(64 days)
No
The summary describes a system for ultrasound imaging, ECG/EGM recording, and impedance-based localization to create 3D cardiac chamber reconstructions and electrical maps. While it involves complex data processing and visualization, there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets for algorithms. The focus is on signal processing and reconstruction techniques.
No
The device is described as a "diagnostic recording system" intended for imaging, navigation, and mapping of cardiac chambers and electrical impulses to help physicians identify sources of arrhythmia. It does not actively treat or directly alter the physiological function of the patient.
Yes
The "Device Description" explicitly states that the "AcQMap High Resolution Imaging and Mapping System, Model 900100 is a diagnostic recording system." Furthermore, it details how the system is used to identify the source(s) of arrhythmias, which is a diagnostic function.
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 details functional subsystems based on hardware: Ultrasound imaging, ECG and EGM recording, and Impedance based electrode localization.
Based on the provided information, the AcQMap System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a physiological state, health, disease, or congenital abnormality.
- AcQMap System Function: The AcQMap System operates in vivo (within the body) using ultrasound and electrical signals to image and map the electrical activity of the heart's atrial chambers. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for use in patients during electrophysiology procedures to visualize anatomy, display electrical impulses, and assist in identifying the source of arrhythmias. This is a diagnostic procedure performed directly on the patient.
Therefore, the AcQMap System 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 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.
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. 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 imaging,
- Three-dimensional position of the AcQMap Catheter and conventional ● electrophysiology catheters,
- Cardiac electrical activity as waveform traces, ●
- 0 Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcOMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Cardiac chambers, 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
Bench Testing:
- Transportation Testing
- AcQMap Verification Testing
- Software Verification and Validation
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
Clinical Testing:
- Study Type: Prospective, non-randomized, open-label study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)"
- Sample Size: 84 patients
- Data Source: Eight clinical sites outside the U.S.
- Key Results: The results demonstrated that the AcQMap System is safe and effective for its intended use.
Key Metrics
Not Found
Predicate Device(s)
AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948)
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" in blue, and the word "ADMINISTRATION" in a smaller font size below that.
April 2, 2019
Acutus Medical, Inc. Serena Sanginthirath Senior Regulatory Affairs Specialist 2210 Faraday Ave.. Suite 100 Carlsbad, California 92008
Re: K190131
Trade/Device Name: AcQMap High Resolution Imaging and Mapping System Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II Product Code: DQK, IYO, ITX Dated: January 23, 2019 Received: January 28, 2019
Dear Serena Sanginthirath:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mande Yellen
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K190131
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 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Notification K_190131
GENERAL INFORMATION [807.92(a)(1)]
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:
Serena Sanginthirath Senior Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1- 442-232-6178 FAX: 1- 442-232-6081 Email: Serena.Sanginthirath@acutus.com
Date Prepared: January 23, 2019
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 II/21 CFR § 870.1425 and Class II/21 CFR § 892.1560
Product Code:
DQK, IYO, ITX
4
PREDICATE DEVICE [807.92(a)(3)]
AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948)
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 Model, 900100 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 imaging,
- Three-dimensional position of the AcQMap Catheter and conventional ● electrophysiology catheters,
- Cardiac electrical activity as waveform traces, ●
- 0 Remapping of the chamber at any time during the procedure; and
- Three-dimensional, dipole density maps overlaid on the cardiac chamber reconstruction to show chamber-wide electrical activation.
The AcOMap System. Model 900100 is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, workstation and an auxiliary interface box. 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.
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 dipole density-based or voltage-based maps of complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
AND
5
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE [807.92(A)(6)]
The indications for use for the AcQMap® High Resolution Imaging and Mapping System, Model 900100 are identical to the predicate device, AcQMap® High Resolution Imaging and Mapping System, Model 900000 (K170948).
The technological characteristics of the predicate device are very similar; with only a few minor differences.
Table 1 provides a comparison of the technological characteristics for the AcQMap System, Model 900100 with the predicate device.
