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

The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.

The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device.

The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).

AI/ML Overview

The information provided does not contain a typical "device performance" section with specific metrics like sensitivity, specificity, accuracy, or other quantifiable measures that would usually be compared against acceptance criteria in a table format.

This 510(k) submission primarily focuses on demonstrating substantial equivalence of a modified AcQMap 3D Imaging and Mapping Catheter (Model 900009) to a predicate AcQMap 3D Imaging and Mapping Catheter (Model 900009) (K201341). The key difference highlighted is the addition of a marker band.

Therefore, the acceptance criteria and study information largely revolve around demonstrating that this minor modification does not negatively impact safety or effectiveness, and that the original device's performance data is still applicable.

Here's an attempt to extract and structure the information based on your request, acknowledging the limitations of the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device demonstrating substantial equivalence, the "acceptance criteria" are implicitly that the modified device performs comparably to the predicate and does not raise new issues of safety or effectiveness. Explicit numerical acceptance criteria are not presented for performance in the given text.

Performance Characteristic	Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Summary)
Overall Safety & Effectiveness	No new or increased safety risks; performance similar to predicate	Demonstrated through nonclinical testing that modified device meets established specifications, and clinical data from original device is applicable.
Ultrasound Data Collection	Able to collect ultrasound data for visualizing the selected chamber.	Functional and Compatibility Testing and Accuracy Testing performed; results support intended use.
Electrical Impulse Recording	Able to record electrical impulses in patients with complex arrhythmias.	Functional and Compatibility Testing and Accuracy Testing performed; results support intended use.
3D Anatomic Map Creation	Enables creation of 3D anatomic maps that display chamber-wide electrical activation.	Nonclinical testing demonstrates device "does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps."
Mechanical Integrity	Meeting mechanical specifications for intended use.	Mechanical Testing performed.
Corrosion Resistance	Resisting corrosion during intended use.	Corrosion Testing performed.
Electrode Coating Integrity	Acceptable particulate levels for electrode coating.	Electrode Coating Particulate Testing performed.
Acoustic Output	Within specified safe limits.	Acoustic Output Testing performed; MI = 0.06, ISTPA.3 = 0.08 (mW/cm²), ISPPA.3 = 1.03.
Usability	User interface and handling are acceptable.	Usability Testing performed.
Biocompatibility	Biologically safe for patient contact.	Biocompatibility Testing performed.

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

For the Modified Device (K210766):
- No new clinical (human patient) test set was described. The submission relies on nonclinical (bench) testing primarily because the modification (marker band) is considered minor and does not affect the core functionality.
- For nonclinical testing, specific sample sizes are not provided for each test but are implied to be sufficient for design verification and validation (e.g., "all necessary bench testing was conducted").
For the Original AcQMap Catheter (K170819), referenced for clinical data:
- Test Set Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

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

For the Modified Device (K210766): Not applicable, as no new clinical study requiring expert ground truth establishment for patient data was performed. Nonclinical testing relies on engineering and scientific evaluation.
For the Original AcQMap Catheter (K170819) clinical study: The text does not specify the number of experts or their qualifications for establishing ground truth in the "DDRAMATIC-SVT" study. It was a clinical study involving patients with "complex arrhythmias," implying diagnosis and assessment by medical professionals, but details are not provided.

4. Adjudication Method for the Test Set

For the Modified Device (K210766): Not applicable for clinical data. For nonclinical tests, adjudication methods are typically internal quality control and verification processes, but no specific multi-reviewer adjudication method is described.
For the Original AcQMap Catheter (K170819) clinical study: The text does not specify any adjudication method used in the "DDRAMATIC-SVT" study.

5. 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

No MRMC comparative effectiveness study is described. The device is a diagnostic and mapping catheter, not explicitly an AI-assisted interpretation tool in the context of MRMC studies typical for image analysis. The "AI" component is not referenced in this document.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes a medical device (catheter) that collects data for visualization and recording electrical impulses. It is used with the AcQMap High Resolution Imaging and Mapping System. The performance described relates to the catheter's ability to acquire accurate data for mapping and imaging. It is not an "algorithm-only" performance study in the sense of a standalone AI diagnostic tool. Its function is to provide inputs for human interpretation and system processing.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the Modified Device (K210766): For nonclinical testing, the "ground truth" would be established engineering specifications, validated test methods, and industry standards.
For the Original AcQMap Catheter (K170819) clinical study: The study "DDRAMATIC-SVT" assessed "safety and effectiveness for its intended use" in patients with complex arrhythmias. This implies that clinical outcomes, diagnostic accuracy in identifying arrhythmias, and safety endpoints defined in the study protocol would form the "ground truth" or primary endpoints. Specific details are not provided.

