AcQRef Introducer Sheath

K171557 · Acutus Medical, Inc. · DYB · Feb 6, 2018 · Cardiovascular

Device Facts

• Record ID: K171557
• Device Name: AcQRef Introducer Sheath
• Applicant: Acutus Medical, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 6, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.

Device Story

AcQRef Introducer Sheath is a sterile, single-use venous access device; consists of straight shaft with lumen, hemostasis valve, flush port, electrodes, and extension cable. Used in percutaneous procedures to facilitate venous access from lower extremities; allows introduction of catheters/devices. Electrodes enable sensing of intravenous signals when connected to compatible mapping systems (e.g., AcQMap). Operated by clinicians in clinical settings. Provides venous conduit and electrical reference; output used by healthcare providers for electrophysiology studies/mapping. Benefits include combined vascular access and signal sensing capability in one device.

Clinical Evidence

No clinical testing submitted. Evidence based on extensive nonclinical bench testing, including packaging, shelf-life, sterilization, biocompatibility, surface/dimensional/electrical integrity, valve air leak, simulated use, pressure leak, flexion/fatigue, electrical safety, corrosion resistance, pull strength, and design validation in an animal model.

Technological Characteristics

7Fr introducer sheath with 4x 90/10 platinum-iridium electrodes for sensing. Shaft material: Pebax 72D SA01, BaSO4 loaded. Includes vessel dilator and 0.038 in. J-tip guidewire. Features hemostasis valve and flush port. Sterilization: EtO. Connectivity: Attached extension cable for electrode signal transmission to external mapping/recording systems.

Indications for Use

Indicated for percutaneous venous access from lower extremities for introduction of catheters and other devices; may be used to sense intravenous signals.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Hemostasis Valve Catheter Introducer Set (K043525)

Reference Devices

• Agilis ES Steerable Introducer (K103083)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. 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 is in blue and consists of the letters "FDA" and the words "U.S. Food & Drug Administration".

February 6, 2018

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

Re: K171557

Trade/Device Name: AcORef Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: January 9, 2018 Received: January 10, 2018

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}------------------------------------------------

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn

(http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M. A. Hillebrenner

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) K171557

Device Name Acutus Medical AcQRef Introducer Sheath

#### Indications for Use (Describe)

The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.

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)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Notification K_K171557

# 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: May 26, 2017

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

## Trade Name:

AcQRef Introducer Sheath

### Generic/Common Name:

Catheter introducer

### Classification:

21 CFR 870.1340

## Product Code:

DYB

{4}------------------------------------------------

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

The predicate device to support substantial equivalence of the AcQRef Introducer Sheath is the Galt Medical Corp. Catheter Introducer, marketed as the Hemostasis Valve Catheter Introducer Set, cleared under K043525. This 510(k) is also citing the St. Jude Agilis ES Steerable Introducer cleared under K103083 as a secondary predicate (reference device).

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

The Acutus Medical AcQRef Introducer Sheath is a sterile, single use, venous access device that consists of a straight shaft with lumen, hemostasis valve, flush port, electrodes, and attached extension cable for electrode connectivity. The AcQRef Introducer Sheath consists of the following components:

- One (1) 7Fr Introducer Sheath with electrodes and connection cable ●
- One (1) 7Fr Vessel Dilator ●
- o One (1) Guide wire - 0.038 in, J-tip

The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System.

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

The Acutus Medical AcQRef Introducer Sheath is indicated for use in percutaneous procedures to facilitate venous access from the lower extremities for introduction of catheters and other devices, and may be used to sense intravenous signals.