6
| Subject Device | Predicate Device | ||
|---|---|---|---|
| Characteristics | AcQMap® High Resolution Imaging and | ||
| Mapping System, Model 900100 | AcQMap® High Resolution Imaging and | ||
| Mapping System, Model 900000 | |||
| (K170948) | Rationale for Substantial Equivalence | ||
| 510(k) Number | TBD | K170948 | N/A |
| 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 | Same Classification/Regulation | ||
| 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 dipole density | |||
| or voltage 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 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. | Same Indications for Use |
7
Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)
| Characteristics | Subject Device
AcQMap® High Resolution Imaging and
Mapping System, Model 900100 | Predicate Device
AcQMap® High Resolution Imaging and
Mapping System, Model 900000 (K170948) | Rationale for Substantial
Equivalence |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Acutus Medical, Inc. | Acutus Medical, Inc. | Same Manufacturer |
| Patient Anatomy | Intracardiac Structures | Intracardiac Structures | Same Patient Anatomy |
| 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, Model 900100
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 60601-2-37:2007 | • IEC 60601-1: 2005 /A1:2012
• IEC 60601-2-37: 2007
• IEC 60601-1-2: 2007 /AC:2010
• IEC60601-1-6:2010 | Same safety standards with compliance
to current revisions. Improved safety
by meeting additional relevant standard,
IEC 60601-2-25:2011 |
Page 47 of 167
8
| 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 (K170948) | |
| 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, Patient Electrode Kit. | Console Workstation Workstation Cable Ablation Interface Unit Ablation Interface Unit Cable Auxiliary Catheter Cable Surface ECG Input Cable Patient Interface Unit, Patient Interface Unit Cable Ablation Generator Catheter Adaptor Cables Patient Electrode Kit | The subject device no longer includes
the Patient Interface Unit and the
Ablation Interface Unit.
Based on the performance test
conducted, any differences in system
components, as well as the addition of
the Auxiliary Interface Box, does not
raise different questions of safety or
effectiveness. |
| Visual/Mapping
Characteristics | 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 Three-dimensional, dipole density maps
overlaid on the cardiac chamber
reconstruction to show chamber-wide
electrical activation. | 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 Three-dimensional, dipole density maps
overlaid on the cardiac chamber
reconstruction to show chamber-wide
electrical activation. | Same |
Table 1: Comparison of Technological Characteristics with the Predicate Device (cont.)
9
| 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 (K170948) | |||
| Visualization | |||
| Device/Catheter | AcQMap Catheter (electrodes and | ||
| transducers, K170819) | AcQMap Catheter (electrodes and transducers, | ||
| K170819) | Same | ||
| Console Physical Characteristics | |||
| Dimensions | 99 cm L x 58 cm W x 76 cm D | 68 cm L x 48.3 cm W x 72.6 cm D | Larger dimensions due to inclusion of |
| locking caster base. The predicate | |||
| device is built with non-locking casters. | |||
| This slightly larger size accommodates | |||
| improvements in clinical safety. The | |||
| difference in dimensions does not raise | |||
| safety or effectiveness as demonstrated | |||
| through performance testing. | |||
| Weight | |||
| Maximum | 80 kg | 50 kg | The difference in the maximum weight |
| does not raise safety or effectiveness as | |||
| demonstrated through performance | |||
| testing. | |||
| Power | |||
| Requirement | 100-127 VAC, 50/60 Hz, 220-230 VAC, 50 | ||
| Hz | 110 – 240 V, 50/60 Hz | The difference in the power | |
| requirement does not raise safety or | |||
| effectiveness, as the power in the | |||
| subject device is lower and is | |||
| demonstrated through performance | |||
| testing. | |||
| Input Current | 4.6 A | 5A | The difference in the input current does |
| not raise safety or effectiveness, as the | |||
| input current in the subject device is | |||
| lower and is demonstrated through | |||
| performance testing. | |||
| Fuse protection | 250 V, 6.3A, two high breaking capacity | ||
| fuses | 250 V, 6.3 A, two high breaking capacity fuses | Same |
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
Page 49 of 167
10
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| 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 (K170948) | |
