(89 days)
Not Found
No
The description focuses on data integration, organization, and workflow tools, with no mention of AI/ML terms or functionalities.
No
The device is described as an electrocardiograph, pacemaker artifact analyzer, transtelephonic ECG receiving station, and a clinic management tool. Its primary function is to collect, organize, and integrate data for cardiac patients, and it does not directly treat or diagnose a medical condition.
Yes
The device is intended for use as a 12-lead electrocardiograph and pacemaker artifact analyzer, which are diagnostic functions. It receives and organizes patient data to enable clinicians to conduct their daily work, indicating its use in diagnosing and monitoring cardiac conditions.
No
The device description explicitly states that the Paceart System "consists of hardware and software" and that this submission is only for the software changes, implying the existence of necessary hardware components.
Based on the provided information, the Paceart System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use describes the device as a 12-lead electrocardiograph, pacemaker artifact analyzer, transtelephonic ECG receiving station, and a database for cardiac patients. These functions relate to analyzing electrical signals from the body and managing patient data, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the functions related to ECG analysis, data integration from implanted devices, and clinic workflow tools. Again, this focuses on in-vivo measurements and data management, not in-vitro analysis of biological samples.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, reagents, or any processes typically associated with IVD devices.
Therefore, the Paceart System falls under the category of a medical device that interacts with the body or manages data related to in-vivo measurements, rather than an IVD device which analyzes samples outside 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 (comma separated list FDA assigned to the subject device)
DPS, DXH, KRE, OUG
Device Description
The Medtronic Paceart Optima System Software, Model POS12D, is intended for use with the Medtronic Paceart System, previously cleared per K024278. The Paceart System is a 12-lead electrocardiograph, transtelephonic receiving station, and a clinic management tool that organizes patient, device and programmer information. The Paceart System is designed to integrate data from implanted cardiac device programmers, pacemaker transmitters, cardiac event recorders, and remote data networks, such as the Medtronic CareLink® Network, into a single patient record, enabling clinicians to conduct their daily work through commonly formatted data and clinic workflow tools. Note: The Paceart System will also be marketed and referred to as the Paceart Optima System when using the Paceart Optima System Software.
The Paceart System consists of hardware and software. There are no design or process changes to the hardware components of the Paceart System as part of this submission. Therefore, the subject of this 510(k) submission is for the Paceart Optima System Software only and contains only information on the software changes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinicians / clinic
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)
Software verification testing and validation testing is performed to demonstrate the Paceart Optima System Software meets established performance criteria and to support equivalency to the referenced predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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).
0
510(k) SUMMARY
| Date Prepared: | March 10, 2010 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Cardiac Rhythm Disease Management | |
| 8200 Coral Sea Street NE | |
| Mounds View, MN 55112 | |
| Contact: | Rachel U. Libi |
| Sr. Principal Regulatory Affairs Specialist | |
| Telephone: | (763) 526-1668 |
| Fax: | (651) 367-0603 |
| E-mail: | rachel.libi@medtronic.com |
| Proprietary Name: | Paceart Optima™ System Software |
| Common Name: | Pacemaker Waveform Analyzer and Digital |
| Electrocardiograph | |
| Device Classification | Class II, 21 CFR 870.2340, 870.2920, 870.3640, |
| Pacemaker Waveform Analyzer and Digital | |
| Electrocardiograph | |
| Class I, 21 CFR 880.6310, Medical Device Data | |
| System (MDDS) | |
| Product Code: | DPS, DXH, KRE and OUG |
Summary of Substantial Equivalence
The intended use, design, materials and performance of the Paceart OptimaTM System Software are substantially equivalent to the Paceart® System Software, which was cleared as part of the following predicate device/system.
- Medtronic Paceart System cleared via 510(k), K024278, on May 29, 2003 .
Device Description
The Medtronic Paceart Optima System Software, Model POS12D, is intended for use with the Medtronic Paceart System, previously cleared per K024278. The Paceart System is a 12-lead electrocardiograph, transtelephonic receiving station, and a clinic management tool that organizes patient, device and programmer information. The Paceart System is designed to integrate data from implanted cardiac device programmers, pacemaker transmitters, cardiac event recorders, and remote data networks, such as the Medtronic CareLink® Network, into a single patient record, enabling clinicians to conduct their daily work through commonly formatted data and clinic workflow tools. Note: The Paceart System will also be marketed and referred to as the Paceart Optima System when using the Paceart Optima System Software.
1
The Paceart System consists of hardware and software. There are no design or process changes to the hardware components of the Paceart System as part of this submission. Therefore, the subject of this 510(k) submission is for the Paceart Optima System Software only and contains only information on the software changes.
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,
Technological Characteristics
Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced.
Summary of Testing
Software verification testing and validation testing is performed to demonstrate the Paceart Optima System Software meets established performance criteria and to support equivalency to the referenced predicate device.
Conclusion
Medtronic considers the Paceart Optima System Software to be substantially equivalent to the previously cleared Paceart System Software (reference K024278) through the data and information presented. No new safety or effectiveness issues were identified.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure. The text is in all caps and appears to be in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Medtronic, Inc. c/o Ms. Rachel U. Libi Sr. Principal Regulatory Affairs Specialist 8200 Coral Sea Street Mounds View, MN 55304
JUN - 8 2011
Re: K110693
Trade/Device Name: Paceart Optima™ System Software Regulation Number: 21 CFR 870.3640 Regulation Name: Indirect pacemaker generator function analyzer Regulatory Class: Class II (two) Product Code: KRE, DPS, DXH, and OUG Dated: May 18, 2011 Received: May 19, 2011
Dear Ms. Libi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Rachel U. Libi
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours
B.
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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INDICATION FOR USE
510(k) Number (if known): Kl 10693
Device Name: Paceart Optima™ System Software
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
ision Sign-Off) vision of Cardiovascular Devices
510(k) Number K110643