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

AI/ML Overview

The provided text describes the Paceart System, a personal computer-based pacemaker testing system, 12-lead electrocardiograph, and transtelephonic receiving station.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on regulatory compliance rather than specific performance metrics against pre-defined acceptance criteria for diagnostic accuracy. The testing performed was against recognized standards for medical devices.

Acceptance Criteria (Implied from testing)	Reported Device Performance (Compliance)
Compliance with AAMI/ANSI EC 11: 1991 (Diagnostic Electrocardiographic Devices)	Device was tested in accordance with applicable sections.
Compliance with AAMI/ANSI EC 38: 1998 (Ambulatory Electrocardiographs)	Device was tested in accordance with applicable sections.
Compliance with FCC CFR 47, Part 68 (Connection of Terminal Equipment to the Telephone Network)	Telephone circuitry was tested to FCC CFR 47, Part 68.
Compliance with FDA Guidance for the Content of Premarket Submissions for Software in Pre-Market Submissions	Requirements were applied.
Compliance with FDA guidance document "Off-The-Shelf Software Use in Medical Devices" (for OTS software)	Information provided in Section 9.0 Off-The-Shelf Software was prepared in accordance with this document.
Substantial Equivalence to Predicate Devices	Medtronic Paceart considers the system to be substantially equivalent based on data, information, and similarities to predicate devices.

2. Sample size used for the test set and the data provenance:

The document does not specify a sample size for a "test set" in the context of diagnostic performance (e.g., number of ECGs or patients). The testing described is against engineering and regulatory standards, not a clinical diagnostic performance study with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided as the submission focuses on engineering and regulatory compliance rather than a diagnostic performance study requiring expert ground truth.

4. Adjudication method for the test set:

This information is not provided as it's not relevant to the type of testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. The device predates the widespread use of "AI" in medical devices as understood today, and the submission is focused on device functionality and regulatory compliance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The submission focuses on the functionality of the system as a tool for analysis and data management, and its compliance with standards. It does not present data on an "algorithm only" performance in the context of diagnostic accuracy. The device, by its nature (pacemaker artifact analyzer, ECG, transtelephonic station), is intended for use by medical professionals.

7. The type of ground truth used:

The concept of "ground truth" as typically understood in diagnostic performance studies (e.g., pathology, outcomes data, expert consensus) is not applicable to the type of testing described in this submission. The "ground truth" for the tests performed was compliance with technical specifications and regulatory standards.

8. The sample size for the training set:

A "training set" in the context of machine learning or AI is not mentioned or relevant to this 510(k) submission.

9. How the ground truth for the training set was established:

This information is not applicable as there is no mention of a training set or AI/machine learning development.

Summary

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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.7000 Central Avenue N.E.Minneapolis, MN 55432
Contact:	Karen Ruth-JarmonSr. Regulatory Affairs Manager
Telephone:	(763) 514-3783
Fax:	(763) 514-6424
E-mail:	karen.ruth.jarmon@medtronic.com
Proprietary Name:	Paceart® System
Common Name:	Pacemaker Waveform Analyzer and DigitalElectrocardiograph
Device Classification:	Class II, 21 CFR § 870.2340, 870.2920, 870.3640
Product Codes:	DPS, DXH, KRE

Device Description

The system is comprised of the following components:

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

mic Confidential

319 -

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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.	K915632Decision date 04/14/1992
Paceart CardioVoice	Paceart, Inc.	K952065Decision 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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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:	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.

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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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Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
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.(b)
Classification. Class II (performance standards).