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 dipole 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.

Device Description

The AcQMap System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcQMap Ablation Interface Unit.

The AcQMap® High Resolution Imaging and Mapping System ("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 the atrial chambers of the heart.

The AcQMap 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. The AcQMap System provides:

3-D cardiac chamber reconstruction imaging,
Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
Cardiac electrical activity as waveform traces,
Remapping of the chamber at any time during the procedure; and
Three-dimensional, dipole density-based maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System. This submission aims to clear an updated version of an already cleared device (K170948) with new software features (Anatomic Reference, Markers Enhancement, and Graphical User Interface Refresh). The core device and its indications for use remain identical to the predicate device.

Given that this is a 510(k) for an updated version of a previously cleared device with new software features, the acceptance criteria and performance data provided focus on demonstrating that these new features do not raise new questions of safety or effectiveness and that the overall system continues to meet its established performance specifications. The document mainly highlights that the indications for use, technological characteristics (beyond the software updates), and safety standards are identical to the predicate device. Therefore, the "acceptance criteria" discussed are largely based on the established safety and performance of the predicate device, supplemented by testing of the new software features.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in this type of FDA document (which summarizes testing rather than providing detailed study protocols or results):

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and corresponding reported device performance metrics in the format requested. Instead, it states that the device was tested to "ensure that it conforms to the design specifications" and that the "results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use."

The updated software features (Anatomic Reference, Markers Enhancement, Graphical User Interface Refresh) are evaluated to ensure they do not alter the fundamental safety or effectiveness. The core "acceptance criteria" are implied to be the successful demonstration that the device (with these updates) continues to meet safety and performance standards equivalent to the predicate device.

Implied Acceptance Criteria and Performance Summary:

Feature/Aspect	Acceptance Criteria (Implied)	Reported Device Performance (Summary from document)
New Software Features: Anatomic Reference, Markers Enhancement, Graphical User Interface Refresh	Do not raise any different questions of safety or effectiveness compared to the predicate device; function as intended without compromising existing device performance.	"Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness." The new features are integrated, and the system continues to demonstrate safety and effectiveness for its intended use. "The collective results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use."
Overall System Performance (Bench/Nonclinical)	Conformance to design specifications; meeting established performance specifications for imaging, navigation, and mapping; adherence to safety standards (e.g., IEC 60601 series). No new safety or effectiveness concerns compared to the predicate.	"The necessary bench testing was performed on the AcQMap System to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device." "The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap System meet the established specifications necessary for consistent performance during its intended use."
Clinical Safety and Effectiveness	Safe and effective for its intended use (reconstructing cardiac chambers, visualizing anatomy, displaying electrical impulses as dipole density-based or voltage-based maps of complex arrhythmias, and displaying catheter positions).	A clinical study (DDRAMATIC-SVT) "demonstrate[d] that the AcQMap System is safe and effective for its intended use" in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia.

2. Sample Size Used for the Test Set and Data Provenance

Clinical Test Set Sample Size: 84 patients.
Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. (The specific countries are not mentioned).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used to establish ground truth in the clinical study, nor does it detail their qualifications. The study focused on the device's ability to "gather data to create right and/or left atrial dipole density activation maps," implying that the "ground truth" might be related to the device's own generated maps and system performance metrics rather than a direct comparison to an external expert-adjudicated "true" diagnosis or condition, especially since it's a diagnostic mapping system.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the clinical test set data from the DDRAMATIC-SVT study. Given it's a diagnostic system, adjudication would typically involve expert interpretation of the generated maps, but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study is not explicitly mentioned. The study "DDRAMATIC-SVT" was a single-arm study to demonstrate the device's safety and performance, not a comparison against human readers or other systems. Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the bench and non-clinical testing sections imply standalone performance evaluation.

"System Accuracy Testing"
"AcQMap Verification Testing"
"Software Verification and Validation"
"Electromagnetic Compatibility and Electrical Safety Testing"
These tests evaluate the device's intrinsic performance characteristics without direct human-in-the-loop diagnostic interpretation in the context of a clinical decision. The clinical study, while involving human operators, still assesses the system's ability to generate data and maps as intended. The "algorithm" for generating the maps is part of the "system" being tested.

7. The Type of Ground Truth Used

For the clinical study: The "ground truth" seems to be intrinsic to the device's function – its ability to "gather data to create right and/or left atrial dipole density activation maps." The study assessed whether the system could effectively perform this function and whether it was safe. It's essentially using the device's own output as its "performance metric" against its design intent, rather than comparing it to an independent, external gold standard like pathology or long-term outcomes to validate diagnostic accuracy.

