(200 days)
Not Found
No
The summary describes a system for imaging, navigation, and mapping using ultrasound, ECG, EGM, and impedance-based localization. It focuses on data acquisition, reconstruction, and display of electrical activity and catheter positions. There is no mention of AI, ML, or related concepts like deep learning, neural networks, or automated interpretation/analysis that would typically indicate the use of AI/ML. The description of the system's functions aligns with conventional signal processing and visualization techniques used in electrophysiology.
No
The device is described as a "diagnostic recording system" intended for visualizing chamber anatomy and displaying electrical impulses to identify complex arrhythmias. Its primary function is to provide physicians with information to identify the source of the arrhythmia, not to directly treat it.
Yes
The device description explicitly states, "The AcQMap High Resolution Imaging and Mapping System ('AcQMap System') is a diagnostic recording system." The intended use also mentions it is used to "displaying electrical impulses as either dipole density-based or voltage-based maps of complex arrhythmias" and "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." These functions are consistent with a diagnostic device.
No
The device description explicitly states that the AcQMap System hardware consists of three functional subsystems: Ultrasound imaging, ECG and EGM recording, and Impedance based electrode Localization. It also mentions a console and a workstation as part of the system. This indicates the device includes significant hardware components beyond just software.
Based on the provided information, the AcQMap® High Resolution Imaging System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The AcQMap System directly interacts with the patient's heart (in vivo) using ultrasound and electrical signals. It does not analyze samples like blood, urine, or tissue outside the body.
- The intended use and device description clearly state its function is to image, navigate, and map the atrial chambers of the heart in patients during electrophysiology procedures. This is an in-vivo diagnostic procedure.
- The system uses ultrasound data and electrical signals from within the body. This is not consistent with the typical inputs for an IVD.
Therefore, the AcQMap System falls under the category of an in-vivo diagnostic device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AcQMap® High Resolution Imaging 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 (comma separated list FDA assigned to the subject device)
DOK, IYO, ITX
Device Description
The AcQMap System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcOMap Ablation Interface Unit.
The AcQMap High Resolution Imaging and Mapping System ("AcQMap System") is a diagnostic recording system. This computer-based system is intended for use in the Electrophysiology (EP) Lab, and it is capable of imaging, navigation and mapping of the atrial chambers of the heart.
The AcQMap System hardware consists of three functional subsystems:
- Ultrasound imaging,
- ECG and EGM recording; and
- Impedance based electrode Localization.
The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter. 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,
- 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 AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Atrial chambers of the heart, cardiac chamber
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
Although clinical testing is not required to demonstrate substantial equivalence to the predicate device for its intended use, Acutus performed a clinical study to demonstrate the safety and performance of the AcQMap High Resolution Imaging and Mapping System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. The study entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" is a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrates that the AcQMap System is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 16, 2017
Acutus Medical, Inc. Brenda Clay Regulatory Affairs Manager 2210 Faraday Ave., Suite 100 Carlsbad, California 92008
Re: K170948
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: DOK, IYO, ITX Dated: September 15, 2017 Received: September 18, 2017
Dear Brenda Clay:
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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
M.A. Wilhelm
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) K170948
Device Name
AcQMap® High Resolution Imaging and Mapping System
Indications for Use (Describe)
The AcQMap® High Resolution Imaging 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) | |
|---|---|
| ☒ 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 K170948
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:
Brenda Clay Regulatory Affairs Manager Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1- 442-232-6161 FAX: 1- 442-232-6081 Email: Brenda.Clay@acutus.com
Date Prepared: March 29, 2017
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:
DOK, IYO, ITX
4
PREDICATE DEVICE(S) [807.92(a)(3)]
- EnSite Velocity™ Cardiac Mapping System (K130594); and o
- iLabTM Ultrasound Imaging System (K130243) ●
DEVICE DESCRIPTION [807.92(a)(4)]
The AcQMap System operates outside of the sterile field and consists of the AcQMap Console, the AcQMap Workstation, the AcQMap Patient Interface Unit, and the AcOMap Ablation Interface Unit.
