(127 days)
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.
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.
The provided text describes the RhythmView Workstation SW V5.0, a computerized system that assists in the diagnosis of complex cardiac arrhythmias by analyzing electrogram and electrocardiogram signals.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document for the RhythmView Workstation SW V5.0 (K151245) indicates that the device's performance was evaluated through verification and validation testing, including Electrical Safety and EMC testing, and usability testing. The document states that these tests provide "reasonable assurance that the proposed device conformances to the appropriate requirements for its intended use" and that "it has been demonstrated that the RhythmView Workstation is safe and effective for its intended use."
However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and their corresponding reported performance values are not explicitly detailed in the provided text. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards rather than quantitative clinical performance metrics.
The "Device Characteristic" table in Appendix 1: 510(k) Summary compares the proposed and predicate RhythmView Workstations in terms of features and functionality. This table can be interpreted as a set of functional requirements or acceptance criteria for the new version, demonstrating that it either maintains existing functionality ("Yes" in both columns) or introduces new features ("Yes" in Proposed, "No" in Predicate).
| Device Characteristic | Expected Performance (Acceptance Criteria, implicit from Predicate) | Reported Device Performance (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 as Predicate | Same as Predicate |
| 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 (new feature) | Yes |
| Spotlight Feature | No (new feature) | Yes |
| Streaming real-time electrograms | No (new feature) | Option available |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the studies mentioned. The testing described is primarily focused on software and hardware verification/validation, and usability, rather than a clinical performance study with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the text. Given that the testing mentioned is primarily verification, validation, and usability, it's unlikely that a traditional "ground truth" for clinical performance, as established by multiple clinical experts, was a primary component of this regulatory submission.
4. Adjudication Method for the Test Set
This information is not provided in the text.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is described as "assisting" in diagnosis and displaying information for a physician's review, but there is no data presented on human reader performance improvement with or without the AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study of the algorithm is not explicitly mentioned in the provided text in terms of quantitative clinical metrics (e.g., sensitivity, specificity). The focus is on the workstation as a whole and its functionality in assisting a physician. The statement "The RhythmView then uses proprietary patented algorithms and methods to compute spatial organization during the heart rhythm disorder" confirms the presence of an algorithm, but its standalone performance is not quantified.
7. The Type of Ground Truth Used
The text does not explicitly state the type of ground truth used for any clinical performance evaluation. The "ground truth" for the verification and validation (V&V) testing would likely refer to engineering specifications and expected software behavior, and for usability testing, it would relate to user task completion and satisfaction. For the underlying algorithms that "compute spatial organization," the ground truth, if evaluated, would typically be established based on accepted electrophysiological principles or expert consensus in the field.
8. The Sample Size for the Training Set
The text does not provide any information regarding a training set sample size. This type of detail is typically associated with the development of the "proprietary patented algorithms and methods" but is not part of this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
The text does not provide any information regarding how the ground truth for a training set was established.
{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.
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'sinformation | Topera, Inc.3668 S. Geyer Road, Suite 365St. Louis, MO 63127Contact: Dennis PozzoPhone 314-300-6580 | |
|---|---|---|
| Device/classificationname | Device Name: RhythmView Workstation, SW V5.0Product Code: DQKClassification No: 21 CFR 870 1425Classification/Common name: Programmable diagnostic computerThe marketed device(s) to which substantial equivalence is claimed:K142901, cleared Dec. 19, 2014K130827, cleared Dec. 16, 2013K123295, cleared April 24, 2013K110878, 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 (optionalcomponent) | Software | |
| RhythmView takes electrical signals collected from multi-polarelectrophysiology catheters and outputs a graphic display that assists in thediagnosis of cardiac arrhythmias. | ||
| The Rhythm View computes and displays electrical rotors or focal beatsources 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 foruse | The RhythmView Workstation is a computerized system that assists in thediagnosis of complex cardiac arrhythmias. The RhythmView Workstation isused to analyze electrogram and electrocardiogram signals and display themin a visual format. |
|---|---|
| Technologicalcharacteristics | Both the proposed and predicate RhythmView Workstations allows the userto: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. |
| Performancedata | 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. |
| Consensusstandards | IEC 60601-1-2 Medical Electrical Equipment, General requirements for safety. Electromagnetic Compatibility and essential performanceIEC 62366 Medical Devices - Application of Usability Engineering to Medical Devices |
{5}------------------------------------------------
Appendix 1: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | PredicateRhythmView™Workstation | ProposedRhythmView™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 videoformat | Yes | Yes |
| Manual tagging by user ofelectrograms | No | No |
| OTS Software requirements | Same | Same |
| Display options for review ofprocessed signals | • Electrical Activity• Contours Only• DContours• Rotational ActivityProfile | • Electrical Activity• Contours Only• DContours• Rotational ActivityProfile” |
| RAP display (optional) | Monochromatic only | Multi-color withmonochromaticoption available |
| RFID Reader/Writer Function | Yes | Yes |
| Data transfer via Two Port Switch | Yes | Yes |
| Direct data transfer via USB cable toRV 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 |
§ 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).