The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

Device Description

The AcQGuide® VUE Steerable Sheath, Model 900201 is a single use, percutaneous catheter introducer designed to provide additional maneuverability to interventional catheters that are advanced through the sheath and into the right or left chambers of the heart. The distal portion of the sheath is comprised of a composite structured single lumen shaft. At the proximal end, an ergonomic handle provides torque and active deflection, a hemostasis valve allows safe introduction of an interventional catheter, and a side port provides access for aspiration, fluid flushes and fluid/medication infusions. There is a cable exiting from the handle of the sheath to provide connection for the distal electrodes. This cable terminates with four standard 2mm pins that are connected to the Auxiliary Interface Box or Auxiliary Catheter Cable of the AcQMap High Resolution Imaging and Mapping System, Model 900100 or 900000. The pin connections are assigned by the user for electrode identification (D1, 2, 3, 4) to the corresponding channel on the AcQMap System 900100. No designated order of pin connection is required. The AcQGuide® VUE Steerable Sheath includes a valve bypass tool as an optional accessory to facilitate the insertion of a loop or circular catheter.

The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart. The dilator has a smooth tapered tip and provides a smooth transition to the round edge of the non-traumatic tip of the sheath. The dilator is able to track over a 0.035″ guidewire. The hub section is attached to the shaft. It is a standard female luer made of high-density polyethylene (HDPE) material.

Some of the key design attributes of the Steerable Sheath include:

Deflectability
Hemostasis
Kink-resistance
Visibility under fluoroscopy
Easily flushed during the procedure
Single-handed operation
Biocompatible materials
Sterile, single use
Combined three-way stopcock

AI/ML Overview

The AcQGuide® VUE Steerable Sheath is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. Its deflection facilitates catheter positioning, and its electrodes aid in visualization with a compatible localization system like the AcQMap System.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

Based on the provided information, the acceptance criteria are largely implied by successful completion of various nonclinical tests, demonstrating the device's conformance to specifications and comparable safety and effectiveness to the predicate device.

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance
Packaging & Shelf-Life	Maintains sterility and product integrity over shelf-life.	Passed. Shelf life is 24 months, differing slightly but not raising new safety/effectiveness concerns compared to predicate's 18 months.
Sterilization	Achieves a sterility assurance level (SAL) of 10^-6 via Ethylene Oxide (EtO).	Passed. Subjected to the identical EtO sterilization process as the predicate, meeting SAL of 10^-6. Confirmed suitable for existing EtO processing cycle. Non-pyrogenic.
Biocompatibility	Biocompatible for external communicating device, with circulating blood contact for ≤24 hours.	Passed. Conducted in accordance with ISO 10993-1:2018 and FDA Guidance. Categorized as external communicating device, circulating blood contact ≤24 hours. Materials similar to predicate.
Dimensional Specifications	All device components meet required dimensions.	Passed. Ensured through dimensional testing.
Visual Inspection	All components free of defects.	Passed. Ensured through visual inspection.
Leak Testing	Packaging meets specifications.	Passed. Ensured through leak testing.
Functional & Compatibility	Meets functional and compatibility requirements.	Passed. Ensured through functional and compatibility testing.
Mechanical Testing	Components withstand expected forces.	Passed. Ensured through mechanical testing.
Handle Torque Testing	Withstands expected torques.	Passed. Ensured through handle torque testing.
Physician Simulated Use	Consistent performance during intended use.	Physician simulated use in an animal model was conducted.
Electrical Safety	Complies with IEC 60601-1 for basic safety and essential performance.	Passed. Assessed for Defibrillation Proof Applied Parts, Dielectric Voltage Withstand, and Sheath Leakage Current.
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 for electromagnetic disturbances.	Passed. Qualification testing of the AcQMap System with applied parts containing cables and Platinum-Iridium Electrodes, and with general-purpose electrophysiology catheters.

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

The document primarily describes nonclinical (bench) testing. For these tests, specific sample sizes are not explicitly provided in the summary. The studies are prospective in nature, as they involve testing newly manufactured devices to verify their performance against established specifications. The data provenance is Acutus Medical, Inc., Carlsbad, CA, U.S.A., implying the testing was conducted or overseen by the company.

