The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Device Description

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.

The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the dilator component of the legally marketed VersaCross Connect™ Transseptal Dilator (K220414) (comprising of a dilator and J-tipped guidewire). A quidewire is not supplied with the subject device. However, the end user can use a separately cleared compatible 0.035″ quidewire.

The VersaCross Connect™ Transseptal Dilator is designed for safe and easy catheterization and angiography of specific heart chambers and locations. The dilator provides torque control and is flexible. The dilator features a tapered tip and a shaft that can be reshaped manually. The echogenic shaft and tip and radiopaque tip maximize visualization of the dilator during manipulation in procedures.

AI/ML Overview

This document describes the premarket notification (K233647) for the VersaCross Connect™ Transseptal Dilator. It is an updated version of a previously cleared device (K220414), with modifications primarily in dimensions and design for compatibility and the absence of a supplied guidewire. The FDA's review confirms substantial equivalence to the predicate device due to identical indications for use, fundamental scientific technology, and operating principles, supported by a comprehensive suite of non-clinical performance tests.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Test/Requirement	Performance Standard/Requirement	Reported Device Performance/Conclusion
Mechanical Testing	Torque Transmission	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Torque Withstand	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Hub-Shaft Tensile	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Flexural Rigidity	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Shapeability	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Curve Retention	Compliance with ISO 11070:2014/Amd.1:2018 and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Tip to Tip Cap Cantilever and Tensile	Compliance with Baylis Medical Co. Inc. requirements.	All test requirements met.
	Clamshell Tensile	Compliance with Baylis Medical Co. Inc. requirements.	All test requirements met.
	Clamshell Cantilever	Compliance with Baylis Medical Co. Inc. requirements.	All test requirements met.
	Shaft Joint Tensile Strength	Compliance with Baylis Medical Co. Inc. requirements.	All test requirements met.
	Shaft Friction test	Compliance with Baylis Medical Co. Inc. requirements.	All test requirements met.
General Physical Testing	Luer Tests	Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Air and Liquid Leakage Tests	Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements.	All test requirements met.
	Corrosion Test	Compliance with ISO 11070:2014/Amd.1:2018, ISO 80369-7:2021, and Baylis Medical Co. Inc. requirements.	All test requirements met.
System Verification	Compatibility Test (with guidewires, introducer, sheaths)	Compatibility with compatible guidewires, introducer, and accessory sheaths, as per Baylis Medical Co. Inc. requirements.	All test requirements met.
	Snap Force Test (with accessory sheath)	Verification of force required to snap and unsnap with compatible accessory sheaths, as per Baylis Medical Co. Inc. requirements.	All test requirements met.
Biocompatibility	Biological Safety	Compliance with ISO 10993-1:2020 and FDA guidance document (Sept 8, 2023).	Conducted through adopted biological data of the predicate device (K220414). Compliant.
Sterilization	Sterilization Assurance Level	Ethylene Oxide sterilization to a SAL of 10-6, compliant with ISO 11135:2014/A1:2019 and ISO 10993-7:2008/A1:2022.	Compliant.
	Residual Limit Verification	Compliance with ISO 10993-7:2008/A1:2022.	Compliant.
Pyrogen Testing	Endotoxin Levels (LAL testing)	Meets current FDA and USP pyrogen limit specifications, as per ANSI/AAMI ST72:2019 and FDA guidance.	Supplied non-pyrogenic; test requirements met.
Packaging Verification	Shipping and Handling Integrity	Maintains packaging integrity through shipping/handling and storage, compliant with ISO 11607-1:2020.	All test requirements met.
	Sterile Barrier Integrity	Maintains sterile barrier integrity over proposed shelf life, compliant with ISO 11607-1:2020.	All test requirements met.
Benchtop Validation	Performance during normal intended use	Validated performance as per ISO 11070:2014/Amd.1:2018 and Baylis requirements. Customer requirements were validated through benchtop validation.	All test requirements met. (Validation confirms performance for intended use).

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 does not specify exact sample sizes for each mechanical, physical, or system verification test conducted. It generally refers to "test requirements" being met. The data provenance is not explicitly stated in terms of country of origin, but the tests were conducted by Baylis Medical Company Inc., which is based in Canada. These tests are non-clinical (benchtop) and are typically performed in a laboratory setting. They would be considered prospective in the sense that they were designed and executed to evaluate the new device.

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)

This device is a medical dilator, not an AI or diagnostic imaging device that requires expert interpretation for "ground truth" in the traditional sense of clinical data. The "ground truth" for this device's performance is established through adherence to recognized international standards (e.g., ISO, ANSI/AAMI) and the manufacturer's internal engineering requirements. Therefore, the "experts" involved would be a team of engineers, regulatory affairs specialists, quality assurance personnel, and potentially design validation specialists from Baylis Medical Company Inc. with expertise in medical device design, testing, and regulatory compliance. The document does not specify the number or specific qualifications of these individuals, as it's typically understood to be part of standard manufacturing and quality system practices.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., reading medical images) to resolve discrepancies among experts. For a physical medical device undergoing non-clinical benchtop testing, the results are objectively measured against predefined scientific and engineering standards, not subject to subjective adjudication among experts.

