(184 days)
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.
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.
The provided text does not contain specific acceptance criteria or details of a study demonstrating the device meets such criteria. It states that "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." However, it does not provide the specifics of this V&V testing, acceptance criteria, or the reported performance.
Therefore, I cannot provide the requested table and study details. The document is a 510(k) summary and the FDA's clearance letter, which describe the device, its intended use, and the regulatory decision, but do not elaborate on the specific performance study results.
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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, FRAPSPhone: 314-753-779010/15/2012 |
|---|---|
| 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. |
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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
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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
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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)
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Owen P. Faris -S
2013.04.24
10:31:49 -04'00'
§ 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).