The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

Device Description

The AcQGuide Steerable Sheath is a sterile, single use device consisting of a composite structured single lumen shaft, an ergonomic handle to provide torque and active deflection, and a hemostasis valve with side flush port, to allow safe introduction of a catheter while simultaneously permitting saline to be flushed via the main shaft. The AcQGuide Steerable Sheath is designed for maneuverability of standard electrophysiology catheters that are advanced through the sheath and into the right or left chambers of the sheath is compatible with diagnostic and therapeutic devices. The AcQGuide Steerable Sheath includes a dilator. The dilator is designed to introduce the Steerable Sheath into the vasculature and into chambers of the heart.

AI/ML Overview

The provided text is a 510(k) premarket notification for the AcQGuide Steerable Sheath. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than strictly proving the device meets acceptance criteria in the way a new, novel AI algorithm might. Therefore, the information typically requested for AI/algorithm performance studies (like sample size for test/training sets, ground truth establishment by experts, adjudication methods, MRMC studies) is not present here.

Instead, the document details nonclinical testing to ensure the device performs as intended and does not raise new questions of safety or effectiveness compared to its predicate.

Here's an attempt to answer your request based on the available information, with the understanding that it won't perfectly fit the structure for an AI performance study:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present "acceptance criteria" in a quantitative, pass/fail table format often seen for AI performance metrics. Instead, it states that "the collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the AcQGuide Steerable Sheath meet the established specifications necessary for consistent performance during its intended use."

The comparison table on pages 4-5 indirectly serves as a form of acceptance criteria by showing how the proposed device is similar to the predicate. The "Analysis of Differences" column confirms that any differences "do not raise different questions of safety or effectiveness."

Feature/Test	Acceptance Criteria (Implied by Predicate Comparison & Testing Objectives)	Reported Device Performance (Summary from Submission)
Functional/Mechanical Performance	- Adequate deflection and reach (similar to predicate, e.g., max deflection ~180 deg, reach ~5.0cm at 90 deg)- Compatible with catheters up to 10.5F in diameter.- Hemostasis valve prevents air incursion and minimizes blood loss.- Flush port provides ability to administer saline flush.- Usable length suitable for intended use (up to 75 cm).- Radiopaque markers for visualization during fluoroscopy.- Guidewire compatibility within acceptable range (e.g., .035").- Mechanical integrity (e.g., handle torque, leak resistance, dimensional accuracy, visual defect absence).	- Maximum deflection: 180 degrees (with catheter inserted).- Reach: 5.0cm at 90 degrees.- Facilitates use with catheters up to 10.5F in diameter.- Hemostasis valve to prevent air incursion and minimizes blood loss.- Flush port provides ability to administer saline flush.- Usable length of up to 75 cm.- Distal sections are visible when using standard or low-level fluoroscopy.- Guidewire compatibility: .035".- Comprehensive nonclinical bench testing including Dimensional Inspection, Visual Inspection, Leak Testing, Functional and Compatibility Testing, Mechanical Testing, Handle Torque Testing. All tests "meet the established specifications necessary for consistent performance."
Safety - Biocompatibility	- Device materials (shaft, dilator) must be biocompatible.- No adverse biological reactions.	- Shaft: Biocompatible copolymer (Pebax®) with stainless steel, platinum/10% Iridium, PTFE.- "Biocompatibility" testing was conducted and collectively demonstrates the device is safe.
Safety - Sterility & Packaging/Shelf-Life	- Device must be sterile.- Packaging maintains sterility and product integrity over shelf-life.- Shelf-life stability confirmed.	- "Sterilization" testing was conducted.- "Packaging and Shelf-Life" testing was conducted. (Implied successful results).
Intended Use Equivalence	- Indications for Use are substantially equivalent to the predicate (e.g., "percutaneous catheter introduction into the vasculature and into the chambers of the heart. The Sheath deflection facilitates catheter positioning").	- "The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning." This statement is identical to the predicate's stated intent.
Overall Safety and Effectiveness Equivalence	- Device does not raise different questions of safety or effectiveness compared to the predicate device.	- "Extensive nonclinical testing has been performed... The collective results confirm that the AcQGuide Steerable Sheath is safe and effective, meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics for its intended use."- "The AcQGuide does not raise different questions of safety or effectiveness when compared to the predicate devices."

