AcQMap High Resolution Imaging and Mapping System

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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. 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. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------| | <span style="font-size:10px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 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 {4}------------------------------------------------ # 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 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, 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. 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. # INDICATIONS FOR USE [807.92(a)(5)] 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 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. {5}------------------------------------------------ # 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. {6}------------------------------------------------ 510(k) Summary | Characteristics | AcQMap® High Resolution<br>Imaging and Mapping System | EnSite™ Velocity™ Cardiac<br>Mapping System | iLab™ Ultrasound Imaging<br>System | Rationale for Substantial<br>Equivalence | |----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulatory | | | | | | 510(k) Number | TBD | K130594 | K130243 | - | | Classification/<br>Regulation<br>Number/Regulation<br>Name/Product<br>Code | Class II/21 CFR §<br>870.1425/Programable diagnostic<br>computer/DQK<br><br>Class II/21 CFR §<br>892.1560/Ultrasonic pulsed echo<br>imaging system/IYO, ITX | Class II/21 CFR §<br>870.1425/Programable<br>diagnostic computer/DQK | Class II/21 CFR §<br>892.1560/Ultrasound pulsed<br>echo imaging system/IYO,<br>ITX | The additional product codes<br>and regulation number for the<br>proposed device are required. | | Indications for Use | The AcQMap System is intended<br>for use in patients for whom<br>electrophysiology procedures have<br>been prescribed.<br><br>When used with the AcQMap<br>Catheters, the AcQMap System is<br>intended to be used to reconstruct<br>the selected chamber from<br>ultrasound data for purposes of<br>visualizing the chamber anatomy<br>and displaying electrical impulses<br>as either dipole density-based or<br>voltage-based maps of complex<br>arrhythmias that may be difficult to<br>identify using conventional<br>mapping systems alone.<br><br>AND<br><br>When used with the specified<br>Patient Electrodes, the AcQMap<br>System is intended to display the<br>position of AcQMap Catheters and<br>conventional electrophysiology<br>(EP) catheters in the heart. | The EnSite™ Velocity™<br>Cardiac Mapping System is a<br>suggested diagnostic tool in<br>patients for whom<br>electrophysiology studies are<br>indicated.<br><br>*When used with the EnSite<br>Array™ Catheter, the EnSite™<br>Velocity™ Cardiac Mapping<br>System is intended to be used<br>in the right atrium of patients<br>with complex arrhythmias that<br>may be difficult to identify<br>using conventional mapping<br>systems alone.<br><br>OR<br><br>*When used with the EnSite™<br>NavX™ Surface Electrode Kit,<br>the EnSite™ Velocity™<br>Cardiac Mapping System is<br>intended to display the<br>position of conventional<br>electrophysiology (EP)<br>catheters in the heart. | The iLab™ Ultrasound<br>Imaging System is intended<br>for ultrasound examinations<br>of intravascular pathology.<br>Intravascular ultrasound is<br>indicated in patients who are<br>candidates for transluminal<br>interventional procedures<br>such as angioplasty and<br>atherectomy. | All devices are intended for<br>electrophysiology procedures.<br>Both the AcQMap System and<br>EnSite System are indicated for<br>complex arrhythmias when<br>used with their respective<br>catheters. Both the AcQMap<br>System and iLab System<br>include the ultrasound<br>performance capabilities in the<br>indications for use statement.<br>The semantic differences in the<br>indications for use do not raise<br>different questions of safety or<br>effectiveness than the<br>predicates as demonstrated by<br>the AcQMap performance<br>testing. | | | | | | | | | 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 manus<br>oftware V/V lectromagnetic and Electrica<br>●<br>●<br>0 | Bench testing; a Animal testing | ctional/performan<br>eroperability testin<br>ctrical Safety tes<br>esting<br>and<br>0 | 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 | ●<br>● | 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 של<br>601 .1<br>●<br>● | Inknowr | Same | | Characteristics | AcQMap® High Resolution<br>Imaging and Mapping System | EnSite™ Velocity™ Cardiac<br>Mapping System | iLab™ Ultrasound Imaging<br>System | Rationale for Substantial<br>Equivalence | | Physical Characteristics | | | | | | System<br>Components | Console, Workstation, Workstation<br>Cable Patient Interface Unit, Patient<br>Interface Unit Cable, Ablation<br>Interface Unit, Ablation Interface<br>Unit Cable, Auxiliary Catheter<br>Cable, Surface ECG Input Cable<br>and Patient Electrode Kit. | Amplifier and Display<br>Workstation (DWS)<br>Amplifier includes Navlink,<br>ArrayLink and CathLink<br>Modules, SJM ECG Cable,<br>Record Connect and<br>GenConnect.<br> | Unknown | Same | | Visual/Mapping<br>Characteristics | 3-D cardiac chamber<br>reconstructions imaging, Three-dimensional position of<br>the AcQMap Catheter and<br>conventional electrophysiology<br>catheters, Cardiac electrical activity as<br>waveform traces, Remapping of the chamber at<br>any time during the procedure;<br>and Three-dimensional, dipole<br>density maps overlaid on the<br>cardiac chamber reconstruction<br>to show chamber-wide<br>electrical activation. | Three-dimensional<br>position of the catheter Display cardiac electrical<br>activity as waveform<br>traces; Three-dimensional maps<br>of the cardiac chamber | Combination of imaging<br>and soft tissue<br>visualization. Visualizes the catheter<br>relative to the anatomical<br>structure | The combination of three-<br>dimensional imaging<br>functionality and ultrasound<br>functionality for display of<br>dipole density maps does not<br>raise different questions of<br>safety or effectiveness as<br>demonstrated through<br>performance testing. | | Visualization<br>Device/Catheter | AcQMap Catheter (electrodes and<br>transducers) | EnSite Array Catheter<br>(electrode) | BSC Ultra ICE - Ultrasound<br>Dx Catheter (transducer) | | | Characteristics | AcQMap® High Resolution Imaging<br>and Mapping System | EnSite™ Velocity™ Cardiac<br>Mapping System | iLab™ Ultrasound Imaging<br>System | Rationale for Substantial<br>Equivalence | | 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 | | Weight<br>Maximum | 50 kg | 31 kg | 213 pounds (System weight) | | | Power<br>Requirement | 110 – 240 V, 50/60 Hz | 100, 110/120, 220/240 V<br>~50/60 Hz | Unknown | | | Input Current | 5A | 450W maximum (4.5A) | Unknown | | | Fuse protection | 250 V, 6.3 A, two high breaking<br>capacity fuses | 250 V, 5 A VAC, two fuses | Unknown | | Table 1: Comparison of Technological Characteristics with the Predicate Devic {7}------------------------------------------------ 510(k) Summary Table 1: Comparison of Technological Characteristics with the Predicate Devices (con {8}------------------------------------------------ 510(k) Summary {9}------------------------------------------------ 510(k) SUMMAR - {10}------------------------------------------------ ## 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. {11}------------------------------------------------ # 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.