(106 days)
No
The summary does not mention AI or ML, and the described improvements relate to image processing and system checks, not AI/ML algorithms.
No.
The device is described as a "diagnostic recording system" and its intended use is to "reconstruct the selected chamber from ultrasound data for purposes of visualizing the chamber anatomy and displaying electrical impulses" and to "identify the source(s) of the arrhythmia". It provides information to aid physicians in diagnosis and treatment planning, but it does not directly treat or cure a disease.
Yes
The "Device Description" explicitly states, "The AcQMap High Resolution Imaging and Mapping System ('AcQMap System Model, 900100') is a diagnostic recording system." The "Intended Use / Indications for Use" section further details its purpose in "displaying electrical impulses as either charge density-based or voltage-based maps of complex arrhythmias" and providing "information about the electrical activity of the heart and about catheter location during the procedure," all of which are diagnostic functions.
No
The device description explicitly states that the system consists of hardware components: the AcQMap Console, the AcQMap Workstation, and the AcQMap Auxiliary Interface Box. It also mentions hardware functional subsystems (Ultrasound imaging, ECG and EGM recording, and Impedance based electrode Localization) and associated catheters.
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 devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- AcQMap System Function: The AcQMap System operates in vivo (within the body) by using ultrasound and electrical signals to reconstruct and map the electrical activity of the heart's chambers. It directly interacts with the patient's internal anatomy and electrical system.
- Intended Use: The intended use clearly states it's for use in patients undergoing electrophysiology procedures, visualizing chamber anatomy, and displaying electrical impulses within the heart.
- Device Description: The description details the system's components and how they are used in the EP Lab, involving catheters inserted into the heart.
The AcQMap System is a diagnostic device, but it is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
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 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 ("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 AcOMap System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording; and Impedance based electrode Localization. The AcQMap System 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 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. There are no changes to the current mapping data. The modifications to the AcQMap System includes: The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data. User-initiated system checks for common connection errors such as cable disconnections and patch . placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors. An improvement to the generation of the anatomic surface from ultrasound points; This . improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac chamber, Intracardiac Structures, atrial chambers of the heart
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)
Nonclinical Testing Summary:
Bench testing was performed on the modified AcQMap High Resolution Imaging and Mapping System to ensure conformity to design specifications and to support substantial equivalence to the predicate device.
The following bench testing was repeated for the modified device: Software Verification and Validation.
The balance of testing (incorporated by reference from the original AcQMap System 510(k)) includes: Transportation Testing, AcQMap Verification Testing, System Accuracy Testing, Electromagnetic Compatibility and Electrical Safety Testing, AcQMap Catheter Validation Testing-Animal Study, Accuracy Validation Testing Animal Study.
Results demonstrated that the modified AcQMap High Resolution Imaging System meets established performance specifications for its intended use and does not raise different questions of safety or effectiveness compared to the predicate device.
Clinical Testing Summary:
No further clinical testing was required for the modified device. Necessary clinical testing was completed for the original AcQMap System (K170948) and incorporated by reference.
Study Name: "Divole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)".
Study Type: Prospective, non-randomized, open-label study.
Sample Size: 84 patients.
Data Source: Conducted at eight clinical sites outside the U.S.
Key Results: The results for 84 patients demonstrated that the AcQMap System is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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.
July 1, 2022
Acutus Medical, Inc. Karla Schaffner Regulatory Affairs Manager 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K220784
Trade/Device Name: AcQMap® High Resolution Imaging and Mapping System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: May 20, 2022 Received: May 23, 2022
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); medical device reporting (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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh Deoras Assistant Director 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
2
Indications for Use
510(k) Number (if known) K220784
Device Name
AcQMap® High Resolution Imaging and Mapping System
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) |
|---|
| ------------------------------------------------- |
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 K
GENERAL INFORMATION [807.92(a)(1)]
Date Prepared: 30 June 2022
| Applicant: | Contact Person: |
|---|---|
| Acutus Medical, Inc. | Sindhu Sridhar |
| 2210 Faraday Ave., Suite 100 | Regulatory Affairs Manager |
| Carlsbad, CA 92008 | Acutus Medical, Inc. |
| USA | 2210 Faraday Ave., Suite 100 |
| Phone: 1-442-232-6080 | Carlsbad, CA 92008 |
| Fax: 1-442-232-6081 | USA |
| Phone: 1-442-999-7630 | |
| Email: sindhu.sridhar@acutus.com |
DEVICE INFORMATION [807.92(a)(2)]
| Trade Name: | AcQMap® High Resolution Imaging and Mapping System |
|---|---|
| Generic/Common Name: | Programable diagnostic computer and |
| Ultrasonic pulsed echo imaging system | |
| Classification: | Class II / 21 CFR § 870.1425 and |
| Class II / 21 CFR § 892.1560 | |
| Product Code(s): | DQK, IYO, ITX |
PREDICATE DEVICE [807.92(a)(3)]
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| AcQMap High Resolution Imaging and | ||
| Mapping System | Acutus Medical, Inc. | K212345 |
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap High Resolution Imaging and Mapping System 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 ("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.
4
The AcOMap System hardware consists of three functional subsystems:
- . Ultrasound imaging,
- . ECG and EGM recording; and
- . Impedance based electrode Localization.
The AcQMap System 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 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.
There are no changes to the current mapping data. The modifications to the AcQMap System includes:
- . The addition of a corresponding mV scale in the color bar of charge density amplitude maps; This is an optional tool to provide the physician with a familiar quantitative metric for signal amplitude that may be used to aid the physician's interpretation of the data.
- User-initiated system checks for common connection errors such as cable disconnections and patch . placement locations; This is an optional tool to provide an on-demand assessment of systemmeasured data that may aid the user in troubleshooting of common connection errors.
