The FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

Device Description

FlexCath Cross™ combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). FlexCath Cross" consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of FlexCath Cross™ is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of FlexCath Cross™. The needle is affixed to a springtensioned actuator in the handle of FlexCath Cross™ that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. FlexCath Cross™ is for single-use only and is provided sterile.

AI/ML Overview

Due to the nature of the device described in the provided text (a catheter introducer - FlexCath Cross™ Transseptal Solution), the acceptance criteria and study detailed are primarily focused on engineering performance and material safety rather than diagnostic accuracy or clinical outcomes in the way often associated with AI/ML-based medical devices. Therefore, many of the typical questions for AI/ML device studies (like those related to expert adjudication of ground truth, effect size with AI assistance, or distinction between training/test sets for algorithm performance) are not applicable here.

The document describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence. The core of the acceptance criteria is demonstrating that the modified device performs as safely and effectively as the predicate device.

Here's a breakdown of the requested information based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" with precise numerical thresholds for each test. Instead, it states that "All necessary bench testing was conducted on the additional models FlexCath Cross™ to support a determination of substantial equivalence to the predicate device" and that the "collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device."

The tests performed and their general outcomes (implied to be successful for showing substantial equivalence) are:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Mechanical/Physical Performance:
Dimensional conformance (Dilator shaft diameter, Handle lock)	Modified dimensions are within predicate device ranges and do not impact safety/effectiveness; "demonstrates that FlexCath Cross™ performs as intended in the specified use conditions."
Shaft to handle tensile strength	Successfully conducted; supports substantial equivalence.
Length compatibility	Successfully conducted; supports substantial equivalence.
Snap engagement	Successfully conducted; supports substantial equivalence.
Kink resistance	Successfully conducted; supports substantial equivalence.
Needle actuation (functionality)	Successfully conducted; supports substantial equivalence.
Sheath compatibility (Insertion/withdrawal)	Successfully conducted; ensures compatibility with specified Medtronic FlexCath Contour sheaths; "Handle tip shape uniquely modified to be compatible with each sheath's proximal hub. Minor differences in tip shape do not potentially impact safety and effectiveness."
Visual inspection (Quality of manufacturing)	Successfully conducted; supports substantial equivalence.
Aspiration/flushing (Lumen patency and integrity)	Successfully conducted; supports substantial equivalence.
Electrical Performance:
Electrical continuity (for EGM monitoring or RF application)	Successfully conducted; supports substantial equivalence.
Electrical Safety & Electromagnetic Compatibility (EMC) compliance	"Previously submitted EMC and Electrical Safety testing of the predicate device, K210685, has been leveraged for the subject device. Testing was completed in accordance with ANSI/AAMI IEC 60601-1:2005, IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2." Modifications do not impact EMC and Electrical Safety. The device is as safe and effective as the predicate.
Biocompatibility:
Biocompatibility with patient tissues	"Biocompatibility testing was performed on the predicate device K210685 in accordance with AAMI/ANSI/ISO 10993-1:2009... The subject models of FlexCath Cross™ are made of identical patient contacting materials to the predicate device. Therefore, the previously submitted biocompatibility testing in K210685 has been leveraged for the subject device, and no additional biocompatibility testing is required." Implies compliance for the subject device.
Sterilization:
Sterility Assurance Level (SAL) of $10^{-6}$	"Sterilization validation was performed on FlexCath Cross™ in accordance per ISO 11135: 2014... FlexCath Cross™ is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 10⁻⁶. The previously submitted sterilization validation of K210685 has been leveraged for the subject device. The new models have been adopted into the existing process per AAMI TIR28..." The device achieves the required SAL.

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

The document refers to "bench testing" and "non-clinical testing." This typically involves testing of physical samples of the device in a laboratory setting. No sample sizes for specific tests are provided, nor is information about country of origin or retrospective/prospective nature as this pertains to clinical data, which is not the focus of this submission. The tests are for engineering performance, not clinical performance based on patient data.

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 device is not an AI/ML diagnostic or prognostic device that requires expert-established ground truth from clinical cases. The "ground truth" for engineering tests is typically based on predefined specifications and standards.

