AcQMap High Resolution Imaging and Mapping System

K220784 · Acutus Medical, Inc. · DQK · Jul 1, 2022 · Cardiovascular

Device Facts

• Record ID: K220784
• Device Name: AcQMap High Resolution Imaging and Mapping System
• Applicant: Acutus Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Jul 1, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended 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 AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

Device Story

Diagnostic recording system for EP labs; images, navigates, and maps atrial chambers. Inputs: ultrasound data from AcQMap catheters, ECG/EGM signals, and impedance-based localization data. System reconstructs 3D cardiac chamber anatomy and overlays dynamic charge density or voltage maps to identify arrhythmia sources. Operates outside sterile field; used by physicians to guide clinical decision-making during procedures. Provides real-time visualization of catheter positions and electrical activity. Benefits: improved identification of complex arrhythmias compared to conventional mapping alone. Includes user-initiated system checks for connection errors and improved ultrasound-based surface reconstruction to reduce manual editing.

Clinical Evidence

No new clinical testing performed. Relies on clinical data from the original AcQMap System (K170948) via the DDRAMATIC-SVT study. This was a prospective, non-randomized, open-label study of 84 patients conducted at eight clinical sites outside the U.S. to validate the system's performance in mapping complex supraventricular tachycardia.

Technological Characteristics

Console-based system with workstation and auxiliary interface box. Uses ultrasound (10 MHz) for imaging and impedance (15-50 kHz) for localization. ECG/EGM bandwidth 0.05-500 Hz. Connectivity includes various catheter/generator adapters. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 60601-2-25, IEC 60601-2-37. Software-based processing for 3D reconstruction and electrical mapping.

Indications for Use

Indicated for patients undergoing electrophysiology procedures. Used for cardiac chamber reconstruction, visualization of anatomy, and mapping of electrical impulses (charge density or voltage) for complex arrhythmias. Also used for tracking the position of AcQMap and conventional 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 (K212345)

Reference Devices

• AcQMap System (K170948)
• AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (K201341)

Submission Summary (Full Text)

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July 1, 2022

Acutus Medical, Inc. Karla Schaffner Regulatory Affairs Manager 2210 Faraday Ave, Suite 100 Carlsbad, California 92008

Re: K220784

Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: May 20, 2022 Received: May 23, 2022

Dear Karla Schaffner:

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 and Part 809 ); medical device reporting (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 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) K220784

#### Device Name

AcQMap® High Resolution Imaging and Mapping System

#### Indications for Use (Describe)

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.

| 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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# 510(K) NOTIFICATION K

# GENERAL INFORMATION [807.92(a)(1)]

### Date Prepared: 30 June 2022

| Applicant: | Contact Person: |
|------------------------------|----------------------------------|
| Acutus Medical, Inc. | Sindhu Sridhar |
| 2210 Faraday Ave., Suite 100 | Regulatory Affairs Manager |
| Carlsbad, CA 92008 | Acutus Medical, Inc. |
| USA | 2210 Faraday Ave., Suite 100 |
| Phone: [phone] | Carlsbad, CA 92008 |
| Fax: [phone] | USA |
| | Phone: [phone] |
| | Email: [e-mail] |

# DEVICE INFORMATION [807.92(a)(2)]

| Trade Name: | AcQMap® High Resolution Imaging and Mapping System |
|----------------------|------------------------------------------------------------------------------|
| Generic/Common Name: | Programable diagnostic computer and<br>Ultrasonic pulsed echo imaging system |
| Classification: | Class II / 21 CFR § 870.1425 and<br>Class II / 21 CFR § 892.1560 |
| Product Code(s): | DQK, IYO, ITX |

#### PREDICATE DEVICE [807.92(a)(3)]

| Predicate Device | Manufacturer | FDA 510(k) |
|------------------------------------------------------|----------------------|------------|
| AcQMap High Resolution Imaging and<br>Mapping System | Acutus Medical, Inc. | K212345 |

#### DEVICE DESCRIPTION [807.92(a)(4)]

The AcQMap High Resolution Imaging and Mapping System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box.

The AcQMap High Resolution Imaging and Mapping System ("AcQMap System Model, 900100") 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.

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The AcOMap System hardware consists of three functional subsystems:

- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.

The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:

- . 3-D cardiac chamber reconstruction – Contact and non-contact (ultrasound),
- Three-dimensional 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.

Additionally, the AcQMap System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one 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 changes to the current mapping data. The modifications to the AcQMap System includes:

- . The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data.
- User-initiated system checks for common connection errors such as cable disconnections and patch . placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors.
- An improvement to the generation of the anatomic surface from ultrasound points; This . improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.

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# INDICATIONS FOR USE [807.92(a)(5)]

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.

