AcQMap High Resolution Imaging and Mapping System

K231091 · Acutus Medical, Inc. · DQK · Jul 10, 2023 · Cardiovascular

Device Facts

• Record ID: K231091
• Device Name: AcQMap High Resolution Imaging and Mapping System
• Applicant: Acutus Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 10, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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.

Device Story

Diagnostic computer-based system for EP labs; used by physicians to map atrial chambers. Inputs: ultrasound data (for chamber reconstruction), ECG/EGM signals, and impedance-based electrode localization. System transforms inputs into 3D cardiac reconstructions, catheter position tracking, and electrical activation maps (charge density/voltage). Features include Dynamic Referencing (monitoring catheter stability via VPR/PPR) and user interface updates. Output: 3D visual maps and waveform traces displayed on workstation. Physicians use output to identify arrhythmia sources and guide treatment decisions. Benefits: improved visualization of complex arrhythmias and real-time remapping capabilities.

Clinical Evidence

No new clinical testing performed. Relies on clinical validation of the original AcQMap System (K170948). The DDRAMATIC-SVT study (prospective, nonrandomized, open-label, 84 patients) demonstrated safety and effectiveness. Bench testing for the subject device included software verification and validation.

Technological Characteristics

Computer-based diagnostic system; console, workstation, auxiliary interface box. Ultrasound imaging (10 MHz), impedance-based localization (15-50 kHz), ECG/EGM recording (0.05-500 Hz). Connectivity via wired interfaces. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-25, IEC 60601-2-37. Software-based mapping and reconstruction.

Indications for Use

Indicated for patients undergoing electrophysiology procedures. Used for cardiac chamber reconstruction, visualization of anatomy, display of electrical impulses (charge density or voltage-based maps), and localization of EP catheters.

Regulatory Classification

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.

Predicate Devices

• AcQMap High Resolution Imaging and Mapping System (K222209)

Reference Devices

• AcQMap High Resolution Imaging and Mapping System (K170948)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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) 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) | |
|---------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> □ Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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: [e-mail] |
| Phone: [phone] | |
| Fax: [phone] | |

| 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.

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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.

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## Comparison of Technological Characteristics:

