(156 days)
The Ablamap® System 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.
The Ablacon Ablamap System is an electrophysiology mapping system used during electrophysiology procedures for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and a workstation with proprietary patented mapping software. Electrogram (EGM) signals are detected by 64-electrode mapping "basket" catheters which are input into, sampled, and amplified by the system's amplifier. The data is transmitted via fiber-optic cable from the amplifier to the workstation and processed by the system's mapping software with the results displayed on the monitor.
The system also accepts EGM data files recorded by EP amplifier recording systems from 64-electrode unipolar "basket" mapping catheters. The EGM data files are electrophysiology (EP) recordings that contain electrogram signals recorded by EP recording systems using 64-electrode "basket" mapping catheters. Compatible EP recording systems 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 the workstation and processed by the mapping software.
Compatible catheters are 64-electrode mapping "basket" catheters with the following dimensions: 50mm and 60mm sizes; an 8 spline x 8 electrode configuration with nominal electrode spacing of 0.354'' and 0.440" for 50mm and 60mm basket sizes respectively.
Through the software user interface, the user selects to record streamed EGM data from the Ablamap System signal amplifier that is saved to the workstation or the user selects an EGM data file recorded by an EP Recording System that has been saved to the workstation. The data file is processed by the Ablamap System software where the EGM signals are converted into electrographic flow® (EGF®) maps indicating flow consistency and direction of the action potential wave propagation during pre-defined 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 Summary Map is displayed that is the graphical representation of the summation 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 provided text, a 510(k) summary for the Ablamap® System, does not contain specific details about a clinical study involving human readers or comparative effectiveness for diagnostic performance. The document focuses on technological characteristics and engineering performance (verification and validation testing, usability testing) to demonstrate substantial equivalence to previously cleared devices.
Therefore, many of the requested details about a study proving the device meets acceptance criteria related to diagnostic performance cannot be extracted from this text. The acceptance criteria mentioned are general (e.g., "meets the specification requirements and performs as designed," "met the user needs and was found to be clinically acceptable").
However, I can extract the information that is present according to your numbered list:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, a direct quantitative table of acceptance criteria and reported device performance for diagnostic accuracy in a clinical setting is not available. The performance discussions relate to engineering verification and validation.
| Acceptance Criteria (General) | Reported Device Performance (General) |
|---|---|
| System meets specification requirements and performs as designed. | "The Ablamap® System is suitable for its intended use." (Page 7) |
| System meets user needs and is clinically acceptable. | "Validation testing... was found to be clinically acceptable by all evaluators." (Page 8) |
| Usability Objectives are met. | "Usability testing demonstrated that the Usability Objectives for the Ablamap® System were met with no User Errors observed." (Page 8) |
| Device meets design requirements and functions as intended. | "Testing demonstrated that the Ablamap® System met design requirements and functioned as intended." (Page 8) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the text for any clinical performance test. The document mentions "Verification Testing," "Validation Testing," and "Usability Testing," which typically involve engineering and usability evaluations rather than large-scale clinical accuracy studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided. While "evaluators" are mentioned for validation testing ("found to be clinically acceptable by all evaluators"), their number or qualifications are not specified. This typically refers to internal evaluators, not independent experts establishing ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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 submission focuses on demonstrating substantial equivalence primarily through technological characteristics and engineering performance, rather than a direct comparison of human reader performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The text states the system "assists in the diagnosis of complex cardiac arrhythmias" and "display results in a visual format for evaluation by a physician." This implies a human-in-the-loop use case. While the software processes EGM signals into EGF® maps, a standalone performance assessment of the algorithm's diagnostic accuracy without human interpretation is not described in this document.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The specific type of ground truth for diagnostic accuracy is not specified in the provided text, as a clinical performance study demonstrating diagnostic accuracy is not detailed. The "ground truth" implicitly referred to in the context of engineering verification and validation would be the design specifications and user needs.
8. The sample size for the training set:
Information regarding a "training set" (implying a machine learning or AI model development) and its sample size is not provided. The device processes EGM data and converts it into "electrographic flow® (EGF®) maps" using a "proprietary algorithm" and "Optical Flow" as the computation method (page 5). This description does not explicitly detail a neural network or machine learning model that would require a distinct "training set" in the context of typical AI device submissions.
9. How the ground truth for the training set was established:
As no training set is described, information on how its ground truth was established is not provided.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 8, 2023
Ablacon, Inc. Frank Rodrigues VP Ouality Assurance & Regulatory Affairs 4800 Wadsworth Blvd. Suite 310 Denver, Colorado 80033
Re: K230008
Trade/Device Name: Ablamap® System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: Class II Product Code: DOK Dated: December 31, 2022 Received: January 3, 2023
Dear Frank Rodrigues:
We have reviewed vour 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
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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 S. Deoras -S
Aneesh Deoras Assistant Director 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) K230008
Device Name Ablamap® System
Indications for Use (Describe)
The Ablamap® System 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 made up of two triangles that are joined together at their vertices. The word "ablacon" is written in a sans-serif font.
