(84 days)
No
The document describes a system for imaging, navigation, and mapping of the heart using ultrasound, ECG, EGM, and impedance-based localization. While it mentions software modifications for "Dynamic Referencing" which involves automatic detection of catheter drift/shift and guided notifications, the description of this feature does not explicitly mention or imply the use of AI or ML algorithms. The core functions described are based on established electrophysiology and imaging techniques.
No
The device is described as a diagnostic recording system intended for imaging, navigation, and mapping of heart chambers to help identify the source of arrhythmias. It provides information to physicians for diagnosis and planning, but does not directly treat the condition.
Yes
Explanation: The "Device Description" section explicitly states, "The AcQMap System is a diagnostic recording system." Furthermore, its intended use is to visualize chambers, display electrical impulses, identify sources of arrhythmias, and provide information about the electrical activity of the heart, all of which are diagnostic functions.
No
The device description explicitly states that the system consists of hardware components (AcQMap Console, Workstation, Auxiliary Interface Box) and is used in conjunction with a catheter. While software modifications are mentioned, the core system is not software-only.
Based on the provided information, the AcQMap High Resolution Imaging and Mapping System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- AcQMap System Function: The AcQMap System operates in vivo (within the living body). It uses ultrasound and electrical signals to image and map the electrical activity of the heart directly in the patient. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for use in patients for whom electrophysiology procedures have been prescribed, and it's used to visualize the heart chamber and display electrical impulses in situ.
- Device Description: The description confirms it's a diagnostic recording system used in the Electrophysiology (EP) Lab, capable of imaging, navigation, and mapping of the atrial chambers of the heart. It interacts directly with the patient via catheters and electrodes.
Therefore, the AcQMap High Resolution Imaging and Mapping System falls under the category of an in vivo diagnostic or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap High Resolution Imaging System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber and displaying electrical impulses as either charge density-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.
Product codes (comma separated list FDA assigned to the subject device)
DOK, ITX, IYO
Device Description
The AcQMap High Resolution Imaging and Mapping System (hereafter referred to as the AcQMap System) operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap System is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three (3) functional subsystems:
- . Ultrasound imaging,
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the AcQMap 3D Imaging and Mapping Catheter (hereafter referred to as the AcQMap Catheter). The AcQMap System provides:
- . 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound),
- 3-D position of the AcQMap Catheter and conventional electrophysiology catheters,
- . Cardiac electrical activity as waveform traces,
- . Contact LAT and voltage amplitude maps
- Remapping of the chamber at any time during the procedure; and
- . Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcQMap System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
In addition, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one (1) another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
There are no modifications to the hardware of the AcQMap System nor its accessories. The modifications to the AcQMap System are specific to the software, which include:
- The addition of the feature, Dynamic Referencing. Dynamic Referencing actively monitors impedance-based stability events like catheter drift or shift. Users will be offered guided notifications when shifts or drifts are automatically detected. Dynamic Referencing combines the capabilities of a Virtual Position Reference (VPR) and a Physical Position Reference (PPR), allowing them to be used together simultaneously. It is designed to be used instead of VPR or PPR alone. VPR and PPR remain available as options and
- Updated elements of the user interface to make it easier for the user to conduct a variety of actions within the software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
atrial chambers of the heart, Intracardiac Structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians in the Electrophysiology (EP) Lab
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)
Non-Clinical Testing Summary:
The necessary bench testing was performed on the subject device to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.
The following bench testing was repeated for the subject device:
- Software Verification and Validation.
The balance of testing is incorporated by reference to the original AcQMap System (K170948), includes the following: - Transportation Testing
- AcQMap High Resolution Imaging and Mapping Verification Testing
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
- Accuracy Validation Testing Animal Study
- Clinical Simulation (Reliability)
- Map Accuracy Evaluation
- In-vitro Localization Accuracy Study
The subject device was tested to verify that it meets the established performance specifications. The collective results of the testing demonstrate that the design of the subject device meets its established performance specifications necessary for performance during its intended use.
