AcQMap High Resolution Imaging and Mapping System

K222209 · Acutus Medical, Inc. · DQK · Oct 17, 2022 · Cardiovascular

Device Facts

• Record ID: K222209
• Device Name: AcQMap High Resolution Imaging and Mapping System
• Applicant: Acutus Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Oct 17, 2022
• 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 and Mapping 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 High Resolution Imaging and Mapping 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 recording system for EP labs; images, navigates, and maps atrial chambers. Inputs: ultrasound data, ECG/EGM signals, impedance-based localization. Operation: console, workstation, and auxiliary interface box process inputs to reconstruct 3D cardiac chamber surfaces and display electrical activity as waveform traces or dynamic charge density/voltage maps. Physician uses output to identify arrhythmia sources and guide catheter placement. Enables contact mapping and catheter localization. Modifications facilitate connectivity with DiamondTemp Ablation Generator. Benefits: improved visualization of complex arrhythmias compared to conventional systems.

Clinical Evidence

No new clinical testing performed. Relies on clinical validation of original system (K170948) via the DDRAMATIC-SVT study: a prospective, non-randomized, open-label study of 84 patients at eight clinical sites outside the U.S. Bench testing (compatibility, RF attenuation, waveform fidelity, safety) supports the modified device.

Technological Characteristics

Class II programmable diagnostic computer and ultrasonic pulsed echo imaging system. Components: console, workstation, auxiliary interface box, various adapter cables. Ultrasound: 10 MHz, <1.0 TI/MI. Localization: 15-50 kHz. ECG/EGM: 0.05-500 Hz bandwidth. Safety standards: IEC 60601-1, IEC 60601-1-2, IEC 62366-1, IEC 60601-2-25, IEC 60601-2-37. IP20 rating.

Indications for Use

Indicated for patients undergoing electrophysiology procedures. Used for reconstruction of cardiac chambers, visualization of anatomy, display of electrical impulses (charge density or voltage maps) for complex arrhythmias, 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 (K220784)

Reference Devices

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

Submission Summary (Full Text)

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October 17, 2022

Acutus Medical, Inc. Subhadra Elango Senior Specialist, Regulatory Affairs 2210 Faraday Ave., Suite 100 Carlsbad, California 92008

Re: K222209

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: DQK, IYO, ITX Dated: July 22, 2022 Received: July 25, 2022

Dear Subhadra Elango:

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 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) K22209

#### 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 AcOMap High Resolution Imaging and Mapping 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 AcOMap 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 AcOMap High Resolution Imaging 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)

| <span style="font-family: Arial;"> <span style="font-size: 10pt;"> Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> | <span style="font-family: Arial;"> <span style="font-size: 10pt;"> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

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### 510(K) Notification K222209

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

### Date Prepared: 17 October 2022

| Applicant: | Contact Person: |
|-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acutus Medical, Inc.<br>2210 Faraday Ave., Suite 100<br>Carlsbad, CA 92008<br>USA<br>Phone: [phone]<br>Fax: [phone] | Subhadra Elango<br>Senior Specialist, Regulatory Affairs<br>Acutus Medical, Inc.<br>2210 Faraday Ave., Suite 100<br>Carlsbad, CA 92008<br>USA<br>Phone: [phone]<br>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<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<br>Imaging and Mapping System | Acutus Medical, Inc. | K220784 |

#### 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 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 High Resolution Imaging and Mapping System hardware consists of three functional subsystems:

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

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

- 3-D cardiac chamber reconstruction Contact and non-contact (ultrasound), ●
K222209

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- . 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 High Resolution Imaging and Mapping 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 High Resolution Imaging and Mapping 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.

The modifications to the AcQMap High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator.

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

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 and Mapping 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 High Resolution Imaging and Mapping 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.

