(157 days)
Not Found
No
The document describes standard electrocardiograph and pacemaker analysis functions, and explicitly states "Not Found" for mentions of AI, DNN, or ML.
No.
The device is used for analysis and data collection of cardiac parameters, including pacemaker performance and ECGs, which are diagnostic and monitoring functions, not therapeutic.
Yes
The device is described as a "12-lead electrocardiograph" and its intended use includes "pacemaker artifact analyzer" and "transtelephonic ECG receiving station." It provides data used to "analyze implanted pacemaker performance based on electrocardiographic measurements." These functions are all indicative of diagnostic capabilities, as they involve the collection and analysis of physiological data to assess a patient's medical condition or device function. Furthermore, the performance studies mention testing in accordance with "AAMI/ANSI EC 11: 1991, Diagnostic Electrocardiographic Devices."
No
The device description explicitly lists hardware components such as a Personal Computer, LaserJet Printer, Parallel and USB modules, Isolation transformer, and Cables, in addition to the software.
Based on the provided information, the Paceart System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Paceart System Function: The Paceart System analyzes electrocardiographic data (electrical signals from the heart) and pacemaker performance. This data is obtained directly from the patient or a programmer, not from a sample taken from the body.
- Intended Use: The intended use clearly states it's for use as an electrocardiograph, pacemaker artifact analyzer, and transtelephonic ECG receiving station. These are all related to analyzing electrical activity and device performance within the body, not analyzing biological samples.
- Device Description: The description reinforces its function as a system for analyzing implanted pacemaker performance based on electrocardiographic measurements.
Therefore, the Paceart System falls under the category of a medical device that interacts with or analyzes data from the body directly, rather than an in vitro diagnostic device that analyzes samples taken from the body.
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 receiving station. It also acts as a database for cardiac patients with or without pacemakers or implantable cardioverter defibrillators.
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) .
- USB module (TTM and Full) ●
- Isolation transformer .
- Cables .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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-Jarmon |
| Sr. 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 Digital |
| 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
- 319 -
1
- 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 |
| Decision date 04/14/1992 | ||
| Paceart CardioVoice | Paceart, Inc. | K952065 |
| 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.
2
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
4
,
:
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. |
(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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