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

Not applicable for this type of device and testing. Adjudication methods are relevant for subjective interpretations of clinical data, especially in AI/ML performance evaluations.

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, and therefore, no MRMC studies or effect size measurements for human readers with AI assistance would be performed or relevant.

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

Not applicable. This is not an algorithm-based device.

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

The "ground truth" for the non-clinical and bench testing is the device's conformance to established engineering specifications, industry standards (e.g., ISO for sterilization, AAMI for biocompatibility, IEC for electrical safety), and its performance being equivalent to the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device as it is not an AI/ML product.

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

Not applicable for a non-AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "U.S. Food & Drug Administration" in blue.

December 17, 2023

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

Re: K233691

Trade/Device Name: FlexCath Cross™ Transseptal Solution Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter introducer Regulatory Class: Class II Product Code: DYB Dated: November 16, 2023 Received: November 16, 2023

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 (the 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 available 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.

{1}------------------------------------------------

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

{2}------------------------------------------------

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Rachel E. Neubrander -S

Rachel Neubrander, PhD Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

Indications for Use

Submission Number (if known)

K233691

Device Name

FlexCath Cross™ Transseptal Solution

Indications for Use (Describe)

The FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

510(k) Summary

General Information [807.92(a)(1)]

Date Prepared: October 6, 2023

Applicant:	Contact Person:
Acutus Medical, Inc.2210 Faraday Ave., Suite 100Carlsbad, CA 92008USAPhone: 1-442-232-6080Fax: 1-442-232-6081	Sarah Clay
	Senior Regulatory Affairs Specialist
	Acutus Medical, Inc.
	2210 Faraday Ave., Suite 100
	Carlsbad, CA 92008
	USA
	Phone: 1-442-232-6080Email: Sarah.clay@acutus.com

Device Information [807.92(a)(2)]

Trade Name:	FlexCath Cross™ Transseptal Solution
Generic/Common Name:	Dilator/Transseptal Needle
Classification:	Class II / 21 CFR § 870.1340
Product Code(s):	DYB, DRE

Predicate Device [807.92(a)(3)]

Predicate Device	Manufacturer	FDA 510(k)
AcQCross™ Qx IntegratedTransseptal Dilator/Needle	Acutus Medical	K210685

Device Description [807.92(a)(4)]

FlexCath Cross™ combines the conventional vessel dilator and transseptal needle into a single device (Figure 1). FlexCath Cross" consists of an elongated shaft with a tapered tip and central lumen to track over a guidewire. The lumen of FlexCath Cross™ is fitted with a hollow stainless steel transseptal needle (Figure 2). Both the shaft and needle are connected to the proximal handle of FlexCath Cross™. The lumen of the needle will allow for guidewires up to 0.032" in diameter. The needle is affixed to a springtensioned actuator in the handle of FlexCath Cross™ that prevents needle extension until the operator purposely advances the needle via a slider button located on the outer surface of the handle. The proximal handle is fitted with a Luer connector to gain access to the central lumen of the needle. The handle is also fitted with an electrical connector that allows for monitoring intracardiac electrograms (EGMs) from the needle while in the heart utilizing the EGM adapter cable, and/or allows for the application of radiofrequency (RF) current from an electrosurgical generator to facilitate the septal puncture utilizing the ES adapter cable. FlexCath Cross™ is for single-use only and is provided sterile.

{5}------------------------------------------------

Image /page/5/Figure/0 description: The image shows two diagrams of a medical device. The top diagram shows an external view of the device, with labels pointing to the dilator shaft, spring-tensioned push button for needle extension, proximal luer fitting, male interlock for mating with introducer hub, and electrical connector for EGM monitoring. The bottom diagram shows a cross-sectional view of the device, with labels pointing to the internal needle, luer fitting, dilator shaft, tension spring, and electrical pin plug.

Figure 1: FlexCath Cross™Integrated Transseptal Dilator/Needle

Image /page/5/Figure/2 description: The image shows two diagrams of a medical instrument, labeled as a needle inside the lumen of a dilator shaft. The top diagram shows a cut-away view of the instrument, revealing the needle inside the dilator shaft. The bottom diagram shows the instrument with the needle extended from the tip of the dilator shaft.

