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, 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
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.

AI/ML Overview

It appears you've provided documentation for a 510(k) premarket notification for a medical device: the AcuQRef Introducer Sheath. This type of submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving a device meets specific "acceptance criteria" through a comprehensive study in the way an AI/ML device would.

The provided text does not contain the information requested in your bullet points regarding AI/ML device performance, ground truth establishment, expert adjudication, or MRMC studies. This is because the AcuQRef Introducer Sheath is a physical medical device (an introducer sheath with electrodes), not an AI/ML diagnostic or prognostic tool.

Therefore, I cannot fulfill your request to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, as the provided document pertains to a different type of medical device submission.

Here's why the provided text doesn't fit your request, and why it's structured differently:

Device Type: The AcuQRef Introducer Sheath is a physical, invasive medical device used for vascular access and sensing electrical signals. It's not a software algorithm that analyzes data to make a diagnostic or prognostic inference.
Regulatory Pathway: The 510(k) pathway is for devices that are "substantially equivalent" to an existing, legally marketed device (a predicate). This means demonstrating it's as safe and effective as the predicate, not necessarily meeting entirely new, performance-based acceptance criteria in the AI/ML sense.
"Acceptance Criteria" in 510(k): For this device, "acceptance criteria" are typically met through:
- Bench Testing: Mechanical, electrical, material, and performance tests (e.g., integrity, leak tests, pull strength, electrical safety, corrosion resistance). The document lists many such tests (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, Design validation testing in an animal model).
- Comparison to Predicate: Demonstrating that its technological characteristics, intended use, and indications for use are "similar" to the predicate, and any differences don't raise new questions of safety or effectiveness.
Lack of AI/ML Specifics: There are no mentions of:
- Sensitivity, specificity, AUC as performance metrics.
- Test sets, training sets in the context of data for an algorithm.
- Experts establishing ground truth for image/data interpretation.
- Adjudication methods for disagreements among experts.
- MRMC studies to evaluate human readers with/without AI assistance.
- Standalone algorithm performance.

In summary: The provided document demonstrates substantial equivalence for a physical medical device through comparison to a predicate and non-clinical bench testing. It does not contain information relevant to AI/ML device acceptance criteria or performance studies.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K171557

Device Name Acutus Medical AcQRef Introducer Sheath

Indications for Use (Describe)

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)

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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: 1-442-232-6080 Fax: 1-442-232-6081

Contact Person:

Brenda Clay Regulatory Affairs Manager Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008 USA Phone: 1-442-232-6161 FAX: 1-442-232-6081 Email: Brenda.Clay@acutus.com

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

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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)]

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)]

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

Feature	Proposed DeviceAcQRef IntroducerSheath(K____)	Predicate DeviceGalt Medical Corp.Catheter IntroducerK043525	Reference DeviceAgilis™ ESSteerableIntroducerK103083	Analysis ofDifferences
Classification	21 CFR § 870.1340	21 CFR § 870.1340	21 CFR § 870.1340	All devices have thesame classificationnumber
Product Code	DYB	DYB	DYB	All devices have thesame product code
Indications forUse	The Acutus MedicalAcQRef IntroducerSheath is indicatedfor use inpercutaneousprocedures tofacilitate venousaccess from the lowerextremities forintroduction ofcatheters and otherdevices, and may beused to senseintravenous signals.	The SheathIntroducer System isindicated for use inpercutaneousprocedures tointroduce cathetersand otherintravascular devicesinto the vasculature.	The Agilis ESSteerable Introduceris indicated whenintroducing variouscardiovascularcatheters into theheart, including theleft side of the heartthrough theinteratrial septum.The Introducer maybe used forrecordingintracardiac signalsand for cardiacstimulation duringelectrophysiologystudies.	Similar indicationfor use languagecompared to thepredicate. Proposedindications for usefall within theintended use for thepredicate device andalso includeslanguage similar tothe reference devicerelated to sensingelectrical signals.The differences inIndications for Usedo not raisedifferent questionsof safety oreffectiveness.
Intended Use	Catheter deliverysystemincluding electrodesfor intravenous signalsensing when usedwith compatiblemapping system.	Catheter DeliverySystem	Mapping/Pacing/Catheter DeliverySystem(The steerableintroducer,constructed of apolymer shaft thatincorporates threeplatinum-iridiumelectrodes, theprimary use ofwhich isvisualization on theEnSite™ System)	Same intended useas the predicatedevice with regardto catheter delivery.Same intended useas the referencedevice with respectsensing electricalsignals for use withanelectrophysiologysystem.
Device InnerDiameter (ID)(French)	7F	4F to 9F	8.5F	Proposed deviceFrench size iswithin the range ofthe predicate device
Device Length	30 cm	5 cm to 110 cm	71cm	Proposed devicelength is within therange of thepredicate device
Feature	Proposed DeviceAcQRef IntroducerSheath(K	Predicate DeviceGalt Medical Corp.Catheter IntroducerK043525	Reference DeviceAgilisTM ESSteerableIntroducerK103083	Analysis ofDifferences
Shaft Material	Pebax 72D SA01,BaSO4 Loaded	unknown polymer	unknown polymer	All devices usebiocompatiblepolymer material.
Deflection(Y/N)	No	No	Yes - Bidirectional(180/90)	Same as thepredicate device
Side Port forFlush	Yes	Yes	Yes	All devices have aside port
Guide wireCompatibility	0.038 in.	0.018, 0.021, 0.035,and 0.038 in. perDilator ID	0.032 in.	Comparable toguidewirecompatibility for thepredicate
Dilator	Yes	Yes	Yes	All devices have adilator
Electrodes	Yes (4x 90/10 Pt-Ir)Sensing Only	No	Yes (3)	Proposed deviceincludes electrodessimilar to thereference device
ElectrodeMaterial	Platinum / iridium	N/A	Platinum / iridium	Same as referencedevice
Connection toRecordingSystem orMappingSystem	Yes	No	Yes	Same as referencedevice
RadiopaqueElements	Yes	Yes	Yes	All devices haveradiopaque elements
Anatomicallocation	Peripheral (Venous)	Peripheral (Vascular)	Peripheral(Vascular)	All devices have thesame anatomical uselocation
PackageContents	Introducer sheath.Guidewire, Dilator	Introducer sheath,Guidewire, Dilator	Introducer sheath,Guidewire, Dilator	All devices havesame maincomponents
SterilizationMethod	EtO	EtO	EtO	All devices havesame sterilizationmethod
SheathHemostasisControl	Yes	Yes	Yes	All devices providefor hemostasiscontrol
BiocompatibleBlood, Bodyand FluidContactingMaterials	Yes	Yes	Yes	All devices employbiocompatiblecomponents forpatient contactingcomponents.

Substantial Equivalence Table – Regulatory Information

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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.

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[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.

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).