AcQGuide Steerable Sheath

K162925 · Acutus Medical, Inc. · DRA · Apr 6, 2017 · Cardiovascular

Device Facts

• Record ID: K162925
• Device Name: AcQGuide Steerable Sheath
• Applicant: Acutus Medical, Inc.
• Product Code: DRA · Cardiovascular
• Decision Date: Apr 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

Device Story

AcQGuide Steerable Sheath is a sterile, single-use device for percutaneous catheter introduction into heart chambers. Device comprises a composite single-lumen shaft, ergonomic handle for torque and active deflection, and hemostasis valve with side flush port. Includes a dilator for vascular access. Operated by physicians in clinical settings to maneuver standard electrophysiology catheters. Deflection mechanism allows precise catheter positioning within cardiac chambers. Hemostasis valve prevents air incursion and minimizes blood loss during procedures. Saline flush port maintains patency. Device facilitates diagnostic and therapeutic electrophysiology interventions.

Clinical Evidence

No clinical data submitted. Evidence consists of nonclinical bench testing, including packaging/shelf-life, sterilization, biocompatibility, dimensional inspection, leak testing, functional/compatibility testing, mechanical testing, handle torque testing, and physician simulated use in an animal model.

Technological Characteristics

Single-lumen shaft constructed of Pebax copolymer, stainless steel, platinum/10% Iridium, and PTFE. Features ergonomic handle for active deflection, hemostasis valve, and radiopaque markers for fluoroscopic visualization. Compatible with 0.035" guidewires and catheters up to 10.5F. Usable length 75cm, total length 92cm. Sterile, single-use.

Indications for Use

Indicated for percutaneous catheter introduction into the vasculature and heart chambers for patients requiring catheter-based procedures.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Medtronic CryoCath LP Flexcath Advance Steerable Sheath and Dilator (K123591)

Submission Summary (Full Text)

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April 6, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Acutus Medical, Inc. Brenda Clay Regulatory Affairs Manager 2210 Faraday Ave Suite 100 Carlsbad, California 92008

Re: K162925

Trade/Device Name: AcQGuide Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: March 3, 2017 Received: March 6, 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Jellman
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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# Indications for Use

510(k) Number (if known) K162925

Device Name AcQGuide Steerable Sheath

Indications for Use (Describe)

The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 510(k) Notification K162925

### 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: April 3, 2017

## DEVICE INFORMATION [807.92(a)(2)]

### Trade Name:

AcQGuide™ Steerable Sheath

### Generic/Common Name:

Steerable Catheter

### Classification:

21 CFR 870.1280

Product Code: DRA

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### PREDICATE DEVICE(S) [807.92(a)(3)]

The predicate device to support substantial equivalence of the AcQGuide Steerable Sheath is the Medtronic CryoCath LP Flexcath Advance® Steerable Sheath and Dilator cleared under K123591.

### DEVICE DESCRIPTION [807.92(a)(4)]

The AcQGuide Steerable Sheath is a sterile, single use device consisting of a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port, to allow safe introduction of a catheter while simultaneously permitting saline to be flushed via the main shaft. The AcQGuide Steerable Sheath is designed for maneuverability of standard electrophysiology catheters that are advanced through the sheath and into the right or left chambers of the sheath is compatible with diagnostic and therapeutic devices. The AcQGuide Steerable Sheath includes a dilator. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart.