| 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 CF, continuous
operation, no sterilization, equipment not suitable
for use in the presence of a flammable anesthetic
mixture with air, oxygen or nitrous oxide | The addition of Defibrillation-Proof
does not raise safety or effectiveness as
demonstrated through performance
testing. |
| Ingress
Protection | The Console is rated IP20 | The Console is rated IP20 | Same |
| Functional and Performance Characteristics | | | |
| | Ultrasound
Output | Frequency: 10 MHz+/-400 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak | Frequency: 10 MHz+/-10 kHz
Maximum Voltage: 50V p-p
Maximum Power: 1 W peak |
| | Ultrasound
Performance | Single operating mode
Thermal Index less than 1.0
Mechanical Index less than 1.0 | Single operating mode A
Thermal Index less than 1.0
Mechanical Index less than 1.0 |
11
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| Characteristics | Subject Device
AcQMap® High Resolution Imaging and
Mapping System, Model 900100 | Predicate Device
AcQMap® High Resolution Imaging and
Mapping System, Model 900000 (K170948) | Rationale for Substantial
Equivalence |
|-------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 | The reduction in localization frequency
increases the input impedance of the
localization system and improves
localization accuracy. The difference
in localization output does not raise
safety or effectiveness as demonstrated
through performance testing. |
| 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 | The change in bandwidth is to meet
international standards. The change in
resolution improves accuracy of dipole
density maps. Changes does not raise
safety or effectiveness as demonstrated
through performance testing. |
| Front Panel Connections | | | |
| AcQMap
Catheter | Custom, black, Defibrillator Protected Type
CF | 100-pin custom, Type CF | Defibrillation-Proof. The AcQMap
Catheter connector is unchanged,
system specifications have changed as
discussed above, and does not raise
different questions of safety or
effectiveness as demonstrated through
performance testing. |
| ECG Input | 12-pin, latching, red, Defibrillator Protected
Type BF | 12-pin, latching, Type BF | Defibrillation-Proof. ECG Input
connector is unchanged, system
specifications have changed as
discussed above, and does not raise
different questions of safety or
effectiveness as demonstrated through
performance testing. |
| ECG Output | 14-pin, latching, blue | -- | The ECG output as a front panel
connection does not raise safety or
effectiveness as demonstrated through
performance testing. |
12
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
| Subject Device | Predicate Device | Rationale for Substantial | |
|---|---|---|---|
| Characteristics | AcQMap® High Resolution Imaging and | AcQMap® High Resolution Imaging and | Equivalence |
| Mapping System, Model 900100 | Mapping System, Model 900000 (K170948) | ||
| Auxiliary | |||
| Interface Box | Custom, green, Defibrillator Protected Type | ||
| CF | -- | Defibrillation-Proof. The AcQMap | |
| Auxiliary Interface Box provides | |||
| connection to the auxiliary catheters | |||
| (optional) used during the procedure. | |||
| The AcQMap Auxiliary Interface Box | |||
| also provides amplification of signals | |||
| collected from auxiliary catheters and | |||
| transfers these signals to the AcQMap | |||
| Console for display. A universal bed | |||
| rail clamp is provided for mounting. | |||
| The addition of the AcQMap Auxiliary | |||
| Interface Box does not raise different | |||
| questions of safety or effectiveness as | |||
| demonstrated through performance | |||
| testing | |||
| AcQRef | |||
| Introducer | |||
| Sheath or | |||
| Electrical | |||
| Reference | |||
| Catheter | 1, 2mm female, yellow, Defibrillator | ||
| Protected Type CF | 1, 2mm female, Type CF | Defibrillation-Proof. The AcQRef | |
| Introducer Sheath connector is | |||
| unchanged, system specifications have | |||
| changed as discussed above, and does | |||
| not raise different questions of safety or | |||
| effectiveness. | |||
| Localization | |||
| Reference | |||
| Electrodes | 6, 2-pin, square, multi-color, Defibrillator | ||
| Protected Type BF | 6, 2-pin, square, Type BF | Defibrillation-Proof. The Localization | |
| Reference Electrodes connector are | |||
| unchanged, system specifications have | |||
| changed as discussed above, and does | |||
| not raise different questions of safety or | |||