2. Sample Size Used for the Test Set and Data Provenance

Test set sample size: Not explicitly stated in terms of a numerical count of devices tested for each individual test. The document refers to "extensive performance bench testing."
Data Provenance: This was "nonclinical testing" and "bench testing" conducted by the manufacturer, Acutus Medical, Inc. It's a prospective testing program designed to evaluate the physical device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" for a physical medical device's performance is typically established through engineering specifications, material science, and direct measurement/testing against those specifications, potentially with input from intended users (physicians).
The document mentions "Physician simulated use in an animal model," which suggests expert input was involved in assessing practical functionality, though details on the number or qualifications of these physicians are not provided.

4. Adjudication Method for the Test Set

Not applicable in the context of an AI ground truth. Device performance testing involves objective measurements and compliance with engineering specifications. Any subjective assessment during simulated use would likely follow standard protocols for observational evaluation by the participating physicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This is a 510(k) for a physical medical device, not an AI algorithm. MRMC studies are specific to evaluating diagnostic performance, often of AI, against human readers.

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

Not applicable. There is no algorithm. The device itself is standalone in its function as a steerable sheath.

7. The Type of Ground Truth Used

For the nonclinical testing, the "ground truth" would be the established engineering specifications, safety standards (e.g., biocompatibility standards), and the performance characteristics of the predicate device. For example, a leak test has a defined pass/fail criterion based on engineering principles. For "Physician simulated use," the ground truth would be the practical observation of the device's steerability, stability, and ease of use in a relevant anatomical model, assessed by a medical professional.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. No training set for an AI model.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

April 6, 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K162925

Trade/Device Name: AcQGuide Steerable Sheath Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: March 3, 2017 Received: March 6, 2017

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mude Jellman
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) K162925

Device Name AcQGuide Steerable Sheath

Indications for Use (Describe)

The AcQGuide is intended for percutaneous catheter introduction into the chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

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)

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510(k) Notification K162925

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: 442-232-6161 FAX: 442-232-6081 Email: Brenda.Clay@acutus.com

Date Prepared: April 3, 2017

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

AcQGuide™ Steerable Sheath

Generic/Common Name:

Steerable Catheter

Classification:

21 CFR 870.1280

Product Code: DRA

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

The predicate device to support substantial equivalence of the AcQGuide Steerable Sheath is the Medtronic CryoCath LP Flexcath Advance® Steerable Sheath and Dilator cleared under K123591.

DEVICE DESCRIPTION [807.92(a)(4)]

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

The AcQGuide is intended for percutaneous catheter introduction into the vasculature and into chambers of the heart. The AcQGuide deflection facilitates catheter positioning.

