K Number

Device Name

AcQRef Introducer Sheath

Manufacturer

Acutus Medical, Inc.

Date Cleared

2019-09-03

(29 days)

Product Code

DYB

Regulation Number

870.1340

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 Description

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, electrode, and attached extension cable for electrode connectivity. The AcQRef Introducer Sheath consists of the following components: - One (1) 7Fr Introducer Sheath with electrode and connection cable - One (1) 7Fr Vessel Dilator - One (1) Guidewire .038 in, J-tip. The electrode is connected to the yellow cable and connector. The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System Models 900000, cleared under 510(k) K181577 and 900100, cleared under 510(k) K190131.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K171557

Reference Devices

K181577, K190131

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a physical introducer sheath with an electrode for sensing signals, and there is no mention of AI or ML in the device description, intended use, or performance studies. The device is compatible with imaging systems, but the sheath itself does not appear to incorporate AI/ML for processing or analysis.

Therapeutic

No
The device is used to facilitate access for other devices and may sense intravenous signals, but it does not directly treat a disease or condition. Its primary function is to enable diagnostic or interventional procedures, not to provide therapy itself.

Diagnostic

No.

The device is an introducer sheath for facilitating venous access and introducing other devices, and it "may be used to sense intravenous signals," but its primary indicated use does not involve diagnosing a condition, disease, or injury. It is a tool for accessing the anatomy and facilitating other procedures.

SaMD (Software as a Medical Device)

The device description clearly outlines physical components such as a sheath, dilator, guidewire, electrode, and cables, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the Acutus Medical AcQRef Introducer Sheath is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the living body.
Device Description and Intended Use: The description clearly states that the AcQRef Introducer Sheath is a device used in percutaneous procedures to facilitate venous access and introduce catheters and other devices into the body. It also mentions sensing intravenous signals, which are signals from within the vein.
Lack of Sample Analysis: There is no mention of the device being used to analyze samples taken from the body. Its function is to provide access and potentially sense signals within the body.

Therefore, the Acutus Medical AcQRef Introducer Sheath is an invasive medical device used for accessing the venous system, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DYB

Device Description

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, electrode, and attached extension cable for electrode connectivity. The AcQRef Introducer Sheath consists of the following components: - One (1) 7Fr Introducer Sheath with electrode and connection cable ● - One (1) 7Fr Vessel Dilator . - One (1) Guidewire .038 in, J-tip . The electrode is connected to the yellow cable and connector. The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System Models 900000, cleared under 510(k) K181577 and 900100, cleared under 510(k) K190131.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Peripheral (Venous)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Prescription Use

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

All necessary bench testing was conducted on the modified AcQRef Introducer Sheath to support a determination of substantial equivalence to the predicate device. Verification and validation studies demonstrated that the modified device met the pre-determined acceptance criteria. The results passed to support a determination of substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

AcQRef Introducer Sheath (K171557)

Reference Device(s)

K181577, K190131

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 3, 2019

Acutus Medical, Inc. Serena Sanginthirath Senior Regulatory Affairs Specialist 2210 Faraday Ave., Suite 100 Carlsbad, California 92008

Re: K192106

Trade/Device Name: AcQRef Introducer Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: August 1, 2019 Received: August 5, 2019

Dear Serena Sanginthirath:

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 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 531-542 of the Act); 21 CFR 1000-1050.

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 mediation-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,

Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K192106

Device Name AcQRef® Introducer Sheath

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Residential Use (Part 21 CFR 601 Subpart D)
☐ Study That Supports Use of a Combination Product

Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Notification K192106

General Information [807.92(a)(1)]

Date Prepared: August 2, 2019

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:

Serena Sanginthirath Senior Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6178 FAX: 1-442-232-6081 Email: Serena.Sanginthirath@acutus.com

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

AcQRef® Introducer Sheath

Generic/Common Name:

Catheter Introducer

Classification:

Class II, 21 CFR §870.1340

Product Code:

DYB

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

AcQRef Introducer Sheath (K171557), manufactured by Acutus Medical, Inc.