8. The Sample Size for the Training Set

The provided document describes a device (catheter) and references a clinical study for its safety and effectiveness. It does not mention any "training set" in the context of machine learning or AI algorithm development. The device's functionality is based on its physical design, sensors, and the underlying system's processing capabilities, not typically on a machine learning training dataset.

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

Not applicable, as no training set for a machine learning algorithm is discussed in this document.

Summary

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June 21, 2022

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

Re: K210766

Trade/Device Name: AcQMap® 3D Imaging and Mapping Catheter, Model 900009 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD. ITX Dated: June 13, 2022 Received: June 14, 2022

Dear Karla Schaffner:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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542 of the Act); 21 CFR 1000-1050.

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-

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K210766

Device Name

AcQMap® 3D Imaging and Mapping Catheter, Model 900009

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with a small orange circle inside the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in orange. The logo is simple and modern, and it is likely used to represent the company's brand.

510(K) Notification K_210766

General Information [807.92(a)(1)]

Date Prepared: 21 June 2022

Applicant	Contact Person
Acutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-232-6080Fax: 1-442-232-6081	Karla SchaffnerPrincipal Regulatory Affairs SpecialistAcutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-232-6161FAX: 1-442-232-6081Email: karla.schaffner@acutus.com

Device Information [807.92(a)(2)]

Trade Name:

AcQMap® 3D Imaging and Mapping Catheter, Model 900009

Generic/Common Name:

Electrode Recording Catheter or Electrode Recording Probe/ Transducer Ultrasonic

Classification:

Class II / 21 CFR § 870.1220 and Class II / 21 CFR § 892.1570

Product Code(s):

MTD/ITX

Predicate Device [807.92(a)(3)]

AcQMap 3D Imaging and Mapping Catheter (K201341)

Reference Device

AcQMap 3D Imaging and Mapping Catheter (K170819)

Device Description [807.92(a)(4)]

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

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

Characteristics	SUBJECTModified AcQMap 3D Imagingand Mapping Catheter, Model900009	PREDICATEAcQMap 3D Imaging andMapping Catheter, Model900009	Rationale forSubstantialEquivalence
Regulatory
510(k) Number	K210766	K201341	--
Classification/Regulation Number/Regulation Name/Product Code	Class II / 21 CFR §870.1220 /Electrode recording catheter orelectrode recording probe / MTDClass II / 21 CFR §892.1570 /Transducer Ultrasonic/ ITX	Class II / 21 CFR §870.1220 /Electrode recording catheter orelectrode recording probe / MTDClass II / 21 CFR §892.1570 /Transducer Ultrasonic/ ITX	Identical
Characteristics	SUBJECTModified AcQMap 3D Imagingand Mapping Catheter, Model900009	PREDICATEAcQMap 3D Imaging andMapping Catheter, Model900009	Rationale forSubstantialEquivalence
Indications for Use	The AcQMap 3D Imaging andMapping Catheter is intended to beused in the right and left atrialchambers to collect ultrasounddata for visualizing the selectedchamber and recording electricalimpulses in patients with complexarrhythmias that may be difficult toidentify using conventional mappingsystems alone.	The AcQMap 3D Imaging andMapping Catheter is intended to beused in the right and left atrialchambers to collect ultrasounddata for visualizing the selectedchamber and recording electricalimpulses in patients with complexarrhythmias that may be difficult toidentify using conventional mappingsystems alone.	Identical
Physical Characteristics
Configuration	Electrode/Transducer mounted onsplines	Electrode/Transducer mounted onsplines	Identical
Deployed Diameter	25mm	25mm	Identical
Working Length	100 cm	100 cm	Identical
Number of Spines	6	6	Identical
Heart Wall Contacting	No	No	Identical
Deflection Y/N	No	No	Identical
Flush Port	Yes	Yes	Identical
Marker Band	Yes	No	Shaft markingprovides visualfeedback for distaltip locationrelative to theAcQGuide MAXsheath tip.Marker is optionalfor use and doesnot improvesafety.
Technical Specifications - Electrical
Voltage	Yes	Yes	Identical
Charge Density	Yes	Yes	Identical
Number of Electrodes	48	48	Identical
Data Points/heartbeat	2500	2500	Identical
Power source	Electrical source from AcQMapSystem	Electrical source from AcQMapSystem	Identical
Technical Specifications - Ultrasound
Characteristics	SUBJECTModified AcQMap 3D Imagingand Mapping Catheter, Model900009	PREDICATEAcQMap 3D Imaging andMapping Catheter, Model900009	Rationale forSubstantialEquivalence
Mode	M-mode	M-mode	Identical
Number oftransducers	48	48
Phased Array Y/N	N	N
Center Frequency	10 MHz	10 MHz
Acoustic Output
MI (Mechanical Index)	0.06	0.06	Identical
ISTPA.3 (DeratedSpatial-PeakTemporal-AverageIntensity (milliwattsper squarecentimeter))	0.08 (mW/cm²)	0.08 (mW/cm²)
ISPPA.3 (DeratedSpatial-Peak PulseAverage Intensity(watts per squarecentimeter))	1.03	1.03
Accessories
DimensionallyCompatible Sheath	For Use with AcutusMedicalAcQGuide MAX 12 F SteerableSheath (K162925 and K211100)	For Use withAcutus MedicalAcQGuide 12 F Steerable Sheath(K162925)	The compatibilitywith the recentlycleared2ndgenerationAcQGuideMAXSteerableSheathdoes not create anew risk as thetwo sheathsarerepresentativeofeach other.
Compatible Guidewire	0.035" (0.89 mm) diameter J-tipguidewire	0.035" (0.89 mm) diameter J-tipguidewire	Identical

