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 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 of 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 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 text does not contain detailed acceptance criteria and device performance results in a table format for the AcQMap High Resolution Imaging and Mapping System. However, it does outline the types of testing performed and states that the device meets its established performance specifications.

Here's a summary of the available information regarding the device's testing and acceptance:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a specific table with numerical acceptance criteria and corresponding device performance values. It broadly states that the device was tested to verify it met established performance specifications.

2. Sample Size and Data Provenance for Test Set:

Test Set (Clinical Study):
- Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
Test Set (Nonclinical Testing):
- The document implies extensive bench and software verification/validation testing was conducted, but does not specify sample sizes for these nonclinical tests.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number of experts used or their qualifications to establish ground truth for either the clinical or non-clinical studies.

4. Adjudication Method:

The document does not specify any adjudication method used for either the clinical or non-clinical data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The clinical study was focused on demonstrating the safety and performance of the AcQMap System itself, not its impact on human reader performance.

6. Standalone (Algorithm Only) Performance:

The document describes the AcQMap System as a diagnostic recording system, implying that its output (e.g., 3-D cardiac chamber reconstruction, electrical maps) is intended for physician interpretation. It does not explicitly state if a standalone (algorithm-only) performance evaluation was conducted distinct from a human-in-the-loop scenario. The clinical study evaluated the system's ability to gather data and create maps for physicians, suggesting a human-in-the-loop context.

7. Type of Ground Truth Used:

For the clinical study, the ground truth indirectly relates to the system's ability to "gather data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia." The "safety and effective for its intended use" conclusion implies that the system's outputs were considered accurate and useful in diagnosing and assessing complex arrhythmias. However, the exact method for establishing this ground truth (e.g., comparison to another gold standard, expert consensus on the generated maps) is not detailed.
For nonclinical testing (e.g., system accuracy, software verification), the ground truth would typically be established based on engineering specifications and known physical properties, but specific details are not provided.

8. Sample Size for Training Set:

The document does not provide any information about the sample size used for a training set. This suggests that if machine learning or AI models were used, the training data details are not included in this summary.

9. How Ground Truth for Training Set Was Established:

As no training set sample size is provided, the document does not describe how ground truth for a training set was established.

Summary of Device Performance and Acceptance Criteria (as described):

The device underwent both nonclinical and clinical testing.

Nonclinical Testing: Included transportation testing, AcQMap verification testing, software verification and validation, system accuracy testing, electromagnetic compatibility and electrical safety testing, and an AcQMap Catheter Validation Testing-Animal Study. The results "demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use." It also "does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation when compared to the predicate devices."
Clinical Testing: A prospective, non-randomized, open-label study (DDRAMATIC-SVT) was conducted on 84 patients outside the U.S. The study aimed to demonstrate the safety and performance of the AcQMap System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. The results lead to the conclusion that the AcQMap System is "safe and effective for its intended use."

The device was deemed "substantially equivalent" to predicate devices (EnSite Velocity™ Cardiac Mapping System and iLab™ Ultrasound Imaging System) based on these tests, implying it met the necessary safety and performance benchmarks for its stated indications for use.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 16, 2017

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

Re: K170948

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, IYO, ITX Dated: September 15, 2017 Received: September 18, 2017

Dear Brenda Clay:

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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

M.A. Wilhelm

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

Enclosure

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Indications for Use

510(k) Number (if known) K170948

Device Name

AcQMap® High Resolution Imaging and Mapping System

Indications for Use (Describe)

The AcQMap® High Resolution Imaging 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)

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510(k) Notification K170948

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:

Brenda Clay Regulatory Affairs Manager Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1- 442-232-6161 FAX: 1- 442-232-6081 Email: Brenda.Clay@acutus.com

Date Prepared: March 29, 2017

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:

DOK, IYO, ITX

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

EnSite Velocity™ Cardiac Mapping System (K130594); and o
iLabTM Ultrasound Imaging System (K130243) ●

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 AcOMap Ablation Interface Unit.

The AcQMap System hardware consists of three functional subsystems:

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

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

o 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 o
Three-dimensional, dipole density maps overlaid on the cardiac chamber o 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.

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

Table 1 provides a comparison of the technological characteristics for the AcQMap System and the predicate devices.

