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 AcQTrack™ Conduction Pattern (Conduction Pattern Recognition) feature, Composite Mapping feature and Complex Fractionated Atrial Electrogram (CFAE) calculation that adds additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. This submission focuses on modifications to the software features of an existing device, adding "AcQTrack™ Conduction Pattern (Conduction Pattern Recognition), Composite Mapping, and Complex Fractionated Atrial Electrogram (CFAE) calculation". The core system and its existing mapping capabilities remain unchanged.

Therefore, the acceptance criteria and performance data provided relate primarily to the demonstration of substantial equivalence for these software modifications to the previously cleared predicate device (K193013), and ultimately to the original AcQMap System cleared under K170948.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative "acceptance criteria" for the new software features in terms of specific metrics like sensitivity or specificity. Instead, the performance is demonstrated through verification and validation activities showing that the additional features function as intended and do not introduce new safety or effectiveness concerns, maintaining substantial equivalence to the predicate.

The "acceptance criteria" here are implicitly focused on:

The new software features (AcQTrack Conduction Pattern, Composite Mapping, CFAE calculation) performing their intended post-processing and data summarization functions correctly.
The overall system maintaining its established safety and performance characteristics, as demonstrated by the predicate device (K193013) and the original device (K170948).
No new questions of safety or effectiveness being raised by the modifications.

Acceptance Criterion (Implicit)	Reported Device Performance
New Software Features Functionality: The AcQTrack Conduction Pattern, Composite Mapping, and CFAE calculation features provide accurate post-processing and summary data display options as intended.	These additional software display features have been "previously documented in the literature," "validated with both simulation and clinical data," and are described as "optional tools to provide a summarization of existing data to expedite the physician's interpretation of the data based on physician-established criteria." The software verification and validation activities and clinical simulation (reliability) studies were repeated for the modified device to confirm these functions.
Maintenance of Foundational Performance (System Accuracy): The system's ability to reconstruct cardiac chambers, display electrical impulses, and locate catheters remains accurate.	Map Accuracy Evaluation was repeated for the modified device. The remaining accuracy testing, including system accuracy testing, was incorporated by reference from the original AcQMap System 510(k) (K170948). The collective results for the modified device demonstrated it "meets the established performance specifications."
Safety and Electrical/Electromagnetic Compatibility: The modified device maintains safety standards and electromagnetic/electrical compatibility.	Electromagnetic and Electrical Safety testing was repeated for the modified device. The balance of testing (including Transportation Testing, AcQMap Verification Testing, Electromagnetic Compatibility and Electrical Safety Testing, System Safety Standards (IEC 60601 series)) was incorporated by reference from the original AcQMap System 510(k). The document states identical safety standards are met, and "there are no changes to hardware."
No New Questions of Safety or Effectiveness: The modifications do not introduce any new safety or effectiveness concerns.	"The modifications...add additional post processing and summary data display options of the mapping data. There are no changes to the current method of data gathering or the type of data gathered." "The collective results of the nonclinical testing...demonstrate that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device." "The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference." The study showed the original system was substantially equivalent.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

For the modifications (new software features): The text mentions these features were "validated with both simulation and clinical data" but does not specify the sample size or provenance for this validation specifically for the new features.
For the original AcQMap System (K170948), which established the foundational equivalence:
- Sample Size: 84 patients.
- Data Provenance: Prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide details on the number or qualifications of experts used to establish ground truth for either the validation of the new software features or the clinical study of the original AcQMap system. The new features are designed to "expedite the physician's interpretation of the data based on physician-established criteria," implying clinical expert interpretation is central, but specifics are missing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not describe any specific adjudication method for establishing ground truth or evaluating the test sets.

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

The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The new features are described as "optional tools to provide a summarization of existing data to expedite the physician's interpretation," suggesting an assistive role, but no formal comparative study of human performance improvement is reported here.

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

The document does not explicitly describe a standalone performance study of the new software features (AcQTrack, Composite Mapping, CFAE calculation) without human-in-the-loop. These features are presented as "additional post processing and summary data display options" to assist physician interpretation rather than operating purely standalone. The core mapping system, however, performs its functions (reconstruction, electrical mapping, localization) without direct human intervention in the data acquisition/initial processing.

