AcQMap High Resolution Imaging and Mapping System

K190131 · Acutus Medical, Inc. · DQK · Apr 2, 2019 · Cardiovascular

Device Facts

• Record ID: K190131
• Device Name: AcQMap High Resolution Imaging and Mapping System
• Applicant: Acutus Medical, Inc.
• Product Code: DQK · Cardiovascular
• Decision Date: Apr 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1425
• Device Class: Class 2

Intended Use

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.

Device Story

AcQMap System (Model 900100) is a computer-based diagnostic recording system for use in electrophysiology (EP) labs by physicians. It processes inputs from ultrasound transducers (on AcQMap catheters), ECG/EGM leads, and impedance-based electrode localization sensors. The system reconstructs 3D cardiac chamber anatomy and generates dipole density or voltage maps to visualize electrical activation. Outputs are displayed on a workstation to assist physicians in identifying arrhythmia sources. The system includes a console, workstation, and auxiliary interface box. It provides real-time 3D navigation of catheters and cardiac electrical waveform traces. By enabling high-resolution mapping of complex arrhythmias, it aids in clinical decision-making for ablation procedures, potentially improving procedural outcomes.

Clinical Evidence

No new clinical data; relies on clinical validation of the predicate (K170948). The DDRAMATIC-SVT study (prospective, non-randomized, open-label, 84 patients) demonstrated safety and effectiveness for the original system, which is applicable to the subject device.

Technological Characteristics

Computer-based diagnostic system; ultrasound imaging (10 MHz), impedance-based localization (15-50 kHz), and ECG/EGM recording (0.05-500 Hz). Components: Console, Workstation, Auxiliary Interface Box. Connectivity: Defibrillator-protected Type CF/BF patient connections. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-25, IEC 60601-2-37. Software-based processing for 3D reconstruction and electrical mapping.

Indications for Use

Indicated for patients undergoing electrophysiology procedures. Used for 3D reconstruction of cardiac chambers via ultrasound, visualization of anatomy, and mapping of electrical impulses (dipole density or voltage) for complex arrhythmias. Also used for tracking position of AcQMap and conventional 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, Model 900000 (K170948)

Submission Summary (Full Text)

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April 2, 2019

Acutus Medical, Inc. Serena Sanginthirath Senior Regulatory Affairs Specialist 2210 Faraday Ave.. Suite 100 Carlsbad, California 92008

Re: K190131

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: January 23, 2019 Received: January 28, 2019

Dear Serena Sanginthirath:

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 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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Mande Yellen
for

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

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K190131

Device Name

AcQMap® High Resolution Imaging and Mapping System, Model 900100

#### Indications for Use (Describe)

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.

| 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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# 510(k) Notification K_190131

# GENERAL INFORMATION [807.92(a)(1)]

#### Applicant:

Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] Fax: [phone]

#### Contact Person:

Serena Sanginthirath Senior Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] FAX: [phone] Email: [e-mail]

# Date Prepared: January 23, 2019

# DEVICE INFORMATION [807.92(a)(2)]

#### Trade Name:

AcQMap® High Resolution Imaging and Mapping System, Model 900100

### 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:

DQK, IYO, ITX

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

AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948)

# DEVICE DESCRIPTION [807.92(a)(4)]

The AcQMap High Resolution Imaging and Mapping System, Model 900100 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, Model 900100 ("AcQMap System Model, 900100") 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 Model, 900100 hardware consists of three functional subsystems:

- Ultrasound imaging, ●
- ECG and EGM recording; and .
- o Impedance based electrode localization.

The AcQMap System. Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter (cleared under K170819). The AcQMap System provides:

- . 3-D cardiac chamber reconstruction imaging,
- Three-dimensional position of the AcQMap Catheter and conventional ● electrophysiology catheters,
- Cardiac electrical activity as waveform traces, ●
- 0 Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.

The AcOMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. The AcQMap System, Model 900100 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

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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.

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

The indications for use for the AcQMap® High Resolution Imaging and Mapping System, Model 900100 are identical to the predicate device, AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948).

The technological characteristics of the predicate device are very similar; with only a few minor differences.

Table 1 provides a comparison of the technological characteristics for the AcQMap System, Model 900100 with the predicate device.

