Who is the manufacturer of AcQMap High Resolution Imaging and Mapping System?

Acutus Medical, Inc. filed the 510(k) submission for AcQMap High Resolution Imaging and Mapping System (K222209).

What is the FDA product code for AcQMap High Resolution Imaging and Mapping System?

DQK. It is classified under 21 CFR 870.1425 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for AcQMap High Resolution Imaging and Mapping System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like AcQMap High Resolution Imaging and Mapping System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

AcQMap High Resolution Imaging and Mapping System

Q: What are the predicate devices for AcQMap High Resolution Imaging and Mapping System?

AcQMap High Resolution Imaging and Mapping System (K220784).

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

Device Facts

Record ID	K222209
Device Name	AcQMap High Resolution Imaging and Mapping System
Applicant	Acutus Medical, Inc.
Product Code	DQK · Cardiovascular
Decision Date	Oct 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1425
Device Class	Class 2

Indications for Use

The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging and Mapping System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure.

Device Story

Diagnostic recording system for EP labs; images, navigates, and maps atrial chambers. Inputs: ultrasound data, ECG/EGM signals, impedance-based localization. Operation: console, workstation, and auxiliary interface box process inputs to reconstruct 3D cardiac chamber surfaces and display electrical activity as waveform traces or dynamic charge density/voltage maps. Physician uses output to identify arrhythmia sources and guide catheter placement. Enables contact mapping and catheter localization. Modifications facilitate connectivity with DiamondTemp Ablation Generator. Benefits: improved visualization of complex arrhythmias compared to conventional systems.

Clinical Evidence

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

Technological Characteristics

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

Indications for Use

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

Regulatory Classification

Identification

A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.

Predicate Devices

AcQMap High Resolution Imaging and Mapping System (K220784)