Figure 2: FlexCath Cross™ Needle inside lumen of dilator shaft

FlexCath Cross™ is designed to be compatible with certain commercially available transseptal sheaths. The new models of FlexCath Cross™ were added to provide the physician with additional sheath selection

{6}------------------------------------------------

for transseptal crossing. Table 1 lists the new models of FlexCath Cross™ for which Acutus Medical, Inc. is seeking clearance.

Table 1: FlexCath Cross™ Model Numbers
Product (Subject Device)	Acutus ModelNumber	Compatible Sheath configurations	MedtronicModel Number
FlexCath Cross™ – FCC10F– 65cm	900310	Medtronic FlexCath Contour 10F 13mmTip	10FCC13
		Medtronic FlexCath Contour 10F 20mmTip	10FCC20
FlexCath Cross™ – FCC12F– 65cm	900311	Medtronic FlexCath Contour 12F 13mmTip	12FCC13
		Medtronic FlexCath Contour 12F 20mmTip	12FCC20

Indications for Use [807.92(a)(5)]

The FlexCath Cross™ Transseptal Solution is indicated to puncture the interatrial septum to gain access to the left side of the heart whereby various cardiovascular catheters are introduced.

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

Tables 2 provides a comparison of the additional models of the FlexCath Cross™ Transseptal Solution and indications for use against the predicate device.

Table 2: Predicate Device Comparison
Characteristics	Predicate DeviceAcQCross Cross™ Qx Integrated TransseptalDilator/Needle(K210685)	Subject DeviceFlexCath Cross™ Transseptal Solution
Classification	Class II	Identical to K210685.
Regulation	21 CFR § 870.1340, Catheter Introducer	Identical to K210685.
Product Code	DYB, DRE	Identical to K210685.
Indications for Use	To puncture the interatrial septum to gainaccess to the left side of the heart wherebyvarious cardiovascular catheters areintroduced.	Identical to K210685.
Patient Anatomy	Intracardiac Structures	Identical to K210685.
Testing to SupportSubstantialEquivalence	Verification Testing,Validation Testing	Identical to K210685.
Physical Characteristics
Key Components	• Elongated shaft with tapered tip andcentral lumen to track over guidewire.• Hollow stainless steel transseptal needle.Shaft and needle connected to proximalhandle.• Needle affixed to a spring tensionedactuator which prevents needle extension	Identical to K210685.
Table 2: Predicate Device Comparison
	Predicate Device	Subject Device
Characteristics	AcQCross Cross™ Qx Integrated TransseptalDilator/Needle(K210685)	FlexCath Cross™ Transseptal Solution
	until operator advances needle via sliderbutton located on the outer surface ofhandle.• Proximal handle fitted with luer connectorto gain access to central lumen of needle.• Handle fitted with electrical connector toallow EGM monitoring or RF application.
Product Diagram	Image: Panel A	Identical to K210685.
Dimensions	Needle effective length: $90.4cm \pm .10cm$Dilator effective length: $83.5cm \pm 2.0cm$French sizes compatible: 8.5F, 12FGuidewire sizes: up to .032"	Needle effective length: $90.4cm \pm$.10cmDilator effective length: $83.5cm \pm$.25cmFrench sizes compatible: 10F, 12FGuidewire sizes: up to .032"Dimensions modified for new modelsto be compatible with associatedsheaths. These minor dimensionaldifferences are within the predicatedevice ranges and do not potentiallyimpact the safety and effectiveness.
Handle lock feature	Handle tip shape modified to be compatiblewith each compatible sheath.Image: FlexCathImage: Agilis, SwartzImage: Vizigo	Handle tip shape modified to becompatible with each compatiblesheath.Image: FlexCath ContourHandle tip shape is uniquely modifiedto be compatible with each sheath'sproximal hub. Minor differences in tip
Table 2: Predicate Device Comparison
Characteristics	Predicate Device	Subject Device
	AcQCross Cross™ Qx Integrated TransseptalDilator/Needle(K210685)	FlexCath Cross™ Transseptal Solution
		shape do not potentially impact safetyand effectiveness
Material	Shaft: Polyethylene Hexene Copolymer;ethylene homopolymer; barium sulfate withblue colorantNeedle: 304 Stainless steel Hypotube: 304stainless steelLuer fitting: polycarbonate	Identical to K210685.
Packaging	Pouch: Tyvek® 1073B Uncoated, Nylon FilmBacker card: High Density Polyethylene(HDPE)Shelf Box: Solid bleach sulfate paperboardShipper: paperboard	Identical to K210685.
Sterilization	Ethylene Oxide (EO)	Identical to K210685.
Shelf Life	24 months	Identical to K210685.