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)

The document does not mention the use of experts to establish a "ground truth" for the nonclinical test sets in the way it would for a clinical study with image interpretation or disease diagnosis. The "truth" for these bench tests is derived from engineering specifications, industry standards (e.g., ISO, IEC), and established medical device testing protocols. The "physician simulated use in an animal model" likely involved qualified medical professionals, but their specific number, qualifications, and their role in establishing a "ground truth" (beyond observing performance) are not detailed.

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

No adjudication method is mentioned. For the nonclinical bench tests described, the outcomes are objective and based on meeting predefined specifications, rather than subjective interpretations requiring adjudication.

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

No MRMC study was conducted or mentioned. The device described is a steerable sheath with electrodes for visualization, not an AI-powered diagnostic tool for human readers.

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

This refers to a medical device's performance without direct human intervention, especially applicable to AI algorithms. The AcQGuide® VUE Steerable Sheath is a physical medical device that inherently requires human-in-the-loop operation by a physician. Therefore, a "standalone algorithm only" performance study is not applicable to this device. Its performance is evaluated in relation to its mechanical, electrical, and material properties, and its interaction with a compatible localization system.

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

For the nonclinical testing described, the "ground truth" is defined by:

Engineering Specifications: For dimensional, mechanical, and functional tests.
International Standards: Such as ISO 10993-1 for biocompatibility, ISO 11135 and AAMI TIR28 for sterilization, and IEC 60601-1/1-2 for electrical safety and EMC.
Predefined Performance Metrics: For tests like leak testing, torque, and compatibility.
Physiological Response: In the animal model for physician simulated use.

8. The sample size for the training set

This question is not applicable. The AcQGuide® VUE Steerable Sheath is a physical medical device, not a software algorithm that requires a training set in the context of machine learning or artificial intelligence.

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

This question is not applicable, as there is no "training set" for this physical device.

Summary

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

May 5, 2022

Acutus Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K221044

Trade/Device Name: AcQGuide® VUE Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable catheter Regulatory Class: Class II Product Code: DRA Dated: April 7, 2022 Received: April 8, 2022

Dear Prithul Bom:

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.

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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 medical devices and radiation-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.

Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221044

Device Name AcQGuide® VUE Steerable Sheath

Indications for Use (Describe)

The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a sans-serif font, with the letters in gray. Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font, with the letters in orange. The logo is simple and modern, and the use of gray and orange gives it a professional look.

510(k) SUMMARY

510(k) Number: K221044

Date Prepared: May 4, 2022

SUBMITTER INFORMATION [807.92(a)(1)]

Manufacturer: Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008, U.S.A Phone: +1-442-232-6080 Fax: +1-442-232-6081

Contact Person:

Sarah Clay Regulatory Affairs Specialist Acutus Medical, Inc. 2210 Faraday Ave., Suite 100 Carlsbad, CA 92008, U.S.A Fax: +1-442-232-6081 E-mail: Sarah.Clay@acutus.com

DEVICE INFORMATION [807.92(a)(2)]

Trade Name	AcQGuide® VUE Steerable Sheath
Common Name	Steerable Sheath
Classification Name	Catheter, Steerable
Regulation	21 CFR § 870.1280
Product Code	DRA
Regulatory Classification:	Class II
Device Panel:	Cardiovascular

PREDICATE DEVICE [807.92(a)(3)]

The predicate device to support substantial equivalence of the AcQGuide® VUE Steerable Sheath, Model 900201 is the Acutus Medical, Inc. AcQGuide® MAX Steerable Sheath, Model 900200, cleared under 510(k) K211100. This 510(k) is also citing the CARTO VIZIGO Bi-Directional Guiding Sheath cleared under K170997 as a reference device to support substantial equivalence for device containing electrodes.

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Image /page/4/Picture/0 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is in large, gray, sans-serif font, with a small orange dot above the left side of the "A". Below "ACUTUS", the word "MEDICAL" is written in a smaller, orange, sans-serif font. The logo is simple and modern.

