(93 days)
Not Found
No
The summary describes the use of "proprietary patented algorithms and methods" to compute spatial organization and display electrical rotors or focal beat sources. While this involves complex computation, there is no mention of AI, ML, deep learning, or any related terms. The performance studies focus on validation of specific algorithms and user interface, not on training or testing of a learning model.
No.
The device's intended use is to assist in the diagnosis of complex cardiac arrhythmias by analyzing and displaying electrophysiological signals, not to treat 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." Additionally, the "Device Description" states it aids "diagnosis by the physician during an electrophysiology study."
No
The device description explicitly states that RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters, which are hardware components. While the system is computerized and uses software for analysis and display, it relies on hardware input from these catheters.
Based on the provided information, the Rhythm View Workstation is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Rhythm View Workstation analyzes electrical signals collected from within the body using electrophysiology catheters. This is an in vivo measurement.
- The device's function is to analyze electrical signals and display them visually to assist in diagnosis. It does not perform tests on biological samples outside of the body.
The device is a computerized system that processes physiological signals collected directly from the patient's heart to aid in the diagnosis of cardiac arrhythmias. This falls under the category of a medical device that performs physiological signal analysis, 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
DOK
Device Description
RhythmView uses electrical signals collected from the electrodes of one or more multi-polar electrophysiology (EP) catheters. It provides a dynamic, simplified representation of wave propagation. The RhythmView computes and displays electrical rotors or focal beat sources that may sustain 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: Bench testing through software and user verification/validation protocols.
Sample size: Not specified.
AUC: Not specified.
MRMC: Not specified.
Standalone performance: Not specified.
Key results: The testing encompassed: Validation of the Stability Map and the default Stability Filter setting using clinical data sets. Verification that the Summation Maps generated are correct compilations of the RAP profiles from individual segments. Validate that RAP detects known rotational targets at least as well as prior versions of RAP. Validate the RAP functionality in RhythmView through Physician reads. Simulated User testing to evaluate new features of UI. The testing has demonstrated that the SW updates for RhythmView V6.1 provide reasonable assurance that the proposed device conforms to the appropriate requirements for its intended use.
Key Metrics
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/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three stylized human profiles facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2017
Abbott Electrophysiology Dennis Pozzo Senior Regulatory Affairs Specialist 3668 S. Gever Road. Suite 365 St. Louis, Missouri 63127
Re: K171583
Trade/Device Name: RhythmView Workstation 6.1 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: August 4, 2017 Received: August 8, 2017
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 (DICE) 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 (DICE) 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.
M.A. Wilhelm
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K171583
Device Name
RhythmView Workstation 6.1
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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (101) 443-6740 EF
3
Section 5: 510(k) Summary per 21CFR §807.92
| Submitter's
information | Abbott Electrophysiology
3668 S. Geyer Road, Suite 365
St. Louis, MO 63127
Contact: Dennis Pozzo
Phone 314-300-6580 | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Device/
classification
name | Device Name: RhythmView Workstation 6.1
●
Classification/Common name: Programmable diagnostic computer
●
Product Code/Classification No .: DQK/21 CFR 870.1425
●
The marketed device to which substantial equivalence is claimed:
●
RhythmView Workstation, K161240, cleared August 10, 2016
RhythmView Workstation, K151245, cleared September 15, 2015
(ventricular function) | |
| Device
description | RhythmView uses electrical signals collected from the electrodes of one or
more multi-polar electrophysiology (EP) catheters. It provides a dynamic,
simplified representation of wave propagation.
The RhythmView computes and displays electrical rotors or focal beat
sources that may sustain 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. | |
| 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 RhythmView Workstation currently 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 greyscale for the particular arrhythmia; Play/Replay the animated graphic representation of electrical signals. Review various display options to assist the provider with the identification of arrhythmia patterns. Evaluate the quality of the electrograms exported from the EP system to RhythmView Workstation ("Signal quality indicator" (SQI)) Enable an option to improvements usability of RAP ("RAP intensity scale" and "Spotlight" feature) Review the composite RAP profile (Stability Map) over the entire epoch under analysis (vs. just a single 4-second time segment) A method of thresholding the Stability Map image analysis tool for delineating the persistence of RAP over the course of the entire epoch A mechanism for displaying and selecting all time segments within an epoch ("epoch timeline") Create a procedure history within RhythmView ("Procedure Notebook") and allow the user to add freeform text notes. The RhythmView software is being modified to improve the feedback and usability during a RhythmView procedure by updating the following functions: Caliper tool; ECG lead; SQI; RAP calculation; and Stability map | |
4
Section 5: 510(k) Summary per 21CFR §807.92, Continued
5
Section 5: 510(k) Summary per 21CFR §807.92, Continued
| Device Characteristic | Predicate
RhythmView
Workstation | Proposed
RhvthmView
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 |
| OTS Software requirements | Same | Same |
| Display options for review of
processed signals
RAP display (optional) | · Electrical Activity
· Contours Only
· DContours
• Rotational Activity
Profile
• Composite RAP
image ("Stability
Map")
• Epoch timeline
· Spotlight
Multi-color with
monochromatic
option available | · Electrical Activity
• Contours Only
· DContours
· Rotational Activity
Profile
· Composite RAP
image ("Stability
Map")
• Epoch timeline
· Spotlight
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 not available | Option available |
| Signal Quality Indicator | Option available | Option available |
| Procedure Notebook | Option available | Option available |
| Device Characteristic | Predicate RhythmView
Workstation | Proposed RhythmView
Workstation |
| **Spotlight Feature | Option available | Option available |
| **Stability Map | Option available | Option available |
| **Epoch Timeline | Option available | Option available |
| Electrical Rating (Technological Comparison) | | |
| Electrical rating – Typical | 120V, 60Hz | 120V, 60Hz |
| Battery | 40 Ah, 12 V DC,
Lithium Iron Phosphate | 40 Ah, 12 V DC, Lithium
Iron Phosphate |
| RF Class per CISPR11 | Group1 | Group 1 |
6
Section 5: Summary per 21CFR §807.92, Continued
*Ventricular Function: predicate 510(k) K151245 **Atrial function only
Applicable standards
-
ISO 14971: 2012, Medical Devices Application of risk management ● to medical devices
Since there are no hardware updates, the EMC and Electrical Safety reports referenced K161240 still apply. -
. IEC 60601-1, 3rd Edition, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2: 2007, Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance -Collateral standard: Electromagnetic compatibility - Requirements and tests
7
Section 5: 510(k) Summary per 21CFR §807.92, Continued
| Performance
data | Bench testing has been conducted through software and user verification/
validation protocols to ensure the RhythmView Workstation meets its
intended use and user needs. |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The testing encompassed:
Validation of the Stability Map and the default Stability Filter setting
using clinical data sets Verification that the Summation Maps generated are correct
compilations of the RAP profiles from individual segments Validate that RAP detects known rotational targets at least as well as
prior versions of RAP. Validate the RAP functionality in RhythmView through Physician
reads Simulated User testing to evaluate new features of UI |
| Conclusion | The testing has demonstrated that the SW updates for RhythmView V6.1
provide reasonable assurance that the proposed device conforms to the |
appropriate requirements for its intended use. Therefore, it is substantially equivalent to the predicate device, safe and effective for its intended use.