PACEART SYSTEM

K024278 · Medtronic Vascular · DPS · May 29, 2003 · Cardiovascular

Device Facts

• Record ID: K024278
• Device Name: PACEART SYSTEM
• Applicant: Medtronic Vascular
• Product Code: DPS · Cardiovascular
• Decision Date: May 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2340
• Device Class: Class 2

Intended Use

The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.

Device Story

Paceart System is a PC-based diagnostic tool for pacemaker performance analysis and ECG monitoring. Inputs include 12-lead ECG signals acquired directly from patients or via transtelephonic transmission. The system processes these signals to measure, store, and display waveforms; it functions as a pacemaker artifact analyzer and a database for cardiac patient records. Operated by clinicians in clinical settings, the system outputs reports and charts via laser printer. It facilitates clinical decision-making by providing objective data on implanted device performance and cardiac rhythm. Benefits include remote monitoring capabilities via transtelephonic receiving and centralized data management for patients with pacemakers or ICDs.

Clinical Evidence

Bench testing only. Testing conducted in accordance with AAMI/ANSI EC 11:1991 (Diagnostic Electrocardiographic Devices) and AAMI/ANSI EC 38:1998 (Ambulatory Electrocardiographs). Telephone circuitry tested to FCC CFR 47, Part 68.

Technological Characteristics

PC-based system including isolation transformer, USB module, and cables. Performs 12-lead ECG acquisition, pacemaker artifact analysis, and transtelephonic data reception. Connectivity via telephone network and laser printer output. Software-based analysis of cardiac signals. Complies with AAMI/ANSI EC 11 and EC 38 standards.

Indications for Use

Indicated for cardiac patients, including those with or without pacemakers or implantable cardioverter defibrillators, requiring 12-lead ECG monitoring, pacemaker artifact analysis, or transtelephonic ECG transmission.

Regulatory Classification

Identification

An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.

Predicate Devices

• Paceart CPTS-86/12 (K915632)
• Paceart CardioVoice (K952065)

Submission Summary (Full Text)

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K024278

MAY 2 9 2003

Paceart System

# 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE

| Date Prepared: | December 20, 2002 |
|------------------------|----------------------------------------------------------------------|
| Submitter: | Medtronic, Inc.<br>7000 Central Avenue N.E.<br>Minneapolis, MN 55432 |
| Contact: | Karen Ruth-Jarmon<br>Sr. Regulatory Affairs Manager |
| 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: | DPS, DXH, KRE |

### Device Description

The Medtronic Paceart System is a personal computer based pacemakertesting 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.

The system is comprised of the following components:

- . Personal Computer
- . Paceart System software
- LaserJet Printer .
- Parallel (TTM, Clinical, and Full) .

mic Confidential

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- USB module (TTM and Full) ●
- Isolation transformer .
- Cables .

#### Intended Use

The Paceart® System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.

### Substantially Equivalent Devices

The Paceart System is substantially equivalent to a combination of features offered by predicate systems identified in the following table.

| Predicate Device | Predicate Device Manufacturer | Predicate 510(k) |
|---------------------|-------------------------------|-------------------------------------|
| Paceart CPTS-86/12 | Paceart, Inc. | K915632<br>Decision date 04/14/1992 |
| Paceart CardioVoice | Paceart, Inc. | K952065<br>Decision date 01/16/1996 |

## Summary of Testing

The device was tested in accordance with applicable sections of AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices and AAMI/ANSI EC 38: 1998, Ambulatory Electrocardiographs. The telephone circuitry was tested to FCC CFR 47, Part 68: Connection of Terminal Equipment to the Telephone Network. The requirements of the FDA document Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions have been applied. The information provided in section 9.0 Off-The-Shelf Software was prepared in accordance with the FDA's guidance document "Off-The-Shelf Software Use in Medical Devices," issued September 9, 1999.

#### Conclusion -

Through the data and information presented, as well as similarities to legally marketed devices, Medtronic Paceart considers the Paceart® System to be substantially equivalent to the previously discussed legally marketed predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol with three curved lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the bird symbol.

MAY 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medtronic, Inc. c/o Ms. Karen Ruth-Jarmon Sr. Regulatory Affairs Manager 7000 Central Avenue NE Minneapolis, MN 55432

Re: K024278

Trade Name: Paceart System Regulation Number: 21 CFR 870.2340, 870.2920, 870.3640 Regulation Name: Pacemaker Waveform Analyzer and Digital Electrocardiograph Regulatory Class: Class II (two) Product Code: DPS, DXH, KRE Dated: April 28, 2003 Received: April 29, 2003

Dear Ms. Ruth-Jarmon:

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.

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

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Page 2 – Ms. Karen Ruth-Jarmon

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.

N.O.ATU
Bram D. Zuckerman, M.D.

am D. Zuckerma 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 |
| Indications For Use: | <p>The Paceart System is intended for use as a 12-lead electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.</p> |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96) | OR |
|----------------------------------------------------------------|----------------------|
| | Over-The-Counter Use |

| (Division Sign-Off) |
|------------------------------------|
| Division of Cardiovascular Devices |

Medtronic Confidential

| - 32510(k) Number | K024278 |
|-------------------|---------|
|-------------------|---------|

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