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
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 - Contact and non-contact (ultrasound),
. Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
o 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 modified 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 coording 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for the AcQMap® High Resolution Imaging and Mapping System, Model 900100. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data for a new AI/ML algorithm.

Therefore, much of the requested information regarding acceptance criteria, multi-reader multi-case studies, and specific performance metrics of an AI model cannot be extracted directly from this document. This document primarily discusses the safety and effectiveness of a medical device (hardware/software system) for cardiac imaging and mapping, not an AI/ML algorithm requiring rigorous clinical validation for its own performance.

However, I can extract information related to the device's validation and the high-level assessment of its performance.

Here's what can be gathered, with limitations noted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or performance metrics in a tabular format as would be expected for an AI/ML algorithm's clinical validation study (e.g., sensitivity, specificity, AUC). Instead, it states that "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" and that the clinical study "demonstrated that the AcQMap System is safe and effective for its intended use."

The document focuses on "functional and performance characteristics" of the system as compared to its predicate, rather than an AI's accuracy against a ground truth.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance (Summary)
System Safety	Conformance to IEC 60601-1, -1-2, -1-6, -2-25, -2-37 standards.	Identical to predicate device, meeting relevant safety standards.
Performance	Meets established performance specifications for intended use.	"The collective results of the testing demonstrate that the design... meets its established performance specifications necessary for performance during its intended use."
Functional Equivalence	Functionally equivalent to predicate device with additional capabilities not raising new safety/effectiveness questions.	"The additional capability to display cardiac electrical activity and catheter location without the AcQMap Catheter present does not raise different questions of safety or effectiveness as demonstrated through performance testing."
Clinical Safety & Effectiveness	Safe and effective for intended use.	"The results for 84 patients demonstrated that the AcQMap System is safe and effective for its intended use." (referencing prior K170948 filing)
Ultrasound Output	Frequency: 10 MHz+/-400 kHz, Max Voltage: 50V p-p, Max Power: 1 W peak.	Identical to predicate device.
Ultrasound Performance	Single operating mode, Thermal Index < 1.0, Mechanical Index < 1.0.	Identical to predicate device.
ECG & EGM Input	Bandwidth: 0.05 Hz to 500 Hz, Resolution: +/-1uV, Timing Accuracy: +/-1.6 microsecond.	Bandwidth: 0.1 Hz to 500 Hz, Resolution: +/-10uV, Timing Accuracy: +/-1.6 microsecond (Note: These values are listed under "Predicate Device" but are noted as "Identical" in the rationale column, implying the subject device matches them. The bandwidth and resolution appear less stringent for the predicate than the requested criteria.)

2. Sample Size and Data Provenance for Test Set:

Test Set Description: The document refers to the "necessary clinical testing" being completed for the original AcQMap System (K170948) and incorporated by reference. This implies that the current submission (K191392) did not involve a new, dedicated clinical "test set" for performance evaluation of a new algorithm, but rather relies on the prior clinical data for the predicate device.
Sample Size: "The results for 84 patients demonstrated that the AcQMap System is safe and effective for its intended use."
Data Provenance: The study was "a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S." (indicating international, prospective data).

3. Number of Experts and Qualifications:

The document does not specify the number or qualifications of experts used to establish ground truth. As this is a medical device for imaging and mapping, the "ground truth" would likely be derived from its direct measurements and comparisons against established methods, rather than expert consensus on image interpretation.

4. Adjudication Method for Test Set:

Not specified. The document does not describe an adjudication method, which is typically relevant for studies involving human readers or subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not explicitly mentioned or described. The document focuses on the device's inherent performance and its equivalence to a predicate, not on how human readers' performance might improve with or without AI assistance. This is consistent with a medical device submission focused on basic safety and effectiveness rather than a specific AI diagnostic algorithm.