Clinical Testing Summary:
No further clinical testing is required to support the subject device. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and Left) Atrial Mapping and Assessment of Therapy in Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, nonrandomized, open-label study conducted at eight (8) clinical sites outside the U.S. The results for eightyfour (84) patients demonstrated that the AcQMap System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AcQMap High Resolution Imaging and Mapping System (K222209)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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July 10, 2023
Acutus Medical Inc Ryan Kenney Director, Regulatory Affairs 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K231091
Trade/Device Name: AcQMap High Resolution Imaging and Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DOK, ITX, IYO Dated: April 17, 2023 Received: April 17, 2023
Dear Ryan Kenney:
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 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
2
Indications for Use
510(k) Number (if known) K231091
Device Name
AcQMap High Resolution Imaging and Mapping System
Indications for Use (Describe)
The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap High Resolution Imaging System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber and displaying electrical impulses as either charge density-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.
| 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) |
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Image /page/3/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a bold, sans-serif font, with a small orange dot above the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font. The logo is simple and modern, and the orange dot adds a touch of color.
| Applicant/Correspondent: | Applicant/Correspondent Contact: |
|---|---|
| Acutus Medical, Inc. | Ryan Kenney |
| 2210 Faraday Ave., Suite 100 | Director, Regulatory Affairs |
| Carlsbad, CA 92008 USA | Email: ryan.kenney@acutus.com |
| Phone: +1 (442) 232-6080 | |
| Fax: +1 (442) 232-6081 |
| Date Prepared: | July 6, 2023 |
|---|---|
| Device Classification Name: | Computer, Diagnostic, Programmable |
| 510(k) Number: | K231091 |
| Device Name: | AcQMap High Resolution Imaging and Mapping System |
| Regulation Number: | 870.1425 |
| Classification Product Code: | DQK |
| Subsequent Product Codes: | ITX, IYO |
| Predicate Device: | AcQMap High Resolution Imaging and Mapping System (K222209) |
Device Description:
The AcQMap High Resolution Imaging and Mapping System (hereafter referred to as the AcQMap System) operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.
The AcQMap System is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three (3) functional subsystems:
- . Ultrasound imaging,
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the AcQMap 3D Imaging and Mapping Catheter (hereafter referred to as the AcQMap Catheter). The AcQMap System provides:
- . 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound),
- 3-D position of the AcQMap Catheter and conventional electrophysiology catheters,
- . Cardiac electrical activity as waveform traces,
- . Contact LAT and voltage amplitude maps
- Remapping of the chamber at any time during the procedure; and
- . Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcQMap System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia.
4
In addition, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one (1) another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter.
There are no modifications to the hardware of the AcQMap System nor its accessories. The modifications to the AcQMap System are specific to the software, which include:
- The addition of the feature, Dynamic Referencing. Dynamic Referencing actively monitors impedance-based stability events like catheter drift or shift. Users will be offered guided notifications when shifts or drifts are automatically detected. Dynamic Referencing combines the capabilities of a Virtual Position Reference (VPR) and a Physical Position Reference (PPR), allowing them to be used together simultaneously. It is designed to be used instead of VPR or PPR alone. VPR and PPR remain available as options and
- Updated elements of the user interface to make it easier for the user to conduct a variety of actions within the software.
Indications for Use Statement:
The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.
When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.
OR
When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.
5
UTUS® M D
Comparison of Technological Characteristics:
| Table 1: Comparison of Technological Characteristics | ||
|---|---|---|
| Characteristics | AcQMap High Resolution Imaging and Mapping System | |
| Predicate Device | ||
| (K222209) | AcQMap High Resolution Imaging and Mapping System | |
| Subject Device | ||
| (K231091) | ||
| Regulation | ||
| Number | 870.1425 | Same as K222209 |
| Classification | ||
| Product Code | DQK | Same as K222209 |
| Subsequent | ||
| Product Codes | ITX, IYO | Same as K222209 |
| Indications for Use | The AcQMap System is intended for use in patients for whom | |
| electrophysiology procedures have been prescribed. |
When used with the AcQMap Catheters, the AcQMap System
is intended to be used to reconstruct the selected chamber
from ultrasound data for purposes of visualizing the chamber
anatomy and displaying electrical impulses as either charge
density-based or voltage-based maps of complex arrhythmias
that may be difficult to identify using conventional mapping
systems alone.