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 to evaluate the new software features. For the clinical study of the original device (K170948), it refers to "electrophysiology procedures" in patients and assessing therapy, suggesting that clinical observations and outcomes from these procedures would inherently form the basis of ground truth for assessing the system's mapping and imaging capabilities. However, specific methods for establishing ground truth (e.g., expert consensus on specific arrhythmia origins) are not detailed.

8. The sample size for the training set

The document does not provide a sample size for any training set. Since the modifications are described as "additional software display features" and post-processing tools, and no new method of data gathering is mentioned, it's possible that the development of these algorithms leveraged existing clinical data previously collected for the predicate device, but this is not specified.

9. How the ground truth for the training set was established

The document does not provide information on how ground truth was established for any training set.

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 5, 2021

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

Re: K210680

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 2, 2021 Received: July 6, 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,

for

Aneesh Deoras Acting Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210680

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 K 210680

GENERAL INFORMATION [807.92(a)(1)]

Date Prepared: 05 March 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 MappingSystem, 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.	K193013

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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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These additional software display features have been previously documented in the literature':1-3.4.56, and/or have been validated with both simulation and clinical data. These are optional tools to provide a summarization of existing data to expedite the physician's interpretation of the data based on physicianestablished criteria.

4 C. D. Cantwell, C. H. Roney, F. S. Ng. J. H. Siggers, S. J. Sherwin, and N. S. Peters, "Techniques for automation time annotation and conduction velocity estimation in cardiac

5 P. V Bayly, B. H. KenKnight, J. M. Rogers, R. E. Hillsley, R. E. Ideker, and W. M. Smith, "Estimation of conduction velocity vector fields from epicardial mapping data,," IEEE Trans. Biomed. Eng., vol. 45, no. 5, pp. 563-71, May 1998, doi: 10.1109/10.641337

T. N. Fitzgerald, D. H. Brooks, and J. K. Triedman, "Identification of cardiac rhythm features by mathematical and your telds," (EEE Trans. Biomed. Eng., vol. 52, no. 1, pp. 19–29, 2005, doi: 10.1109/TBME.2004.839636.

2 S. Honarbakhsh et al., "Automated detection of repetitive focal activations in persistent atrial fibrillation: Validation of a novel detection algorithm and application through panoranic and sequential mapping," J. Cardiovasc. Electrophysiol., vol. 30, no. 1, pp. 58-66, 2019, doi: 10.1111/jce.13752.

3 E. G. Daoud et al., "Identification of Repetitive Activation Novel Computational Analysis of Multielectrode Recordings During Atrial Fibrillation and Flutter in Humans," JACC Clin. Electrophysiol., vol. 3, no. 3, 2016, doi: 10.1016/j.jacep.2016.08.001.

6 Nademanee, Koonlawee, et al. "Catheter ablation guided by complex fractionated atrial electrogram mapping of atrial fibrillation substrate." Journal of cardiology 55.1 (2010): 1-12.

Verma, Atul, et al. "Selective Complex Fractionated Atrial Electrograms Targeting for Atrial Fibrillation Study (SELECT AF) A Multicenter, Randomized Trial." Circulation: Arrhythmia and Electrophysiology 7.1 (2014): 55-62.

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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.

When used with the AcQMap Catheters, the AcQMap System is intended to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.

AND

When used with the specified Patient Electrodes, the AcQMap System is intended to display the position of AcQMap Catheters and conventional electrophysiology (EP) catheters in the heart.

OR

When used with conventional electrophysiology catheters, the AcQMap System provides information about the electrical activity of the heart and about catheter location during the procedure.