- An improvement to the generation of the anatomic surface from ultrasound points; This . improvement eliminates many types of geometric artifacts, thus reducing the number of potential manual editing steps that may need to be performed by the user. This improvement also has the potential to preserve anatomic detail in the resulting shell with the reduction of the geometric artifacts. There are no changes to the current method of ultrasound data gathering or the type of data gathered.
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 1 and 2 provides a comparison of the modified AcQMap System classification for use against the predicate device. Table 3 provides a comparison of the technological characteristics for the modified AcQMap System against the predicate device.
| Table 1. Comparison of Classification with the Predicate Device | |||
|---|---|---|---|
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial Equivalence |
| AcQMap® High | |||
| Resolution Imaging and | |||
| Mapping System | AcQMap® High | ||
| Resolution Imaging and | |||
| Mapping System | |||
| 510(k) Number | K220784 | K212345 | -- |
| 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 | Identical |
| Table 2. Comparison of Indications for Use with the Predicate Device | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial
Equivalence |
| | AcQMap® High Resolution Imaging and
Mapping System | AcQMap® High Resolution Imaging and
Mapping System | |
| 510(k) Number | K220784 | K212345 | |
| Indications for
Use | The AcQMap System is intended for use in
patients for whom electrophysiology procedures
have been prescribed. | The AcQMap System is intended for use in
patients for whom electrophysiology procedures
have been prescribed. | Identical |
| | 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 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 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. | 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. | |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device | | | |
| | Subject Device | Predicate Device | |
| Characteristics | AcQMap® High Resolution Imaging and Mapping
System | AcQMap® High Resolution Imaging and Mapping
System (K212345) | Rationale for Substantial
Equivalence |
| 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, and Animal Testing | Identical |
| System Safety
Standards | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | IEC 60601-1:2005 /A1:2012 IEC 60601-1-2:2014 IEC 62366-1: 2015 IEC 60601-2-25:2015 IEC 60601-2-37:2015 | Identical. |
| Physical Characteristics | | | |
| 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 Patient Electrode Kit | The subject device includes
additional Carto Force
Adapter cable. The Carto
Force Adapter Cable is used
in conjunction with the
SmartAblate Generator to
support SmartTouch
navigation to the AcQMap
System. The SmartAblate
Generator was cleared to
use with AcQMap system in |
| | | | |
| 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 | AcQMap® High Resolution Imaging and Mapping
System (K212345) | |
| | Patient Electrode Kit Ampere generator adapter SmartAblate generator adapter Maestro generator adapter Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable – Generator Carto Force Adapter Cable | Ampere generator adapter SmartAblate generator adapter Maestro generator adapter Adapter Cable- Short - Ablation Adapter Adapter Cable- Long - Ablation Adapter SmartAblate Adapter Cable - Catheter Maestro Adapter Cable - Catheter Maestro Adapter Cable - Generator | the predicate 510k
K212345. |
| Table 3: Comparison of Technological Characteristics Against the Predicate Device (Continued) | | | |
| Characteristics | Subject Device | Predicate Device | Rationale for Substantial
Equivalence |
| Visual/Mapping
Characteristics | 3-D cardiac chamber reconstructions – Contact and non-contact (ultrasound) Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters Cardiac electrical activity as waveform traces Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure Dynamic, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | 3-D cardiac chamber reconstructions - Contact and non-contact (ultrasound) Three-dimensional position of the AcQMap Catheter and conventional electrophysiology catheters Cardiac electrical activity as waveform traces Contact LAT and voltage amplitude maps Remapping of the chamber at any time during the procedure Dynamic, three-dimensional, Charge Density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation. | Identical |
| Visualization
Device/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 | AcQMap® High Resolution Imaging and Mapping
System, Model 900000 (K212345) | |
| 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 | Frequency: Variable 15 kHz to 50 kHz
Maximum current: 1.2mA | Identical |
| ECG & EGM
Input | Bandwidth: 0.05 Hz to 500 Hz
Resolution: +/-1uV
Timing Accuracy: +/-1.6 microsecond | Bandwidth: 0.05 Hz to 500 Hz
Resolution: +/-1uV
Timing 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 | AcQMap® High Resolution Imaging and Mapping
System, Model 900000 (K212345) | |
| 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 |
6
ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
7
8
ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
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ACQMAP® HIGH RESOLUTION IMAGING AND MAPPING SYSTEM
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SUBSTANTIAL EQUIVALENCE
The AcQMap System is intended to reconstruct the physiology the anatomic and electrical data in the same way. These modifications are to improve the ease-of-use of some system capabilities. The updates to the mapping software includes:
- . The addition of a corresponding mV scale in the color bar of charge density amplitude maps;
- . User-initiated system checks for common connection errors such as cable disconnections and patch placement locations:
- An improvement to the generation of the anatomic surface from ultrasound points; .
These modifications are to improve the ease-of-use of some system capabilities. There are no changes to the current mapping data. 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, is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the modified AcQMap System to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical testing is required to support the subject device.
NONCLINICAL TESTING SUMMARY [807.92(b)(1)]
The necessary bench testing was performed on the modified AcQMap High Resolution Imaging and Mapping System 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:
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Software Verification and Validation
The balance of testing is incorporated by reference to the original AcQMap System 510(k), includes the following: -
· Transportation Testing
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· AcQMap Verification Testing
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System Accuracy Testing
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· Electromagnetic Compatibility and Electrical Safety Testing
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AcQMap Catheter Validation Testing-Animal Study
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· Accuracy Validation Testing Animal Study
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The modified AcQMap High Resolution Imaging and Mapping System 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 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 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. The necessary clinical testing was completed for the original AcQMap System (K170948) and is incorporated by reference. That study, entitled, "Divole 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 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 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 is substantially equivalent to the predicate device.