(49 days)
Unknown
The description mentions "proprietary patented algorithms and methods" but does not explicitly state whether these algorithms utilize AI or ML. The lack of mention of training or test sets further suggests that AI/ML may not be involved, but it's not conclusive.
No.
The device is used to assist in the diagnosis of complex cardiac arrhythmias by analyzing and displaying electrogram and electrocardiogram signals, not to treat or modify a physiological function.
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" section mentions that the system displays information to "aid diagnosis by the physician."
No
The device description explicitly lists hardware components such as a Cart, Monitor/Display, Computer, Keyboard, and Mouse as part of the RhythmView™ Workstation, in addition to the software.
Based on the provided information, the Rhythm View™ Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices analyze specimens taken from the human body. The Rhythm View™ Workstation analyzes electrical signals collected directly from within the heart during an electrophysiological study. These are not specimens like blood, urine, or tissue.
- The device's function is to process and display electrical signals to assist in diagnosis. It doesn't perform tests on biological samples to detect diseases or conditions.
The Rhythm View™ Workstation falls under the category of a medical device that processes physiological signals for diagnostic assistance.
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 RhythmView™ Workstation is used to analyze electrogram and electrocardiogram signals and display them in a visual format.
Product codes
DQK
Device Description
The RhythmView™ Workstation is comprised of the following components: Cart, Monitor/Display, Computer, Keyboard, Mouse, 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 RhythmView™ 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 Rhythm View™ 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)
Based upon the software testing that has been performed, which provide reasonable assurance that the proposed device has been tested to verify conformance to requirements for its intended use. 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)
Reference Device(s)
Not Found
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
Special Premarket Notification Topera, Inc., Rhythm ViewTM Workstation 4.1 October 24, 2013
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
Date: Oct. 24, 2013 | DEC 16 2013 | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--|--|--|
| Device/
classification
name | Device Name: RhythmView™ Workstation
Classification/Common name: Programmable diagnostic computer
The marketed device(s) to which substantial equivalence is claimed:
• 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 | 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 RhythmView™ 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 Rhythm View™ 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.
Continued on next page
1
Special Premarket Notification Topera, Inc., RhythmView™ Workstation 4.1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Indications for
use | The Rhythm View™ 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 Rhythm View™ 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 (or replay) this animated graphic representation of electrical
signals.
The new Rhythm View™ provides an additional display option, "Rotational
Activity Profile" display as an overlay on the UI.
Both are software driven devices that translate electrical signals within the
heart into graphic representations in order to assist the physician in diagnosis. | | | | | |
| | Device Characteristic | Predicate Device
Rhythm View™ 4.0 | Proposed Device
Rhythm View™ 4.1 | | | |
| | 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 | | | |
2
Special Premarket Notification Topera, Inc., RhythmView™ Workstation 4.1
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Technological
characteristics
continued | Display options for
review of processed
signals | • Electrical Activity
• Contours Only
• DContours
• P+RContours
• P+Contours
• P+DContours | • Electrical Activity
• Contours Only
• DContours
• Rotational Activity
Profile” |
|-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Performance
data | Based upon the software testing that has been performed, which provide
reasonable assurance that the proposed device has been tested to verify
conformance to requirements for its intended use. Therefore, it has been
demonstrated that the RhythmView™ Workstation is safe and effective for its
intended use. | | |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 16, 2013
Topera, Inc. Mr. Dennis Pozzo 3668 S. Geyer Road Suite 365 St. Louis, MO 63127 US
Re: K133305
Trade/Device Name: Rhythm View Workstation V4.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 15, 2013 Received: November 18, 2013
Dear Mr. 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.
4
Page 2 - Mr. Dennis Pozzo
ーンでおーしい
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 devicerelated 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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,
Owen P. Faris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Appendix 2: Indications for Use Statement
Statement The Indications for Use Statement:
510(k) Number: K_133305
Device Name: Rhythm View™ Workstation
The Rhythm View™ 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.
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)
Digitally signed by Owen
P. Faris -S
Date: 2013.12.16 16:30:51
-05'00'
Page _ of _