{5}------------------------------------------------

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

| Feature | Proposed Device<br>AcQRef Introducer<br>Sheath<br>(K____) | Predicate Device<br>Galt Medical Corp.<br>Catheter Introducer<br>K043525 | Reference Device<br>Agilis™ ES<br>Steerable<br>Introducer<br>K103083 | Analysis of<br>Differences |
|----------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | 21 CFR § 870.1340 | 21 CFR § 870.1340 | 21 CFR § 870.1340 | All devices have the<br>same classification<br>number |
| Product Code | DYB | DYB | DYB | All devices have the<br>same product code |
| Indications for<br>Use | The Acutus Medical<br>AcQRef Introducer<br>Sheath is indicated<br>for use in<br>percutaneous<br>procedures to<br>facilitate venous<br>access from the lower<br>extremities for<br>introduction of<br>catheters and other<br>devices, and may be<br>used to sense<br>intravenous signals. | The Sheath<br>Introducer System is<br>indicated for use in<br>percutaneous<br>procedures to<br>introduce catheters<br>and other<br>intravascular devices<br>into the vasculature. | The Agilis ES<br>Steerable Introducer<br>is indicated when<br>introducing various<br>cardiovascular<br>catheters into the<br>heart, including the<br>left side of the heart<br>through the<br>interatrial septum.<br>The Introducer may<br>be used for<br>recording<br>intracardiac signals<br>and for cardiac<br>stimulation during<br>electrophysiology<br>studies. | Similar indication<br>for use language<br>compared to the<br>predicate. Proposed<br>indications for use<br>fall within the<br>intended use for the<br>predicate device and<br>also includes<br>language similar to<br>the reference device<br>related to sensing<br>electrical signals.<br>The differences in<br>Indications for Use<br>do not raise<br>different questions<br>of safety or<br>effectiveness. |
| Intended Use | Catheter delivery<br>system<br>including electrodes<br>for intravenous signal<br>sensing when used<br>with compatible<br>mapping system. | Catheter Delivery<br>System | Mapping/Pacing/<br>Catheter Delivery<br>System<br>(The steerable<br>introducer,<br>constructed of a<br>polymer shaft that<br>incorporates three<br>platinum-iridium<br>electrodes, the<br>primary use of<br>which is<br>visualization on the<br>EnSite™ System) | Same intended use<br>as the predicate<br>device with regard<br>to catheter delivery.<br>Same intended use<br>as the reference<br>device with respect<br>sensing electrical<br>signals for use with<br>an<br>electrophysiology<br>system. |
| Device Inner<br>Diameter (ID)<br>(French) | 7F | 4F to 9F | 8.5F | Proposed device<br>French size is<br>within the range of<br>the predicate device |
| Device Length | 30 cm | 5 cm to 110 cm | 71cm | Proposed device<br>length is within the<br>range of the<br>predicate device |
| Feature | Proposed Device<br>AcQRef Introducer<br>Sheath<br>(K | Predicate Device<br>Galt Medical Corp.<br>Catheter Introducer<br>K043525 | Reference Device<br>AgilisTM ES<br>Steerable<br>Introducer<br>K103083 | Analysis of<br>Differences |
| Shaft Material | Pebax 72D SA01,<br>BaSO4 Loaded | unknown polymer | unknown polymer | All devices use<br>biocompatible<br>polymer material. |
| Deflection<br>(Y/N) | No | No | Yes - Bidirectional<br>(180/90) | Same as the<br>predicate device |
| Side Port for<br>Flush | Yes | Yes | Yes | All devices have a<br>side port |
| Guide wire<br>Compatibility | 0.038 in. | 0.018, 0.021, 0.035,<br>and 0.038 in. per<br>Dilator ID | 0.032 in. | Comparable to<br>guidewire<br>compatibility for the<br>predicate |
| Dilator | Yes | Yes | Yes | All devices have a<br>dilator |
| Electrodes | Yes (4x 90/10 Pt-Ir)<br>Sensing Only | No | Yes (3) | Proposed device<br>includes electrodes<br>similar to the<br>reference device |
| Electrode<br>Material | Platinum / iridium | N/A | Platinum / iridium | Same as reference<br>device |
| Connection to<br>Recording<br>System or<br>Mapping<br>System | Yes | No | Yes | Same as reference<br>device |
| Radiopaque<br>Elements | Yes | Yes | Yes | All devices have<br>radiopaque elements |
| Anatomical<br>location | Peripheral (Venous) | Peripheral (Vascular) | Peripheral<br>(Vascular) | All devices have the<br>same anatomical use<br>location |
| Package<br>Contents | Introducer sheath.<br>Guidewire, Dilator | Introducer sheath,<br>Guidewire, Dilator | Introducer sheath,<br>Guidewire, Dilator | All devices have<br>same main<br>components |
| Sterilization<br>Method | EtO | EtO | EtO | All devices have<br>same sterilization<br>method |
| Sheath<br>Hemostasis<br>Control | Yes | Yes | Yes | All devices provide<br>for hemostasis<br>control |
| Biocompatible<br>Blood, Body<br>and Fluid<br>Contacting<br>Materials | Yes | Yes | Yes | All devices employ<br>biocompatible<br>components for<br>patient contacting<br>components. |

# Substantial Equivalence Table – Regulatory Information

{6}------------------------------------------------

{7}------------------------------------------------

### SUBSTANTIAL EQUIVALENCE

The proposed AcQRef Introducer 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. In addition, AcQRef was compared to a reference device as both devices provide a venous conduit and electrical reference within one product. Thus, AcQRef is substantially equivalent to the predicate device with regard to vascular access and is comparable to the reference device with respect to the sensing of electrical signals.

## PERFORMANCE DATA [807.92(B)]

All necessary testing was conducted on the AcQRef Introducer 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 AcQRef Introducer Sheath. This testing was performed to ensure that the AcQRef Introducer Sheath performs as intended. The nonclinical testing included:

- Packaging and Shelf-Life
- Sterilization
- Biocompatibility
- Surface, Dimensional, and Electrical Integrity ●
- Valve Air Leak Test
- Simulated Use Test
- Pressure Leak Test ●
- Flexion and Fatigue ●
- Electrical Safety
- Corrosion Resistance
- Pull Strength
- o Design validation testing in an animal model

The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQRef Introducer Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQRef device does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature.

{8}------------------------------------------------

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

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 AcQRef Introducer Sheath to evaluate the overall performance of the device. The collective results confirm that the AcQRef Introducer Sheath is safe meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics to perform per its intended use.

### SUMMARY

The AcQRef Introducer Sheath is substantially equivalent to the predicate device.