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Image /page/5/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, block letters, with a small orange circle in the lower left corner of the "A". Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. The logo is simple and modern, and the use of color helps to make it stand out.

ACQMAP® 3D IMAGING AND MAPPING CATHETER

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Image /page/6/Picture/0 description: The image shows the logo for Acutus Medical. The logo has the word "ACUTUS" in gray, block letters. Below that, the word "MEDICAL" is spelled out in smaller, orange letters. There is a registered trademark symbol to the right of the letter "S" in "ACUTUS".

ACQMAP® 3D IMAGING AND MAPPING CATHETER

Substantial Equivalence

The indications for use of the subject device are identical to those of the predicate device. The difference between the subject and predicate AcQMap Catheter model 900009 is the addition of the marker band on the shaft of the catheter. This is an optional feature, to allow the user to visualize whether the distal

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array is inside or outside the AcQGuide MAX Steerable Sheath (900200). The marker band does not improve safety, nor is it detrimental if used with the AcQGuide MAX Steerable Sheath (K162925). This difference between the devices does not raise any different questions of safety or effectiveness. Thus, the modified AcQMap 3D Imaging and Mapping Catheter, is substantially equivalent to the predicate AcQMap 3D Imaging and Mapping Catheter device.

PERFORMANCE DATA [807.92(b)]

All necessary bench testing was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap Catheter (K170819) and is incorporated by reference. No further clinical testing is required to support the subject device.

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

The nonclinical, bench testing is repeated or included in this submission by reference. A full list of the nonclinical testing is provided below:

. Design Verification
- Dimensional Inspection O
- O Visual Inspection
- 0 Functional and Compatibility Testing
- Mechanical Testing O
- 0 Corrosion Testing
- Electrode Coating Particulate Testing O
- Acoustic Output Testing O
- 0 Accuracy Testing
Design Validation
- Usability Testing 0
- 0 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 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.

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Image /page/8/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with the word "MEDICAL" in orange underneath. The "A" in "ACUTUS" has an orange dot in the middle. There is a registered trademark symbol next to the "S" in "ACUTUS".

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

As discussed above, no further clinical testing is required to support the modified AcQMap 3D Imaging and Mapping Catheter. The necessary clinical testing was completed for the original AcQMap 3D Imaging and Mapping Catheter (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Comblex Supraventricular Tachycardia, (DDRAMATIC-SVT)" was a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrated that the AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use.

Conclusions

Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap 3D Imaging and Mapping Catheter 510(k), was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. The clinical validation of the original AcQMap 3D Imaging and Mapping Catheter (K170819) is applicable to the modified device. The subject device 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).