DEVICE DESCRIPTION [807.92(a)(4)]

The AcQRef Introducer Sheath consists of the following components:

One (1) 7Fr Introducer Sheath with electrode and connection cable ●
One (1) 7Fr Vessel Dilator .
One (1) Guidewire .038 in, J-tip .

The electrode is connected to the yellow cable and connector. The AcQRef Introducer Sheath is compatible for use with the AcQMap® High Resolution Imaging and Mapping System Models 900000, cleared under 510(k) K181577 and 900100, cleared under 510(k) K190131.

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

Substantial Equivalence Table
Feature	Subject Device
AcQRef Introducer
Sheath
TBD	Predicate Device
AcQRef Introducer
Sheath
(K171557)	Analysis of
Differences
Classification	21 CFR § 870.1340	21 CFR § 870.1340	Identical
Product Code	DYB	DYB	Identical
Indications for
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.	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.	Identical
Intended Use	Catheter delivery system
including electrodes for
intravenous signal sensing
when used with compatible
mapping system.	Catheter delivery system
including electrodes for
intravenous signal sensing
when used with compatible
mapping system.	Identical
Device Inner
Diameter (ID)
(French)	7F	7F	Identical
Device Length	30 cm	30 cm	Identical
Shaft Material	Pebax 72D SA01, BaSO4
Loaded	Pebax 72D SA01, BaSO4
Loaded	Identical
Deflection (Y/N)	No	No	Identical
Side Port for
Flush	Yes	Yes	Identical
Guide wire
Compatibility	0.038 in.	0.038 in.	Identical
Substantial Equivalence Table (continued)
Feature	Subject Device
AcQRef Introducer
Sheath
TBD	Predicate Device
AcQRef Introducer
Sheath
(K171557)	Analysis of
Differences
Dilator, Locking
Feature	Yes
Locking feature	No
Locking feature	The subject device has
a lock-in feature. This
change does not raise
new questions of safety
and efficacy.
The Dilator functions the
same and has the same
purpose as the cleared
dilator.
Dilator Material	HDPE	Polypropylene	All devices use
biocompatible polymer
material.
Electrodes	Yes (1x 90/10 Pt-Ir)
Sensing Only	Yes (4x 90/10 Pt-Ir)
Sensing Only	The subject device is
simplified It has only 1
of the original 4
electrodes. This
change does not raise
any new questions of
safety or efficacy.
Electrode
Material	Platinum / iridium	Platinum / iridium	Identical
Connection to
Recording
System or
Mapping System	Yes	Yes	Identical
Radiopaque
Elements	Yes	Yes	Identical
Anatomical
location	Peripheral (Venous)	Peripheral (Vascular)	Identical
Package
Contents	Introducer sheath,
Guidewire, Dilator	Introducer sheath,
Guidewire, Dilator	Identical
Sterilization
Method	EtO	EtO	Identical
Sheath
Hemostasis
Control	Yes	Yes	Identical
Biocompatible
Blood, Body and
Fluid Contacting
Materials	Yes	Yes	Identical
Shelf Life	24 months	24 months	Identical
Substantial Equivalence Table (continued)
Feature	Subject Device
AcQRef Introducer
Sheath
TBD	Predicate Device
AcQRef Introducer
Sheath
(K171557)	Analysis of
Differences
Connector Cable	1 (yellow)	2 (1 yellow and 1 blue)	The subject device has
been simplified. This
change does not raise
new questions of safety
and efficacy.

Comparison of Technological Characteristics with the Predicate Devices [807.92(A)(6)]

5 I 0(K) Summary

510(K) Summary

SUBSTANTIAL EQUIVALENCE

The indication for use of the subject device is substantially equivalent to the predicate. Any differences in the technological characteristics between the devices do not raise any different questions of safety or effectiveness. The assessment of non-clinical performance data demonstrates that the modified AcQRef® Introducer Sheath does not change the fundamental scientific technology of the device.

PERFORMANCE DATA [807.92(B)]

CONCLUSION [807.92(B)(3)]

The AcQRef® Introducer Sheath is substantially equivalent in its intended use, technological characteristics and performance to the previously cleared AcQReet® Introducer Sheath (K171557). The subject device has the same fundamental technological characteristics, principles of operation, specifications and is biocompatible to perform per its intended use.