Predicate Device	Manufacturer	FDA 510(k)	Product Code
AcQGuide® MAX Steerable Sheath	Acutus Medical, Inc.	K211100	DRA

Reference Device	Manufacturer	FDA 510(k)	Product Code
CARTO VIZIGO Bi-DirectionalGuiding Sheath	Biosense Webster	K170997	DYB

DEVICE DESCRIPTION [807.92(a)(4)]

Some of the key design attributes of the Steerable Sheath include:

Deflectability
Hemostasis
Kink-resistance
Visibility under fluoroscopy
Easily flushed during the procedure
Single-handed operation
Biocompatible materials
Sterile, single use
Combined three-way stopcock

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Image /page/5/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of two lines of text. The top line says "ACUTUS" in a sans-serif font, with a small orange dot above the left side of the "A". The bottom line says "MEDICAL" in a smaller, orange sans-serif font. The logo is simple and modern.

The AcQGuide® VUE Steerable Sheath contents include the following:

One (1) Acutus Medical AcQGuide® VUE Steerable Sheath
One (1) Acutus Medical AcQGuide® Dilator
One (1) Acutus Medical Valve Bypass Tool
Product Information/Documentation (Instructions for Use)

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

The AcQGuide® VUE Steerable Sheath with electrodes is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart.

The AcQGuide® VUE deflection facilitates catheter positioning.

The electrodes help facilitate visualization of the sheath when used with a compatible localization system, such as the AcQMap System.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject device AcQGuide® VUE Steerable Sheath, Model 900201 has the same intended use and fundamental scientific technology as the predicate device. The predicate device, AcQGuide MAX Steerable Sheath, Model 900200(K211100), and the AcQGuide® VUE Steerable Sheath are identical in most technological characteristics, except for the addition of electrodes and related components used for sheath localization when used with a compatible mapping system. In addition, the AcQGuide® VUE when compared to the reference device provides electrical reference for visualization on the AcQMap System. The purpose of this submission is to introduce the AcQGuide® VUE Steerable Sheath. Table 1 below provides a comparison of the predicate AcQGuide® MAX Steerable Sheath and the reference device CARTO VIZIGO Bi-Directional Guiding Sheath, with regards to classification, comparison of the indications for use, and a comparison of the technological characteristics against the subject device.

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Image /page/6/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a sans-serif font, with the letters in gray. Below the word "ACUTUS" is the word "MEDICAL" in a smaller, orange sans-serif font. The dot above the letter "i" in Acutus is also orange.

