Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system for imaging, navigation, and mapping using ultrasound, ECG, EGM, and impedance-based localization. It focuses on reconstructing cardiac chambers and displaying electrical activity. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.

Therapeutic

No.
The device is described as a "diagnostic recording system" intended for imaging, navigation, and mapping to identify the source(s) of arrhythmia, rather than directly treating a condition.

Diagnostic

Yes

The "Device Description" section explicitly states, "The AcQMap High Resolution Imaging and Mapping System, Model 900100 ('AcQMap System Model, 900100') is a diagnostic recording system." Furthermore, its intended use involves visualizing chamber anatomy, displaying electrical impulses, and identifying sources of arrhythmias, all of which are diagnostic functions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the system consists of hardware components (AcQMap Console, AcQMap Workstation, AcQMap Auxiliary Interface Box) and is used in conjunction with a catheter. It is a computer-based system that performs imaging, navigation, and mapping, relying on ultrasound imaging, ECG/EGM recording, and impedance-based electrode localization, all of which involve hardware.

IVD (In Vitro Diagnostic)

Based on the provided text, the AcQMap System is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
AcQMap System Function: The AcQMap System operates in vivo (within the body) by using ultrasound and electrical signals to reconstruct and map the heart's chambers and electrical activity. It directly interacts with the patient's heart during an electrophysiology procedure.
Intended Use: The intended use clearly states it's for use in patients for whom electrophysiology procedures have been prescribed, and it's used to visualize anatomy, display electrical impulses, and locate catheters within the heart.
Device Description: The description confirms it's a "diagnostic recording system" used in the "Electrophysiology (EP) Lab" and operates "outside of the sterile field" but is used in conjunction with catheters inserted into the heart.

The AcQMap System is a diagnostic device, but it performs its diagnostic function in vivo rather than in vitro on specimens.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either 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.

Product codes

DQK, IYO, ITX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

atrial chambers of the heart, Intracardiac Structures

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Physicians in the Electrophysiology (EP) Lab

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Bench testing was conducted on the modified AcQMap System to support substantial equivalence. This included:

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

Clinical testing for the original AcQMap System (K170948), an open-label, prospective, non-randomized study, was conducted at eight clinical sites outside the U.S. with 84 patients. The results demonstrated that the AcQMap System is safe and effective for its intended use.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

AcQMap High Resolution Imaging and Mapping System, Model 900100 (K190131)

Reference Device(s)

CARTO® 3 EP Navigation System, Version 6.0 And Accessories (K170600)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)

Not Found

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).

Summary

0

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

1

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

2

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.

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.

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.

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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3

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 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.

5

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

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

When used with the AcQMap Catheters, the AcQMap System is intended to be used to reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses as either 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 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® High
Resolution Imaging and
Mapping System, Model
900100	AcQMap® High
Resolution Imaging and
Mapping System, Model
900100 (K190131)	CARTO® 3 EP
Navigation System,
Version 6.0 And
Accessories
510(k) Number	TBD	K190131	K170600	--
Classification/
Regulation
Number/
Regulation Name/
Product Code	Class II/ 21 CFR §
870.1425/ Programable
diagnostic computer/
DQK
Class II/ 21 CFR §
892.1560/ Ultrasonic
pulsed echo imaging
system/ IYO, ITX	Class II/ 21 CFR §
870.1425/ Programable
diagnostic computer/
DQK
Class II/ 21 CFR §
892.1560/ Ultrasonic
pulsed echo imaging
system/ IYO, ITX	Class II/ 21 CFR §
870.1425/
Programable
diagnostic
computer/DQK	The subject device is
identical to the
predicate. The
additional product code
and regulation number
for the subject and
predicate device versus
the reference device
are 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 Mapping
System, Model 900100	AcQMap® High Resolution Imaging and Mapping
System, Model 900100 (K190131)	CARTO® 3 EP
Navigation System,
Ver. 6.0 And
Accessories	Rationale for
Substantial
Equivalence
510(k) Number	TBD	K190131	K170600
Indications for
Use	The AcQMap System is intended for use in
patients for whom electrophysiology
procedures have been prescribed.

When used with the AcQMap Catheters, the
AcQMap System is intended to be used to
reconstruct the selected chamber from
ultrasound data for purposes of visualizing the
chamber anatomy and displaying electrical
impulses as either 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 System
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. | The AcQMap System is intended for use in
patients for whom electrophysiology
procedures have been prescribed.

