(463 days)
No
The summary describes a device for collecting ultrasound and electrical data for mapping, but there is no mention of AI or ML being used for data processing, analysis, or interpretation.
No
Explanation: The device is described as an imaging and mapping catheter that collects ultrasound data and records electrical impulses for visualizing chambers and identifying complex arrhythmias. There is no mention of it administering therapy or having a therapeutic effect.
Yes
The device is intended to collect ultrasound data for visualizing the selected chamber and recording electrical impulses, specifically for "identifying complex arrhythmias that may be difficult to identify using conventional mapping systems alone." This function clearly fits the definition of a diagnostic device as it gathers data to identify a medical condition.
No
The device description clearly details a physical, invasive catheter with electrodes and ultrasound transducers, which is a hardware component, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The AcQMap Catheter is an invasive device that is inserted directly into the heart chambers. Its purpose is to collect ultrasound data for visualizing the chamber and recording electrical impulses within the heart.
- No Specimen Analysis: The device does not analyze any specimens taken from the body. It interacts directly with the internal anatomy and physiological signals.
Therefore, the AcQMap 3D Imaging and Mapping Catheter falls under the category of an in vivo (within the living body) diagnostic and therapeutic device, not an in vitro diagnostic device.
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
MTD, ITX
Device Description
The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.
The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device.
The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
right and left atrial chambers of the heart
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 is repeated or included in this submission by reference. A full list of the nonclinical testing is provided below:
- 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: No further clinical testing is required to support the modified AcQMap 3D Imaging and Mapping Catheter. The necessary clinical testing was completed for the original AcQMap 3D Imaging and Mapping Catheter (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Comblex 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 3D Imaging and Mapping Catheter is safe and effective for its intended use.
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
§ 870.1220 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 shows 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 21, 2022
Acutus Medical, Inc. Karla Schaffner Principal Regulatory Affairs Specialist 2210 Faraday Ave, Suite 100 Carlsbad, California 92008
Re: K210766
Trade/Device Name: AcQMap® 3D Imaging and Mapping Catheter, Model 900009 Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD. ITX Dated: June 13, 2022 Received: June 14, 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
542 of the Act); 21 CFR 1000-1050.
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) 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-
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) K210766
Device Name
AcQMap® 3D Imaging and Mapping Catheter, Model 900009
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with a small orange circle inside the letter "A". Below the word "ACUTUS" is the word "MEDICAL" in orange. The logo is simple and modern, and it is likely used to represent the company's brand.
510(K) Notification K_210766
General Information [807.92(a)(1)]
Date Prepared: 21 June 2022
| Applicant | Contact Person |
|---|---|
| Acutus Medical, Inc. | |
| 2210 Faraday Ave., Suite 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-232-6080 | |
| Fax: 1-442-232-6081 | Karla Schaffner |
| Principal Regulatory Affairs Specialist | |
| Acutus Medical, Inc. | |
| 2210 Faraday Ave., Suite 100 | |
| Carlsbad, CA 92008 | |
| USA | |
| Phone: 1-442-232-6161 | |
| FAX: 1-442-232-6081 | |
| Email: karla.schaffner@acutus.com |
Device Information [807.92(a)(2)]
Trade Name:
AcQMap® 3D Imaging and Mapping Catheter, Model 900009
Generic/Common Name:
Electrode Recording Catheter or Electrode Recording Probe/ Transducer Ultrasonic
Classification:
Class II / 21 CFR § 870.1220 and Class II / 21 CFR § 892.1570
Product Code(s):
MTD/ITX
Predicate Device [807.92(a)(3)]
AcQMap 3D Imaging and Mapping Catheter (K201341)
Reference Device
AcQMap 3D Imaging and Mapping Catheter (K170819)
Device Description [807.92(a)(4)]
4
The AcQMap 3D Imaging and Mapping Catheter ("AcQMap Catheter") is provided sterile and is a singleuse, non-pyrogenic, invasive device that is inserted into the femoral vein and advanced through the venous circulatory system to the inferior vena cava and into the right and/or left atrium of the heart.
The AcQMap Catheter consists of a shaft with a lumen, an integral handle with a deployment mechanism and a flush port, and a connector. The AcQMap Catheter is intended to be used with the AcQMap High Resolution Imaging and Mapping System ("AcQMap System"). The AcQMap Catheter will provide ultrasound imaging and non-contact electrograms for Charge Density/Voltage heart chamber mapping. The AcQMap Catheter has six (6) splines at the distal end that support a configuration of 48 electrodes and 48 ultrasound transducers. The AcQMap Catheter is placed within the desired heart chamber and the distal end is deployed. There is no requirement for the electrodes or transducers to be in contact with the heart wall. The AcQMap Catheter is capable of over-the-wire delivery and contains a flexible distal segment that allows it to be directed via a steerable sheath to various locations of interest within the heart. Refer to for images of the device.
The AcQMap Catheter, Model 900009 is sterilized by EO method, has a reusable interface cable, is compatible with a 0.035" guidewire, and has minor design changes to improve manufacturability. The shaft of the catheter has a shaft marker band, as an optional feature, to allow the user to visualize whether the distal array is inside or outside the AcQGuide MAX Steerable Sheath (900200).
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.
Comparison of Technological Characteristics with The Predicate Devices [807.92(A)(6)]
| Characteristics | SUBJECT
Modified AcQMap 3D Imaging
and Mapping Catheter, Model
900009 | PREDICATE
AcQMap 3D Imaging and
Mapping Catheter, Model
900009 | Rationale for
Substantial
Equivalence |
|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory | | | |
| 510(k) Number | K210766 | K201341 | -- |
| 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
Class II / 21 CFR §892.1570 /
Transducer Ultrasonic/ ITX | Identical |
| Characteristics | SUBJECT
Modified AcQMap 3D Imaging
and Mapping Catheter, Model
900009 | PREDICATE
AcQMap 3D Imaging and
Mapping Catheter, Model
900009 | Rationale for
Substantial
Equivalence |
| 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. | 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. | Identical |
| Physical Characteristics | | | |
| Configuration | Electrode/Transducer mounted on
splines | Electrode/Transducer mounted on
splines | Identical |
| Deployed Diameter | 25mm | 25mm | Identical |
| Working Length | 100 cm | 100 cm | Identical |
| Number of Spines | 6 | 6 | Identical |
| Heart Wall Contacting | No | No | Identical |
| Deflection Y/N | No | No | Identical |
| Flush Port | Yes | Yes | Identical |
| Marker Band | Yes | No | Shaft marking
provides visual
feedback for distal
tip location
relative to the
AcQGuide MAX
sheath tip.
Marker is optional
for use and does
not improve
safety. |
| Technical Specifications - Electrical | | | |
| Voltage | Yes | Yes | Identical |
| Charge Density | Yes | Yes | Identical |
| Number of Electrodes | 48 | 48 | Identical |
| Data Points/heartbeat | 2500 | 2500 | Identical |
| Power source | Electrical source from AcQMap
System | Electrical source from AcQMap
System | Identical |
| Technical Specifications - Ultrasound | | | |
| Characteristics | SUBJECT
Modified AcQMap 3D Imaging
and Mapping Catheter, Model
900009 | PREDICATE
AcQMap 3D Imaging and
Mapping Catheter, Model
900009 | Rationale for
Substantial
Equivalence |
| Mode | M-mode | M-mode | Identical |
| Number of
transducers | 48 | 48 | |
| Phased Array Y/N | N | N | |
| Center Frequency | 10 MHz | 10 MHz | |
| Acoustic Output | | | |
| MI (Mechanical Index) | 0.06 | 0.06 | Identical |
| ISTPA.3 (Derated
Spatial-Peak
Temporal-Average
Intensity (milliwatts
per square
centimeter)) | 0.08 (mW/cm²) | 0.08 (mW/cm²) | |
| ISPPA.3 (Derated
Spatial-Peak Pulse
Average Intensity
(watts per square
centimeter)) | 1.03 | 1.03 | |
| Accessories | | | |
| Dimensionally
Compatible Sheath | For Use with Acutus
Medical
AcQGuide MAX 12 F Steerable
Sheath (K162925 and K211100) | For Use with
Acutus Medical
AcQGuide 12 F Steerable Sheath
(K162925) | The compatibility
with the recently
cleared
2nd
generation
AcQGuide
MAX
Steerable
Sheath
does not create a
new risk as the
two sheaths
are
representative
of
each other. |
| Compatible Guidewire | 0.035" (0.89 mm) diameter J-tip
guidewire | 0.035" (0.89 mm) diameter J-tip
guidewire | Identical |
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Image /page/5/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, block letters, with a small orange circle in the lower left corner of the "A". Below the word "ACUTUS" is the word "MEDICAL" in smaller, orange letters. The logo is simple and modern, and the use of color helps to make it stand out.
ACQMAP® 3D IMAGING AND MAPPING CATHETER
6
Image /page/6/Picture/0 description: The image shows the logo for Acutus Medical. The logo has the word "ACUTUS" in gray, block letters. Below that, the word "MEDICAL" is spelled out in smaller, orange letters. There is a registered trademark symbol to the right of the letter "S" in "ACUTUS".
ACQMAP® 3D IMAGING AND MAPPING CATHETER
Substantial Equivalence
The indications for use of the subject device are identical to those of the predicate device. The difference between the subject and predicate AcQMap Catheter model 900009 is the addition of the marker band on the shaft of the catheter. This is an optional feature, to allow the user to visualize whether the distal
7
array is inside or outside the AcQGuide MAX Steerable Sheath (900200). The marker band does not improve safety, nor is it detrimental if used with the AcQGuide MAX Steerable Sheath (K162925). This difference between the devices does not raise any different questions of safety or effectiveness. Thus, the modified AcQMap 3D Imaging and Mapping Catheter, is substantially equivalent to the predicate AcQMap 3D Imaging and Mapping Catheter device.
PERFORMANCE DATA [807.92(b)]
All necessary bench testing was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to support a determination of substantial equivalence to the predicate device. The necessary clinical testing was completed for the original AcQMap Catheter (K170819) and is incorporated by reference. No further clinical testing is required to support the subject device.
Nonclinical Testing Summary [807.92(b)(1)]
The nonclinical, bench testing is repeated or included in this submission by reference. A full list of the nonclinical testing is provided below:
- . Design Verification
- Dimensional Inspection O
- O Visual Inspection
- 0 Functional and Compatibility Testing
- Mechanical Testing O
- 0 Corrosion Testing
- Electrode Coating Particulate Testing O
- Acoustic Output Testing O
- 0 Accuracy Testing
- Design Validation
- Usability Testing 0
- 0 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.
8
Image /page/8/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in gray, with the word "MEDICAL" in orange underneath. The "A" in "ACUTUS" has an orange dot in the middle. There is a registered trademark symbol next to the "S" in "ACUTUS".
Clinical Testing Summary [807.92(b)(2)]
As discussed above, no further clinical testing is required to support the modified AcQMap 3D Imaging and Mapping Catheter. The necessary clinical testing was completed for the original AcQMap 3D Imaging and Mapping Catheter (K170948) and is incorporated by reference. That study, entitled, "Dipole Density Right (and left) Atrial Mapping and Assessment of Therapy In Comblex 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 3D Imaging and Mapping Catheter is safe and effective for its intended use.
Conclusions
Extensive nonclinical performance testing, either repeated for the modified device or incorporated by reference to the original AcQMap 3D Imaging and Mapping Catheter 510(k), was conducted on the modified AcQMap 3D Imaging and Mapping Catheter to evaluate the overall performance of the device. The clinical validation of the original AcQMap 3D Imaging and Mapping Catheter (K170819) is applicable to the modified device. The subject device is substantially equivalent to the predicate device.