The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

Device Description

Electrode Recording Catheter/Transducer Ultrasound

AI/ML Overview

The provided text describes the AcQMap 3D Imaging and Mapping Catheter, but it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner an AI/ML device would typically be evaluated (e.g., accuracy, sensitivity, specificity for classification tasks).

However, I can extract the information relevant to a "study" that assessed the device's performance, even if it's not a typical AI/ML validation study. The closest an AI/ML validation study with the criteria you listed comes is the "DDRAMATIC-SVT" clinical study.

Here's the breakdown based on the provided text:

Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria for parameters like sensitivity, specificity, or image quality, as it's a 510(k) submission focused on substantial equivalence for a medical device that collects data for imaging and mapping, not an AI/ML diagnostic output. The "performance" is primarily described in terms of the device's ability to safely and effectively perform its intended function.

Acceptance Criteria (Implied)	Reported Device Performance
Safety for intended use	Demonstrated as safe in a clinical study of 84 patients.
Effectiveness for intended use (gathering data to create 3D maps and record electrical impulses)	Demonstrated as effective in a clinical study of 84 patients. The AcQMap System can create right and/or left atrial dipole density activation maps.
Compliance with established specifications for consistent performance	Nonclinical testing (dimensional, visual, functional, mechanical, corrosion, electrode coating, acoustic output, accuracy) met established specifications.

Study Details (Based on the DDRAMATIC-SVT Clinical Study):

Sample size used for the test set and the data provenance:
- Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The study describes "gathering data to create... dipole density activation maps" and "recording electrical impulses," implying physician interpretation of the generated maps and electrical data, but the number and qualifications of experts for ground truth establishment are not detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the text.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This was not a MRMC comparative effectiveness study and does not involve AI assistance for human readers in the context described. The device itself is a data collection and imaging tool, not an AI diagnostic algorithm.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This was not a standalone algorithm performance study. The device's function is to collect data for physicians to interpret. The text states it helps in "identifying complex arrhythmias that may be difficult to identify using conventional mapping systems alone," implying human interpretation of the device's output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The text describes the study as demonstrating "safety and performance in gathering data to create right and/or left atrial dipole density activation maps." The "ground truth" for the effectiveness of the device as a data collection tool would implicitly be its ability to generate these maps and record electrical impulses as intended, likely verified by the practicing cardiologists using the system during the study. It's not explicitly tied to a definitive "ground truth" like pathology or a hard clinical outcome in the same way an AI diagnostic would be.
The sample size for the training set:
- This information is not applicable/not provided. The device is a hardware system for data collection and imaging, not an AI/ML model that requires a training set.
How the ground truth for the training set was established:
- This information is not applicable/not provided as there is no training set for an AI/ML model.

Summary

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October 16, 2017

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

Re: K170819

Trade/Device Name: AcOMap 3D Imaging and Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD, ITX Dated: September 6, 2017 Received: September 7, 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, 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 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170819

Device Name

AcQMap 3D Imaging and Mapping Catheter

Indications for Use (Describe)

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 K170819

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 16, 2017

DEVICE INFORMATION [807.92(a)(2)]

Trade/Proprietary Name: AcQMap® 3D Imaging and Mapping Catheter

Generic/Common Name:

Electrode Recording Catheter/Transducer Ultrasound

Classification: II

Product Code: MTD/ITX

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

Predicate Device

Constellation Multiple Electrode Recording and Pacing Catheter ("Constellation Catheter") (K140733)

Reference Devices EnSite Array Multi-Electrode Diagnostic Catheter ("EnSite Catheter") (K121006) Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter ("Ultra Ice Catheter") (K160173)

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

Characteristics	AcQMap 3D Imagingand Mapping Catheter	ConstellationMultiple ElectrodeRecording andPacing Catheter	Analysis
Regulatory
510(k) Number	K170819	K140733	--
Classification/RegulationNumber/RegulationName/Product Code	Class II/21 CFR §870.1220/ Electroderecording catheter orelectrode recordingprobe/MTDClass II/21 CFR §892.1570/ TransducerUltrasonic/ITX	Class II/21 CFR §870.1220/ Electroderecording catheter orelectrode recordingprobe/MTD	The additional productcodes for the proposeddevice are required.
Indications for Use	The AcQMap 3D Imagingand Mapping Catheter isintended to be used in theright and left atrialchambers to collectultrasound data forvisualizing the selectedchamber and recordingelectrical impulses inpatients with complexarrhythmias that may bedifficult to identify usingconventional mappingsystems alone.	For use in right atrialand left EPprocedures to assistin the diagnosis ofcomplex arrhythmiasthat may be difficultto identify usingconventionalmapping systemsalone (i.e. linearmappingcatheters). TheConstellationMultiple ElectrodeRecording andPacing CatheterSystem may also beused for delivery of	The intended use of thedevices is the same.