Reference Devices

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

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 17, 2022 Acutus Medical, Inc. Subhadra Elango Senior Specialist, Regulatory Affairs 2210 Faraday Ave., Suite 100 Carlsbad, California 92008 Re: K222209 Trade/Device Name: AcQMap High Resolution Imaging and Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: July 22, 2022 Received: July 25, 2022 Dear Subhadra Elango: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K22209 #### Device Name AcQMap High Resolution Imaging and Mapping System #### Indications for Use (Describe) The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcOMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. #### AND When used with the specified Patient Electrodes, the AcOMap High Resolution Imaging System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. #### OR When used with conventional electrophysiology catheters, the AcOMap High Resolution Imaging System provides information about the electrical activity of the heart and about catheter location during the procedure. Type of Use (Select one or both, as applicable) | 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." {3}------------------------------------------------ ### 510(K) Notification K222209 ### GENERAL INFORMATION [807.92(a)(1)] ### Date Prepared: 17 October 2022 | Applicant: | Contact Person: | |-----------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6080 Fax: 1-442-232-6081 | Subhadra Elango Senior Specialist, Regulatory Affairs Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-999-7630 Email: Subhadra.elango@acutus.com | ### 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 Class II / 21 CFR § 892.1560 | | Product Code(s): | DQK, IYO, ITX | #### PREDICATE DEVICE [807.92(a)(3)] | Predicate Device | Manufacturer | FDA 510(k) | |------------------------------------------------------|----------------------|------------| | AcQMap High Resolution Imaging and Mapping System | Acutus Medical, Inc. | K220784 | #### DEVICE DESCRIPTION [807.92(A)(4)] The AcQMap High Resolution Imaging and Mapping System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation and the AcQMap Auxiliary Interface Box. The AcQMap High Resolution Imaging and Mapping System is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation, and mapping of the atrial chambers of the heart. The AcQMap High Resolution Imaging and Mapping System hardware consists of three functional subsystems: - Ultrasound imaging, . - ECG and EGM recording; and - . Impedance based electrode Localization. The AcQMap High Resolution Imaging and Mapping System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 (cleared under K201341). The AcQMap High Resolution Imaging and Mapping System provides: - 3-D cardiac chamber reconstruction Contact and non-contact (ultrasound), ● K222209 {4}------------------------------------------------ - . Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters, - . Cardiac electrical activity as waveform traces, - . Contact LAT and voltage amplitude maps - Remapping of the chamber at any time during the procedure; and - . Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. The AcQMap High Resolution Imaging and Mapping System is intended to create a surface reconstruction of the cardiac chamber as well as an electrical map of the substrate. The surface reconstruction and electrical map are then used by physicians to identify the source(s) of the arrhythmia. Additionally, the AcQMap High Resolution Imaging and Mapping System allows physicians to perform traditional contact mapping activities, including establishing a coordinate system, localizing conventional electrophysiology catheters relative to one another within the coordinate system, recording contact electrograms, and initiating a procedure without the AcQMap Catheter present. Based on the information captured in the contact electrograms, the physician may decide to treat an arrythmia without deploying the AcQMap Catheter. The modifications to the AcQMap High Resolution Imaging System include the addition of new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and DiamondTemp™ Ablation Generator. {5}------------------------------------------------ ## INDICATIONS FOR USE [807.92(A)(5)] The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. ### AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging and Mapping System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. - OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure. ## Comparison of Technological Characteristics with the Predicate Devices [807.92(A)(6)] Tables 1 and 2 provides a comparison of the modified AcQMap High Resolution Imaging and Mapping System classification and indications for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap High Resolution Imaging and Mapping System against the predicate device. | Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence | | | |-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|-------------------------------------------| | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System (K220784) | Rationale for Substantial Equivalence | | | | 510(k) Number | K222209 | K220784 | -- | | | | Classification/ | Class II | Class II | Identical | | | | Regulation | 21 CFR § 870.1425, Programable diagnostic computer 21 CFR § 892.1560, Ultrasonic pulsed echo imaging system | 21 CFR § 870.1425, Programable diagnostic computer 21 CFR § 892.1560, Ultrasonic pulsed echo imaging system | Identical | | | | Product Code | DQK, IYO, and ITX | DQK, IYO, and ITX | Identical | | | | Table 2: Comparison of Indications for Use with the Predicate Device | | | | | | | Characteristics | Subject Device AcQMap® High Resolution Imaging and Mapping System | Predicate Device AcQMap® High Resolution Imaging and Mapping System (K220784) | Rationale for Substantial Equivalence | | | | Indications for Use | The AcQMap High Resolution Imaging and Mapping System is intended for use in patients for whom electrophysiology procedures have been prescribed. When used with the AcQMap Catheters, the AcQMap High Resolution Imaging and Mapping System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density- based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap High Resolution Imaging and Mapping System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap High Resolution Imaging and Mapping System provides information about the electrical activity of the heart and about catheter location during the procedure. | The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed. 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 charge density- based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone. AND When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart. OR When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure. | Identical, with the exception of device trade name. | | | | Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | | | | | Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence | | | | | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System (K220784) | | | | | Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical | | | | Testing to Support Substantial Equivalence | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Software V/V Electromagnetic and Electrical Safety Verification Testing, Accuracy Testing, and Animal Testing | Identical | | | | System Safety Standards | IEC 60601-1:2005 / A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 / A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Identical | | | | Physical Characteristics | | | | | | | System Components & Accessories | Console Workstation Workstation Cable Auxiliary Interface Box ECG Input Cable Ampere Ablation Catheter Adapter Cable Ampere RF Generator Adapter Cable ECG Output Cable Ablation Reference Cable Ablation Electrogram Cable ECG w/Snaps Cable ECG POST Cable 2mm Pin Jumper Set Patient Electrode Kit Ampere Generator Adapter SmartAblate Generator Adapter Maestro Generator Adapter Adapter Cable- Short - Ablation Adapter | Console Workstation Workstation Cable Auxiliary Interface Box ECG Input Cable Ampere Ablation Catheter Adapter Cable Ampere RF Generator Adapter Cable ECG Output Cable Ablation Reference Cable Ablation Electrogram Cable ECG w/Snaps Cable ECG POST Cable 2mm Pin Jumper Set Patient Electrode Kit Ampere Generator Adapter SmartAblate Generator Adapter Maestro Generator Adapter Adapter Cable- Short - Ablation Adapter | All system components are identical, except the new accessories. Verification testing on the new accessories demonstrates that the AcQMap High Resolution Imaging and Mapping System and the new accessories perform as intended. There are no different questions of safety or effectiveness. | | | | Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | | | | | Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence | | | | | AcQMap® High Resolution Imaging and Mapping System | AcQMap® High Resolution Imaging and Mapping System (K220784) | | | | | | Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable – Generator Carto Force Adapter Cable DiamondTemp Generator Adapter DiamondTemp Adapter Cable – Generator | Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator Carto Force Adapter Cable | | | | | | Visual/Mapping Characteristics | 3-D cardiac chamber reconstructions – Contact and non-contact (ultrasound); Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time during the procedure; Dynamic, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | | | | | | | Visualization Device/Catheter | | | | | | | | | Weight | | | |…

AcQMap High Resolution Imaging and Mapping System

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