(66 days)
None
No
The summary mentions "proprietary patented algorithms and methods" but does not explicitly mention AI, ML, or related terms, nor does it describe characteristics typically associated with AI/ML development like training or test sets.
No
The device is used for the diagnosis of cardiac arrhythmias by analyzing electrogram and electrocardiogram signals, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that "The Rhythm View Workstation is a computerized system that assists in the diagnosis of complex cardiac arrhythmias." The "Device Description" also mentions that the output "assists in the diagnosis of cardiac arrhythmias" and "to aid diagnosis by the physician during an electrophysiology study."
No
The device description explicitly lists multiple hardware components (Cart, Keyboard, Monitor/Display, Mouse, RFID Reader/Writer, Two Port USB Switch, Solid State Hard Drive) in addition to the computer software. The performance studies also include hardware testing.
Based on the provided information, the Rhythm View Workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Rhythm View Workstation's Function: The Rhythm View Workstation analyzes electrical signals (electrogram and electrocardiogram signals) collected directly from within the heart during an electrophysiological study. It does not analyze biological specimens.
- Intended Use: The intended use is to assist in the diagnosis of cardiac arrhythmias by analyzing electrical signals and displaying them visually. This is a direct physiological measurement and analysis, not an in vitro test.
Therefore, the Rhythm View Workstation falls under the category of a medical device that analyzes physiological signals, not an IVD.
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
DQK
Device Description
The RhythmView™ Workstation is comprised of the following components:
Cart
Keyboard
Monitor/Display
Mouse
Computer
Software
Radio-Frequency Identification (RFID) Reader/Writer (new component)
Two Port USB Switch (new component)
Solid State Hard Drive (new optional component)
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 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, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed 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 Rhythm View™ 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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines beneath them. The profiles are black, and the text is also in black.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2014
Topera, Inc. Dennis Pozzo Senior Regulatory Affairs Master Specialist 3668 S. Gever Road. Suite 365 St. Louis, Missouri 63127
K142901 Trade/Device Name: Rhythmview Workstation Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK Dated: November 24, 2014 Received: November 25, 2014
Dear Dennis Pozzo,
Re:
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 yours,
Melissa A. Torres -S
For Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
RhythmView Workstation
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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
Date: May XX, 2014 | | | | | | | | | | |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|
| Device/classification name | Device Name: RhythmView™ Workstation Classification/Common name: Programmable diagnostic computer The marketed device(s) to which substantial equivalence is claimed: 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 Software Radio-Frequency Identification (RFID) Reader/Writer (new component) Two Port USB Switch (new component) Solid State Hard Drive (new optional component) | | | | | | | | | | |
| | 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 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.
Continued on next page
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 are software
driven devices that translate electrical signals within the heart into graphic
representations in order to assist the physician in diagnosis. They also allow
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. Furthermore, The ventricular maps appear in the panoramic animation display in the
same manner as atrial maps. All of the same display options available in atrial maps may be used
for ventricular maps. |
Continued on next page
5
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Predicate Device
RhythmView™ 4.1 | Proposed Device
RhythmView™ 4.2 |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| 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" |
| RFID Reader/Writer Function | No | Yes |
| Data transfer via Two Port Switch | No | Yes |
| Direct data transfer via USB cable
to RV Workstation from EP system | No | Option available |
| Atrial Function | Yes | Yes |
| Ventricular Function | No | Option available |
The Software, Hardware (RFID, Two Port USB Switch and SSD Performance data Qualification Testing and EMC Testing) and User testing that have been performed 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 Rhythm View™ Workstation is safe and effective for its intended use.