(210 days)
No
The summary does not mention AI, ML, or related concepts, and the device description and intended use focus on traditional ultrasound and electrical mapping technologies.
No.
The device is used for visualizing and recording electrical impulses, which are diagnostic functions, not therapeutic ones.
Yes
The device is described as collecting ultrasound data for visualizing a chamber and recording electrical impulses to identify complex arrhythmias, which are diagnostic activities.
No
The device description explicitly states "Electrode Recording Catheter/Transducer Ultrasound," indicating it includes hardware components (catheter, transducer).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is a catheter used within the body (in the right and left atrial chambers) to collect ultrasound data and record electrical impulses. It is used for in vivo (within a living organism) imaging and mapping, not for testing samples outside the body.
- Intended Use: The intended use is to visualize and map electrical activity within the heart chambers, which is an in vivo procedure.
Therefore, the AcQMap 3D Imaging and Mapping Catheter falls under the category of an in vivo diagnostic or therapeutic device, not an IVD.
N/A
Intended Use / Indications for Use
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
Product codes (comma separated list FDA assigned to the subject device)
MTD, ITX
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound data
Anatomical Site
right and left atrial chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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: The nonclinical, bench testing included: - Design Verification - Dimensional Inspection - Visual Inspection - Functional and Compatibility Testing - Mechanical Testing - Corrosion Testing - Electrode Coating Particulate Testing - Acoustic Output Testing - Accuracy Testing - Design Validation - Usability Testing - Animal Testing - Biocompatibility Testing. In addition, Acutus performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap 3D Imaging and Mapping Catheter meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap 3D Imaging and Mapping Catheter 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 device.
Clinical Testing Summary: Acutus performed a clinical study to demonstrate the safety and performance of the AcQMap High Resolution Imaging and Mapping System (AcQMap 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 Catheter 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.
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
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA 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: K170819
Trade/Device Name: AcOMap 3D Imaging and Mapping Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD, ITX Dated: September 6, 2017 Received: September 7, 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, 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 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
AcQMap 3D Imaging and Mapping Catheter
Indications for Use (Describe)
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW .
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FORM FDA 3881 (8/14)
PSC Publishing Services (301) 443-6740 FF
3
510(k) Notification K170819
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 16, 2017
DEVICE INFORMATION [807.92(a)(2)]
Trade/Proprietary Name: AcQMap® 3D Imaging and Mapping Catheter
Generic/Common Name:
Electrode Recording Catheter/Transducer Ultrasound
Classification: II
Product Code: MTD/ITX
4
PREDICATE DEVICE(S) [807.92(a)(3)]
Predicate Device
Constellation Multiple Electrode Recording and Pacing Catheter ("Constellation Catheter") (K140733)
Reference Devices EnSite Array Multi-Electrode Diagnostic Catheter ("EnSite Catheter") (K121006) Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter ("Ultra Ice Catheter") (K160173)
INDICATIONS FOR USE [807.92(a)(5)]
The AcQMap 3D Imaging and Mapping Catheter is intended to be used in the right and left atrial chambers to collect ultrasound data for visualizing the selected chamber and recording electrical impulses in patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone.
| Characteristics | AcQMap 3D Imaging
and Mapping Catheter | Constellation
Multiple Electrode
Recording and
Pacing Catheter | Analysis |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Regulatory | | | |
| 510(k) Number | K170819 | K140733 | -- |
| Classification/
Regulation
Number/Regulation
Name/Product Code | Class II/21 CFR §
870.1220/ Electrode
recording catheter or
electrode recording
probe/MTD
Class II/21 CFR §
892.1570/ Transducer
Ultrasonic/ITX | Class II/21 CFR §
870.1220/ Electrode
recording catheter or
electrode recording
probe/MTD | The additional product
codes for the proposed
device are required. |
| Indications for Use | The AcQMap 3D Imaging
and Mapping Catheter is
intended to be used in the
right and left atrial
chambers to collect
ultrasound data for
visualizing the selected
chamber and recording
electrical impulses in
patients with complex
arrhythmias that may be
difficult to identify using
conventional mapping
systems alone. | For use in right atrial
and left EP
procedures to assist
in the diagnosis of
complex arrhythmias
that may be difficult
to identify using
conventional
mapping systems
alone (i.e. linear
mapping
catheters). The
Constellation
Multiple Electrode
Recording and
Pacing Catheter
System may also be
used for delivery of | The intended use of the
devices is the same. |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]
5
510(k) SUMMARY
| Characteristics | AcQMap 3D Imaging
and Mapping Catheter | Constellation
Multiple Electrode
Recording and
Pacing Catheter | Analysis |
|-----------------|-------------------------------------------|-------------------------------------------------------------------------|----------|
| | | externally generated
pacing stimuli | |
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] (cont.)
| Characteristics | AcQMap 3D Imaging
and Mapping Catheter | Constellation
Multiple Electrode
Recording and
Pacing Catheter | Analysis |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Characteristics | | | |
| Configuration | Electrode/Transducer
mounted on splines | Electrode Array in
Basket | The differences in
physical construction of
the two devices do not
raise different questions
of safety or effectiveness
than the predicate as |
| Basket Diameter | 25 mm | 31, 38, 60 and 75mm | |
| Working Length | 100 cm | 90 cm - 130 cm
(length) | |
| Number of Splines | 6 | 8 | demonstrated by the |
| Heart Wall Contacting | No | Yes | AcQMap performance |
| Flush Port | Yes | Unknown | testing. |
| Technical Specifications - Electrical | | | |
| Voltage | Yes | Yes | Differences in electrical |
| Dipole Density | Yes | No | specifications do not |
| Number of Electrodes | 48 | 32 - 64 | raise different questions
of safety or effectiveness
than the predicate as
demonstrated by the
AcQMap performance
testing. |
| Data Points/heart beat | 2500 | Unknown | |
| Power source | Electrical source from
AcQMap System | Electrical source
from standard EP
mapping and
recording Systems | |
| Technical Specifications - Ultrasound | | | |
| Mode | M-mode | N/A | The predicate device
does not have ultrasound
functionality.
The reference device
does have ultrasound
functionality. |
| Number of transducers | 48 | N/A | |
| Phased Array Y/N | N | N/A | |
| Center Frequency | 10 MHz | N/A | |
| Acoustic Output | | | |
| MI (Mechanical
Index) | 0.06 | N/A | The predicate device
does not have ultrasound
functionality.
The reference device
does have ultrasound
functionality. |
| ISTPA.3 (Derated
Spatial-Peak
Temporal-Average
Intensity (milliwatts
per square
centimeter)) | 0.08 (mW/cm2) | N/A | |
| ISPPA.3 (Derated
Spatial-Peak Pulse
Average Intensity
(watts per square
centimeter)) | 1.03 | N/A | |
| Characteristics | AcQMap 3D Imaging
and Mapping Catheter | Constellation
Multiple Electrode
Recording and
Pacing Catheter | Analysis |
| Compatible Sheath | For Use with Acutus
Medical AcQGuide 12 F
Steerable Sheath | 9F | Any differences in
accessory sizes do not
raise different questions
of safety or
effectiveness. |
| Compatible Guidewire | 0.032" (0.81 mm) diameter
J-tip guidewire | Not to exceed 0.035"
diameter J-tip
guidewire | |
6
510(k) SUMMARY
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate device is substantially equivalent to the proposed indications for use for the AcQMap 3D Imaging and Mapping Catheter. Any differences in the technological characteristics between the devices do not raise different questions of safety or effectiveness. Thus, the AcQMap 3D Imaging and Mapping Catheter is substantially equivalent to the predicate device.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the AcQMap 3D Imaging and Mapping Catheter to support a determination of substantial equivalence to the predicate device.
[807.92(b)(1)| Nonclinical Testing Summary:
The nonclinical, bench testing included:
- Design Verification .
- Dimensional Inspection O
- Visual Inspection O
- Functional and Compatibility Testing O
- Mechanical Testing o
- Corrosion Testing O
- Electrode Coating Particulate Testing O
- O Acoustic Output Testing
- o Accuracy Testing
- Design Validation
- Usability Testing O
- o Animal Testing
- Biocompatibility Testing ●
In addition, Acutus performed sterilization, shelf life and packaging validations. The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQMap 3D Imaging and Mapping Catheter meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQMap 3D Imaging and
7
510(k) SUMMARY
Mapping Catheter 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 device.
Clinical Testing Summary [807.92(b)(2)]:
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 (AcQMap 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 Catheter is safe and effective for its intended use.
CONCLUSIONS [807.92(b)(3)]
Extensive nonclinical performance testing was conducted on the AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. Acutus also performed validation testing including usability, accuracy and clinical testing to evaluate the performance of the AcQMap 3D Imaging and Mapping Catheter with the AcQMap System. The collective results demonstrate that the AcQMap 3D Imaging and Mapping Catheter is safe and effective for its intended use.
SUMMARY
The AcQMap 3D Imaging and Mapping Catheter is substantially equivalent to the predicate device.