For bench and non-clinical testing: The ground truth would be based on engineering specifications, established test methods, and potentially simulated data or measurements from phantoms.

8. The Sample Size for the Training Set

The document does not provide details about a "training set" or "validation set" in the context of an AI/ML algorithm being developed. The AcQMap System is described as a "diagnostic recording system" and "computer-based system," but the documentation focuses on its substantial equivalence to a predicate device and verification/validation testing of its software features rather than an AI development paradigm.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" for an AI/ML algorithm is not explicitly mentioned, the method for establishing its ground truth is not provided. The development process described aligns more with traditional software verification and validation where specifications define the expected behavior.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized caduceus. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name in blue text.

February 7, 2019

Acutus Medical, Inc. Greg Geissinger Director, Regulatory Affairs & Ouality Assurance 2210 Faraday Ave. Suite 100 Carlsbad, California 92008

Re: K181577

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: January 2, 2019 Received: January 3, 2019

Dear Greg Geissinger:

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 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

{1}------------------------------------------------

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181577

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.

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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

510(k) Notification K181577

GENERAL INFORMATION [807.92(a)(1)]

Applicant:

Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6080 Fax: 1-442-232-6081

Contact Person:

Karla Schaffner Principal Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 Fax: 1-442-232-6081 Email: karla.schaffner(@acutus.com

Date Prepared: 02 January 2018

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

AcQMap® High Resolution Imaging and Mapping System

Generic/Common Name:

Programable diagnostic computer and Ultrasonic pulsed echo imaging system

Classification:

Class II/21 CFR § 870.1425 and Class II/21 CFR § 892.1560

Product Code:

DQK, IYO, ITX

{4}------------------------------------------------

PREDICATE DEVICE [807.92(a)(3)]

AcQMap® High Resolution Imaging and Mapping System (K170948)

DEVICE DESCRIPTION [807.92(a)(4)]

The AcQMap System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcQMap Ablation Interface Unit.

The AcQMap System hardware consists of three functional subsystems:

Ultrasound imaging.
ECG and EGM recording; and ●
Impedance based electrode Localization. 0

The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter. The AcOMap System provides:

3-D cardiac chamber reconstruction imaging, ●
0 Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
Cardiac electrical activity as waveform traces, ●
Remapping of the chamber at any time during the procedure; and
Three-dimensional, dipole density-based maps overlaid on the cardiac chamber ● reconstruction to show chamber-wide electrical activation.

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

The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

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.

{5}------------------------------------------------

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

This submission is seeking the clearance of the updated AcQMap System, which has the included software features, Anatomic Reference, Markers Enhancement, and Graphical User Interface Refresh.

Anatomic Reference allows the Anatomic Reference Channels to be used to subtract respiratory motion from all devices navigated by the system. With Marker Enhancement, markers can now be optionally "snapped" to the anatomy when the user-selected electrode is within 4mm of the reconstructed surface. Graphical User Interface Refresh is a functionality that was previously accessed through dropdown menus but can now be additionally accessed through readily available icons within the user interface.