The AcQMap High Resolution Imaging and Mapping System ("AcQMap System") 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, 0
- ECG and EGM recording; and o
- Impedance based electrode Localization. 0
The AcQMap System is used in conjunction with the associated AcQMap 3D Imaging and Mapping Catheter. The AcQMap System provides:
- o 3-D cardiac chamber reconstruction 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 o
- Three-dimensional, dipole density maps overlaid on the cardiac chamber o reconstruction to show chamber-wide electrical activation.
The AcQMap System is a diagnostic recording system consisting of ultrasound, electrical mapping components, a console, and a workstation. 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.
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
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.
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(A)(6)]
Table 1 provides a comparison of the technological characteristics for the AcQMap System and the predicate devices.
6
510(k) Summary
| Characteristics | AcQMap® High Resolution
Imaging and Mapping System | EnSite™ Velocity™ Cardiac
Mapping System | iLab™ Ultrasound Imaging
System | Rationale for Substantial
Equivalence |
|----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | | |
| 510(k) Number | TBD | K130594 | K130243 | - |
| 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/Ultrasound pulsed
echo imaging system/IYO,
ITX | The additional product codes
and regulation number for the
proposed device are required. |
| 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. | The EnSite™ Velocity™
Cardiac Mapping System is a
suggested diagnostic tool in
patients for whom
electrophysiology studies are
indicated.
*When used with the EnSite
Array™ Catheter, the EnSite™
Velocity™ Cardiac Mapping
System is intended to be used
in the right atrium of patients
with complex arrhythmias that
may be difficult to identify
using conventional mapping
systems alone.
OR
*When used with the EnSite™
NavX™ Surface Electrode Kit,
the EnSite™ Velocity™
Cardiac Mapping System is
intended to display the
position of conventional
electrophysiology (EP)
catheters in the heart. | The iLab™ Ultrasound
Imaging System is intended
for ultrasound examinations
of intravascular pathology.
Intravascular ultrasound is
indicated in patients who are
candidates for transluminal
interventional procedures
such as angioplasty and
atherectomy. | All devices are intended for
electrophysiology procedures.
Both the AcQMap System and
EnSite System are indicated for
complex arrhythmias when
used with their respective
catheters. Both the AcQMap
System and iLab System
include the ultrasound
performance capabilities in the
indications for use statement.
The semantic differences in the
indications for use do not raise
different questions of safety or
effectiveness than the
predicates as demonstrated by
the AcQMap performance
testing. |
| | | | | |
| | able 1: "Comparison of Techniological Characteristics and | Tharacteristics with the Fredicate Devices (count.) tion | | ationale for Substant |
| tient Anator | acardiac Struct | cardiac Struct | ravascular Anator | ased on the performan Sting Continues and Children and China China There monimalian and Children and China Mesting salistics and Children and Children Checkives since so |
| festing to Suppor ubstantial Iquivalence | Safety Testing Testing Creating National Testing Comments National Testing Comments Nichinal Testing manus
oftware V/V lectromagnetic and Electrica
●
●
0 | Bench testing; a Animal testing | ctional/performan
eroperability testin
ctrical Safety tes
esting
and
0 | omplete performance testing onders parformance as alternale and and and the compressioners of the compressionelly of the contribution of the chives the chives the chivenest w |
| System Safet Standards | ●
● | ר הייתר משותר משותר משושים של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של המושב של
601 .1
●
● | Inknowr | Same |
| Characteristics | AcQMap® High Resolution
Imaging and Mapping System | EnSite™ Velocity™ Cardiac
Mapping System | iLab™ Ultrasound Imaging
System | Rationale for Substantial
Equivalence |
| Physical Characteristics | | | | |
| System
Components | Console, Workstation, Workstation
Cable Patient Interface Unit, Patient
Interface Unit Cable, Ablation
Interface Unit, Ablation Interface
Unit Cable, Auxiliary Catheter
Cable, Surface ECG Input Cable
and Patient Electrode Kit. | Amplifier and Display
Workstation (DWS)
Amplifier includes Navlink,
ArrayLink and CathLink
Modules, SJM ECG Cable,
Record Connect and
GenConnect.