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| | Subject Device | Predicate Device | |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Characteristics | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000<br>(K170948) | Rationale for Substantial Equivalence |
| 510(k) Number | TBD | K170948 | N/A |
| Classification/<br>Regulation<br>Number/Regulation<br>Name/Product Code | Class II/21 CFR § 870.1425/Programable<br>diagnostic computer/DQK<br>Class II/21 CFR § 892.1560/Ultrasonic<br>pulsed echo imaging system/IYO, ITX | Class II/21 CFR § 870.1425/Programable<br>diagnostic computer/DQK<br>Class II/21 CFR § 892.1560/Ultrasonic<br>pulsed echo imaging system/IYO, ITX | Same Classification/Regulation |
| Indications for Use | The AcQMap System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br>When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing<br>the chamber anatomy and displaying<br>electrical impulses as either dipole density<br>or voltage maps of complex arrhythmias<br>that may be difficult to identify using<br>conventional mapping systems alone.<br>AND<br>When used with the specified Patient<br>Electrodes, the AcQMap System is intended<br>to display the position of AcQMap<br>Catheters and conventional<br>electrophysiology (EP) catheters in the<br>heart. | The AcQMap System is intended for use in<br>patients for whom electrophysiology<br>procedures have been prescribed.<br>When used with the AcQMap Catheters, the<br>AcQMap System is intended to be used to<br>reconstruct the selected chamber from<br>ultrasound data for purposes of visualizing<br>the chamber anatomy and displaying<br>electrical impulses as either dipole density-<br>based or voltage-based maps of complex<br>arrhythmias that may be difficult to identify<br>using conventional mapping systems alone.<br>AND<br>When used with the specified Patient<br>Electrodes, the AcQMap System is intended<br>to display the position of AcQMap<br>Catheters and conventional<br>electrophysiology (EP) catheters in the<br>heart. | Same Indications for Use |

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## Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)

| Characteristics | Subject Device<br>AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | Predicate Device<br>AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000 (K170948) | Rationale for Substantial<br>Equivalence |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acutus Medical, Inc. | Acutus Medical, Inc. | Same Manufacturer |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Same Patient Anatomy |
| Testing to Support<br>Substantial<br>Equivalence | • Software V/V<br>• Electromagnetic and Electrical Safety<br>• Verification Testing,<br>• Accuracy Testing, and<br>• Animal Testing | • Software V/V<br>• Electromagnetic and Electrical Safety<br>• Verification Testing,<br>• Accuracy Testing.<br>• Animal Testing; and<br>• Clinical Testing | Complete performance testing<br>conducted by Acutus demonstrates that<br>the AcQMap System, Model 900100<br>performs as intended and that there are<br>no different questions of safety or<br>effectiveness. |
| System Safety<br>Standards | • IEC 60601-1:2005 /A1:2012<br>• IEC 60601-1-2:2014<br>• IEC 60601-1-6:2010/A1:2013<br>• IEC 60601-2-25:2015<br>• IEC 60601-2-37:2007 | • IEC 60601-1: 2005 /A1:2012<br>• IEC 60601-2-37: 2007<br>• IEC 60601-1-2: 2007 /AC:2010<br>• IEC60601-1-6:2010 | Same safety standards with compliance<br>to current revisions. Improved safety<br>by meeting additional relevant standard,<br>IEC 60601-2-25:2011 |

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| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000 (K170948) | |
| Physical Characteristics | | | |
| System<br>Components | 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. | Console Workstation Workstation Cable Ablation Interface Unit Ablation Interface Unit Cable Auxiliary Catheter Cable Surface ECG Input Cable Patient Interface Unit, Patient Interface Unit Cable Ablation Generator Catheter Adaptor Cables Patient Electrode Kit | The subject device no longer includes<br>the Patient Interface Unit and the<br>Ablation Interface Unit.<br>Based on the performance test<br>conducted, any differences in system<br>components, as well as the addition of<br>the Auxiliary Interface Box, does not<br>raise different questions of safety or<br>effectiveness. |
| Visual/Mapping<br>Characteristics | 3-D cardiac chamber reconstructions<br>imaging, Three-dimensional position of the<br>AcQMap Catheter and conventional<br>electrophysiology catheters, Cardiac electrical activity as waveform<br>traces, Remapping of the chamber at any time<br>during the procedure; and Three-dimensional, dipole density maps<br>overlaid on the cardiac chamber<br>reconstruction to show chamber-wide<br>electrical activation. | 3-D cardiac chamber reconstructions<br>imaging, Three-dimensional position of the<br>AcQMap Catheter and conventional<br>electrophysiology catheters, Cardiac electrical activity as waveform<br>traces, Remapping of the chamber at any time<br>during the procedure; and Three-dimensional, dipole density maps<br>overlaid on the cardiac chamber<br>reconstruction to show chamber-wide<br>electrical activation. | Same |

#### Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)