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

{6}------------------------------------------------

Characteristics	AcQMap® High ResolutionImaging and Mapping System	AcQMap® High ResolutionImaging and Mapping System	Rationale forSubstantialEquivalence
Regulatory
510(k) Number	K181577	K170948	Identical
Classification/RegulationNumber/Regulation Name/Product Code	Class II/ 21 CFR § 870.1425/Programable diagnostic computer/DQKClass II/ 21 CFR § 892.1560/Ultrasonic pulsed echo imagingsystem/ IYO, ITX	Class II/ 21 CFR § 870.1425/Programable diagnostic computer/DQKClass II/ 21 CFR § 892.1560/Ultrasonic pulsed echo imagingsystem/ IYO, ITX	Identical
Indications for Use	The AcQMap System is intendedfor use in patients for whomelectrophysiology procedures havebeen prescribed.When used with the AcQMapCatheters, the AcQMap System isintended to be used to reconstructthe selected chamber fromultrasound data for purposes ofvisualizing the chamber anatomyand displaying electrical impulsesas either dipole density or voltagemaps of complex arrhythmias thatmay be difficult to identify usingconventional mapping systemsalone.ANDWhen used with the specifiedPatient Electrodes, the AcQMapSystem is intended to display theposition of AcQMap Catheters andconventional electrophysiology(EP) catheters in the heart.	The AcQMap System is intendedfor use in patients for whomelectrophysiology procedures havebeen prescribed.When used with the AcQMapCatheters, the AcQMap System isintended to be used to reconstructthe selected chamber fromultrasound data for purposes ofvisualizing the chamber anatomyand displaying electrical impulses aseither dipole density or voltagemaps of complex arrhythmias thatmay be difficult to identify usingconventional mapping systemsalone.ANDWhen used with the specifiedPatient Electrodes, the AcQMapSystem is intended to display theposition of AcQMap Catheters andconventional electrophysiology (EP)catheters in the heart.	Identical
Patient Anatomy	Intracardiac Structures	Intracardiac Structures	Identical
Testing to SupportSubstantialEquivalence	Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, Animal Testing; and Clinical Testing	Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, Animal Testing; and Clinical Testing	Identical
System SafetyStandards	IEC 60601-1: 2005 /A1:2012 IEC 60601-2-37: 2007 IEC 60601-1-2: 2007 /AC:2010 IEC60601-1-6:2010	IEC 60601-1: 2005 /A1:2012 IEC 60601-2-37: 2007 IEC 60601-1-2: 2007 /AC:2010 IEC60601-1-6:2010	Identical
Characteristics	AcQMap® High ResolutionImaging and Mapping System(K181577)	AcQMap® High ResolutionImaging and Mapping System(K170948)	Rationale forSubstantialEquivalence
Physical Characteristics
SystemComponents	Console, Workstation,Workstation Cable PatientInterface Unit, Patient InterfaceUnit Cable, Ablation InterfaceUnit, Ablation Interface UnitCable, Auxiliary CatheterCable, Surface ECG InputCable and Patient Electrode Kit.	Console, Workstation,Workstation Cable PatientInterface Unit, Patient InterfaceUnit Cable, Ablation InterfaceUnit, Ablation Interface UnitCable, Auxiliary CatheterCable, Surface ECG InputCable and Patient Electrode Kit.	Identical
Visual/MappingCharacteristics	CT-like cardiac chamber reconstructions imaging, Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, Cardiac electrical activity as waveform traces, Remapping of the chamber at any time during the procedure; and Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.	CT-like cardiac chamber reconstructions imaging, Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, Cardiac electrical activity as waveform traces, Remapping of the chamber at any time during the procedure; and Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.	Identical
VisualizationDevice/Catheter	AcQMap Catheter (electrodes andtransducers)	AcQMap Catheter (electrodes andtransducers)	Identical
Physical Characteristics - Console/Amplifier Comparison
Dimensions	68 cm L x 48.3 cm W x 72.6 cm D	68 cm L x 48.3 cm W x 72.6 cm D	Identical
Weight Maximum	50 kg	50 kg
PowerRequirement	110 - 240 V, 50/60 Hz	110 - 240 V, 50/60 Hz
Input Current	5A	5A
Fuse protection	250 V, 6.3 A, two high breakingcapacity fuses	250 V, 6.3 A, two high breakingcapacity fuses

Table 1: Comparison of Technological Characteristics with the Predicate Device

{7}------------------------------------------------

Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)

{8}------------------------------------------------

SUBSTANTIAL EQUIVALENCE

The indications for use for the AcOMap High Resolution Imaging and Mapping System predicate device are identical to the proposed indications for use for the AcQMap High Resolution Imaging and Mapping System in this submission. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the AcQMap System is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

All necessary bench and clinical testing was conducted on the AcQMap System to support a determination of substantial equivalence to the predicate device.

[807.92(b)(1)] Nonclinical Testing Summary

The necessary bench testing was performed on the AcQMap System to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device. The bench testing performed included the following:

Transportation Testing ●
AcQMap Verification Testing ●
Software Verification and Validation ●
System Accuracy Testing
Electromagnetic Compatibility and Electrical Safety Testing ●
o AcQMap Catheter Validation Testing-Animal Study

The AcQMap System device was tested to verify that the device met the established performance specifications.

The collective results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use.

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap System does not raise different questions of safety or effectiveness.

[807.92(b)(2)] Clinical Testing Summary

Although clinical testing is not required to demonstrate substantial equivalence to the predicate device for its intended use. Acutus performed a clinical study to demonstrate the safety and performance of the AcQMap High Resolution Imaging and Mapping System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. The study entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" is a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrate that the AcQMap System is safe and effective for its intended use.

{9}------------------------------------------------

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical performance testing was conducted on the AcQMap System to evaluate the overall performance of the device. The collective results demonstrate that the AcQMap System is safe and effective for its intended use.

SUMMARY

The AcQMap System is substantially equivalent to the predicate device, the previously cleared AcQMap System.

Regulation Number and Section

§ 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).