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 and indications 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
	Subject Device	Predicate Device
Characteristics	AcQMap® HighResolution Imaging andMapping System, Model900100	AcQMap® HighResolution Imaging andMapping System, Model900100 (K193013)	Rationale for Substantial Equivalence
510(k) Number	K210680	K193013	--
Classification/RegulationNumber/Regulation Name/Product Code	Class II/ 21 CFR §870.1425/ Programablediagnostic computer/DQKClass II/ 21 CFR §892.1560/ Ultrasonicpulsed echo imagingsystem/ IYO, ITX	Class II/ 21 CFR §870.1425/ Programablediagnostic computer/DQKClass II/ 21 CFR §892.1560/ Ultrasonicpulsed echo imagingsystem/ IYO, ITX	Identical
Table 2. Comparison of Indications for Use with the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
510(k) Number	K210680	K193013
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.	Identical
Table 3: Comparison of Technological Characteristics Against the Predicate Device
Characteristics	Subject Device	Predicate Device	Rationale for Substantial Equivalence
	AcQMap® High Resolution Imaging and MappingSystem, Model 900100	AcQMap® High Resolution Imaging and MappingSystem, Model 900100 (K193013)
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	Complete performancetesting conducted by Acutusdemonstrates that theAcQMap System performsas intended and that thereare no different questions ofsafety or effectiveness.
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 60601-1-6:2010/A1:2013•IEC 60601-2-25:2015•IEC 60601-2-37:2015	Identical. There are nochanges to hardware.
SystemComponents	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	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	Identical
Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued)
Characteristics	Subject Device	Predicate Device	Rationale for Substantial Equivalence
Visual/MappingCharacteristics	AcQMap® High Resolution Imaging and MappingSystem, Model 900100 3-D cardiac chamber reconstructions -Contact and non-contact (ultrasound); Three-dimensional position of the AcQMapCatheter and conventional electrophysiologycatheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time duringthe procedure; Dynamic, three-dimensional, Charge Densitymaps overlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation.	AcQMap® High Resolution Imaging and MappingSystem, Model 900100 (K193013) 3-D cardiac chamber reconstructions - Contactand non-contact (ultrasound); Three-dimensional position of the AcQMapCatheter and conventional electrophysiologycatheters; Cardiac electrical activity as waveform traces; Contact LAT and voltage amplitude maps; Remapping of the chamber at any time duringthe procedure; Dynamic, three-dimensional, Charge Densitymaps overlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation.	Identical
VisualizationDevice/Catheter	AcQMap Catheter (electrodes & transducers)or Conventional electrophysiology catheters	AcQMap Catheter (electrodes & transducers)or Conventional electrophysiology catheters
Physical Characteristics - Console/Amplifier Comparison
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 900000 (K193013)
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-pMaximum Power: 1 W peak	Frequency: 10 MHz+/-400 kHzMaximum Voltage: 50V p-pMaximum Power: 1 W peak	Identical
Ultrasound Performance	Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0	Single operating modeThermal Index less than 1.0Mechanical Index less than 1.0	Identical
Localization Output	Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA RMS	Frequency: Variable 30 kHz to 60 kHzMaximum current: 2.2mA/cm2	Identical
ECG & EGM Input	Bandwidth: 0.05 Hz to 500 HzResolution: +/-1uVTiming Accuracy: +/-1.6 microsecond	Bandwidth: 0.1 Hz to 500 HzResolution: +/-10uVTiming Accuracy: +/-1.6 microsecond	Identical
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 900000 (K193013)
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
Auxiliary InterfaceBox	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 provide additional post processing and summary data display options of the mapping data.

Specifically, the updates to the mapping software allow the user to have additional visual tools such as:

AcQTrack Conduction Pattern (Conduction Pattern Recognition) ●
. Composite Mapping and
Complex Fractionated Atrial Electrogram (CFAE) ●

These features provide a summarization of existing data that can expedite the physician's interpretation of the data based on physician-established criteria. There are no changes to the current mapping data or display options. 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 AcOMap 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:

Software Verification and Validation
· Clinical Simulation (Reliability)
· Map Accuracy Evaluation

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

Transportation Testing
· AcQMap Verification Testing

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· System Accuracy Testing
· Electromagnetic Compatibility and Electrical Safety Testing
· AcQMap Catheter Validation Testing-Animal Study
· Accuracy Validation Testing Animal Study

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.

510(K) SUMMARY

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).