| Unknown | Same |
| 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. | Three-dimensional
position of the catheter Display cardiac electrical
activity as waveform
traces; Three-dimensional maps
of the cardiac chamber | Combination of imaging
and soft tissue
visualization. Visualizes the catheter
relative to the anatomical
structure | The combination of three-
dimensional imaging
functionality and ultrasound
functionality for display of
dipole density maps does not
raise different questions of
safety or effectiveness as
demonstrated through
performance testing. |
| Visualization
Device/Catheter | AcQMap Catheter (electrodes and
transducers) | EnSite Array Catheter
(electrode) | BSC Ultra ICE - Ultrasound
Dx Catheter (transducer) | |
| Characteristics | AcQMap® High Resolution Imaging
and Mapping System | EnSite™ Velocity™ Cardiac
Mapping System | iLab™ Ultrasound Imaging
System | Rationale for Substantial
Equivalence |
| Physical Characteristics - Console/Amplifier Comparison | | | | |
| Dimensions | 68 cm L x 48.3 cm W x 72.6 cm D | 49 cm H x 46 cm W x 51 cm D | Unknown | Same |
| Weight
Maximum | 50 kg | 31 kg | 213 pounds (System weight) | |
| Power
Requirement | 110 – 240 V, 50/60 Hz | 100, 110/120, 220/240 V
~50/60 Hz | Unknown | |
| Input Current | 5A | 450W maximum (4.5A) | Unknown | |
| Fuse protection | 250 V, 6.3 A, two high breaking
capacity fuses | 250 V, 5 A VAC, two fuses | Unknown | |
Table 1: Comparison of Technological Characteristics with the Predicate Devic
7
510(k) Summary
Table 1: Comparison of Technological Characteristics with the Predicate Devices (con
8
510(k) Summary
9
510(k) SUMMAR
10
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate devices is substantially equivalent to the proposed indications for use for the AcQMap System. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. Thus, the AcQMap System is substantially equivalent to the predicate devices.
PERFORMANCE DATA [807.92(b)]
All necessary bench and clinical testing was conducted on the AcQMap System to support a determination of substantial equivalence to the predicate devices.
[807.92(b)(1)] Nonclinical Testing Summary
The necessary bench testing was performed on the AcOMap System to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device. The bench testing performed included the following:
- Transportation Testing ●
- AcQMap Verification Testing ●
- Software Verification and Validation
- System Accuracy Testing
- Electromagnetic Compatibility and Electrical Safety Testing
- . AcQMap Catheter Validation Testing-Animal Study
The AcQMap System device was tested to verify that the device met the established performance specifications.
The collective results of the testing demonstrate that the design of the AcQMap System meets its established performance specifications necessary for performance during its intended use.
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap System meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap System does not raise different questions of safety or effectiveness for collecting data that enables the creation of 3D anatomic maps that display chamber-wide electrical activation when compared to the predicate devices.
[807.92(b)(2)] Clinical Testing Summary
Although clinical testing is not required to demonstrate substantial equivalence to the predicate device for its intended use, Acutus performed a clinical study to demonstrate the safety and performance of the AcQMap High Resolution Imaging and Mapping System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. The study entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Complex Supraventricular Tachycardia, (DDRAMATIC-SVT)" is a prospective, non-randomized, open-label study conducted at eight clinical sites outside the U.S. The results for 84 patients demonstrates that the AcQMap System is safe and effective for its intended use.
11
CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical performance testing was conducted on the AcQMap System to evaluate the overall performance of the device. Acutus also performed clinical validation testing to evaluate the performance of the AcQMap System with the AcQMap 3D Imaging and Mapping Catheter. The collective results demonstrate that the AcQMap System is safe and effective for its intended use.
SUMMARY
The AcQMap System is substantially equivalent to the predicate devices.