| effectiveness. | |||
| Patient | |||
| Reference | |||
| Electrode | 1, 2-pin, square, blue, Defibrillator Protected | ||
| Type BF | 1, 2-pin, square, Type BF | Defibrillation-Proof. The Patient | |
| Reference Electrode connector is | |||
| unchanged, system specifications have | |||
| changed as discussed above, and does | |||
| not raise different questions of safety or | |||
| effectiveness. |
Page 52 of 167
13
| Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.) | |||
|---|---|---|---|
| Characteristics | Subject Device | ||
| AcQMap® High Resolution Imaging and | |||
| Mapping System, Model 900100 | Predicate Device | ||
| AcQMap® High Resolution Imaging and | |||
| Mapping System (K170948) | Rationale for Substantial | ||
| Equivalence | |||
| Ablation | |||
| Generator | 10-pin, latching, grey | 10-pin, male, Type CF | The Ablation Generator connector is |
| unchanged, system specifications have | |||
| changed as discussed above, and does | |||
| not raise different questions of safety or | |||
| effectiveness. | |||
| Ablation | |||
| Catheter | 10-pin, latching, grey, Defibrillator Protected | ||
| Type CF | 10-pin, female, Type CF | Defibrillation-Proof. The Ablation | |
| Catheter connector is unchanged, | |||
| system specifications have changed as | |||
| discussed above, and does not raise | |||
| different questions of safety or | |||
| effectiveness. | |||
| Ablation | |||
| Reference | 1, 2mm, female, black, Defibrillator | ||
| Protected Type BF | -- | Defibrillation-Proof. The ablation | |
| reference does not raise different | |||
| questions of safety or effectiveness as | |||
| demonstrated through performance | |||
| testing. | |||
| Ablation | |||
| Electrogram | |||
| Interface | 1, 13-pin, latching, white | -- | This new cable added to the subject |
| device does not raise different | |||
| questions of safety or effectiveness as | |||
| demonstrated through performance | |||
| testing |
Table 1: Comparison of Technological Characteristics with the Predicate Devices (cont.)
14
SUBSTANTIAL EQUIVALENCE
The indication for use for the subject device, AcQMap® High Resolution Imaging and Mapping System. Model 900100, is substantially equivalent to the predicate. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the 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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 to support a determination of substantial equivalence to the predicate device. The necessary clinical study was completed for the original AcQMap System (K170948) and is incorporated by reference. No further clinical study is required to support the subject device.
Nonclinical Testing Summary [807.92(b)(1)]
The necessary bench testing was performed on the AcQMap 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 subject device or incorporated by reference to the original AcOMap System 510(k), included the following:
- Transportation Testing ●
- AcOMap Verification Testing ●
- Software Verification and Validation
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- AcQMap Catheter Validation Testing-Animal Study
The 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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 meets its established performance specifications necessary for performance during its intended use.
The collective results of the nonclinical testing either repeated for the proposed device or incorporated by reference to the original AcQMap System 510(k), demonstrate that the materials chosen. the manufacturing processes, and design of the AcOMap® High Resolution Imaging and Mapping System, Model 900100 meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.
Clinical Testing Summary [807.92(b)(2)]
As discussed above, no further clinical testing is required to support the 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
15
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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 or incorporated by reference to the original AcQMap System 510(k), was conducted on the AcQMap System Model, 900100 to evaluate the overall performance of the device. The clinical validation of the original AcQMap System (K170948) is applicable to the subject device. The collective results demonstrate that the 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 AcQMap® High Resolution Imaging and Mapping System, Model 900100 is as safe and effective for its intended use and is substantially equivalent to the predicate device.