(322 days)
No
The description mentions a "proprietary patented algorithm" but does not use any terminology typically associated with AI or ML (e.g., neural networks, deep learning, machine learning, AI). The processing described appears to be deterministic signal processing and visualization.
No.
The device is described as assisting in the diagnosis of complex cardiac arrhythmias by analyzing electrogram signals and displaying results. It does not directly treat or prevent a disease or condition; it provides information to a physician for diagnostic purposes.
Yes
The 'Intended Use / Indications for Use' section explicitly states that the software is used "to assist in the diagnosis of complex cardiac arrhythmias." Additionally, the 'Device Description' mentions that the graphical maps generated by the software "are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias."
Yes
The device description explicitly states "The Ablacon Ablamap® Software is a stand-alone software device". While it processes data from other medical devices (catheters and EP recording systems), the device itself is the software installed on a standard PC.
Based on the provided information, the Ablamap® Software is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to obtain information for diagnostic or monitoring purposes.
- Ablamap® Software's Function: The Ablamap® Software analyzes electrogram (EGM) signals which are electrical signals recorded directly from within the heart during an electrophysiology procedure. These are not specimens taken from the body in the traditional sense of an IVD.
- Input Data: The input data is described as "electrophysiology (EP) recordings that contain intra-cardiac electrogram signals." This is in-vivo data, not in-vitro data.
- Purpose: The software assists in the diagnosis of complex cardiac arrhythmias by analyzing these electrical signals and presenting them visually. While it aids in diagnosis, it does so by processing in-vivo electrical activity, not by analyzing biological specimens.
Therefore, the Ablamap® Software falls under the category of a medical device that processes physiological signals, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
Product codes
DOK
Device Description
The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed.
The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.
A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes.
These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.
The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. The device analyzes electrogram (EGM) signals.
Anatomical Site
Not Found. It analyzes intra-cardiac electrogram signals.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Ablamap® Software is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.
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)
Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed. The Ablamap Software is suitable for its intended use. Performance testing for the subject device included the following: Software design verification and validation testing was performed and complies with: IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes. ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices ISO 14971:2007 Medical devices Application of risk management to medical devices. The software is considered minor level of concern in accordance with FDA guidelines as a malfunction or failure would not likely contribute to a hazard leading to an injury. Software usability testing was performed as part of verification and validation testing for functionality and performance. Testing demonstrated that the software met design requirements and functioned as intended.
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
August 31, 2021
Ablacon, Inc. Frank Rodrigues V.P. of Quality Assurance/Regulatory Affairs 4800 Wadsworth Blvd. Suite 310 Wheat Ridge, Colorado 80033
Re: K203084
Trade/Device Name: Ablamap® Software Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK Dated: July 20, 2021 Received: July 30, 2021
Dear Frank Rodrigues:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director (Acting) Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203084
Device Name Ablamap® Software
Indications for Use (Describe)
The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
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)
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Image /page/3/Picture/0 description: The image shows the Ablacon logo. The logo consists of an orange heart-shaped icon on the left and the word "ablacon" in black letters on the right. The heart-shaped icon is a stylized heart with a gradient from light to dark orange. The word "ablacon" is written in a sans-serif font.
510(k) Summary per 21 CFR 807.92
| Date summary prepared: | April 29, 2021 |
|---|---|
| 510(k) Submitter/Holder: | Ablacon, Inc. |
| 4800 Wadsworth Blvd. Ste 310 | |
| Wheat Ridge, CO 80033 | |
| Contact: | Frank Rodrigues |
| VP Quality Assurance & Regulatory Affairs | |
| Telephone: 303-955-5763 | |
| Fax: 720-390-7541 | |
| Email: fr@ablacon.com | |
| Trade Name: | Ablamap® Software |
| Common Name: | Diagnostic Software |
| Classification Name: | Programmable Diagnostic Computer |
| Classification: | Class II |
| Product Code: | DQK |
| Review Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1425 |
Predicate Device(s):
| Trade/Proprietary Name: | RhythmView™ Workstation |
|---|---|
| Common/Usual Name: | Diagnostic Computer |
| Classification Name: | Programmable Diagnostic Computer |
| Class: | Class II |
| Product Code: | DQK |
| Regulation: | 21 CFR 870.1425 |
| Review Panel: | Cardiovascular |
| 510(k) Submitter/Holder: | Abbott Electrophysiology |
| 3668 S. Geyser Road Ste 365 | |
| St. Louis, MO 63127 | |
| 510(k) #s: | K171583 |
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Device Description
The Ablacon Ablamap® Software is a stand-alone software device that uses a proprietary patented algorithm to process electrogram (EGM) signals from data files. The EGM data files are electrophysiology (EP) recordings that contain intra-cardiac electrogram signals recorded by EP recording systems using Abbott Electrophysiology FIRMap™ Catheters, 50mm and 60mm sizes; cleared under 510(k) K163709; a 64-electrode "basket" mapping catheter. The EP recording systems used are the Boston Scientific LabSystem Pro™, the GE Healthcare CardioLab™ XT, and the St. Jude Medical WorkMate™ Claris System. The recorded EGM data files are saved onto a computer with the Ablamap® Software installed.
