(30 days)
No
The device description and performance studies indicate it is a mechanical medical instrument for transseptal procedures, with no mention of AI, ML, or data processing capabilities that would suggest an AI model.
No
The device is a dilator used to facilitate access to the left atrium. It is a tool for a procedure, not a device that provides therapy itself.
No
The device is a dilator used to facilitate access to the left atrium and guide other devices. It is not described as providing diagnostic information.
No
The device is a physical medical instrument (dilator) designed for use in transseptal procedures. Its description details its physical characteristics, materials, and mechanical functions. The performance studies also focus on physical and material properties (e.g., torque transmission, rigidity, biocompatibility, sterilization) rather than software performance.
No.
The device is a transseptal dilator used for physical access to the left atrium. It is an invasive surgical tool and not used for in vitro diagnostic testing on specimens derived from the human body.
N/A
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.
Product codes
DRE
Device Description
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) is a single-use device that is supplied sterile to the user.
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).
The VersaCross Connect™ Transseptal Dilator (VXA-AG) 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.
The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy and echocardiography
Anatomical Site
left atrium, atrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Applicable non-clinical performance verification and validation were completed to demonstrate safety and effectiveness and substantial equivalence of the subject device to the predicate device. All design requirements were met as per applicable standards and test protocols. The following verification and validation activities were completed to demonstrate the safety and effectiveness of the subject device:
Design Requirements Verification: Applicable design 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, ISO 80369-20:2015 and Baylis Medical Company Inc. to verify the functional, performance, product interface and compatibility design requirements for the device. The following design requirements have been verified:
- Torque Transmission
- Dilator Protrusion Length
- Aggregate Curve Reach
- Shaft Outer Diameter
- Snap Force
- Accessory Sheath Compatibility
- Guidewire Compatibility
- Shapeability
- Corrosion
- Luer Tests
- Torque Withstand
- Flexural Rigidity
- Curve Retention
- Hub-Shaft Tensile
- Tip to Tip Cap Cantilever and Tensile
- Clamshell Tensile
- Clamshell Cantilever
- Air and Liquid Leakage
Biocompatibility Verification: Biological safety was evaluated for the subject device to verify compliance with the current applicable requirements of ISO 10993-1:2018 and the September 8, 2023 FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Biocompatibility verification of the subject VersaCross Connect™ Transseptal Dilator was conducted through adopted biological data of the predicate device VersaCross Connect™ Transseptal Dilator (K241720).
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/A1:2018 and ISO 10993-7:2008/A1:2019. 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 guidance 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 ISO 11607-1:2019 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.
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 effectiveness, 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
FDA 510(k) Clearance Letter - VersaCross Connect™ Transseptal Dilator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 29, 2025
Baylis Medical Company, Inc.
Ezgi Tas
Regulatory Affairs Specialist
5825 Explorer Drive
Mississauga, ON L4W5P6
Canada
Re: K251325
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: April 28, 2025
Received: April 29, 2025
Dear Ezgi Tas:
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"
Page 2
K251325 - Ezgi Tas
Page 2
(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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
K251325 - Ezgi Tas
Page 3
Sincerely,
Katherine N. Trivedi -S
Katherine Trivedi
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
Enclosure
Page 4
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known): K251325
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):
☒ 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."
Page 5
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 1
13. 510(K) SUMMARY
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 5825 Explorer Drive
Mississauga, Ontario L4W 5P6
Canada
C. Company Phone: +1 (905) 602-4875
D. Contact Person: Ezgi Tas
Regulatory Affairs Specialist, III
E. Date Summary Prepared: 28-April-2025
Device Identification
A. Device Trade Name: VersaCross Connect™ Transseptal Dilator
B. Device Common Name: Dilator
C. Classification Name: CFR 870.1310 – Vessel dilator for percutaneous catheterization
D. Product Code: DRE
E. Device Class: Class II
Page 6
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 2
Identification of Legally Marketed Device
Table 13.1: Predicate Device
| Predicate Device | Manufacturer | 510(k) | Indications for Use |
|---|---|---|---|
| VersaCross Connect™ Transseptal Dilator | Baylis Medical Company Inc. | K241720 | The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired. |
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 (VXA-AG) is a single-use device that is supplied sterile to the user.