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

Feature	Proposed DeviceAcQGuide ™ Steerable Sheath(K162925)	Predicate DeviceFlexCath Advance® SteerableSheathK123591	Analysis ofDifferences
Classification	21 CFR § 870.1280	21 CFR § 870.1280	Sameclassification
Product Code	DRA	DRA	Same productcode
Indicationsfor Use	The AcQGuide Steerable Sheath isintended for percutaneous catheterintroduction into the vasculatureand into the chambers of the heart.The Sheath deflection facilitatescatheter positioning.	The FlexCath Steerable Sheath isintended for percutaneous catheterintroduction into the vasculatureand into the chambers of the heart.The Sheath deflection facilitatescatheter positioning.	Same intended use
KeyComponents	Employs single deflection curvewith atraumatic tip. Sheathdeflection facilitates accuratecatheter positioning. Facilitates usewith catheters up to 10.5F indiameter. Hemostasis valve toprevent air incursion and minimizesblood loss. Flush port providesability to administer saline flush	Ergonomic handle withunidirectional deflection.Hemostasis valve allows forintroduction, withdrawal, andexchanging of catheters and guidewires, while preventing air ingressand minimizing blood loss.Facilitates use with catheters up to	Similar designfeatures. Minordifferences do notraise differentquestions of safetyor effectiveness.
Feature	Proposed DeviceAcQGuide™ Steerable Sheath(K162925)	Predicate DeviceFlexCath Advance® SteerableSheathK123591	Analysis ofDifferences
	throughout procedure. Usablelength of up to 75 cm.	10.5F in diameter. Usable length ofup to 65 cm.
Method ofUse	Percutaneous catheter introductioninto the vasculature and into thechambers of the heart. The sheathdeflection facilitates catheterpositioning.	Percutaneous catheter introductioninto the vasculature and into thechambers of the heart. The sheathdeflection facilitates catheterpositioning.	Same method ofuse
Sheath Size	Inner diameter: 12.8FrOuter Diameter: 16FrUsable length: 75cmTotal length: 92cmRadiopaque marker: distal sectionsare visible when using standard orlow level fluoroscopy	Inner diameter: 12FrOuter Diameter: 15FrUsable length: 65cmTotal length: 81cmRadiopaque marker: 5mmproximal to sheath tip	Products havesimilar inner andouter diameter andsimilar lengths.Both devicesincluderadiopaquecomponents forvisualization. Theminor differencesdo not raisedifferent questionsof safety oreffectiveness.
Compatibility	Guidewire compatibility: .035"	Guidewire compatibility: .032" to.035"	The guidewirecompatibility ofAcQGuide fallswithin the rangeof the predicate.
Deflectionand reach	Maximum deflection: 180 degrees(with catheter inserted)Reach: 5.0cm at 90 degrees	Maximum deflection: 135 degrees(with catheter inserted)Reach: 5.5cm at 90 degrees	Both devicesallow deflectionand have a similarreach.
SheathMaterial	Shaft: Biocompatible copolymer(Pebax®) with stainless steel,platinum/10% Iridium, PTFE	Shaft: Biocompatible copolymer(Pebax®) with barium sulfateblend	Both devices areconstructed ofbiocompatiblematerials
Dilator	Total length:95.5cmOuter diameter: 4.1mm	Total length: 87cm	The dilators ofAcQGuide and thepredicate are ofsimilar length

Table 5.1: Substantial Equivalence Table - Regulatory Information

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510(k) SUMMARY K162925

SUBSTANTIAL EQUIVALENCE

The proposed AcQGuide Steerable 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. Thus, the AcQGuide is substantially equivalent to the predicate device.

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PERFORMANCE DATA [807.92(B)]

All necessary testing was conducted on the AcQGuide Steerable 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 AcOGuide Steerable Sheath. This testing was performed in order to ensure that the AcQGuide Steerable Sheath performs as intended. The nonclinical testing included:

Packaging and Shelf-Life ●
Sterilization
Biocompatibility ●
Design Verification and Validation studies, including: ●
- Dimensional Inspection of Sheath and Dilator o
- 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 Steerable Sheath meet the established specifications necessary for consistent performance during its intended use. In addition, the collective bench testing demonstrates that the AcQGuide does not raise different questions of safety or effectiveness for percutaneous catheter introduction into the vasculature and into chambers of the heart when compared to the predicate devices.

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

This section is not applicable. 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 AcQGuide Steerable Sheath to evaluate the overall performance of the device. The collective results confirm that the AcOGuide Steerable Sheath is safe and effective, meets its specifications, is biocompatible, and exhibits the required mechanical and functional characteristics for its intended use.

SUMMARY

The AcQGuide Steerable Sheath is substantially equivalent to 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).