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

AND

When used with the specified Patient
Electrodes, the AcQMap System is intended to
display the position of AcQMap Catheters and
conventional electrophysiology (EP) catheters in
the heart. | The intended use of
the CARTO® 3
System is catheter-
based cardiac
electrophysiological
(EP) procedures. The
CARTO® 3 System
provides information
about the electrical
activity of the heart
and about catheter
location during the
procedure. The
system can be used on
patients who are
eligible for a
conventional
electrophysiological
procedure. The
system has no special
contraindications. | All devices are
intended for
electrophysiology
procedures. The
additional paragraph
in the modified
AcQMap System
indications for use is
aligned with the
indications for use
of the reference
device. The
indications for use
in the modified
AcQMap System are
otherwise identical
to the predicate.
The additional
capability raises no
new questions of
safety or
effectiveness as
demonstrated by
the AcQMap
performance 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 Mapping
System, Model 900100 | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 (K190131) | | |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Identical | |
| Testing to Support
Substantial
Equivalence | 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 performance
testing conducted by
Acutus demonstrates that
the AcQMap System
performs as intended and
that there are no different
questions of safety or
effectiveness. | |
| System Safety
Standards | 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 no
changes to hardware. | |
| System
Components | Console Workstation Workstation Cable Auxiliary Interface Box ECG Input Cable Ampere Ablation Catheter Adapter Cable Ampere RF Generator Adapter Cable ECG Output Cable Ablation Reference Cable Ablation Electrogram Cable ECG w/Snaps Cable ECG POST Cable 2mm Pin Jumper Set | 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/Mapping
Characteristics | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 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. | AcQMap® High Resolution Imaging and Mapping
System, Model 900100 (K190131) 3-D cardiac chamber reconstructions imaging; Three-dimensional position of the AcQMap
Catheter and conventional electrophysiology
catheters; Cardiac electrical activity as waveform traces; Remapping of the chamber at any time during
the procedure; and Dynamic, three-dimensional, Dipole Density
maps overlaid on the cardiac chamber
reconstruction to show chamber-wide
electrical activation. | 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. | |
| Visualization
Device/Catheter | AcQMap Catheter (electrodes & transducers)
or
Conventional 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 | | |
| 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
AcQMap® High Resolution Imaging and Mapping System, Model 900100 | Predicate Device
AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K190131) | Rationale for Substantial
Equivalence | |
| 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 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak | Frequency: 10 MHz+/-400 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak | Identical | |
| Ultrasound
Performance | Single operating mode
Thermal Index less than 1.0
Mechanical Index less than 1.0 | Single operating mode
Thermal Index less than 1.0
Mechanical Index less than 1.0 | Identical | |
| Localization
Output | Frequency: Variable 15 kHz to 50 kHz
Maximum current: 1.2mA RMS | Frequency: Variable 30 kHz to 60 kHz
Maximum current: 2.2mA/cm2 | Identical | |
| 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 | Identical | |
| 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 (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 Interface
Box | Custom, green, Defibrillator Protected Type CF | Custom, green, Defibrillator Protected Type CF | Identical | |
| AcQRef Introducer
Sheath or Electrical
Reference Catheter | 1, 2mm female, yellow, Defibrillator Protected Type
CF | 1, 2mm female, yellow, Defibrillator Protected Type
CF | Identical | |
| Localization
Reference
Electrodes | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | 6, 2-pin, square, multi-color, Defibrillator Protected
Type BF | Identical | |
| Patient
Reference
Electrode | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | 1, 2-pin, square, blue, Defibrillator Protected Type
BF | Identical | |
| Ablation Generator | 10-pin, latching, grey | 10-pin, latching, grey | Identical | |
| Ablation Catheter | 10-pin, latching, grey, Defibrillator Protected Type
CF | 10-pin, latching, grey, Defibrillator Protected Type
CF | Identical | |
| Ablation Reference | 1, 2mm, female, black, Defibrillator Protected Type
BF | 1, 2mm, female, black, Defibrillator Protected Type
BF | Identical | |
| Ablation
Electrogram
Interface | 1, 13-pin, latching, white | 1, 13-pin, latching, white | Identical | |

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AcQMap® High Resolution Imaging and Mapping System, model 900100

7

8

9

10

AcQMap® High Resolution Imaging and Mapping System, model 900100

11

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.