510(k) Summary
| Date summary prepared: | December 30, 2022 |
|---|---|
| 510(k) Submitter/Holder: | Ablacon, Inc.4800 Wadsworth Blvd. Ste 310Wheat Ridge, CO 80033 |
| Contact: | Frank RodriguesVP Quality Assurance & Regulatory AffairsTelephone: 303-955-5763Fax: 720-390-7541Email: fr@ablacon.com |
| Trade Name: | Ablamap® System |
| Common Name: | Diagnostic System |
| Classification Name: | Programmable Diagnostic Computer |
| Classification: | Class II |
| Product Code: | DQK |
| Review Panel: | Cardiovascular |
| Regulation: | 21 CFR 870.1425 |
| 510(k) Number: | K230008 |
| Predicate Device(s): |
| Trade/ProprietaryName: | Ablamap® Software(Primary) | LabSystem Pro™ EP RecordingSystem (Secondary) |
|---|---|---|
| Common/Usual Name: | Diagnostic Computer | Diagnostic Computer |
| Classification Name: | Programmable DiagnosticComputer | Programmable Diagnostic Computer |
| Class: | Class II | Class II |
| Product Code: | DQK | DQK |
| Regulation: | 21 CFR 870.1425 | 21 CFR 870.1425 |
| Review Panel: | Cardiovascular | Cardiovascular |
| 510(k)Submitter/Holder: | Ablacon, Inc.4800 Wadsworth Blvd. Ste 310Wheat Ridge, CO 80033 | Boston Scientific Corp.55 Technology Dr.Lowell, MA 01851 |
| 510(k) #s: | K203084 | K141185 |
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Image /page/4/Picture/0 description: The image shows the Ablacon logo. The logo consists of a stylized orange heart shape on the left and the word "ablacon" in black, sans-serif font on the right. The heart shape is made up of several triangles, creating a faceted appearance. The word "ablacon" is written in lowercase letters.
Device Description
The Ablacon Ablamap System is an electrophysiology mapping system used during electrophysiology procedures for assisting in the diagnosis of complex cardiac arrhythmias. The system consists of several hardware elements including an amplifier, cart, monitor, and a workstation with proprietary patented mapping software. Electrogram (EGM) signals are detected by 64-electrode mapping "basket" catheters which are input into, sampled, and amplified by the system's amplifier. The data is transmitted via fiber-optic cable from the amplifier to the workstation and processed by the system's mapping software with the results displayed on the monitor.
The system also accepts EGM data files recorded by EP amplifier recording systems from 64electrode unipolar "basket" mapping catheters. The EGM data files are electrophysiology (EP) recordings that contain electrogram signals recorded by EP recording systems using 64-electrode "basket" mapping catheters. Compatible EP recording systems 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 the workstation and processed by the mapping software.
Compatible catheters are 64-electrode mapping "basket" catheters with the following dimensions: 50mm and 60mm sizes; an 8 spline x 8 electrode configuration with nominal electrode spacing of 0.354'' and 0.440" for 50mm and 60mm basket sizes respectively.
Through the software user interface, the user selects to record streamed EGM data from the Ablamap System signal amplifier that is saved to the workstation or the user selects an EGM data file recorded by an EP Recording System that has been saved to the workstation. The data file is processed by the Ablamap System software where the EGM signals are converted into electrographic flow® (EGF®) maps indicating flow consistency and direction of the action potential wave propagation during pre-defined 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 Summary Map is displayed that is the graphical representation of the summation 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.
Intended Use
The Ablamap® System 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® System 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 System is an electrophysiological mapping system that uses a proprietary algorithm to process EGM signals and display electrical wave propagation information in a visual
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Image /page/5/Picture/0 description: The image shows the Ablacon logo. The logo consists of an orange, geometric shape resembling a stylized heart or diamond on the left, followed by the word "ablacon" in a bold, sans-serif font. The text is in a dark gray or black color, providing a strong contrast against the white background.
format during pre-defined time intervals. The intended use, indications for use, and fundamental performance are the same as the primary predicate device.
