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.

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.

Device Description

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 hardware consists of three functional subsystems:

. Ultrasound imaging,
. ECG and EGM recording; and
Impedance based electrode Localization. .

The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:

. 3-D cardiac chamber reconstruction - 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; and
Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction . to show chamber-wide electrical activation.

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.

Additionally, the AcQMap 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 System, Model 900100 includes addition of new accessories (cables and adapters) to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and compatible RF Ablation Generators.

AI/ML Overview

This FDA 510(k) summary document focuses on demonstrating substantial equivalence of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 (K212345) to its predicate device (K201015). The modifications primarily involve the addition of new accessories (cables and adapters) to facilitate connectivity with commercially available RF Ablation Generators. Since the changes do not impact the core hardware or software of the original system, the document refers to the clinical testing performed for the original AcQMap System (K170948).

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance based on the clinical study. Instead, it states that the "collective results of the testing demonstrate that the design of the modified AcQMap High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use."

For the clinical study, the reported performance is qualitative: "the results for 84 patients demonstrated that the AcQMap System is substantially equivalent to the predicate device." This implies that the device performed comparably to existing, legally marketed devices.

The document lists various non-clinical tests that were performed, either repeated for the modified device or incorporated by reference. These tests would have their own internal acceptance criteria, but these are not specified in this document. Examples of these non-clinical tests include:

Third party system Compatibility with AcQMap system, Model 900100 Testing
System RF Attenuation characterization
Therapeutic Waveform Fidelity Assessment
Safety Testing
Packaging Testing
Inspection and Labeling Review
Common Mode Choke (CMC) performance verification Testing
In-vitro Localization Accuracy Study
Transportation Testing
AcQMap Verification Testing
System Accuracy Testing
Electromagnetic Compatibility and Electrical Safety Testing
AcQMap Catheter Validation Testing-Animal Study
Accuracy Validation Testing Animal Study
Software Verification and Validation
Clinical Simulation (Reliability)
Map Accuracy Evaluation

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

Sample Size for Test Set: 84 patients
Data Provenance: The study was a 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

The document does not specify the number of experts used to establish ground truth in the clinical study or their qualifications. The study focused on demonstrating "substantially equivalent" performance to a predicate device, but the method for assessing this equivalence (e.g., comparison against established diagnostic standards or expert interpretation) is not detailed.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of an MRMC comparative effectiveness study or any assessment of human reader improvement with or without AI assistance. The document describes the system as "computer-based" and capable of "imaging, navigation and mapping," and "displaying electrical impulses as either charge density-based or voltage-based maps." However, its primary function appears to be diagnostic support for electrophysiology procedures, not an AI-assisted diagnostic interpretation tool with a human-in-the-loop comparison.

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

The document does not explicitly describe a standalone algorithm-only performance study. While it mentions the computer-based nature of the system and its mapping capabilities, the "Indications for Use" clearly state it's "intended for use in patients for whom electrophysiology procedures have been prescribed" and "intended to be used to reconstruct... and displaying electrical impulses." This implies a system that provides information for a physician to interpret and act upon, rather than an independent diagnostic algorithm.

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

The document does not explicitly state the type of ground truth used in the clinical study (DDRAMATIC-SVT). Since the study aimed to demonstrate "substantially equivalent" performance to a predicate device in the context of "mapping and assessment of therapy in complex supraventricular tachycardia," it's highly probable that electrophysiological data agreed upon by treating clinicians, potentially involving follow-up on therapeutic outcomes, served as the de facto "ground truth" for assessing the system's accuracy in identifying arrhythmias. However, this is an inference based on the nature of the device and study.

8. The Sample Size for the Training Set

The document does not provide any information regarding a training set because it describes a device that is a diagnostic recording system, not an AI/ML device that requires a distinct training and test set. The clinical study mentioned (DDRAMATIC-SVT) is for validation, not for training.

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

As no training set is mentioned for an AI/ML device, this question is not applicable to the information provided.

Summary

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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 Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2021

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

Re: K212345

Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System, Model 900100 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX, Dated: July 26, 2021 Received: July 28, 2021

Dear Sindhu Sridhar:

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

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 (Acting) 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) K212345

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.

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.

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.

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

☒ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) NOTIFICATION K212345

GENERAL INFORMATION [807.92(a)(1)]

Date Prepared: 26 July 2021

Applicant:	Contact Person:
Acutus Medical, Inc.	Sindhu Sridhar
2210 Faraday Ave., Suite 100	Regulatory Affairs Manager
Carlsbad, CA 92008	Acutus Medical, Inc.
USA	2210 Faraday Ave., Suite 100
Phone: 1-442-232-6080	Carlsbad, CA 92008
Fax: 1-442-232-6081	USA
	Phone: 1-442-999-7630
	Email: sindhu.sridhar@acutus.com

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:	AcQMap® High Resolution Imaging and Mapping System, Model 900100
Generic/Common Name:	Programable diagnostic computer andUltrasonic pulsed echo imaging system
Classification:	Class II / 21 CFR § 870.1425 andClass II / 21 CFR § 892.1560
Product Code(s):	DQK, IYO, ITX

PREDICATE DEVICES [807.92(a)(3)]

Predicate Device	Manufacturer	FDA 510(k)
AcQMap High ResolutionImaging and Mapping System,Model 900100	Acutus Medical, Inc.	K201015

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DEVICE DESCRIPTION [807.92(a)(4)]

The AcQMap System hardware consists of three functional subsystems:

. Ultrasound imaging,
. ECG and EGM recording; and
Impedance based electrode Localization. .