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| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
|----------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000 (K170948) | |
| Visualization<br>Device/Catheter | AcQMap Catheter (electrodes and<br>transducers, K170819) | AcQMap Catheter (electrodes and transducers,<br>K170819) | Same |
| Console Physical Characteristics | | | |
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 68 cm L x 48.3 cm W x 72.6 cm D | Larger dimensions due to inclusion of<br>locking caster base. The predicate<br>device is built with non-locking casters.<br>This slightly larger size accommodates<br>improvements in clinical safety. The<br>difference in dimensions does not raise<br>safety or effectiveness as demonstrated<br>through performance testing. |
| Weight<br>Maximum | 80 kg | 50 kg | The difference in the maximum weight<br>does not raise safety or effectiveness as<br>demonstrated through performance<br>testing. |
| Power<br>Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50<br>Hz | 110 – 240 V, 50/60 Hz | The difference in the power<br>requirement does not raise safety or<br>effectiveness, as the power in the<br>subject device is lower and is<br>demonstrated through performance<br>testing. |
| Input Current | 4.6 A | 5A | The difference in the input current does<br>not raise safety or effectiveness, as the<br>input current in the subject device is<br>lower and is demonstrated through<br>performance testing. |
| Fuse protection | 250 V, 6.3A, two high breaking capacity<br>fuses | 250 V, 6.3 A, two high breaking capacity fuses | Same |

# Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)

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## Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)

| Characteristics | Subject Device | Predicate Device | Rationale for Substantial<br>Equivalence |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000 (K170948) | |
| System Specifications | | | |
| Safety<br>Information | IEC 60601-1, Class I, Type Defibrillator<br>Protected CF, continuous operation, no<br>sterilization, equipment not suitable for use<br>in the presence of a flammable anesthetic<br>mixture with air, oxygen or nitrous oxide | IEC 60601-1, Class I, Type CF, continuous<br>operation, no sterilization, equipment not suitable<br>for use in the presence of a flammable anesthetic<br>mixture with air, oxygen or nitrous oxide | The addition of Defibrillation-Proof<br>does not raise safety or effectiveness as<br>demonstrated through performance<br>testing. |
| Ingress<br>Protection | The Console is rated IP20 | The Console is rated IP20 | Same |
| Functional and Performance Characteristics | | | |
| | Ultrasound<br>Output | Frequency: 10 MHz+/-400 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: 1 W peak | Frequency: 10 MHz+/-10 kHz<br>Maximum Voltage: 50V p-p<br>Maximum Power: 1 W peak |
| | Ultrasound<br>Performance | Single operating mode<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 | Single operating mode A<br>Thermal Index less than 1.0<br>Mechanical Index less than 1.0 |

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## Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)

| Characteristics | Subject Device<br>AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | Predicate Device<br>AcQMap® High Resolution Imaging and<br>Mapping System, Model 900000 (K170948) | Rationale for Substantial<br>Equivalence |
|-------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Localization<br>Output | Frequency: Variable 15 kHz to 50 kHz<br>Maximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHz<br>Maximum current: 2.2mA/cm2 | The reduction in localization frequency<br>increases the input impedance of the<br>localization system and improves<br>localization accuracy. The difference<br>in localization output does not raise<br>safety or effectiveness as demonstrated<br>through performance testing. |
| ECG & EGM<br>Input | Bandwidth: 0.05 Hz to 500 Hz<br>Resolution: +/-1uV<br>Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.1 Hz to 500 Hz<br>Resolution: +/-10uV<br>Timing Accuracy: +/-1.6 microsecond | The change in bandwidth is to meet<br>international standards. The change in<br>resolution improves accuracy of dipole<br>density maps. Changes does not raise<br>safety or effectiveness as demonstrated<br>through performance testing. |
| Front Panel Connections | | | |
| AcQMap<br>Catheter | Custom, black, Defibrillator Protected Type<br>CF | 100-pin custom, Type CF | Defibrillation-Proof. The AcQMap<br>Catheter connector is unchanged,<br>system specifications have changed as<br>discussed above, and does not raise<br>different questions of safety or<br>effectiveness as demonstrated through<br>performance testing. |
| ECG Input | 12-pin, latching, red, Defibrillator Protected<br>Type BF | 12-pin, latching, Type BF | Defibrillation-Proof. ECG Input<br>connector is unchanged, system<br>specifications have changed as<br>discussed above, and does not raise<br>different questions of safety or<br>effectiveness as demonstrated through<br>performance testing. |
| ECG Output | 14-pin, latching, blue | -- | The ECG output as a front panel<br>connection does not raise safety or<br>effectiveness as demonstrated through<br>performance testing. |