TABLE 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Table 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Characteristics	Subject DeviceAcQGuide® VUESteerable Sheath(K221044)	Predicate DeviceAcQGuide MAXSteerable SheathK211100	Reference DeviceCARTO VIZIGO Bi-Directional GuidingSheath K170997	Analysis ofDifferences
Classification	21 CFR § 870.1280	21 CFR § 870.1280	21 CFR § 870.1340	The subject device andpredicate device have thesame classification number.The different classificationnumber for the referencedevice does not raise a newor different question ofsafety and effectiveness.
Product Code	DRA	DRA	DYB	The subject device andpredicate device have thesame product code. Thedifferent product code forthe reference device doesnot raise a new or differentquestion of safety andeffectiveness.
Indicationsfor Use	The AcQGuide® VUESteerable Sheath withelectrodes is intended forpercutaneous catheterintroduction into thevasculature and into thechambers of the heart.The AcQGuide® VUEdeflection facilitatescatheter positioning. Theelectrodes help facilitatevisualization of the sheathwhen used with acompatible localizationsystem, such as theAcQMap System.	The AcQGuide MAX isintended forpercutaneouscatheter introductioninto the vasculatureand into thechambers of theheart. The AcQGuideMAX deflectionfacilitates catheterpositioning.	The Biosense WebsterCARTO VIZIGO™ 8.5FBi-Directional GuidingSheath is indicated forintroducing variouscardiovascularcatheters into theheart, including the leftside of the heartthrough the interatrialseptum. The sheathcurve can be visualizedwhen used withcompatible CARTO 3 EPNavigation Systems.	Similar indication for uselanguage compared tothe predicate. Proposedindications for use fallwithin the intended usefor the predicate device.Similar indication for usecompared to thereference device, relatedto utilizing electrodes tohelp visualization of thesheath. The differences inIndications for Use do notraise different questionsof safety oreffectiveness.
Table 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Characteristics	Subject DeviceAcQGuide® VUESteerable Sheath(K221044)	Predicate DeviceAcQGuide MAXSteerable SheathK211100	Reference DeviceCARTO VIZIGO Bi-Directional GuidingSheath K170997	Analysis ofDifferences
Intended Use	Catheter DeliverySystem with sheathvisualization when usedwith compatiblemapping system	Catheter DeliverySystem	Catheter DeliverySystem with shaftvisualization when usedwith a compatibleCARTO 3EP navigationsystem.	Same intended use as thepredicate device withregard to catheterdelivery. Similar intendeduse as the referencedevice with respect touse of electrodes withcatheter delivery systemto assist with visualizationwhen used withcompatible mappingsystem. The differencesin Intended Use do notraise different questionsof safety oreffectiveness.
Key Components	Employs singledeflection curve withatraumatic tip. Sheathdeflection facilitatesaccurate catheterpositioning. Able tofacilitate use withcatheters up to 12 Fr indiameter. Hemostasisvalve to prevent airincursion and minimizesblood loss. Flush portprovides ability toadminister saline flushthroughout procedure.Usable length of up to 70cm. Visibility of distalelectrode underfluoroscopy. Electrodesthat aide in visualizationof sheath when usedwith the AcQMapSystem.	Employs singledeflection curve withatraumatic tip. Sheathdeflection facilitatesaccurate catheterpositioning. Facilitatesuse with catheters upto 12 Fr in diameter.Hemostasis valve toprevent air incursionand minimizes bloodloss. Flush portprovides ability toadminister saline flushthroughoutprocedure.Usable length of up to70 cm.	Bi-directional steerablesheath fitted with ahemostasis valve tominimize blood loss.Radiopaque tip markerto allow fluoroscopicvisualization. 4electrodes spacedalong shaft to enableshaft visualization.	Identical key componentsas the predicate device withregards to usable length,French size compatibility,sheath deflection,hemostasis valve, and sideflush port.Identical key componentsas the reference devicewith regards to sheathvisibility of distalelectrode underfluoroscopy, andelectrodes that aide invisualization of sheathwhen used with acompatible mappingsystem.
Deflectionand Reach	Maximum deflection:180 degreesReach: 5.0 cm at 90degrees	Maximum deflection:180 degreesReach: 5.0 cm at 90degrees	Maximum deflection:180 degrees clockwiseand counter clockwiseReach: Not available	Identical deflectionmechanism and reach asthe predicate device.
Characteristics	Subject DeviceAcQGuide® VUESteerable Sheath(K221044)	Predicate DeviceAcQGuide MAXSteerable SheathK211100	Reference DeviceCARTO VIZIGO Bi-Directional GuidingSheath K170997	Analysis ofDifferences
Side Port forFlushing(Y/N)	Yes	Yes	Yes	Identical
Device InnerDiameter (ID)(French)	12.4 Fr (4.1 mm)	12.4 Fr (4.1 mm)	8.5Fr	Identical to predicatedevice.
Device OuterDiameter(OD)	15.2 Fr (5.1)mm	15.2 Fr (5.1)mm	11.5Fr	Identical to the predicatedevice.
Device UsableLength	70 cm	70 cm	71 cm	Identical to predicatedevice.
Device OverallLength	85cm	85cm	Not available	Identical to the predicatedevice
Device Materials	Sheath: PTFE Liner formain lumen Pebax 4033with 20-25% BaSO4,Pantone 422C, Pebax 5533Pantone 419C, Pebax 3533Pantone 422C, Pebax 6333Pantone 422C, Pebax 7233Pantone 422CHemostasis Valve: Silicone.80 NVR 50D (100578)	Sheath: PTFE Liner formain lumen Pebax 4033with 20-25% BaSO4,Pantone 422C, Pebax 5533Pantone 419C, Pebax 3533Pantone 422C, Pebax 6333Pantone 422C, Pebax 7233Pantone 422CHemostasis Valve:Silicone .80 NVR 50D(100578)	Not available	Identical to the predicatedevice.
Device ColorAdditives	Dupont 2020T 9002-88-4,Pebax	Dupont 2020T 9002-88-4, Pebax	Not available	Identical to the predicatedevice.
RadiopaqueMarker	Total Length: .039" (0.99mm). Distal sections arevisible when usingstandard or low-levelfluoroscopy	Total Length: .039"(0.99 mm). Distalsections are visiblewhen using standardor low-levelfluoroscopy	Radiopaque tip markerto allow fluoroscopicvisualization.	Identical to predicatedevice.
Characteristics	Subject DeviceAcQGuide® VUESteerable Sheath(K221044)	Predicate DeviceAcQGuide MAXSteerable SheathK211100	Reference DeviceCARTO VIZIGO Bi-Directional GuidingSheath K170997	Analysis ofDifferences
Guide wirecompatibility	.035"	.035"	Not available	Identical to predicatedevice.
Dilator	YesOverall Length: 90.02cmUsable Length: 87.4 cmOuter Diameter: 4 mmInner Diameter: .039"(0.99 mm)	YesOverall Length:90.02cmUsable Length: 87.4 cmOuter Diameter: 4 mmInner Diameter: .039"(0.99 mm)	Not available	Identical to predicatedevice.
Electrodes	YesPlatinum / Iridium	No	YesNot available	Similar electrode materialas the reference device.Minor differences inmaterial do not raisedifferent questions ofsafety or effectiveness.
Able to visualizesheath onMapping System	YesAcutus AcQMap SystemModel 900100 or 900000	No	Yes	Subject device is able to bevisualized on the AcQMapSystem which is identicalto the reference deviceused with compatiblemapping system.
SterilizationMethod	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Identical
Shelf Life	24 months	18 months	Not available	Minor differences in shelflife do not raise differentquestions of safety oreffectiveness.
BiocompatibleBlood, Body andFluid ContactingMaterials	Yes	Yes	Yes	Identical