6. Standalone (Algorithm Only) Performance:

The AcQMap System is a hardware-software integrated device. The "performance data" describes the system's ability to perform its core functions (imaging, mapping, catheter localization). It is not a standalone AI algorithm that provides a diagnosis or measurement without human interaction with the device. Therefore, a "standalone algorithm only" performance study in the typical AI sense is not applicable or described. The performance tested refers to the entire system.

7. Type of Ground Truth Used:

The nature of the "ground truth" is implied by the device's function: it's intended to reconstruct chamber anatomy and display electrical impulses. The "truth" would be the physiological parameters or anatomical structures it measures. The document states "Accuracy Testing" and "Accuracy Validation Testing Animal Study" were performed, suggesting comparison against known or benchmarked physical/physiological parameters.
The clinical study was described as "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)". This suggests the ground truth was related to the physiological electrical activity and anatomical representation of the heart, likely validated against established clinical methods or direct measurements during procedures. It is not stated to be expert consensus (e.g., on images), pathology results, or outcomes data directly, though outcomes (therapy assessment) would have been part of the clinical study.

8. Sample Size for Training Set:

This is a 510(k) submission for a medical device (hardware/software system), not a de novo submission for a new AI/ML algorithm. Therefore, the concept of a "training set" for an AI model (as understood in machine learning) is not applicable in this document's context and is not described. The system itself has software, but the document refers to "Software Verification and Validation" (V&V), which is a standard engineering process for ensuring software meets specifications, not AI model training.

9. How Ground Truth for Training Set was Established:

As the concept of an AI "training set" is not applicable, this information is not provided.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 6, 2019

Acutus Medical, Inc. Karla Schaffner Principal Regulatory Affairs Specialist 2210 Faraday Ave., Suite 100 Carlsbad, California 92008

Re: K191392

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: August 12, 2019 Received: August 13, 2019

Dear Karla Schaffner:

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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: 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) K191392

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)
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 K191392

General Information [807.92(a)(1)]

Date Prepared: 23 May 2019

Applicant:

Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6080 Fax: 1-442-232-6081

Contact Person:

Karla Schaffner Principal Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 FAX: 1-442-232-6081 Email: karla.schaffner@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 and Ultrasonic pulsed echo imaging system

Classification:

Class 11/21 CFR § 870.1425 and Class 11/21 CFR § 892.1560

Product Code:

DQK, IYO, ITX

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

Predicate Device AcQMap High Resolution Imaging and Mapping System, Model 900100 (K190131) Reference Device CARTO® 3 EP Navigation System, Version 6.0 And Accessories (K170600)

DEVICE DESCRIPTION [807.92(a)(4)]

The AcQMap System 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 - Contact and non-contact (ultrasound),
. Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters,
o 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.

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 I provides a comparison of the modified AcQMap System classifications for use against the predicate and reference devices. Table 2 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.