{7}------------------------------------------------

{8}------------------------------------------------

Substantial Equivalence

FlexCath Cross™ is made of identical patient contacting materials and has minimal design modifications as referenced in Table 2 to that of the predicate device. FlexCath Cross™ performs as intended and presents no unacceptable risks to the intent population or end user. The non-clinical bench data support the safety of the device and demonstrate that FlexCath Cross™ performs as intended in the specified use conditions. The additional FlexCath Cross™ models do not raise any new questions regarding safety or effectiveness of the device as compared to the predicate device. The nonclinical tests demonstrate that the device is as safe and effective as the predicate device.

Performance Data [807.92(b)]

All necessary bench testing was conducted on the additional models FlexCath Cross™ to support a determination of substantial equivalence to the predicate device.

Non-clinical Testing Summary [807.92(b)(1)]

Bench Testing

The necessary bench testing was performed on the additional models of FlexCath Cross™ to ensure that it conforms to the design specifications and to support a determination of substantial equivalence to the predicate device.

Other than the following modifications, the additional models of FlexCath Cross™ are identical to that of the predicate device, AcQCross™ Qx(K210685). Therefore, the testing was performed on the subject device which focused on the safety and performance related to the modifications. These modifications are limited to dimensional changes which facilitate compatibility with different transseptal sheaths and are as follows:

{9}------------------------------------------------

Dilator shaft diameter
Handle lock feature
Colorant update to non-patient contacting handle components align with Medtronic branding

FlexCath Cross™ and the predicate device are otherwise identical in terms of materials, dimensions, packaging, shelf-life and sterilization. Therefore, performance testing has been leveraged from AcQCross™ Qx(K210685) for the subject device. The following performance testing was conducted in support of the substantial equivalence determination:

Dimensional Inspection
. Shaft to handle tensile
Length compatibility .
Snap engagement
Kink resistance ●
Needle actuation ●
Visual inspection
Aspiration/flushing
Electrical continuity
Sheath compatibility: Insertion/withdrawal ●

The collective bench testing demonstrates that the proposed device does not raise different questions of safety or effectiveness when compared to the predicate device.

Biocompatibility

Biocompatibility testing was performed on the predicate device K210685 in accordance with AAMI/ANSI/ISO 10993-1:2009 - Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. The subject models of FlexCath Cross™ are made of identical patient contacting materials to the predicate device. Therefore, the previously submitted biocompatibility testing in K210685 has been leveraged for the subject device, and no additional biocompatibility testing is required.

Sterilization

Sterilization validation was performed on FlexCath Cross™ in accordance per ISO 11135: 2014 -Sterilization of health-care products- Ethylene Oxide- Requirements for development, validation and routine control of a sterilization process for medical devices. FlexCath Cross™ is subjected to the identical ethylene oxide (EO) sterilization process as the predicate device to meet a sterility assurance level (SAL) of 10°. The previously submitted sterilization validation of K210685 has been leveraged for the subject device. The new models have been adopted into the existing process per AAMI TIR28, Product Adoption and Process Equivalence for Ethylene Oxide Sterilization, and requires no further process validation.

Electrical Safety and Electromagnetic Compatibility (EMC)

The modifications to the new models of FlexCath Cross™ do not impact EMC and Electrical Safety. Therefore, the previously submitted EMC and Electrical Safety testing of the predicate device, K210685, has been leveraged for the subject device. Testing was completed in accordance with ANSI/AAMI IEC 60601-1:2005, IEC 60601-1. Medical electrical equipment-Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for the basic safety and essential performance – Collateral standard: Electromagnetic

{10}------------------------------------------------

compatibility - Requirements and IEC 60601-2-2, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories.

Conclusions [807.92(b)(3)]

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).