(23 days)
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No
The summary describes a system for ECG analysis, pacemaker artifact analysis, and data management, but there is no mention of AI or ML technologies being used for these functions. The description focuses on standard signal processing and database capabilities.
No.
The device is used for diagnostic purposes (e.g., 12-lead electrocardiograph, pacemaker artifact analyzer, transtelephonic ECG monitor, and analyzing implanted pacemaker performance), not for treating conditions.
Yes
Explanation: The device is intended for use as a 12-lead electrocardiograph and pacemaker artifact analyzer, and it provides data that can be used to analyze implanted pacemaker performance based on electrocardiographic measurements, all of which are diagnostic functions.
No
The device description explicitly states it is a "personal computer based pacemaker-testing system, a 12-lead electrocardiograph, and a transtelephonic receiving station," indicating it includes hardware components beyond just software.
Based on the provided information, the Paceart System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Paceart System's intended use and device description clearly state that it analyzes electrocardiographic measurements taken directly from the patient or programmer. It also functions as a database for patient information and a transtelephonic receiving station.
- There is no mention of the system analyzing any biological specimens.
Therefore, the Paceart System falls under the category of a medical device that analyzes physiological signals (ECG) and manages patient data, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 870.3640 Indirect pacemaker generator function analyzer.
(a)
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.(b)
Classification. Class II (performance standards).
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OCT 1 5 2003
Paceart System - EKG Speaks
510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE
| Date Prepared: | 19 September 2003 |
|---|---|
| Submitter: | Medtronic, Inc. |
| 7000 Central Avenue N.E. | |
| Minneapolis, MN 55432 | |
| Contact: | Kristyn M. Benson |
| Regulatory Affairs Specialist | |
| Telephone: | (763) 514-4617 |
| Fax: | (763) 514-6424 |
| E-mail: | kristyn.m.benson@medtronic.com |
| Proprietary Name: | Paceart® System |
| Common Name: | Pacemaker Waveform Analyzer and Digital |
| 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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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, represented by three curved lines that suggest a profile. The figure is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a sans-serif font.
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 (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 may be obtained 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,
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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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.