(184 days)
Not Found
No
The summary describes a computerized system for analyzing electrogram and electrocardiogram signals and displaying them visually. It does not mention AI, ML, or any related terms, and the description of the software's function is consistent with traditional signal processing and display.
No
The device is used to assist in the diagnosis of cardiac arrhythmias by analyzing electrogram and electrocardiogram signals, not to treat them.
Yes
The device is used to "assist in the diagnosis of complex cardiac arrhythmias" by analyzing electrogram and electrocardiogram signals.
No
The device description explicitly states that the RhythmView is comprised of both hardware (Cart, Computer, monitor, keyboard, and mouse) and software.
Based on the provided information, the RhythmView™ Workstation is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- RhythmView's Function: The RhythmView Workstation analyzes electrical signals (electrogram and electrocardiogram) collected directly from the patient's body via catheters. It does not process samples taken from the body.
- Input: The input is electrical signals, not biological samples.
- Output: The output is a graphic display of these electrical signals to assist in diagnosis.
Therefore, the RhythmView Workstation falls under the category of a medical device that analyzes physiological signals in vivo (within the living body), rather than an in vitro diagnostic device.
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™M 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 is comprised of these major components,
- RhythmView hardware - Cart, 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
Not Found
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)
Based upon the RhythmView 4.0 Software V&V Testing and the documentation required to support a Moderate Level of Concern Software Device (per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices), it has been demonstrated that the RhythmView 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.
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
Special Premarket Notification Topera, Inc.
K123295 1/1 10/15/2012
.
Appendix 1: 510(k) Summary per 21CFR §807.92
APR 2 4 2013
RhythmView 510(k) Summary
| Submitter's information | Topera, Inc.
Contact: Melissa Walker, MS, RAC, FRAPS
Phone: 314-753-7790
10/15/2012 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device/classification name | Device Name: RhythmView WorkstationProduct Code: DQKRegulation Number: 870.1425Regulation Name: Programmable diagnostic computerClassification/Common name: Programmable diagnostic computer The marketed device(s) to which substantial equivalence is claimed: RhythmView 3.X K110878 |
| Device description | The RhythmView is comprised of these major components,
RhythmView hardware - Cart, Computer, monitor, keyboard, and mouseRhythmView 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. |
| Technological characteristics | The technological characteristics for the modified RhythmView Workstation are the same as the predicate. |
| Performance data | Based upon the RhythmView 4.0 Software V&V Testing and the documentation required to support a Moderate Level of Concern Software Device (per FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices), it has been demonstrated that the RhythmView is safe and effective for its intended use. |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure, with three flowing lines forming the body and head. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 24, 2013
Topera, Inc. C/O Ms. Melissa Walker, MS, RAC, FRAPS Sr. VP Regulatory, Quality, & Clinical 1324 Clarkson Clayton Ctr #332 Ballwin, MO 6301 1
Re: K123295
Trade Name: Rhythm View V4.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: II Product Code: DQK Dated: April 1, 2013 Received: April 2, 2013
Dear Ms. Walker:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
2
Page 2 - Ms. Melissa Walker
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/Resourcesfor You/Industry/default.htm. 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 vours,
Owen[PDFaris -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Appendix 2: Indications for Use Statement
Indications
Statement The Indications for Use Statement:
510(k) Number: K123295
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.
X Prescription Use 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 ___________________________________________________________________________________________________________________________________________________________________
Owen P. Faris -S
2013.04.24
10:31:49 -04'00'