The AcQMap System, Model 900100 is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter models 900003 and 900009 (cleared under K201341). The AcQMap System provides:

. 3-D cardiac chamber reconstruction - 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; and
Dynamic, three-dimensional, charge density maps overlaid on the cardiac chamber reconstruction . to show chamber-wide electrical activation.

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

The AcQMap System is intended for use in patients for whom electrophysiology procedures have been prescribed.

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.

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.

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

Tables 1 and 2 provides a comparison of the modified AcQMap System classification for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.

Table 1. Comparison of Classification with the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for Substantial Equivalence
	AcQMap® High Resolution Imaging and Mapping System, Model 900100	AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015)
510(k) Number	K212345	K201015	--
Classification/RegulationNumber/Regulation Name/Product Code	Class II/ 21 CFR § 870.1425/ Programmable diagnostic computer/ DQKClass II/ 21 CFR § 892.1560/ Ultrasonic pulsed echo imaging system/ IYO, ITX	Class II/ 21 CFR § 870.1425/ Programmable diagnostic computer/ DQKClass II/ 21 CFR § 892.1560/ Ultrasonic pulsed echo imaging system/ IYO, ITX	Identical
Table 2. Comparison of Indications for Use with the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
	AcQMap® High Resolution Imaging andMapping System, Model 900100	AcQMap® High Resolution Imaging andMapping System, Model 900100 (K201015)
510(k) Number	K212345	K201015	Identical
Indications forUse	The AcQMap System is intended for use inpatients for whom electrophysiology procedureshave been prescribed.When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizing thechamber anatomy and displaying electricalimpulses as either charge density-based orvoltage-based maps of complex arrhythmias thatmay be difficult to identify using conventionalmapping systems alone.ANDWhen used with the specified Patient Electrodes,the AcQMap System is intended to display theposition of AcQMap Catheters and conventionalelectrophysiology (EP) catheters in the heart.ORWhen used with conventional electrophysiologycatheters, the AcQMap System providesinformation about the electrical activity of theheart and about catheter location during theprocedure.	The AcQMap System is intended for use inpatients for whom electrophysiology procedureshave been prescribed.When used with the AcQMap Catheters, theAcQMap System is intended to be used toreconstruct the selected chamber fromultrasound data for purposes of visualizing thechamber anatomy and displaying electricalimpulses as either charge density-based orvoltage-based maps of complex arrhythmias thatmay be difficult to identify using conventionalmapping systems alone.ANDWhen used with the specified Patient Electrodes,the AcQMap System is intended to display theposition of AcQMap Catheters and conventionalelectrophysiology (EP) catheters in the heart.ORWhen used with conventional electrophysiologycatheters, the AcQMap System providesinformation about the electrical activity of theheart and about catheter location during theprocedure.
Table 3: Comparison of Technological Characteristics Against the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
Patient Anatomy	Intracardiac Structures	Intracardiac Structures	Identical
Testing to SupportSubstantialEquivalence	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 SafetyStandards	IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 60601-1-6:2010/A1:2013 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	Different. IEC 60601-1-6:2010/ A1: 2013 has beenwithdrawn and replacedwith IEC 62366-1: 2015.
Physical Characteristics
SystemComponents&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	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	All system components areidentical, except the newaccessories. Verificationtesting on the newaccessories demonstratesthat the AcQMap Systemand the new accessoriesperform as intended. Thereare no different questions ofsafety or effectiveness.
Table 3: Comparison of Technological Characteristics Against the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
	AcQMap® High Resolution Imaging and Mapping System, Model 900100	AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015)
	Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator

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Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued)
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
Visual/MappingCharacteristics	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.	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.	Identical
VisualizationDevice/Catheter	AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters	AcQMap Catheter (electrodes & transducers) or Conventional electrophysiology catheters	Identical
Physical Characteristics - Console/Amplifier Comparison

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Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued)
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
Dimensions	99 cm L x 58 cm W x 76 cm D	99 cm L x 58 cm W x 76 cm D	Identical
Weight Maximum	80 kg	80 kg
Power Requirement	100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz	100-127 VAC, 50/60 Hz, 220-230 VAC, 50 Hz
Input Current	4.6 A	4.6 A
Fuse protection	250 V, 6.3A, two high breaking capacity fuses	250 V, 6.3A, two high breaking capacity fuses

Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued)
Characteristics	Subject Device	Predicate Device	Rationale for Substantial Equivalence
	AcQMap® High Resolution Imaging and Mapping System, Model 900100	AcQMap® High Resolution Imaging and Mapping System, Model 900100 (K201015)
System Specifications
Safety Information	IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide	IEC 60601-1, Class I, Type Defibrillator Protected CF, continuous operation, no sterilization, equipment not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide	Identical
Ingress Protection	The Console is rated IP20	The Console is rated IP20	Identical
Functional and Performance Characteristics
Ultrasound Output	Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-p	Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-p	Identical

K212345

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	Maximum Power: 1 W peak	Maximum Power: 1 W peak
UltrasoundPerformance	Single operating mode	Single operating mode	Identical
	Thermal Index less than 1.0	Thermal Index less than 1.0
	Mechanical Index less than 1.0	Mechanical Index less than 1.0
LocalizationOutput	Frequency: Variable 15 kHz to 50 kHz	Frequency: Variable 15 kHz to 50 kHz	Identical
	Maximum current: 1.2mA	Maximum current: 1.2mA
ECG & EGMInput	Bandwidth: 0.05 Hz to 500 Hz	Bandwidth: 0.05 Hz to 500 Hz	Identical
	Resolution: +/-1uV	Resolution: +/-1uV
	Timing Accuracy: +/-1.6 microsecond	Timing Accuracy: +/-1.6 microsecond
Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued)
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
	AcQMap® High Resolution Imaging and MappingSystem, Model 900100	AcQMap® High Resolution Imaging and MappingSystem, Model 900100 (K201015)
Front Panel Connections
AcQMap Catheter	Custom, black, Defibrillator Protected Type CF	Custom, black, Defibrillator Protected Type CF	Identical
ECG Input	12-pin, latching, red, Defibrillator Protected Type BF	12-pin, latching, red, Defibrillator Protected Type BF	Identical
ECG Output	14-pin, latching, blue	14-pin, latching, blue	Identical
AuxiliaryInterfaceBox	Custom, green, Defibrillator Protected Type CF	Custom, green, Defibrillator Protected Type CF	Identical
AcQRef IntroducerSheath or ElectricalReference Catheter	1, 2mm female, yellow, Defibrillator Protected TypeCF	1, 2mm female, yellow, Defibrillator Protected TypeCF	Identical
LocalizationReferenceElectrodes	6, 2-pin, square, multi-color, Defibrillator ProtectedType BF	6, 2-pin, square, multi-color, Defibrillator ProtectedType BF	Identical
PatientReferenceElectrode	1, 2-pin, square, blue, Defibrillator Protected TypeBF	1, 2-pin, square, blue, Defibrillator Protected TypeBF	Identical
Ablation Generator	10-pin, latching, grey	10-pin, latching, grey	Identical
Ablation Catheter	10-pin, latching, grey, Defibrillator Protected TypeCF	10-pin, latching, grey, Defibrillator Protected TypeCF	Identical
Ablation Reference	1, 2mm, female, black, Defibrillator Protected TypeBF	1, 2mm, female, black, Defibrillator Protected TypeBF	Identical
AblationElectrogramInterface	1, 13-pin, latching, white	1, 13-pin, latching, white	Identical

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SUBSTANTIAL EQUIVALENCE

The AcQMap System is intended to reconstruct the physiology and display the anatomic and electrical data in the same way. These modifications are to include the below new accessories to facilitate connectivity between the cleared AcQMap High Resolution Imaging and Mapping System and some commercially available compatible RF Ablation Generators.

Generator adapters and ●
Adapter cables

The changes submitted in this 510(k) do not impact the hardware and software of the original AcQMap System, Model 900100. The indications for use of the subject device are identical to those of the predicate device. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the modified 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 modified AcQMap System to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical testing is required to support the subject device.

NONCLINICAL TESTING SUMMARY [807.92(b)(1)]

The necessary bench testing was performed on the modified AcQMap High Resolution Imaging and Mapping 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 following bench testing was repeated for the modified device:

. Third party system Compatibility with AcQMap system, Model 900100 Testing
System RF Attenuation characterization ●
Therapeutic Waveform Fidelity Assessment .
. Safety Testing
. Packaging Testing
Inspection and Labeling Review
Common Mode Choke (CMC) performance verification Testing ●
In-vitro Localization Accuracy Study ●

The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following:

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

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Accuracy Validation Testing Animal Study ●
. Software Verification and Validation
Clinical Simulation (Reliability) ●
Map Accuracy Evaluation ●

The modified 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 modified 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 modified device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen, the manufacturing processes, and design of the modified AcQMap 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 modified 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 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 substantially equivalent to the predicate device.

CONCLUSIONS [807.92(b)(3)]

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

SUMMARY

Based on the performance testing and the technological characteristics, it can be concluded that the modified AcQMap® High Resolution Imaging and Mapping System, Model 900100 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
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.(b)
Classification. Class II (performance standards).