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Image /page/7/Picture/0 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is written in a sans-serif font in gray color. Below the word "ACUTUS", the word "MEDICAL" is written in a smaller sans-serif font in orange color.

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Image /page/8/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of the word "ACUTUS" in a stylized, sans-serif font, with a small orange dot above the left side of the letter A. Below the word "ACUTUS" is the word "MEDICAL" in a smaller, sans-serif font, with each letter spaced out. The word "MEDICAL" is also in orange.

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Image /page/9/Picture/0 description: The image shows the logo for Acutus Medical. The logo features the company name in a stylized font, with the word "ACUTUS" in gray and "MEDICAL" in orange. The letters are spaced out, and the overall design is modern and clean.

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Image /page/10/Picture/0 description: The image shows the logo for Acutus Medical. The logo is composed of two lines of text. The top line says "ACUTUS" in gray, sans-serif font. The bottom line says "MEDICAL" in a smaller, orange, sans-serif font.

PERFORMANCE DATA [807.92(b)]

All necessary testing was conducted on the AcQGuide® VUE Steerable Sheath, Model 900201 to support a determination of substantial equivalence to the predicate device.

NONCLINICAL TESTING SUMMARY - BENCH [807.92(b)(1)]

The necessary bench testing was performed on the AcQGuide® VUE Steerable Sheath, Model 900201 in order to ensure that it conformed to the design specifications and to support a determination of substantial equivalence to the predicate device. The bench testing performed on the AcQGuide® VUE Steerable Sheath, Model 900201 consisted of the following:

Packaging and shelf-life
Sterilization
Biocompatibility
Design Verification and Validation studies, including:
- O Dimensional inspection of Sheath and Dilator
- 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® VUE Steerable Sheath, Model 900201 meets the specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQGuide® VUE Steerable Sheath, Model 900201 does not have any potential impact on the safety or effectiveness for percutaneous catheter introduction into the vasculature and into chambers of the heart, when compared to the predicate device.

The AcQGuide® VUE Steerable Sheath, Model 900201 was tested to verify that the device met its established performance specifications. This was done by utilizing dimensional testing to ensure that all components met the required dimensions per specifications, visual inspection to ensure that all components were free of defects, leak testing to ensure the packaging meets its specifications, functional and compatibility testing to ensure the functional and compatibility requirements are met, mechanical testing to ensure the components are able to withstand the expected forces, and handle torque testing to ensure it can withstand the expected torques.