| Table 1: Comparison of Technological Characteristics | | |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Characteristics | AcQMap High Resolution Imaging and Mapping System<br>Predicate Device<br>(K222209) | AcQMap High Resolution Imaging and Mapping System<br>Subject Device<br>(K231091) |
| Regulation<br>Number | 870.1425 | Same as K222209 |
| Classification<br>Product Code | DQK | Same as K222209 |
| Subsequent<br>Product Codes | ITX, IYO | Same as K222209 |
| Indications for Use | The AcQMap System is intended for use in patients for whom<br>electrophysiology procedures have been prescribed.<br><br>When used with the AcQMap Catheters, the AcQMap System<br>is intended to be used to reconstruct the selected chamber<br>from ultrasound data for purposes of visualizing the chamber<br>anatomy and displaying electrical impulses as either charge<br>density-based or voltage-based maps of complex arrhythmias<br>that may be difficult to identify using conventional mapping<br>systems alone.<br><br>AND<br><br>When used with the specified Patient Electrodes, the AcQMap<br>System is intended to display the position of AcQMap<br>Catheters and conventional electrophysiology (EP) catheters in<br>the heart.<br><br>OR<br><br>When used with conventional electrophysiology catheters, the<br>AcoMan System provides information about the electrical | Same as K222209 |
| Table 1: Comparison of Technological Characteristics | | |
| Characteristics | AcQMap High Resolution Imaging and Mapping System<br>Predicate Device<br>(K222209) | AcQMap High Resolution Imaging and Mapping System<br>Subject Device<br>(K231091) |
| | activity of the heart and about catheter location during the procedure. | |
| Patient Anatomy | • Intracardiac Structures | Same as K222209 |
| Testing to Support<br>Substantial<br>Equivalence | • Software Verification/Validation<br>• Electromagnetic and Electrical Safety<br>• Verification Testing<br>• Accuracy Testing<br>• Animal Testing | Same as K222209 |
| System Safety<br>Standards | • IEC 60601-1:2005 /A1:2012<br>• IEC 60601-1-2:2014<br>• IEC 60601-2-25:2015<br>• IEC 60601-2-37:2015<br>• IEC 62366-1: 2015 | Same as K222209 |
| Physical Characteristics | | |
| System<br>Components | • Console<br>• Workstation<br>• Workstation Cable<br>• Auxiliary Interface Box<br>• ECG Input Cable<br>• Ampere Ablation Catheter Adapter Cable<br>• Ampere RF Generator Adapter Cable<br>• ECG Output Cable<br>• Ablation Reference Cable<br>• Ablation Electrogram Cable<br>• ECG w/Snaps Cable<br>• ECG POST Cable<br>• 2mm Pin Jumper Set<br>• Patient Electrode Kit<br>• 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<br>Predicate Device<br>(K222209) | AcQMap High Resolution Imaging and Mapping System<br>Subject Device<br>(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<br>Maximum Voltage: 50 V p-p<br>Maximum Power: 1 W Peak | Same as K222209 |
| Ultrasound<br>Performance | Single Operating Mode<br>Thermal Index: < 1.0<br>Mechanical Index: < 1.0 | Same as K222209 |
| Localization<br>Output | Frequency: Variable 15 kHz to 50 kHz<br>Maximum Current: 1.2 mA | Same as K222209 |
| ECG & EGM Input | Bandwidth: 0.05 Hz to 500 Hz<br>Resolution: ± 1 uV<br>Timing Accuracy: ± 1.6 microsecond | Same as K222209 |
| Front Panel Connections | | |
| AcQMap Catheter | Custom, Black, Defibrillator Protected Type CF | Same as K222209 |
| ECG Input | 12-pin, Latching, Red, Defibrillator Protected Type BF | Same as K222209 |
| ECG Output | 14-pin, Latching, Blue | Same as K222209 |
| Auxiliary Interface<br>Box | Custom, Green, Defibrillator Protected Type CF | Same as K222209 |
| AcQRef Introducer<br>Sheath or<br>Electrical<br>Reference<br>Catheter | 1, 2mm Female, Yellow, Defibrillator Protected Type CF | Same as K222209 |
| Table 1: Comparison of Technological Characteristics | | |
| Characteristics | AcQMap High Resolution Imaging and Mapping System<br>Predicate Device<br>(K222209) | AcQMap High Resolution Imaging and Mapping System<br>Subject Device<br>(K231091) |
| Localization<br>Reference<br>Electrodes | 6, 2-pin, Square, Multi-color, Defibrillator Protected Type BF | Same as K222209 |
| Patient Reference<br>Electrode | 1, 2-pin, Square, Blue, Defibrillator Protected Type BF | Same as K222209 |
| Ablation<br>Generator | 10-pin, Latching, Grey | Same as K222209 |
| Ablation Catheter | 10-pin, Latching, Grey, Defibrillator Protected Type CF | Same as K222209 |
| Ablation<br>Reference | 1, 2mm, Female, Black, Defibrillator Protected Type BF | Same as K222209 |
| Ablation<br>Electrogram<br>Interface | 1, 13-pin, Latching, White | Same as K222209 |

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#### Cutus. M D

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#### JTUS. M D

K231091

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### US® M D

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### TTUS® M D

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## Substantial Equivalence:

The AcQMap System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. These modification are to improve the ease-of-use of some system capabilities. The updates to the mapping software includes:

- The addition of a corresponding mV scale in the color bar of charge density amplitude maps;
- User-initiated system checks for common connection errors such as cable disconnections and patch placement locations; and
- An improvement to the generation of the anatomic surface from ultrasound points.

These modification are to improve the ease-of-use of some system capabilities. There are no changes to the current mapping data. There are no differences between the subject device and the predicate(s) with respect to indications and intended use. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the predicate device.

## Performance Data:

All necessary bench testing was conducted on the subject device to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical testing is required to support the subject device.

## 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.

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The collective results of the non-clinical testing, either repeated for the subject device or incorporated by reference to the original AcQMap System (K170948), demonstrate that the materials chosen, the manufacturing processes, and design of the subject device meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the subject device does not raise different questions of safety or effectiveness when compared to the predicate device.

## Clinical Testing Summary:

As discussed above, 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.

## Conclusion:

Extensive non-clinical performance testing, either repeated for the subject device or incorporated by reference to the original AcQMap System (K170948), was conducted to evaluate the overall performance of the device. The clinical validation of the original AcQMap System (K170948) is applicable to the subject device. Based on the performance testing and the technological characteristics, it can be concluded that the subject device is substantially equivalent to the predicate device.