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

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510(k) SUMMARY

Characteristics	AcQMap 3D Imagingand Mapping Catheter	ConstellationMultiple ElectrodeRecording andPacing Catheter	Analysis
		externally generatedpacing stimuli

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] (cont.)

Characteristics	AcQMap 3D Imagingand Mapping Catheter	ConstellationMultiple ElectrodeRecording andPacing Catheter	Analysis
Physical Characteristics
Configuration	Electrode/Transducermounted on splines	Electrode Array inBasket	The differences inphysical construction ofthe two devices do notraise different questionsof safety or effectivenessthan the predicate as
Basket Diameter	25 mm	31, 38, 60 and 75mm
Working Length	100 cm	90 cm - 130 cm(length)
Number of Splines	6	8	demonstrated by the
Heart Wall Contacting	No	Yes	AcQMap performance
Flush Port	Yes	Unknown	testing.
Technical Specifications - Electrical
Voltage	Yes	Yes	Differences in electrical
Dipole Density	Yes	No	specifications do not
Number of Electrodes	48	32 - 64	raise different questionsof safety or effectivenessthan the predicate asdemonstrated by theAcQMap performancetesting.
Data Points/heart beat	2500	Unknown
Power source	Electrical source fromAcQMap System	Electrical sourcefrom standard EPmapping andrecording Systems
Technical Specifications - Ultrasound
Mode	M-mode	N/A	The predicate devicedoes not have ultrasoundfunctionality.The reference devicedoes have ultrasoundfunctionality.
Number of transducers	48	N/A
Phased Array Y/N	N	N/A
Center Frequency	10 MHz	N/A
Acoustic Output
MI (MechanicalIndex)	0.06	N/A	The predicate devicedoes not have ultrasoundfunctionality.The reference devicedoes have ultrasoundfunctionality.
ISTPA.3 (DeratedSpatial-PeakTemporal-AverageIntensity (milliwattsper squarecentimeter))	0.08 (mW/cm2)	N/A
ISPPA.3 (DeratedSpatial-Peak PulseAverage Intensity(watts per squarecentimeter))	1.03	N/A
Characteristics	AcQMap 3D Imagingand Mapping Catheter	ConstellationMultiple ElectrodeRecording andPacing Catheter	Analysis
Compatible Sheath	For Use with AcutusMedical AcQGuide 12 FSteerable Sheath	9F	Any differences inaccessory sizes do notraise different questionsof safety oreffectiveness.
Compatible Guidewire	0.032" (0.81 mm) diameterJ-tip guidewire	Not to exceed 0.035"diameter J-tipguidewire

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510(k) SUMMARY

SUBSTANTIAL EQUIVALENCE

The indications for use for the predicate device is substantially equivalent to the proposed indications for use for the AcQMap 3D Imaging and Mapping Catheter. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the AcQMap 3D Imaging and Mapping Catheter is substantially equivalent to the predicate device.

PERFORMANCE DATA [807.92(b)]

All necessary bench testing was conducted on the AcQMap 3D Imaging and Mapping Catheter to support a determination of substantial equivalence to the predicate device.

[807.92(b)(1)| Nonclinical Testing Summary:

The nonclinical, bench testing included:

Design Verification .
- Dimensional Inspection O
- Visual Inspection O
- Functional and Compatibility Testing O
- Mechanical Testing o
- Corrosion Testing O
- Electrode Coating Particulate Testing O
- O Acoustic Output Testing
- o Accuracy Testing
Design Validation
- Usability Testing O
- o Animal Testing
Biocompatibility Testing ●

In addition, Acutus performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap 3D Imaging and Mapping Catheter meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap 3D Imaging and

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510(k) SUMMARY

Mapping Catheter 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 device.

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

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 (AcQMap 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 Catheter is safe and effective for its intended use.

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical performance testing was conducted on the AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. Acutus also performed validation testing including usability, accuracy and clinical testing to evaluate the performance of the AcQMap 3D Imaging and Mapping Catheter with the AcQMap System. The collective results demonstrate that the AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use.

SUMMARY

The AcQMap 3D Imaging and Mapping Catheter is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1220 Electrode recording catheter or electrode recording probe.

(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).