(127 days)
Not Found
No
The description mentions "proprietary patented algorithms and methods" but does not explicitly state or imply the use of AI or ML. There is no mention of training or test sets, which are typical for ML-based devices.
No
The device is used to assist in the diagnosis of cardiac arrhythmias by analyzing electrogram and electrocardiogram signals and displaying them. It does not provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "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" and computations "to aid diagnosis by the physician during an electrophysiology study."
No
The device description explicitly lists multiple hardware components (Cart, Monitor/Display, Computer, RFID Reader/Writer, Solid State Hard Drive, Keyboard, Mouse, Two Port USB Switch, Video Splitter, Panel box) as part of the RhythmView Workstation, and the performance studies section mentions verification and validation testing of both Software and Hardware.
Based on the provided information, the Rhythm View Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The Rhythm View Workstation analyzes electrical signals (electrogram and electrocardiogram) collected directly from within the heart during an electrophysiological study. These are not specimens in the traditional sense of an IVD (like blood, urine, tissue, etc.).
- The intended use is to assist in the diagnosis of cardiac arrhythmias by analyzing electrical signals. This is a physiological measurement and analysis, not an in vitro examination of a biological sample.
- The device description focuses on the hardware and software used to process and display electrical signals. It does not mention any reagents, kits, or procedures for analyzing biological specimens.
Therefore, the Rhythm View Workstation falls under the category of a medical device used for physiological monitoring and analysis, rather than an IVD device.
N/A
Intended Use / Indications for Use
The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
Product codes (comma separated list FDA assigned to the subject device)
DQK
Device Description
The RhythmView Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Radio-Frequency Identification (RFID) Reader/Writer, Solid State Hard Drive (optional component), Keyboard, Mouse, Two Port USB Switch, Video Splitter (new component - streaming option only), Panel box required, Software. RhythmView takes electrical signals collected from multi-polar electrophysiology catheters and outputs a graphic display that assists in the diagnosis of cardiac arrhythmias. The Rhythm View computes and displays electrical rotors or focal beat sources responsible for maintaining human heart rhythm disorders including focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician during an electrophysiology study.
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 Software and Hardware (video splitter, panel box and computer) had undergone verification and validation testing, including Electrical Safety and EMC testing to provide reasonable assurance that the proposed device conformances to the appropriate requirements for its intended use. The Workstation has also undergone usability testing. Therefore, it has been demonstrated that the RhythmView Workstation is safe and effective for its intended use.
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.
K142901, K130827, K123295, K110878
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
§ 870.1425 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Topera, Inc. Dennis Pozzo Sr. Regulatory Affairs Specialist 3668 S. Geyer Road Suite 365 St. Louis, MO 63127
Re: K151245
Trade/Device Name: RhythmView Workstation SW V5.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: May 8, 2015 Received: May 11, 2015
Dear Dennis Pozzo:
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.
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 of medical device
1
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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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 vours.
Mitchell Stein
forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K151245
Device Name
Rhythm View Workstation SW V5.0
Indications for Use (Describe)
The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias. The Rhythm View Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| > Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
Appendix 1: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Topera, Inc.
3668 S. Geyer Road, Suite 365
St. Louis, MO 63127
Contact: Dennis Pozzo
Phone 314-300-6580 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Device/
classification
name | Device Name: RhythmView Workstation, SW V5.0
Product Code: DQK
Classification No: 21 CFR 870 1425
Classification/Common name: Programmable diagnostic computer
The marketed device(s) to which substantial equivalence is claimed:
K142901, cleared Dec. 19, 2014
K130827, cleared Dec. 16, 2013
K123295, cleared April 24, 2013
K110878, cleared Sept. 23, 2011 | |
| Device description | The RhythmView Workstation is comprised of the following components: | |
| | Cart | Keyboard |
| | Monitor/Display | Mouse |
| | Computer | Two Port USB Switch |
| | Radio-Frequency Identification
(RFID) Reader/Writer | Video Splitter (new component -
streaming option only)
*Panel box required |
| | Solid State Hard Drive (optional
component) | Software |
| | RhythmView takes electrical signals collected from multi-polar
electrophysiology catheters and outputs a graphic display that assists in the
diagnosis of cardiac arrhythmias. | |
| | The Rhythm View computes and displays electrical rotors or focal beat
sources responsible for maintaining human heart rhythm disorders including | |
focal AT, AFL, other SVT, AF, VT and VF in a given patient. The product takes as input electrical signals recorded during the heart rhythm disorder under consideration, typically from multiple specified locations within the heart during an electrophysiological study. The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder. These computed elements are displayed graphically in interactive form for review to aid diagnosis by the physician during an electrophysiology study.
4
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| 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. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | Both the proposed and predicate RhythmView Workstations allows the user
to:
Review and select a time sequence of electrical signals from various electrodes; Analyze the signals; View a graphic display (Electrical Activity) of the signal potentials showing progressive depolarization and repolarization in grayscale for the particular arrhythmia; Play/Replay the animated graphic representation of electrical signals. All display options are available for both atrial and ventricular maps. Other than the additional display options (SQI, Multi-color RAP and the spotlight feature) associated with the proposed RhythmView workstation, the major difference between the predicate and proposed workstation is the addition of the optional streaming and associated SQI of the streaming data.
It is important to note that the import of the streaming electrograms vs. non-streaming electrograms is identical with the exception of a few new workflow steps. |
| Performance
data | The Software and Hardware (video splitter, panel box and computer) had undergone verification and validation testing, including Electrical Safety and EMC testing to provide reasonable assurance that the proposed device conformances to the appropriate requirements for its intended use. The Workstation has also undergone usability testing. Therefore, it has been demonstrated that the RhythmView Workstation is safe and effective for its intended use. |
| Consensus
standards | IEC 60601-1-2 Medical Electrical Equipment, General requirements for safety. Electromagnetic Compatibility and essential performance
IEC 62366 Medical Devices - Application of Usability Engineering to Medical Devices |
5
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Predicate
RhythmView™
Workstation | Proposed
RhythmView™
Workstation |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Signal processing | Yes | Yes |
| Post-processing display | Yes | Yes |
| Grid display of electrode signals | Yes | Yes |
| Programming Language | C++ | C++ |
| Export of processed file into video
format | Yes | Yes |
| Manual tagging by user of
electrograms | No | No |
| OTS Software requirements | Same | Same |
| Display options for review of
processed signals | • Electrical Activity
• Contours Only
• DContours
• Rotational Activity
Profile | • Electrical Activity
• Contours Only
• DContours
• Rotational Activity
Profile” |
| RAP display (optional) | Monochromatic only | Multi-color with
monochromatic
option available |
| RFID Reader/Writer Function | Yes | Yes |
| Data transfer via Two Port Switch | Yes | Yes |
| Direct data transfer via USB cable to
RV Workstation from EP system | Option available | Option available |
| Atrial Function | Yes | Yes |
| Ventricular Function | Option available | Option available |
| Signal Quality Indicator | No | Yes |
| Spotlight Feature | No | Yes |
| Streaming real time electrograms | No | Option available |