The user selects an EGM data file through the software user interface and the file is processed by the software where the EGM signals are converted into electrographic flow (EGFTM) maps indicating relative velocity and direction of the action potential wave propagation during predefined time intervals. The resulting EGF™ film maps display the flow with respect to the catheter electrodes and show the activity of sources of excitation where action potentials originate.
A prevalence map is displayed that is the graphical representation of the activity of EGF™ sources from all segments of the EGM data file recording indicating the rate of occurrence i.e. prevalence of sources of EGF™ with respect to the catheter electrodes.
These graphical maps are evaluated by the physician to assist in the diagnosis of complex cardiac arrhythmias during electrophysiology procedures.
The Ablamap® Software may be installed on any commercially available workstation personal computer (PC) with a Linux Ubuntu 18 LTS operating system and that meets minimum requirements for CPU and GPU processing, random access memory (RAM), and hard drive size.
Intended Use
The Ablamap® Software is intended to be used during electrophysiology procedures on patients for whom an electrophysiology procedure has been prescribed and only by qualified medical professionals who are trained in electrophysiology.
Indications for Use
The Ablamap® Software is used to analyze electrogram (EGM) signals and display results in a visual format for evaluation by a physician in order to assist in the diagnosis of complex cardiac arrhythmias.
Comparative Technological Characteristics
The Ablacon Ablamap® Software is an electrophysiological mapping application that uses a proprietary algorithm to process EGM signals and display electrical wave propagation information in a visual format during pre-defined time intervals. The intended use, indications for use, and fundamental performance are the same as the predicate device.
A comparison summary of the technological characteristics of the subject device and the predicate device are as follows:
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| Device Characteristic | Subject Device
Ablamap® Software | Predicate Device
Abbott
Electrophysiology
RhythmView™
Workstation (K171583) |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Device classification, Class, and
Product code | Same | Same |
| Indications For Use | Used to analyze electrogram
(EGM) signals and display
results in a visual format for
evaluation by a physician in
order to assist in the diagnosis
of complex cardiac
arrhythmias | Same |
| Intended Use | Intended to be used during
electrophysiology procedures
on patients for whom an
electrophysiology procedure
has been prescribed and only
by qualified medical
professionals who are trained
in electrophysiology. | Same |
| System | Stand-alone software that may
be installed on any
commercially available
computer meeting minimum
performance specifications. | Fundamentally the same.
Workstation cart with
software installed on a
desktop computer with
monitor, keyboard and
mouse. |
| Compatible Diagnostic Catheters | Abbott Electrophysiology
FIRMap™ Catheter; 50mm
and 60mm sizes | Same |
| Compatible EP Recording Systems | Boston Scientific
(formerly C.R. Bard)
LabSystem Pro™ | Same |
| | GE Healthcare
(formerly Prucka)
CardioLab™ | Same |
| | St. Jude Medical
(formerly EP MedSystems)
WorkMate™ Claris System | Same |
| Signal processing | Yes | Yes |
| Post-processing display | Yes | Yes |
| Grid display of electrode signals | Yes | Yes |
| Graphic display view of signal
potentials (wave propagation) | Yes | Yes |
| Method to select and display all time | Yes | Yes |
| segments of the entire electrogram
recording | | |
| Play/replay animated (film) graphic
representation of signals | Yes | Yes |
| Various display options to assist the
user with identification of
arrhythmia patterns | Electrical activity
Rotational activity
Recording timeline
Variability (Stability) | Same |
| Evaluate the quality of the
electrogram recording exported from
the EP recording system | Yes | Yes |
| Display the electrogram signals
(EGM chart) | Yes | Yes |
| Select and review a time sequence of
the electrogram signals from various
electrodes | Yes | Yes |
| Programming language | Object-oriented (Python) | Fundamentally the same.
Object-oriented (C++) |
| Processing computation method for
electrical wave propagation | Optical Flow | Phase Angle |
| Generate a procedure history file | Yes | Yes |
| Allow user to add text
notes/comments | Yes | Yes |
| Anatomical location capability | No | No |
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Performance
Performance testing was completed on the Ablamap® Software which verified that the software device meets the specification requirements and performs as designed. The Ablamap Software is suitable for its intended use.
Performance testing for the subject device included the following:
Software design verification and validation testing was performed and complies with:
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes .
- ANSI/AAMI/IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- ISO 14971:2007 Medical devices Application of risk management to medical devices .
The software is considered minor level of concern in accordance with FDA guidelines as a malfunction or failure would not likely contribute to a hazard leading to an injury.
Software usability testing was performed as part of verification and validation testing for functionality and performance.
Testing demonstrated that the software met design requirements and functioned as intended.
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Conclusion
The data presented in this submission demonstrates that the proposed Ablacon Ablamap® Software operated as intended and is substantially equivalent to the cleared predicate device, the Abbott Electrophysiology RhythmView™ Workstation.