## Comparison of Technological Characteristics with the Predicate Devices [807.92(A)(6)]

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

| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence | | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------|
| AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System<br>(K220784) | Rationale for Substantial Equivalence | | |
| 510(k) Number | K222209 | K220784 | -- | | |
| Classification/ | Class II | Class II | Identical | | |
| Regulation | 21 CFR § 870.1425,<br>Programable diagnostic<br>computer<br>21 CFR § 892.1560,<br>Ultrasonic pulsed echo<br>imaging system | 21 CFR § 870.1425,<br>Programable diagnostic<br>computer<br>21 CFR § 892.1560,<br>Ultrasonic pulsed echo<br>imaging system | Identical | | |
| Product Code | DQK, IYO, and ITX | DQK, IYO, and ITX | Identical | | |
| Table 2: Comparison of Indications for Use with the Predicate Device | | | | | |
| Characteristics | Subject Device<br>AcQMap® High Resolution Imaging and<br>Mapping System | Predicate Device<br>AcQMap® High Resolution Imaging and<br>Mapping System (K220784) | Rationale for Substantial<br>Equivalence | | |
| Indications for Use | The AcQMap High Resolution Imaging and<br>Mapping System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br>When used with the AcQMap Catheters,<br>the AcQMap High Resolution Imaging and<br>Mapping System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing<br>the chamber anatomy and displaying<br>electrical impulses as either charge density-<br>based or voltage-based maps of complex<br>arrhythmias that may be difficult to identify<br>using conventional mapping systems alone.<br>AND<br>When used with the specified Patient<br>Electrodes, the AcQMap High Resolution<br>Imaging and Mapping System is intended to<br>display the position of AcQMap Catheters<br>and conventional electrophysiology (EP)<br>catheters in the heart.<br>OR<br>When used with conventional<br>electrophysiology catheters, the AcQMap<br>High Resolution Imaging and Mapping<br>System provides information about the<br>electrical activity of the heart and about<br>catheter location during the procedure. | The AcQMap System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br>When used with the AcQMap Catheters,<br>the AcQMap System is intended to be used<br>to reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing<br>the chamber anatomy and displaying<br>electrical impulses as either charge density-<br>based or voltage-based maps of complex<br>arrhythmias that may be difficult to identify<br>using conventional mapping systems alone.<br>AND<br>When used with the specified Patient<br>Electrodes, the AcQMap System is intended<br>to display the position of AcQMap<br>Catheters and conventional<br>electrophysiology (EP) catheters in the<br>heart.<br>OR<br>When used with conventional<br>electrophysiology catheters, the AcQMap<br>System provides information about the<br>electrical activity of the heart and about<br>catheter location during the procedure. | Identical, with the exception of<br>device trade name. | | |
| 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<br>Mapping System | AcQMap® High Resolution Imaging and<br>Mapping System (K220784) | | | |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical | | |
| Testing to<br>Support<br>Substantial<br>Equivalence | Software V/V<br>Electromagnetic and Electrical Safety<br>Verification Testing,<br>Accuracy Testing, and<br>Animal Testing | Software V/V<br>Electromagnetic and Electrical Safety<br>Verification Testing,<br>Accuracy Testing, and<br>Animal Testing | Identical | | |
| System Safety<br>Standards | IEC 60601-1:2005 / A1:2012<br>IEC 60601-1-2:2014<br>IEC 62366-1: 2015<br>IEC 60601-2-25:2015<br>IEC 60601-2-37:2015 | IEC 60601-1:2005 / A1:2012<br>IEC 60601-1-2:2014<br>IEC 62366-1: 2015<br>IEC 60601-2-25:2015<br>IEC 60601-2-37:2015 | Identical | | |
| Physical Characteristics | | | | | |
| System<br>Components &<br>Accessories | 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<br>SmartAblate Generator Adapter<br>Maestro Generator Adapter<br>Adapter Cable- Short - Ablation Adapter | 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<br>SmartAblate Generator Adapter<br>Maestro Generator Adapter<br>Adapter Cable- Short - Ablation Adapter | All system components<br>are identical, except the<br>new accessories.<br>Verification testing on<br>the new accessories<br>demonstrates that the<br>AcQMap High<br>Resolution Imaging and<br>Mapping System and<br>the new accessories<br>perform as intended.<br>There are no different<br>questions of safety or<br>effectiveness. | | |
| 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<br>Mapping System | AcQMap® High Resolution Imaging and<br>Mapping System (K220784) | | | |
| | Adapter Cable- Long - Ablation Adapter<br>SmartAblate Adapter Cable - Catheter<br>Maestro Adapter Cable - Catheter<br>Maestro Adapter Cable – Generator<br>Carto Force Adapter Cable<br>DiamondTemp Generator Adapter<br>DiamondTemp Adapter Cable – Generator | Adapter Cable- Long - Ablation Adapter<br>SmartAblate Adapter Cable - Catheter<br>Maestro Adapter Cable - Catheter<br>Maestro Adapter Cable - Generator<br>Carto Force Adapter Cable | | | |
| | Visual/Mapping<br>Characteristics | 3-D cardiac chamber reconstructions –<br>Contact and non-contact (ultrasound);<br>Three-dimensional position of the AcQMap<br>Catheter and conventional electrophysiology<br>catheters;<br>Cardiac electrical activity as waveform traces;<br>Contact LAT and voltage amplitude maps;<br>Remapping of the chamber at any time during<br>the procedure;<br>Dynamic, three-dimensional, Charge Density<br>maps overlaid on the cardiac chamber<br>reconstruction to show chamber-wide<br>electrical activation. | | | |
| | | Visualization<br>Device/Catheter | | | |
| | | | | Weight | |
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