Table I. Comparison of Classification with the Predicate and Reference Devices
	Subject Device	Predicate Device	Reference Device	Rationale for Substantial Equivalence
Characteristics	AcQMap® HighResolution Imaging andMapping System, Model900100	AcQMap® HighResolution Imaging andMapping System, Model900100 (K190131)	CARTO® 3 EPNavigation System,Version 6.0 AndAccessories
510(k) Number	TBD	K190131	K170600	--
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	Class II/ 21 CFR §870.1425/Programablediagnosticcomputer/DQK	The subject device isidentical to thepredicate. Theadditional product codeand regulation numberfor the subject andpredicate device versusthe reference deviceare required.
Table 2. Comparison of Indications for Use with the Predicate and Reference Devices
	Subject Device	Predicate Device	Reference Device
Characteristics	AcQMap® High Resolution Imaging and MappingSystem, Model 900100	AcQMap® High Resolution Imaging and MappingSystem, Model 900100 (K190131)	CARTO® 3 EPNavigation System,Ver. 6.0 AndAccessories	Rationale forSubstantialEquivalence
510(k) Number	TBD	K190131	K170600
Indications forUse	The AcQMap System is intended for use inpatients for whom electrophysiologyprocedures have 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 SystemElectrodes, the AcQMap System is intended todisplay the position of AcQMap Catheters andconventional electrophysiology (EP) catheters inthe 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 electrophysiologyprocedures have 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 dipole density-based orvoltage-based maps of complex arrhythmias thatmay be difficult to identify using conventionalmapping systems alone.ANDWhen used with the specified PatientElectrodes, the AcQMap System is intended todisplay the position of AcQMap Catheters andconventional electrophysiology (EP) catheters inthe heart.	The intended use ofthe CARTO® 3System is catheter-based cardiacelectrophysiological(EP) procedures. TheCARTO® 3 Systemprovides informationabout the electricalactivity of the heartand about catheterlocation during theprocedure. Thesystem can be used onpatients who areeligible for aconventionalelectrophysiologicalprocedure. Thesystem has no specialcontraindications.	All devices areintended forelectrophysiologyprocedures. Theadditional paragraphin the modifiedAcQMap Systemindications for use isaligned with theindications for useof the referencedevice. Theindications for usein the modifiedAcQMap System areotherwise identicalto the predicate.The additionalcapability raises nonew questions ofsafety oreffectiveness asdemonstrated bythe AcQMapperformance testing.
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 (K190131)
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, Animal Testing; and Clinical Testing	Complete performancetesting conducted byAcutus demonstrates thatthe AcQMap Systemperforms as intended andthat there are no differentquestions of safety oreffectiveness.
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 SubstantialEquivalence
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 (K190131) 3-D cardiac chamber reconstructions imaging; Three-dimensional position of the AcQMapCatheter and conventional electrophysiologycatheters; Cardiac electrical activity as waveform traces; Remapping of the chamber at any time duringthe procedure; and Dynamic, three-dimensional, Dipole Densitymaps overlaid on the cardiac chamberreconstruction to show chamber-wideelectrical activation.	The additional capability todisplay cardiac electricalactivity and catheterlocation without theAcQMap Catheter presentdoes not raise differentquestions of safety oreffectiveness asdemonstrated throughperformance testing.
VisualizationDevice/Catheter	AcQMap Catheter (electrodes & transducers)orConventional electrophysiology catheters	AcQMap Catheter (electrodes & transducers)
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
PowerRequirement	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 DeviceAcQMap® High Resolution Imaging and Mapping System, Model 900100	Predicate DeviceAcQMap® High Resolution Imaging and Mapping System, Model 900000 (K190131)	Rationale for SubstantialEquivalence
System Specifications
SafetyInformation	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
IngressProtection	The Console is rated IP20	The Console is rated IP20	Identical
Functional and Performance Characteristics
UltrasoundOutput	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
UltrasoundPerformance	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
LocalizationOutput	Frequency: Variable 15 kHz to 50 kHzMaximum current: 1.2mA RMS	Frequency: Variable 30 kHz to 60 kHzMaximum current: 2.2mA/cm2	Identical
ECG & EGMInput	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
Characteristics	Subject Device	Predicate Device	Rationale for SubstantialEquivalence
	AcQMap® High Resolution Imaging and MappingSystem, Model 900100	AcQMap® High Resolution Imaging and MappingSystem, Model 900000 (K190131)
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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AcQMap® High Resolution Imaging and Mapping System, model 900100

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AcQMap® High Resolution Imaging and Mapping System, model 900100

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SUBSTANTIAL EQUIVALENCE

The indications for use of the subject device are substantially equivalent to those of the predicate and reference 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 (KI70948) 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 bench testing, either repeated for the modified device or incorporated by reference to the original AcQMap System 510(k), included the following:

o Transportation Testing
. AcQMap Verification Testing
Software Verification and Validation .
. System Accuracy Testing
. Electromagnetic Compatibility and Electrical Safety Testing
AcQMap Catheter Validation Testing-Animal Study .
. Contact Mapping 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 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.

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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 safe and effective for its intended use.

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 device. 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 safe and effective for its intended use.

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 safe and effective for its intended use and 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).