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(A)(6)]

Tables 1 and 2 provides a comparison of the modified AcQMap System classification for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.

| Table 1. Comparison of Classification with the Predicate Device | | | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| | AcQMap® High<br>Resolution Imaging and<br>Mapping System | AcQMap® High<br>Resolution Imaging and<br>Mapping System | |
| 510(k) Number | K220784 | K212345 | -- |
| Classification/<br>Regulation<br>Number/<br>Regulation Name/<br>Product Code | Class II/ 21 CFR §<br>870.1425/ Programable<br>diagnostic computer/<br>DQK<br><br>Class II/ 21 CFR §<br>892.1560/ Ultrasonic<br>pulsed echo imaging<br>system/ IYO, ITX | Class II/ 21 CFR §<br>870.1425/ Programable<br>diagnostic computer/<br>DQK<br><br>Class II/ 21 CFR §<br>892.1560/ Ultrasonic<br>pulsed echo imaging<br>system/ IYO, ITX | Identical |
| Table 2. Comparison of Indications for Use with the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and<br>Mapping System | AcQMap® High Resolution Imaging and<br>Mapping System | |
| 510(k) Number | K220784 | K212345 | |
| Indications for<br>Use | The AcQMap System is intended for use in<br>patients for whom electrophysiology procedures<br>have been prescribed. | The AcQMap System is intended for use in<br>patients for whom electrophysiology procedures<br>have been prescribed. | Identical |
| | When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing the<br>chamber anatomy and displaying electrical<br>impulses as either charge density-based or<br>voltage-based maps of complex arrhythmias that<br>may be difficult to identify using conventional<br>mapping systems alone.<br>AND | When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing the<br>chamber anatomy and displaying electrical<br>impulses as either charge density-based or<br>voltage-based maps of complex arrhythmias that<br>may be difficult to identify using conventional<br>mapping systems alone.<br>AND | |
| | When used with the specified Patient Electrodes,<br>the AcQMap System is intended to display the<br>position of AcQMap Catheters and conventional<br>electrophysiology (EP) catheters in the heart.<br>OR | When used with the specified Patient Electrodes,<br>the AcQMap System is intended to display the<br>position of AcQMap Catheters and conventional<br>electrophysiology (EP) catheters in the heart.<br>OR | |
| | When used with conventional electrophysiology<br>catheters, the AcQMap System provides<br>information about the electrical activity of the<br>heart and about catheter location during the<br>procedure. | When used with conventional electrophysiology<br>catheters, the AcQMap System provides<br>information about the electrical activity of the<br>heart and about catheter location during the<br>procedure. | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
| | Subject Device | Predicate Device | |
| Characteristics | AcQMap® High Resolution Imaging and Mapping<br>System | AcQMap® High Resolution Imaging and Mapping<br>System (K212345) | Rationale for Substantial<br>Equivalence |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical |
| Testing to Support<br>Substantial<br>Equivalence | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Identical |
| System Safety<br>Standards | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Identical. |
| Physical Characteristics | | | |
| System<br>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 | 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 | The subject device includes<br>additional Carto Force<br>Adapter cable. The Carto<br>Force Adapter Cable is used<br>in conjunction with the<br>SmartAblate Generator to<br>support SmartTouch<br>navigation to the AcQMap<br>System. The SmartAblate<br>Generator was cleared to<br>use with AcQMap system in |
| | | | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and Mapping<br>System | AcQMap® High Resolution Imaging and Mapping<br>System (K212345) | |
| | Patient Electrode Kit Ampere generator adapter 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 | Ampere generator adapter 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 | the predicate 510k<br>K212345. |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| Visual/Mapping<br>Characteristics | 3-D cardiac chamber reconstructions – Contact and non-contact (ultrasound) Three-dimensional 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, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | 3-D cardiac chamber reconstructions - Contact and non-contact (ultrasound) Three-dimensional 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, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | Identical |
| Visualization<br>Device/Catheter | AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters | AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters | |
| Physical Characteristics - Console/Amplifier Comparison | | | |
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 99 cm L x 58 cm W x 76 cm D | Identical |
| Weight Maximum | 80 kg | 80 kg | |
| Power Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz | |
| Input Current | 4.6 A | 4.6 A | |
| Fuse protection | 250 V, 6.3A, two high breaking capacity fuses | 250 V, 6.3A, two high breaking capacity fuses | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and Mapping<br>System | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900000 (K212345) | |
| System Specifications | | | |
| Safety<br>Information | IEC 60601-1, Class I, Type Defibrillator Protected CF,<br>continuous operation, no sterilization, equipment not<br>suitable for use in the presence of a flammable<br>anesthetic mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type Defibrillator Protected<br>CF, continuous operation, no sterilization, equipment<br>not suitable for use in the presence of a flammable<br>anesthetic mixture with air, oxygen or nitrous oxide | Identical |
| Ingress<br>Protection | The Console is rated IP20 | The Console is rated IP20 | Identical |
| Functional and Performance Characteristics | | | |
| Ultrasound<br>Output | Frequency: 10 MHz+/-400 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: 1 W peak | Frequency: 10 MHz+/-400 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: 1 W peak | Identical |
| Ultrasound<br>Performance | Single operating mode<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 | Single operating mode<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 | Identical |
| Localization<br>Output | Frequency: Variable 15 kHz to 50 kHz<br>Maximum current: 1.2mA | Frequency: Variable 15 kHz to 50 kHz<br>Maximum current: 1.2mA | Identical |
| ECG & EGM<br>Input | Bandwidth: 0.05 Hz to 500 Hz<br>Resolution: +/-1uV<br>Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.05 Hz to 500 Hz<br>Resolution: +/-1uV<br>Timing Accuracy: +/-1.6 microsecond | Identical |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
| | AcQMap® High Resolution Imaging and Mapping<br>System | AcQMap® High Resolution Imaging and Mapping<br>System, Model 900000 (K212345)…