#### INDICATIONS FOR USE [807.92(a)(5)]

The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

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

| Feature | Proposed Device<br>AcQGuide ™ Steerable Sheath<br>(K162925) | Predicate Device<br>FlexCath Advance® Steerable<br>Sheath<br>K123591 | Analysis of<br>Differences |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR § 870.1280 | 21 CFR § 870.1280 | Same<br>classification |
| Product Code | DRA | DRA | Same product<br>code |
| Indications<br>for Use | The AcQGuide Steerable Sheath is<br>intended for percutaneous catheter<br>introduction into the vasculature<br>and into the chambers of the heart.<br>The Sheath deflection facilitates<br>catheter positioning. | The FlexCath Steerable Sheath is<br>intended for percutaneous catheter<br>introduction into the vasculature<br>and into the chambers of the heart.<br>The Sheath deflection facilitates<br>catheter positioning. | Same intended use |
| Key<br>Components | Employs single deflection curve<br>with atraumatic tip. Sheath<br>deflection facilitates accurate<br>catheter positioning. Facilitates use<br>with catheters up to 10.5F in<br>diameter. Hemostasis valve to<br>prevent air incursion and minimizes<br>blood loss. Flush port provides<br>ability to administer saline flush | Ergonomic handle with<br>unidirectional deflection.<br>Hemostasis valve allows for<br>introduction, withdrawal, and<br>exchanging of catheters and guide<br>wires, while preventing air ingress<br>and minimizing blood loss.<br>Facilitates use with catheters up to | Similar design<br>features. Minor<br>differences do not<br>raise different<br>questions of safety<br>or effectiveness. |
| Feature | Proposed Device<br>AcQGuide™ Steerable Sheath<br>(K162925) | Predicate Device<br>FlexCath Advance® Steerable<br>Sheath<br>K123591 | Analysis of<br>Differences |
| | throughout procedure. Usable<br>length of up to 75 cm. | 10.5F in diameter. Usable length of<br>up to 65 cm. | |
| Method of<br>Use | Percutaneous catheter introduction<br>into the vasculature and into the<br>chambers of the heart. The sheath<br>deflection facilitates catheter<br>positioning. | Percutaneous catheter introduction<br>into the vasculature and into the<br>chambers of the heart. The sheath<br>deflection facilitates catheter<br>positioning. | Same method of<br>use |
| Sheath Size | Inner diameter: 12.8Fr<br>Outer Diameter: 16Fr<br>Usable length: 75cm<br>Total length: 92cm<br>Radiopaque marker: distal sections<br>are visible when using standard or<br>low level fluoroscopy | Inner diameter: 12Fr<br>Outer Diameter: 15Fr<br>Usable length: 65cm<br>Total length: 81cm<br>Radiopaque marker: 5mm<br>proximal to sheath tip | Products have<br>similar inner and<br>outer diameter and<br>similar lengths.<br>Both devices<br>include<br>radiopaque<br>components for<br>visualization. The<br>minor differences<br>do not raise<br>different questions<br>of safety or<br>effectiveness. |
| Compatibility | Guidewire compatibility: .035" | Guidewire compatibility: .032" to<br>.035" | The guidewire<br>compatibility of<br>AcQGuide falls<br>within the range<br>of the predicate. |
| Deflection<br>and reach | Maximum deflection: 180 degrees<br>(with catheter inserted)<br>Reach: 5.0cm at 90 degrees | Maximum deflection: 135 degrees<br>(with catheter inserted)<br>Reach: 5.5cm at 90 degrees | Both devices<br>allow deflection<br>and have a similar<br>reach. |
| Sheath<br>Material | Shaft: Biocompatible copolymer<br>(Pebax®) with stainless steel,<br>platinum/10% Iridium, PTFE | Shaft: Biocompatible copolymer<br>(Pebax®) with barium sulfate<br>blend | Both devices are<br>constructed of<br>biocompatible<br>materials |
| Dilator | Total length:95.5cm<br>Outer diameter: 4.1mm | Total length: 87cm | The dilators of<br>AcQGuide and the<br>predicate are of<br>similar length |

#### Table 5.1: Substantial Equivalence Table - Regulatory Information

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### 510(k) SUMMARY K162925

#### SUBSTANTIAL EQUIVALENCE

The proposed AcQGuide Steerable Sheath was compared to the predicate device with respect to product labeling, intended use, anatomical sites, patient population, performance testing, technological characteristics and safety characteristics. Based on this comparison, there were only minor differences in the technological characteristics between the devices which do not raise any different questions of safety or effectiveness. Thus, the AcQGuide is substantially equivalent to the predicate device.

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### PERFORMANCE DATA [807.92(B)]

All necessary testing was conducted on the AcQGuide Steerable Sheath to support a determination of substantial equivalence to the predicate device.

### [807.92(b)(1)] Nonclinical Testing Summary:

Extensive performance bench testing was conducted on the AcOGuide Steerable Sheath. This testing was performed in order to ensure that the AcQGuide Steerable Sheath performs as intended. The nonclinical testing included:

- Packaging and Shelf-Life ●
- Sterilization
- Biocompatibility ●
- Design Verification and Validation studies, including: ●
- Dimensional Inspection of Sheath and Dilator o
- Visual Inspection for any defects O
- Leak Testing O
- Functional and Compatibility Testing O
- Mechanical Testing O
- Handle Torque Testing O
- Physician simulated use in an animal model

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQGuide Steerable Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQGuide does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature and into chambers of the heart when compared to the predicate devices.

### [807.92(b)(2)] Clinical Testing Summary:

This section is not applicable. No clinical testing is being submitted to support review of this 510(k) premarket notification.

### CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical testing has been performed on the AcQGuide Steerable Sheath to evaluate the overall performance of the device. The collective results confirm that the AcOGuide Steerable Sheath is safe and effective, meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics for its intended use.

### SUMMARY

The AcQGuide Steerable Sheath is substantially equivalent to the predicate device