EKG SPEAKS

K032926 · Medtronic Vascular · KRE · Oct 15, 2003 · Cardiovascular

Device Facts

• Record ID: K032926
• Device Name: EKG SPEAKS
• Applicant: Medtronic Vascular
• Product Code: KRE · Cardiovascular
• Decision Date: Oct 15, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3640
• Device Class: Class 2

Intended Use

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

Device Story

Paceart System is PC-based pacemaker-testing system, 12-lead electrocardiograph, and transtelephonic receiving station. Inputs include ECG signals from patients or programmers. System measures, stores, and displays 12 standard leads; analyzes pacemaker performance via artifact measurement. Used in clinical settings by healthcare providers; optional software enables unattended transtelephonic receiving. Output includes reports, charts, and patient database records. Facilitates clinical decision-making by providing diagnostic data on implanted device function and patient cardiac rhythm.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

PC-based system; 12-lead ECG acquisition; digital storage; laser printer output; transtelephonic receiving capability; database management software.

Indications for Use

Indicated for patients requiring 12-lead ECG monitoring, pacemaker performance analysis, or transtelephonic ECG monitoring. Used for patients with implanted pacemakers or implantable cardioverter defibrillators.

Regulatory Classification

Identification

An indirect pacemaker generator function analyzer is an electrically powered device that is used to determine pacemaker function or pacemaker battery function by periodically monitoring an implanted pacemaker's pulse rate and pulse width. The device is noninvasive, and it detects pacemaker pulse rate and width via external electrodes in contact with the patient's skin.

Submission Summary (Full Text)

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K032926

OCT 1 5 2003

Paceart System - EKG Speaks

## 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Date Prepared: | 19 September 2003 |
|------------------------|----------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Contact: | Kristyn M. Benson<br>Regulatory Affairs Specialist |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |
| Proprietary Name: | Paceart® System |
| Common Name: | Pacemaker Waveform Analyzer and Digital<br>Electrocardiograph |
| Device Classification: | Class II, 21 CFR § 870.2340, 870.2920, 870.3640 |
| Product Codes: | DPJ, DXH, KRE |

## Device Description

The Medtronic Paceart® System is a personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station. It provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, either taken directly from the patient or programmer. The system can measure, store, and display any of the 12 standard leads. Reports and charts are available by means of a laser printer. The system also includes a database that collects and stores patient data. Optional software allows the device to function as an unattended transtelephonic receiving station.

Image /page/0/Picture/8 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized human figure inside a circle. The word "Medtronic" is written in a bold, sans-serif font. The word "Confidential" is written in a smaller, sans-serif font.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2003

Ms. Kristyn M. Benson Regulatory Affairs Specialist Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K032926

Trade Name: Paceart® System EKG Speaks™M Regulation Number: 21 CFR 870.3640 Regulation Name: Indirect Pacemaker Generator Function Analyzer Regulatory Class: Class II (two) Product Code: KRE Dated: September 19, 2003 Received: September 22, 2003

Dear Ms. Benson:

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. Kristyn M. Benson

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 may be obtained 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,

Uejasmap

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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## INDICATIONS FOR USE

510(k) Number if known: N/A

Device Name:

Paceart System - EKG SpeaksTM

Indications For Use:

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG monitor. It also acts as a database for pacemaker and implantable cardioverter defibrillator patients.

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Concurrence of CDRH, Office of Device Evaluation (ODE) 510(k) Nun

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Image /page/3/Picture/13 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized caduceus symbol on the left and the company name "Medtronic" in bold, sans-serif font on the right. The word "Confidential" is in a smaller, regular font.