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510(k) Summary

Characteristics	AcQMap® High ResolutionImaging and Mapping System	EnSite™ Velocity™ CardiacMapping System	iLab™ Ultrasound ImagingSystem	Rationale for SubstantialEquivalence
Regulatory
510(k) Number	TBD	K130594	K130243	-
Classification/RegulationNumber/RegulationName/ProductCode	Class II/21 CFR §870.1425/Programable diagnosticcomputer/DQKClass II/21 CFR §892.1560/Ultrasonic pulsed echoimaging system/IYO, ITX	Class II/21 CFR §870.1425/Programablediagnostic computer/DQK	Class II/21 CFR §892.1560/Ultrasound pulsedecho imaging system/IYO,ITX	The additional product codesand regulation number for theproposed device are required.
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-based orvoltage-based maps of complexarrhythmias that may be difficult toidentify using conventionalmapping systems alone.ANDWhen used with the specifiedPatient Electrodes, the AcQMapSystem is intended to display theposition of AcQMap Catheters andconventional electrophysiology(EP) catheters in the heart.	The EnSite™ Velocity™Cardiac Mapping System is asuggested diagnostic tool inpatients for whomelectrophysiology studies areindicated.When used with the EnSiteArray™ Catheter, the EnSite™Velocity™ Cardiac MappingSystem is intended to be usedin the right atrium of patientswith complex arrhythmias thatmay be difficult to identifyusing conventional mappingsystems alone.ORWhen used with the EnSite™NavX™ Surface Electrode Kit,the EnSite™ Velocity™Cardiac Mapping System isintended to display theposition of conventionalelectrophysiology (EP)catheters in the heart.	The iLab™ UltrasoundImaging System is intendedfor ultrasound examinationsof intravascular pathology.Intravascular ultrasound isindicated in patients who arecandidates for transluminalinterventional proceduressuch as angioplasty andatherectomy.	All devices are intended forelectrophysiology procedures.Both the AcQMap System andEnSite System are indicated forcomplex arrhythmias whenused with their respectivecatheters. Both the AcQMapSystem and iLab Systeminclude the ultrasoundperformance capabilities in theindications for use statement.The semantic differences in theindications for use do not raisedifferent questions of safety oreffectiveness than thepredicates as demonstrated bythe AcQMap performancetesting.

	able 1: "Comparison of Techniological Characteristics and	Tharacteristics with the Fredicate Devices (count.) tion		ationale for Substant
tient Anator	acardiac Struct	cardiac Struct	ravascular Anator	ased on the performan Sting Continues and Children and China China There monimalian and Children and China Mesting salistics and Children and Children Checkives since so
festing to Suppor ubstantial Iquivalence	Safety Testing Testing Creating National Testing Comments National Testing Comments Nichinal Testing manusoftware V/V lectromagnetic and Electrica●●0	Bench testing; a Animal testing	ctional/performaneroperability testinctrical Safety tesestingand0	omplete performance testing onders parformance as alternale and and and the compressioners of the compressionelly of the contribution of the chives the chives the chivenest w
System Safet Standards	●●	ר הייתר משותר משותר משושים של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של601 .1●●	Inknowr	Same
Characteristics	AcQMap® High ResolutionImaging and Mapping System	EnSite™ Velocity™ CardiacMapping System	iLab™ Ultrasound ImagingSystem	Rationale for SubstantialEquivalence
Physical Characteristics
SystemComponents	Console, Workstation, WorkstationCable Patient Interface Unit, PatientInterface Unit Cable, AblationInterface Unit, Ablation InterfaceUnit Cable, Auxiliary CatheterCable, Surface ECG Input Cableand Patient Electrode Kit.	Amplifier and DisplayWorkstation (DWS)Amplifier includes Navlink,ArrayLink and CathLinkModules, SJM ECG Cable,Record Connect andGenConnect.	Unknown	Same
Visual/MappingCharacteristics	3-D cardiac chamberreconstructions imaging, Three-dimensional position ofthe AcQMap Catheter andconventional electrophysiologycatheters, Cardiac electrical activity aswaveform traces, Remapping of the chamber atany time during the procedure;and Three-dimensional, dipoledensity maps overlaid on thecardiac chamber reconstructionto show chamber-wideelectrical activation.	Three-dimensionalposition of the catheter Display cardiac electricalactivity as waveformtraces; Three-dimensional mapsof the cardiac chamber	Combination of imagingand soft tissuevisualization. Visualizes the catheterrelative to the anatomicalstructure	The combination of three-dimensional imagingfunctionality and ultrasoundfunctionality for display ofdipole density maps does notraise different questions ofsafety or effectiveness asdemonstrated throughperformance testing.
VisualizationDevice/Catheter	AcQMap Catheter (electrodes andtransducers)	EnSite Array Catheter(electrode)	BSC Ultra ICE - UltrasoundDx Catheter (transducer)
Characteristics	AcQMap® High Resolution Imagingand Mapping System	EnSite™ Velocity™ CardiacMapping System	iLab™ Ultrasound ImagingSystem	Rationale for SubstantialEquivalence
Physical Characteristics - Console/Amplifier Comparison
Dimensions	68 cm L x 48.3 cm W x 72.6 cm D	49 cm H x 46 cm W x 51 cm D	Unknown	Same
WeightMaximum	50 kg	31 kg	213 pounds (System weight)
PowerRequirement	110 – 240 V, 50/60 Hz	100, 110/120, 220/240 V~50/60 Hz	Unknown
Input Current	5A	450W maximum (4.5A)	Unknown
Fuse protection	250 V, 6.3 A, two high breakingcapacity fuses	250 V, 5 A VAC, two fuses	Unknown

Table 1: Comparison of Technological Characteristics with the Predicate Devic

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510(k) Summary

Table 1: Comparison of Technological Characteristics with the Predicate Devices (con

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510(k) Summary

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510(k) SUMMAR

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SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate devices is substantially equivalent to the proposed indications for use for the AcQMap System. 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 devices.

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 devices.

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

The necessary bench testing was performed on the AcOMap 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
. 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 for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation when compared to the predicate devices.

[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 demonstrates that the AcQMap System is safe and effective for its intended use.

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CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical performance testing was conducted on the AcQMap System to evaluate the overall performance of the device. Acutus also performed clinical validation testing to evaluate the performance of the AcQMap System with the AcQMap 3D Imaging and Mapping Catheter. 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 devices.

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).