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 a physical medical device (dilator), not an AI algorithm for diagnostic interpretation or a device designed to assist human readers. Therefore, an MRMC comparative effectiveness study, which is relevant for AI-powered diagnostic tools, was not performed.

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. Benchtop tests are inherently "standalone" in the sense that the device's physical properties and performance are measured objectively without human-in-the-loop clinical scenarios.

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

The "ground truth" for the performance tests conducted on the VersaCross Connect™ Transseptal Dilator is based on:

International Standards: e.g., ISO 11070:2014/Amd.1:2018 (Vessel Dilators), ISO 80369-7:2021 (Luer connectors), ISO 10993-1:2020 (Biocompatibility), ISO 11135:2014/A1:2019 (Sterilization), ISO 10993-7:2008/A1:2022 (EO residuals), ANSI/AAMI ST72:2019 (Pyrogen testing), ISO 11607-1:2020 (Packaging).
Manufacturer's Internal Requirements: Baylis Medical Company Inc. requirements, often derived from risk assessments and design specifications.
Predicate Device Data: For biocompatibility, data from the predicate device (K220414) was adopted, indicating that prior established safety profiles serve as a ground truth baseline.

8. The sample size for the training set

Not applicable. This is a physical medical device undergoing non-clinical testing, not an AI model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 14, 2023

Baylis Medical Company, Inc. Christina Dowd Senior Regulatory Affairs Specialist 5825 Explorer Drive Mississauga, ON L4W5P6 Canada

Re: K233647

Trade/Device Name: VersaCross Connect™ Transseptal Dilator Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE Dated: November 13, 2023 Received: November 14, 2023

Dear Christina Dowd:

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.

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).

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

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 OS 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 (QS) 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 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,

Katherine N. Trivedi -S

for Rachel Neubrander Assistant 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

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

Indications for Use

510(k) Number (if known) K233647

Device Name

VersaCross Connect™ Transseptal Dilator

Indications for Use (Describe)

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired

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)

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."

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

510(K) SUMMARY (K233647)

Submitter Information

A. Company Name:	Baylis Medical Company Inc.
B. Company Address:	5825 Explorer DriveMississauga, Ontario L4W 5P6Canada
C. Company Phone:	+1 (905) 602-4875
D. Contact Person:	Christina DowdSenior Regulatory Affairs Specialist
E. Date Summary Prepared:	13-Nov-2023

Device Identification

A. Device Trade Name:	VersaCross Connect ™: Transseptal Dilator
B. Device Common Name:	Dilator
C. Classification Name:	CFR 870.1310 - Vessel dilator forpercutaneous catheterization
D. Product Code:	DRE
E. Device Class:	Class II

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

Identification of Legally Marketed Device

Predicate Device	Manufacturer	510(k)	Indications for Use
VersaCrossConnectTMTransseptal Dilator	Baylis MedicalCompany Inc.	K220414	The VersaCross ConnectTMTransseptal Dilator is indicatedfor use in procedures whereaccess to the left atrium via thetransseptal technique isdesired.

Intended Use/ Indications for Use

The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.

Device Description

The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. The device is comprised of a single dilator.

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

The dilator can be used with separately cleared compatible access sheaths such as FARADRIVE™ Steerable sheaths. The dilator may also be used as a standalone device to facilitate access to the left atrium following transseptal puncture. The dilator provides support and helps quide separately cleared compatible transseptal wires to the atrial septum for puncture. The dilator subsequently dilates the atrial septal defect to enable larger diameter devices to cross the septum. The subject device can be used by electrophysiologists, interventional cardiologists, and other users trained in catheter techniques for any procedure that requires left atrial access via transseptal puncture.

Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.

Comparison of Characteristics with Predicate Device

The intended use and indications for use of the proposed VersaCross Connect™ Transseptal Dilator remains unchanged from the predicate VersaCross Connect™ Transseptal Dilator (K220414). The subject and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action, packaging configuration and sterilization method.

The differences between the predicate and subject device are due to dimensional and design updates for compatibility with separately cleared compatible access sheaths, removal of a guidewire supplied with the device, and labeling update to reflect use of the subject dilator with and without a compatible access sheath.

Differences between the subject and predicate devices do not raise new or different questions of safety and effectiveness (Table 13.2). The results of verification and validation testing provide reasonable assurance of substantial

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

equivalence of the proposed VersaCross Connect™ Transseptal Dilator with the predicate device.