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## Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)

| | Subject Device | Predicate Device | Rationale for Substantial |
|--------------------------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | AcQMap® High Resolution Imaging and | AcQMap® High Resolution Imaging and | Equivalence |
| | Mapping System, Model 900100 | Mapping System, Model 900000 (K170948) | |
| Auxiliary<br>Interface Box | Custom, green, Defibrillator Protected Type<br>CF | -- | Defibrillation-Proof. The AcQMap<br>Auxiliary Interface Box provides<br>connection to the auxiliary catheters<br>(optional) used during the procedure.<br>The AcQMap Auxiliary Interface Box<br>also provides amplification of signals<br>collected from auxiliary catheters and<br>transfers these signals to the AcQMap<br>Console for display. A universal bed<br>rail clamp is provided for mounting.<br>The addition of the AcQMap Auxiliary<br>Interface Box does not raise different<br>questions of safety or effectiveness as<br>demonstrated through performance<br>testing |
| AcQRef<br>Introducer<br>Sheath or<br>Electrical<br>Reference<br>Catheter | 1, 2mm female, yellow, Defibrillator<br>Protected Type CF | 1, 2mm female, Type CF | Defibrillation-Proof. The AcQRef<br>Introducer Sheath connector is<br>unchanged, system specifications have<br>changed as discussed above, and does<br>not raise different questions of safety or<br>effectiveness. |
| Localization<br>Reference<br>Electrodes | 6, 2-pin, square, multi-color, Defibrillator<br>Protected Type BF | 6, 2-pin, square, Type BF | Defibrillation-Proof. The Localization<br>Reference Electrodes connector are<br>unchanged, system specifications have<br>changed as discussed above, and does<br>not raise different questions of safety or<br>effectiveness. |
| Patient<br>Reference<br>Electrode | 1, 2-pin, square, blue, Defibrillator Protected<br>Type BF | 1, 2-pin, square, Type BF | Defibrillation-Proof. The Patient<br>Reference Electrode connector is<br>unchanged, system specifications have<br>changed as discussed above, and does<br>not raise different questions of safety or<br>effectiveness. |

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| Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.) | | | |
|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | Subject Device<br>AcQMap® High Resolution Imaging and<br>Mapping System, Model 900100 | Predicate Device<br>AcQMap® High Resolution Imaging and<br>Mapping System (K170948) | Rationale for Substantial<br>Equivalence |
| Ablation<br>Generator | 10-pin, latching, grey | 10-pin, male, Type CF | The Ablation Generator connector is<br>unchanged, system specifications have<br>changed as discussed above, and does<br>not raise different questions of safety or<br>effectiveness. |
| Ablation<br>Catheter | 10-pin, latching, grey, Defibrillator Protected<br>Type CF | 10-pin, female, Type CF | Defibrillation-Proof. The Ablation<br>Catheter connector is unchanged,<br>system specifications have changed as<br>discussed above, and does not raise<br>different questions of safety or<br>effectiveness. |
| Ablation<br>Reference | 1, 2mm, female, black, Defibrillator<br>Protected Type BF | -- | Defibrillation-Proof. The ablation<br>reference does not raise different<br>questions of safety or effectiveness as<br>demonstrated through performance<br>testing. |
| Ablation<br>Electrogram<br>Interface | 1, 13-pin, latching, white | -- | This new cable added to the subject<br>device does not raise different<br>questions of safety or effectiveness as<br>demonstrated through performance<br>testing |

## Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)

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## SUBSTANTIAL EQUIVALENCE

The indication for use for the subject device, AcQMap® High Resolution Imaging and Mapping System. Model 900100, is substantially equivalent to the predicate. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the AcQMap® High Resolution Imaging and Mapping System, Model 900100 is substantially equivalent to the predicate device.

# PERFORMANCE DATA [807.92(b)]

All necessary bench testing was conducted on the AcQMap® High Resolution Imaging and Mapping System, Model 900100 to support a determination of substantial equivalence to the predicate device. The necessary clinical study was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical study is required to support the subject device.

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

The necessary bench testing was performed on the AcQMap System, Model 900100 to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device. The bench testing, either repeated for the subject device or incorporated by reference to the original AcOMap System 510(k), included the following:

- Transportation Testing ●
- AcOMap Verification Testing ●
- Software Verification and Validation
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study

The AcQMap® High Resolution Imaging and Mapping System, Model 900100 was tested to verify that the device meets the established performance specifications.

The collective results of the testing demonstrate that the design of the AcQMap® High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use.

The collective results of the nonclinical testing either repeated for the proposed device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen. the manufacturing processes, and design of the AcOMap® High Resolution Imaging and Mapping System, Model 900100 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.

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

As discussed above, no further clinical testing is required to support the AcQMap® High Resolution Imaging and Mapping System, Model 900100. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by

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reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex 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 System is safe and effective for its intended use.

# CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical performance testing, either repeated for the AcQMap® High Resolution Imaging and Mapping System, Model 900100 or incorporated by reference to the original AcQMap System 510(k), was conducted on the AcQMap System Model, 900100 to evaluate the overall performance of the device. The clinical validation of the original AcQMap System (K170948) is applicable to the subject device. The collective results demonstrate that the AcQMap System, Model 900100 is safe and effective for its intended use.

### SUMMARY

Based on the performance testing and the technological characteristics, it can be concluded that the AcQMap® High Resolution Imaging and Mapping System, Model 900100 is as safe and effective for its intended use and is substantially equivalent to the predicate device.