTrends™ software is intended for the analysis, summary and reporting of up to 3 channels of prerecorded ambulatory ECG data. reporting of up to 5 chainters of the MPW (Multipole Paramater Weighted) HRV.

## Device Description:

The HeartTrends™ software is employed as a measuring tool to present Heart Rate Variability (HRV) to qualified clinician review, edit and assessment. It provides measurements of the MPW (Multipole Paramater Weighted) HRV. The HeartTrends™ software is based on an algorithm, which is constructed The HeartTronos - sorvice, based on a physical-mathematical description of complex time series.

The multipole method generates several parameters, multipoles, where every single one describes the HRV.

#### Substantial Equivalence:

Lev-El Ltd. believes that the HeartTrends™ is substantially equivalent to the Biosensor Corporation Ambulatory (Holter) Recording System cleared under K950944 in respect to intended use, technological characteristics, performance, and labeling.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAR 1 9 2002

Lev-El, Ltd. c/o Ms. Einat Shammai Arazy Group Mizpe Aviv Industrial Park 13 M.P. Misgav, 20187 ISRAEL

Re: K012825

Trade Name: HeartTrends™ Software, Version 1.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 16, 2001 Received: December 19, 2001

Dear Ms. Shammai:

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 - Ms. Einat Shammai

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I DT has made a active manufactions administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 comply with an all aller of 21 CFR Part 801); good manufacturing practice requirements as set CI K Part 607); adoning (21 OFF regulation (21 CFR Part 820); and if applicable, the electronic rord in and quality by some (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) I mis lotter will and w your to by finding of substantial equivalence of your device to a legally marketed predicated 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of I Crain 6646. Additionally, for questions on the promotion and advertising of Compinates at (301) 594-461 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation entired, "Thisocialism" responsibilities under the Act may be obtained from the Ourision 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,

ha. Dertteth

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

Enclosure

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# INDICATIONS FOR USE STATEMENT

K012825 510(k) Number:

HeartTrends™ Device Name:

# Indications for Use:

The HeartTrends™ software is intended for the analysis, summary and reporting of up The Ficart Fredesto 3 channels of prerecorded ambulatory ECG data.

to 3 channels of prevecorded antouratory DOC caref the MPW (Multipole Paramater Weighted) HRV.

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

Prescription Use ﮐﮯ (Per 21 CFR 801.109)

OR

Over the Counter Use_

Division of Cardiovascular & Respiratory Devices
510(k) Number K012885

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