AND
When used with the specified Patient Electrodes, the AcQMap
System is intended to display the position of AcQMap
Catheters and conventional electrophysiology (EP) catheters in
the heart.
OR
When used with conventional electrophysiology catheters, the
AcoMan System provides information about the electrical | Same as K222209 |
| Table 1: Comparison of Technological Characteristics | | |
| Characteristics | AcQMap High Resolution Imaging and Mapping System
Predicate Device
(K222209) | AcQMap High Resolution Imaging and Mapping System
Subject Device
(K231091) |
| | activity of the heart and about catheter location during the procedure. | |
| Patient Anatomy | • Intracardiac Structures | Same as K222209 |
| Testing to Support
Substantial
Equivalence | • Software Verification/Validation
• Electromagnetic and Electrical Safety
• Verification Testing
• Accuracy Testing
• Animal Testing | Same as K222209 |
| System Safety
Standards | • IEC 60601-1:2005 /A1:2012
• IEC 60601-1-2:2014
• IEC 60601-2-25:2015
• IEC 60601-2-37:2015
• IEC 62366-1: 2015 | Same as K222209 |
| Physical Characteristics | | |
| System
Components | • Console
• Workstation
• Workstation Cable
• Auxiliary Interface Box
• ECG Input Cable
• Ampere Ablation Catheter Adapter Cable
• Ampere RF Generator Adapter Cable
• ECG Output Cable
• Ablation Reference Cable
• Ablation Electrogram Cable
• ECG w/Snaps Cable
• ECG POST Cable
• 2mm Pin Jumper Set
• Patient Electrode Kit
• Ampere Generator Adapter | Same as K222209 |
| Table 1: Comparison of Technological Characteristics | | |
| Characteristics | AcQMap High Resolution Imaging and Mapping System Predicate Device (K222209) | AcQMap High Resolution Imaging and Mapping System Subject Device (K231091) |
| | SmartAblate Generator Adapter Maestro Generator Adapter Adapter Cable-Short - Ablation Adapter Adapter Cable-Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator Carto Force Adapter Cable DiamondTemp Generator Adapter DiamondTemp Adapter Cable - Generator | |
| Visual/Mapping Characteristics | 3-D cardiac chamber reconstructions - Contact and non-contact (ultrasound) 3-D position of the AcQMap Catheter and conventional electrophysiology catheters Cardiac electrical activity as waveform traces Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure Dynamic, 3-D, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation | Same as K222209 |
| Visualization Device/Catheter | AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters | Same as K222209 |
| Physical Characteristics – Console/Amplifier Comparison | | |
| Dimensions | 99 cm L x 58 cm W x 76 cm D | Same as K222209 |
| Weight Maximum | 80 kg | Same as K222209 |
| Power Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | Same as K222209 |
| Input Current | 4.6 A | Same as K222209 |
| Table 1: Comparison of Technological Characteristics | | |
| Characteristics | AcQMap High Resolution Imaging and Mapping System
Predicate Device
(K222209) | AcQMap High Resolution Imaging and Mapping System
Subject Device
(K231091) |
| Fuse Protection | 250 V, 6.3A, two high breaking capacity fuses | Same as K222209 |
| System Specifications | | |
| Safety Information | IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide | Same as K222209 |
| Ingress Protection | The Console is rated IP20 | Same as K222209 |
| Functional and Performance Characteristics | | |
| Ultrasound Output | Frequency: 10 MHz ± 400 kHz
Maximum Voltage: 50 V p-p
Maximum Power: 1 W Peak | Same as K222209 |
| Ultrasound
Performance | Single Operating Mode
Thermal Index: