AcQMap 3D Imaging and Mapping Catheter

K170819 · Acutus Medical, Inc. · MTD · Oct 16, 2017 · Cardiovascular

Device Facts

• Record ID: K170819
• Device Name: AcQMap 3D Imaging and Mapping Catheter
• Applicant: Acutus Medical, Inc.
• Product Code: MTD · Cardiovascular
• Decision Date: Oct 16, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended 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.

Device Story

The AcQMap 3D Imaging and Mapping Catheter is an electrophysiology device used in the right and left atrial chambers to facilitate the diagnosis of complex arrhythmias. The catheter features 48 electrodes and 48 ultrasound transducers mounted on six splines. It collects ultrasound data for chamber visualization and records electrical impulses, which are processed by the AcQMap System to generate 3D dipole density activation maps. The device is operated by a physician in a clinical setting. By providing high-resolution, chamber-wide electrical activation data, the device assists clinicians in identifying complex arrhythmia substrates that are challenging to map with conventional systems, potentially improving the accuracy of diagnosis and subsequent therapeutic interventions.

Clinical Evidence

A prospective, non-randomized, open-label study (DDRAMATIC-SVT) was conducted at eight clinical sites outside the U.S. with 84 patients. The study evaluated the safety and performance of the AcQMap System in gathering data to create right and/or left atrial dipole density activation maps in subjects with supraventricular tachycardia. Results demonstrated the device is safe and effective for its intended use.

Technological Characteristics

The device is a 6-spline catheter with 48 electrodes and 48 ultrasound transducers (10 MHz center frequency). It operates in M-mode. It is used with the AcQGuide 12F Steerable Sheath. Electrical power is supplied by the AcQMap System. Biocompatibility, sterilization, and shelf-life validations were performed. The device does not require heart wall contact.

Indications for Use

Indicated for patients with complex arrhythmias that may be difficult to identify using conventional mapping systems alone, requiring visualization of right and left atrial chambers and recording of electrical impulses.

Regulatory Classification

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.

Predicate Devices

• Constellation Multiple Electrode Recording and Pacing Catheter (K140733)

Reference Devices

• EnSite Array Multi-Electrode Diagnostic Catheter (K121006)
• Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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#### 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)

K170819

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)

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## 510(k) Notification K170819

## GENERAL INFORMATION [807.92(a)(1)]

#### Applicant:

Acutus® Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] Fax: [phone]

#### Contact Person:

Brenda Clay Regulatory Affairs Manager Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: [phone] FAX: [phone] Email: [e-mail]

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

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## 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<br>and Mapping Catheter | Constellation<br>Multiple Electrode<br>Recording and<br>Pacing Catheter | Analysis |
|-------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| Regulatory | | | |
| 510(k) Number | K170819 | K140733 | -- |
| Classification/<br>Regulation<br>Number/Regulation<br>Name/Product Code | Class II/21 CFR §<br>870.1220/ Electrode<br>recording catheter or<br>electrode recording<br>probe/MTD<br>Class II/21 CFR §<br>892.1570/ Transducer<br>Ultrasonic/ITX | Class II/21 CFR §<br>870.1220/ Electrode<br>recording catheter or<br>electrode recording<br>probe/MTD | The additional product<br>codes for the proposed<br>device are required. |
| Indications for Use | The AcQMap 3D Imaging<br>and Mapping Catheter is<br>intended to be used in the<br>right and left atrial<br>chambers to collect<br>ultrasound data for<br>visualizing the selected<br>chamber and recording<br>electrical impulses in<br>patients with complex<br>arrhythmias that may be<br>difficult to identify using<br>conventional mapping<br>systems alone. | For use in right atrial<br>and left EP<br>procedures to assist<br>in the diagnosis of<br>complex arrhythmias<br>that may be difficult<br>to identify using<br>conventional<br>mapping systems<br>alone (i.e. linear<br>mapping<br>catheters). The<br>Constellation<br>Multiple Electrode<br>Recording and<br>Pacing Catheter<br>System may also be<br>used for delivery of | The intended use of the<br>devices is the same. |

#### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)]

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# 510(k) SUMMARY

| Characteristics | AcQMap 3D Imaging<br>and Mapping Catheter | Constellation<br>Multiple Electrode<br>Recording and<br>Pacing Catheter | Analysis |
|-----------------|-------------------------------------------|-------------------------------------------------------------------------|----------|
| | | externally generated<br>pacing stimuli | |

# COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES [807.92(a)(6)] (cont.)

| Characteristics | AcQMap 3D Imaging<br>and Mapping Catheter | Constellation<br>Multiple Electrode<br>Recording and<br>Pacing Catheter | Analysis |
|-------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|---------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical Characteristics | | | |
| Configuration | Electrode/Transducer<br>mounted on splines | Electrode Array in<br>Basket | The differences in<br>physical construction of<br>the two devices do not<br>raise different questions<br>of safety or effectiveness<br>than the predicate as |
| Basket Diameter | 25 mm | 31, 38, 60 and 75mm | |
| Working Length | 100 cm | 90 cm - 130 cm<br>(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<br>of safety or effectiveness<br>than the predicate as<br>demonstrated by the<br>AcQMap performance<br>testing. |
| Data Points/heart beat | 2500 | Unknown | |
| Power source | Electrical source from<br>AcQMap System | Electrical source<br>from standard EP<br>mapping and<br>recording Systems | |
| Technical Specifications - Ultrasound | | | |
| Mode | M-mode | N/A | The predicate device<br>does not have ultrasound<br>functionality.<br>The reference device<br>does have ultrasound<br>functionality. |
| Number of transducers | 48 | N/A | |
| Phased Array Y/N | N | N/A | |
| Center Frequency | 10 MHz | N/A | |
| Acoustic Output | | | |
| MI (Mechanical<br>Index) | 0.06 | N/A | The predicate device<br>does not have ultrasound<br>functionality.<br>The reference device<br>does have ultrasound<br>functionality. |
| ISTPA.3 (Derated<br>Spatial-Peak<br>Temporal-Average<br>Intensity (milliwatts<br>per square<br>centimeter)) | 0.08 (mW/cm2) | N/A | |
| ISPPA.3 (Derated<br>Spatial-Peak Pulse<br>Average Intensity<br>(watts per square<br>centimeter)) | 1.03 | N/A | |
| Characteristics | AcQMap 3D Imaging<br>and Mapping Catheter | Constellation<br>Multiple Electrode<br>Recording and<br>Pacing Catheter | Analysis |
| Compatible Sheath | For Use with Acutus<br>Medical AcQGuide 12 F<br>Steerable Sheath | 9F | Any differences in<br>accessory sizes do not<br>raise different questions<br>of safety or<br>effectiveness. |
| Compatible Guidewire | 0.032" (0.81 mm) diameter<br>J-tip guidewire | Not to exceed 0.035"<br>diameter J-tip<br>guidewire | |

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#### 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

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### 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.