(177 days)
No
The summary describes a computerized system for analyzing electrogram and electrocardiogram signals and displaying them visually. It mentions software but does not include any terms or descriptions indicative of AI or ML, such as "AI," "ML," "deep learning," "neural network," or descriptions of training/test sets for such algorithms. The performance studies focus on bench testing and comparison to predicate devices without mentioning AI/ML-specific validation metrics.
No
Explanation: The device is described as assisting in the diagnosis of cardiac arrhythmias by analyzing and displaying electrogram and electrocardiogram signals. It does not perform any direct therapeutic action.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias." Additionally, the "Device Description" mentions that it "outputs a graphic display that assists in the diagnosis of cardiac arrhythmias."
No
The device description explicitly states that the RhythmView is comprised of both hardware (computer, monitor, keyboard, mouse) and software.
Based on the provided information, the RhythmView™ Workstation is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The RhythmView Workstation analyzes electrical signals collected from electrophysiology catheters, which are inserted into the body. It's analyzing signals within the body, not a sample taken from the body.
- The intended use is to assist in the diagnosis of cardiac arrhythmias by analyzing electrogram and electrocardiogram signals. This is a direct analysis of physiological signals, not an analysis of a biological sample like blood, urine, or tissue.
The device is clearly focused on analyzing electrical activity within the heart, which falls under the category of a medical device used for physiological monitoring and analysis, not an IVD.
N/A
Intended Use / Indications for Use
The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
Product codes
DQK
Device Description
The RhythmView is comprised of these major components,
- RhythmView hardware – Computer, monitor, keyboard, and mouse
- RhythmView Software – Software pre-installed
The RhythmView Workstation takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias.
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
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 RhythmView System underwent extensive bench testing, including a data wide variety of cardiac electrogram data, to demonstrate that it was as safe and as effective as the predicate devices.
The Rhythm View System passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria. There were no new questions of safety and effectiveness raised.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
No predicate devices were used to claim substantial equivalence.
Reference Device(s)
Astronomer + (K003362), CARTO XP Mapping System (K013083)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
pg 1 of 2
Appendix 4 — 510(k) Summary
510(k) Summary of Safety and Effectiveness
SEP 2 3 2011
| Submitter's
information | Topera, Inc.
Contact: Ruchir Sehra, MD
Phone: 858 367-3395
03/22/2011 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/
classification
name | Device Name:
• RhythmView Workstation
Classification/Common name:
• Programmable diagnostic computer
The marketed device(s) to which substantial equivalence is claimed:
• Astronomer + (K003362)
• CARTO XP Mapping System (K013083) |
| Device
description | The RhythmView is comprised of these major components,
- RhythmView hardware – Computer, monitor, keyboard, and mouse
- RhythmView Software – Software pre-installed
The RhythmView Workstation takes electrical signals collected from multi-
polar electrophysiology catheters and outputs a graphic display that assists in
the diagnosis of cardiac arrhythmias. |
| Indications for
use | The RhythmView™ Workstation is a computerized system that assists in the
diagnosis of complex cardiac arrhythmias. The RhythmView™ Workstation
is used to analyze electrogram and electrocardiogram signals and display
them in a visual format. |
| | Continued on next page |
1
510(k) Summary of Safety and Effectiveness, Continued
Technological The table below lists the technological characteristics for both the new and characteristics predicate devices
| Device Characteristic | New Device
Rhythm ViewTM | Predicate Device
Astronomer + | Predicate Device
CARTO XP |
|----------------------------------------------|-----------------------------|----------------------------------|------------------------------|
| Signal capture | No | Yes | Yes |
| Signal processing | Yes | Yes | Yes |
| Location capability | No | Yes | Yes |
| Post processing display -
propagation map | Yes | No | Yes |
| Grid display of electrode
signals | Yes | Yes | No |
Performance The RhythmView System underwent extensive bench testing, including a data wide variety of cardiac electrogram data, to demonstrate that it was as safe and as effective as the predicate devices.
The Rhythm View System passed all verification and validation tests in accordance with predetermined specifications and appropriate test criteria. There were no new questions of safety and effectiveness raised.
Conclusion Verification and validation testing were conducted to establish the performance characteristics of the RhythmView System. The results demonstrate that the Rhythm View is safe and effective when used in accordance with its intended use and labeling.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three lines forming a shape resembling a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WC066-G609 Silver Spring, MD 20993-0002
Topera, Inc. c/o Dr. Ruchir Schra 11445 E. Via Linda Suite 2 P.O. Box 224 Scousdale. AZ 85259
SEP 2 3 201
Re: K110878
Trade/Device Name: RhythmView Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: September 8, 2011 Received: September 12, 2011
Dear Dr. Sehra:
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 interestate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendonants, or 10 devices that have been reclassified in accordance with the provisions of the Federal Food, youg, 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 The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbaranding and adulteration. Please note: CDRH does not evaluate information related to contractly antity 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
3
Page 2 - Dr. Ruchir Schra
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 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 Pari 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
uckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix 3 - Indications for Use
Indications for Use Statement
Statement The Indications for Use Statement:
510(k) Number: K110878
Device Name: RhythmView Workstation
The RhythmView™ Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The RhythmView™M Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
Prescription Use X -AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Page of | |
|---|---|
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |
| 510(k) Number | K110878 |
Topera, Inc.