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.

AI/ML Overview

This document refers to an AcQRef Introducer Sheath, a medical device for facilitating venous access and sensing intravenous signals. The information provided is a 510(k) premarket notification summary to the FDA, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the sense of a clinical trial or AI performance study.

Therefore, many of the requested categories for AI/clinical studies are not applicable or cannot be extracted from this type of document.

Here's an analysis based on the provided text, focusing on the available information:

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of specific numerical acceptance criteria and reported device performance values for the new AcQRef Introducer Sheath. Instead, it states that "All necessary bench testing was conducted... to support a determination of substantial equivalence...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."

The "Acceptance Criteria" here are implicitly linked to demonstrating substantial equivalence to the predicate device (K171557) across various features, as shown in the "Substantial Equivalence Table." The "Reported Device Performance" is summarized as having "met the pre-determined acceptance criteria" and "passed to support a determination of substantial equivalence," without specifying the exact quantitative results.

Here's a reinterpretation of "acceptance criteria" based on the provided "Substantial Equivalence Table":

Feature	Acceptance Criteria (Implicit from Predicate)	Reported Device Performance (Subject Device)
Classification	21 CFR § 870.1340	Identical
Product Code	DYB	Identical
Indications for Use	As defined for predicate	Identical
Intended Use	As defined for predicate	Identical
Device Inner Diameter (ID)	7F	Identical
Device Length	30 cm	Identical
Shaft Material	Pebax 72D SA01, BaSO4 Loaded	Identical
Deflection	No	Identical
Side Port for Flush	Yes	Identical
Guide wire Compatibility	0.038 in.	Identical
Dilator, Locking Feature	No Locking feature (Predicate)	Yes Locking feature. Analysis of Differences: "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	Polypropylene (Predicate)	HDPE. Analysis of Differences: "All devices use biocompatible polymer material."
Electrodes	4x 90/10 Pt-Ir, Sensing Only (Predicate)	1x 90/10 Pt-Ir, Sensing Only. Analysis of Differences: "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	Identical
Connection to Recording System/Mapping	Yes	Identical
Radiopaque Elements	Yes	Identical
Anatomical location	Peripheral (Vascular) (Predicate)	Peripheral (Venous). Note: The table explicitly states "Peripheral (Venous)" for Subject and "Peripheral (Vascular)" for Predicate, but under "Analysis of Differences" it says "Identical". This might imply 'vascular' here encompasses 'venous' or it's a minor discrepancy in the table's detail vs. conclusion.
Package Contents	Introducer sheath, Guidewire, Dilator	Identical
Sterilization Method	EtO	Identical
Sheath Hemostasis Control	Yes	Identical
Biocompatible Blood, Body/Fluid	Yes	Identical
Shelf Life	24 months	Identical
Connector Cable	2 (1 yellow and 1 blue) (Predicate)	1 (yellow). Analysis of Differences: "The subject device has been simplified. This change does not raise new questions of safety and efficacy."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document details bench testing for a medical device (introducer sheath) aiming for 510(k) clearance via substantial equivalence to a predicate device. It is not an AI or clinical study with a "test set" of patient data.

Sample Size for Test Set: Not applicable in the context of clinical/AI studies. The text mentions "bench testing" and "verification and validation studies," which would involve testing individual device units, but specific sample sizes for these tests are not provided.
Data Provenance: Not applicable. The testing would be laboratory-based and device-specific.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert-established ground truth on patient data. The "truth" or "standard" for the device's performance would be engineering specifications and predicate device characteristics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No adjudication method for a test set of patient data is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic device, nor is it a multi-reader, multi-case study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this type of device submission is adherence to engineering specifications, safety standards, and functional equivalence to the legally marketed predicate device. This is typically established through bench testing (e.g., mechanical strength, material compatibility, electrical performance for the sensing function, sterility, etc.) rather than clinical endpoints or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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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

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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

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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

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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 .

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

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Substantial Equivalence Table
Feature	Subject DeviceAcQRef IntroducerSheathTBD	Predicate DeviceAcQRef IntroducerSheath(K171557)	Analysis ofDifferences
Classification	21 CFR § 870.1340	21 CFR § 870.1340	Identical
Product Code	DYB	DYB	Identical
Indications forUse	The Acutus MedicalAcQRef Introducer Sheathis indicated for use inpercutaneous proceduresto facilitate venous accessfrom the lower extremities,for introduction of cathetersand other devices, andmay be used to senseintravenous signals.	The Acutus MedicalAcQRef Introducer Sheathis indicated for use inpercutaneous proceduresto facilitate venous accessfrom the lower extremities,for introduction of cathetersand other devices, andmay be used to senseintravenous signals.	Identical
Intended Use	Catheter delivery systemincluding electrodes forintravenous signal sensingwhen used with compatiblemapping system.	Catheter delivery systemincluding electrodes forintravenous signal sensingwhen used with compatiblemapping system.	Identical
Device InnerDiameter (ID)(French)	7F	7F	Identical
Device Length	30 cm	30 cm	Identical
Shaft Material	Pebax 72D SA01, BaSO4Loaded	Pebax 72D SA01, BaSO4Loaded	Identical
Deflection (Y/N)	No	No	Identical
Side Port forFlush	Yes	Yes	Identical
Guide wireCompatibility	0.038 in.	0.038 in.	Identical
Substantial Equivalence Table (continued)
Feature	Subject DeviceAcQRef IntroducerSheathTBD	Predicate DeviceAcQRef IntroducerSheath(K171557)	Analysis ofDifferences
Dilator, LockingFeature	YesLocking feature	NoLocking feature	The subject device hasa lock-in feature. Thischange does not raisenew questions of safetyand efficacy.The Dilator functions thesame and has the samepurpose as the cleareddilator.
Dilator Material	HDPE	Polypropylene	All devices usebiocompatible polymermaterial.
Electrodes	Yes (1x 90/10 Pt-Ir)Sensing Only	Yes (4x 90/10 Pt-Ir)Sensing Only	The subject device issimplified It has only 1of the original 4electrodes. Thischange does not raiseany new questions ofsafety or efficacy.
ElectrodeMaterial	Platinum / iridium	Platinum / iridium	Identical
Connection toRecordingSystem orMapping System	Yes	Yes	Identical
RadiopaqueElements	Yes	Yes	Identical
Anatomicallocation	Peripheral (Venous)	Peripheral (Vascular)	Identical
PackageContents	Introducer sheath,Guidewire, Dilator	Introducer sheath,Guidewire, Dilator	Identical
SterilizationMethod	EtO	EtO	Identical
SheathHemostasisControl	Yes	Yes	Identical
BiocompatibleBlood, Body andFluid ContactingMaterials	Yes	Yes	Identical
Shelf Life	24 months	24 months	Identical
Substantial Equivalence Table (continued)
Feature	Subject DeviceAcQRef IntroducerSheathTBD	Predicate DeviceAcQRef IntroducerSheath(K171557)	Analysis ofDifferences
Connector Cable	1 (yellow)	2 (1 yellow and 1 blue)	The subject device hasbeen simplified. Thischange does not raisenew questions of safetyand efficacy.

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

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5 I 0(K) Summary

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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)]

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.

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.

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).