Characteristic	Subject Device Comparedto Predicate VersaCross®Connect™ TransseptalDilator (K220414)	Comment
Intended Use	Identical	Both subject and predicate device are
Indications for Use	Identical	indicated for use in procedures whereaccess to the left atrium via thetransseptal technique is desired.
Fundamentalscientific technology	Identical	Both subject and predicate device rely ontransfer of mechanical force to achievetissue dilation.
Operating principles	Identical	The principles of operation for both subjectand predicate device is the transfer ofmechanical force to achieve tissue dilation.
Mechanism of action	Identical	Both subject and predicate device dilatetissue to achieve its intended use.
Environment of Use	Identical	Both the predicate and subject device areused in facilities equipped with staff toperform diagnostic and interventionalprocedures.
Material	Identical	Both the predicate and subject devicecontain the same patient contactingmaterials.
Technologicalcharacteristics(Dimensions, design)	Similar	Both the predicate and subject deviceshare the same fundamental design.The subject device differs from thepredicate device as follows:• Dilator shaft dimensional changes• Taper tip length change

Table 13.2: Comparison of Subject and Predicate Device
--------------------------------------------------------	--	--

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

		Snap fit hub geometry change No guidewire supplied with dilator One curve size option; Update to curve radius and reach
Labeling	Similar	Option to use without a compatible sheath.
Packaging configuration	Identical	The predicate and subject device contain the same packaging (pouch, die cut card, shelf box and shipper box).
Sterilization method	Identical	Both subject and predicate device are Single Use, Ethylene Oxide sterilized

Summary of Non-Clinical Performance Testing

Non-clinical performance testing was completed to demonstrate safety and effectiveness and substantial equivalence of the subject device to the predicate device. All test requirements were met as specified by applicable standards and test protocols. The following verification and validation activities were completed to demonstrate the substantial equivalence of the subject device:

Mechanical Testing

Mechanical verification was conducted for the subject device to ensure compliance the applicable requirements of ISO 11070:2014/Amd.1:2018 and Baylis Medical Company Inc. requirements. The following mechanical tests were performed:

. Torque Transmission
. Torque Withstand
. Hub-Shaft Tensile
. Flexural Rigidity
. Shapeability
Curve Retention ●
. Tip to Tip Cap Cantilever and Tensile

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

. Clamshell Tensile
Clamshell Cantilever .
Shaft Joint Tensile Strength .
. Shaft Friction test

General Physical Testing

General physical verification was conducted for the subject device to ensure compliance with the applicable requirements of ISO 11070:2014/Amd.1:2018, ISO 80369-7: 2021, and Baylis Medical Company Inc. requirements. The following general physical test was performed:

Luer Tests .
. Air and Liquid Leakage Tests
. Corrosion Test

System Verification Testing

System verification tests were conducted for the subject device to verify the compatibility with compatible quidewires, introducer and accessory sheaths as well as to verify the force required to snap and unsnap the subject device and the compatible accessory sheath based on Baylis Medical Company Inc. requirements.

. Compatibility Test
. Snap Force Test

Biocompatibility Verification

Biological safety was evaluated for the subject device to verify compliance with the current applicable requirements of ISO 10993-1:2020 and the September 8, 2023 FDA quidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."

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

Biocompatibility verification of the subject VersaCross™ Connect Transseptal Dilator was conducted through adopted biological data of the predicate device VersaCross® Connect Transseptal Dilator (K220414).

Sterilization Verification

Sterilization and residual limit verification were evaluated for the subject device to verify compliance with the current applicable requirements of ISO 11135:2014/A1:2019 and ISO 10993-7:2008/A1:2022. Sterilization was performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6.

Pyrogen Testing

The subject device is supplied non-pyrogenic. Limulus Amoebocyte Lysate (LAL) testing was evaluated using the Kinetic Chromogenic method, as per ANSI/AAMI ST72:2019 and the FDA quidance document, "Guidance for Industry – Pyrogens and Endotoxins Testing: Questions and Answers," to verify the subject device meets current FDA and USP pyrogen limit specifications.

Packaging Verification

Ship testing was evaluated to verify the integrity of the subject device packaging through the rigors of shipping and handling as well as storage over time. The sterile barrier integrity was also evaluated to verify compliance with the current applicable requirements of ISO 11607-1:2020 over the proposed intended shelf life of the subject device.

Benchtop Validation

Customer requirements were validated through benchtop validation activities. Benchtop validation testing was performed to validate the performance of the subject device during normal intended use as per current applicable requirements of ISO 11070:2014/Amd.1:2018 and Baylis requirements.

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

The proposed VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities for safety and effectivenenss, along with the testing completed for the design changes demonstrated the subject device meets its intended use and is as safe, as effective, and performs in a manner that is substantially equivalent to the predicate device.

Conclusions

The subject and predicate devices share the same indications for use, intended use, and fundamental scientific technology, including principles of operation and mechanism of action. Differences between the subject and predicate devices do not raise new or different questions of safety and effectiveness. The results of verification and validation activities support substantial equivalence of the proposed VersaCross Connect™ Transseptal Dilator to the predicate device.

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).