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Image /page/11/Picture/0 description: The image shows the logo for Acutus Medical. The word "ACUTUS" is written in a sans-serif font in gray color. Below the word "ACUTUS", the word "MEDICAL" is written in a smaller sans-serif font in orange color.

CLINICAL TESTING SUMMARY [807.92(b)(2)]

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

BIOCOMPATIBILITY

The AcQGuide® VUE Steerable Sheath, Model 900201 is manufactured from materials similar to the predicate AcQGuide® MAX Steerable Sheath, Model 900200, and has passed all of the appropriate biocompatibility tests. Biocompatibility testing for the AcQGuide® VUE Steerable Sheath, Model 900201 was conducted in accordance with ISO 10993-1:2018 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and the FDA Guidance Document titled, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" issued on September 4, 2020. The AcQGuide® VUE Steerable Sheath, Model 900201 has three components: a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port. Each component was evaluated per the above standards and guidance documents to determine the appropriate biocompatibility testing. Per ISO 10993-1:2018. The AcQGuide® VUE Steerable Sheath is categorized as an external communicating device, which comes into contact with circulating blood for a limited (≤24 hours) contact duration.

STERILIZATION

AcQGuide® VUE is labeled and marketed as "Sterile" by Acutus Medical, Inc. AcQGuide® VUE is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device, AcQGuide® MAX Steerable Sheath, Model 900200, to meet a sterility assurance level (SAL) of 10 ്. .Acutus Medical, Inc. conducted a technical review to establish that the subject device can be adopted into the existing AcQGuide EtO processing cycle number ACU-537 at Steris Corporation. The following aspects were used to perform the evaluation per AAMI TIR28:2009 and ISO 11135:2014: Packaging System Evaluation, Product Design/Materials, Barrier System, Load Configuration, and Bioburden Resistance.

Shelf life study was performed to confirm acceptable product performance and ability to withstand sterilization. All materials identified were suitable for EtO sterilization and were not known to retain high EtO residual levels, or adversely impact the ability of EtO process parameters to be met. In addition, Acutus Medical, Inc. performed material mediated pyrogenicity testing, to evaluate its potential to produce a pyrogenic response when tested in New Zealand white rabbits, per 21 CFR Part 58 Compliance Good Laboratory Practice for Nonclinical Laboratory Studies. The subject AcQGuide® VUE Steerable Sheath, Model 900201 is considered non-pyrogenic per the requirements of ISO 10993-11 guidelines.

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ELECTRICAL SAFETY AND ELECTROMAGNETIC COMPATIBILITY (EMC)

For the purpose of this submission, the subject device AcQGuide® VUE Steerable Sheath requires an electrical safety evaluation. The AcQGuide® VUE has been assessed for electrical safety in accordance with IEC 60601-1, Medical electrical equipment Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances – requirements and tests. The AcQGuide® VUE Steerable Sheath is a CF Defibrillation proof applied part, used with the AcQMap System or any other 3D cardiac mapping system. The verification testing of the AcQGuide® VUE was constrained to the subset of Clauses 8.1 - 8.11 of IEC 60601-1. The completion of the following tests demonstrated that the AcQGuide® VUE is safe for its intended use:

Defibrillation Proof Applied Parts (IEC 60601-1, Clause 8.5.5)
. Dielectric Voltage Withstand (IEC 60601-1, Clause 8.8.3)
Sheath Leakage Current (IEC 60601-1, Clause 8.7)

The relevant test sections of IEC 60601-1-2 is as follows:

Qualification testing of the AcQMap System with applied parts containing cables and Platinum-Iridium Electrodes.
. Qualification testing of the AcQMap System using general-purpose electrophysiology catheters to connect to the Auxiliary inputs.

The AcQGuide® VUE is built and constructed to be a general-purpose electrophysiology applied part. Therefore, using the AcQGuide® VUE as one of the applied parts does not invalidate or require retesting of the AcQMap Console. Additionally, retesting of the electromagnetic compatibility (EMC) is not required in order to release the AcQGuide® VUE catheter for use with the AcQMap System.

CONCLUSIONS [807.92(b)(3)]

Extensive nonclinical testing has been performed on the AcQGuide® VUE Steerable Sheath, Model 900201 to evaluate the overall performance of the device. The nonclinical tests demonstrated that the device is as safe and effective as the predicate device.

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).