A comparison summary of the technological characteristics of the subject device and the predicate devices are as follows:
| Device Characteristic | Subject DeviceAblamap® System(K230008) | Predicate Device(Primary)Ablamap®Software(K203084) | Predicate Device(Secondary)Boston ScientificLabSystem Pro™ EPRecording System(K141185)(Clearsign Amplifiercomponent only) |
|---|---|---|---|
| Device Classification,Classification Name,and Product CodeIndications For Use | Same | Same | Same |
| Indications For Use | Used to analyze electrogram(EGM) signals and displayresults in a visual format forevaluation by a physician inorder to assist in thediagnosis of complex cardiacarrhythmias. | Same | A computer andsoftware driven dataacquisition andanalysis tool designedto facilitate thegathering, display,analysis by aphysician, pacemapping and storageof cardiacelectrophysiologicdata. |
| Intended Use | Intended to be used duringelectrophysiology procedureson patients for whom anelectrophysiology procedurehas been prescribed and onlyby qualified medicalprofessionals who are trainedin electrophysiology. | Same | Same |
| System | Components include anamplifier, cart, monitor, anda computer workstation withAblamap® mapping software. | Same (excludingamplifier)Stand-alone softwaremay be installed onany commerciallyavailable computermeeting minimumperformancespecifications e.g. aworkstation and | Amplifier componentonly |
| Device Characteristic | Subject DeviceAblamap® System(K230008) | Predicate Device(Primary)Ablamap®Software(K203084) | Predicate Device(Secondary)Boston ScientificLabSystem Pro™ EPRecording System(K141185)(Clearsign Amplifiercomponent only) |
| Compatible DiagnosticCatheters | 64-electrode unipolar"basket" mapping catheters;50mm and 60mm sizes; 8spline x 8 electrode withnominal electrode spacing of0.354" and 0.440" for 50mmand 60mm basket sizesrespectively. | Same | Same |
| Compatible EPRecording Systems | Boston ScientificLabSystem Pro™ | Same | N/A |
| GE HealthcareCardioLab™ | Same | N/A | |
| St. Jude MedicalWorkMate™ Claris System | Same | N/A | |
| Signal amplificationup to 140 channels | Yes | No | Yes; 40 to 160channels |
| Amplifies EGM andECG signals andtransmits to aWorkstation | Yes | No | Yes |
| Signal filter settings-Notch (Power Line)-High-Pass | - Yes- Yes | - No- Same | - Yes- Yes |
| Signal processing(EGM) | Yes | Same | N/A |
| Post-processingdisplay | Yes | Same | N/A |
| Grid display ofelectrode signals | Yes | Same | N/A |
| Graphic display viewof signal potentials(wave propagation) | Yes | Same | N/A |
| Method to select anddisplay all timesegments of the entireelectrogram recording | Yes | Same | N/A |
| Play/replay animated(film) graphicrepresentation of | Yes | Same | N/A |
| Device Characteristic | Subject DeviceAblamap® System(K230008) | Predicate Device(Primary)Ablamap®Software(K203084) | Predicate Device(Secondary)Boston ScientificLabSystem Pro™ EPRecording System(K141185)(Clearsign Amplifiercomponent only) |
| signalsVarious displayoptions to assist theuser with identificationof arrhythmia patterns | Electrical activityRotational activityRecording timelineStability/VariabilityFlow consistency | Same | N/A |
| Evaluate the quality ofthe electrogramrecording | Yes | Same | N/A |
| Display theelectrogram andelectrocardiogramsignals (EGM chartincluding ECGsignals) | Yes | Same | N/A |
| Select and review atime sequence of thesignals from variouselectrodes | Yes | Same | N/A |
| Programminglanguage | Object-oriented (Python) | Same | N/A |
| Processingcomputation methodfor electrical wavepropagation | Optical Flow | Same | N/A |
| Generate a procedurehistory file | Yes | Same | N/A |
| Allow user to add textnotes/comments | Yes | Same | N/A |
| Anatomical locationcapability | No | No | No |
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Image /page/6/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 font of the word "ablacon" is sans-serif and appears to be bolded.
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Image /page/7/Picture/0 description: The image shows the Ablacon logo. The logo consists of an orange, geometric shape resembling a stylized heart or diamond on the left. To the right of the shape is the word "ablacon" in a bold, sans-serif font. The text is in a dark gray or black color, providing a strong contrast against the white background.
Performance Data
Performance testing was completed on the Ablamap® System which verified that the system meets the specification requirements and performs as designed. The Ablamap® System is suitable for its intended use.
Bench Testing for the subject device included and applied the following standards:
- IEC 60601-1 Ed. 3.1 and applicable Collateral Standards .
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Image /page/8/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 made up of four triangles that form a heart shape. The word "ablacon" is written in a sans-serif font.
- IEC 62304 Edition 1.1 2015-06 Medical device software Software life cycle processes
- ANSVAAMI/IEC 62366-1:2015 Medical devices Part 1: Application of usability ● engineering to medical devices
- . ISO 15223-1:2021 Medical devices - Symbols to be used with information to be supplied by the manufacturer; Part 1: General Requirements
Verification Testing
Verification testing was performed demonstrating the Ablamap® System met design specifications.
Validation Testing
Validation testing was performed demonstrating the Ablamap® System met the user needs and was found to be clinically acceptable by all evaluators.
Usability Testing
Usability testing demonstrated that the Usability Objectives for the Ablamap® System were met with no User Errors observed.
Testing demonstrated that the Ablamap® System met design requirements and functioned as intended.
Conclusion
The data presented in this submission demonstrates that the proposed Ablamap® System operated as intended and is substantially equivalent to the cleared primary predicate device. the Ablamap Software, and the signal amplifier component of the cleared secondary predicate device, the Boston Scientific LabSystem Pro™ EP Recording System.
§ 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).