The subject VersaCross Connect™ Transseptal Dilator (VXA-AG) represents modifications to the legally marketed VersaCross Connect™ Transseptal Dilator (K241720).
The VersaCross Connect™ Transseptal Dilator (VXA-AG) 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.
The dilator can be used with separately cleared compatible access sheaths such as Agilis™ NxT Steerable Introducer (K061363 or K081645). The dilator provides support and helps guide 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.
Page 7
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 3
Comparison of Characteristics with Predicate Device
The intended use and indications for use of the proposed VersaCross Connect™ Transseptal Dilator (VXA-AG) remains unchanged from the predicate VersaCross Connect™ Transseptal Dilator (K241720). The subject and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action, environment of use, packaging configuration and sterilization method. The changes between the predicate and subject devices include design, non-patient contacting material, and associated labeling changes.
Differences in technological characteristics 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 support substantial equivalence of the proposed VersaCross Connect™ Transseptal Dilator with the predicate device.
Table 13.2: Comparison of Subject and Predicate Devices
| Characteristic | Subject Device Compared to Predicate VersaCross Connect™ Transseptal Dilator (K241720) | Comment |
|---|---|---|
| Intended Use/Indications for Use | Identical | Both subject and predicate device are indicated for use in procedures where access to the left atrium via the transseptal technique is desired. |
| Fundamental scientific technology | Identical | Both subject and predicate device rely on transfer of mechanical force to achieve tissue dilation. |
| Operating principles | Identical | The operation principle for both subject and predicate device is the transfer of mechanical force to achieve tissue dilation. |
| Mechanism of action | Identical | Both subject and predicate device dilate tissue to achieve its intended use. |
| Environment of Use | Identical | Both the predicate and subject device are used in facilities equipped with staff to perform diagnostic and interventional procedures. |
| Material | Patient contacting: Identical | |
| Non-patient contacting: Similar | Both the predicate and subject device contain the same patient contacting materials. | |
| Both the predicate and subject device contain similar non-patient contacting materials. |
Page 8
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 4
| Characteristic | Subject Device Compared to Predicate VersaCross Connect™ Transseptal Dilator (K241720) | Comment |
|---|---|---|
| Technological characteristics (dimensions, design) | Similar | Both the predicate and subject device share the same fundamental design. The subject device differs from the predicate device as follows: |
| • Device hub color change | ||
| • Dilator shaft dimensional changes | ||
| • Snap fit hub geometry and hub length | ||
| Labelling | Similar | The subject device labelling has modifications to reflect the associated changes in design: |
| • Updates to identify the compatible access sheaths, model numbers and device specifications | ||
| Packaging configuration | Identical | The predicate and subject device contain the same packaging configuration (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 Verification and Validation
Applicable non-clinical performance verification and validation were completed to demonstrate safety and effectiveness and substantial equivalence of the subject device to the predicate device. All design requirements were met as per applicable standards and test protocols. The following verification and validation activities were completed to demonstrate the safety and effectiveness of the subject device:
Design Requirements Verification
Applicable design 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, ISO 80369-20:2015 and Baylis Medical Company Inc. to verify the functional, performance, product interface and compatibility design requirements for the device. The following design requirements have been verified:
- Torque Transmission
- Dilator Protrusion Length
- Aggregate Curve Reach
- Shaft Outer Diameter
- Snap Force
- Accessory Sheath Compatibility
Page 9
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 5
- Guidewire Compatibility
- Shapeability
- Corrosion
- Luer Tests
- Torque Withstand
- Flexural Rigidity
- Curve Retention
- Hub-Shaft Tensile
- Tip to Tip Cap Cantilever and Tensile
- Clamshell Tensile
- Clamshell Cantilever
- Air and Liquid Leakage
Biocompatibility Verification
Biological safety was evaluated for the subject device to verify compliance with the current applicable requirements of ISO 10993-1:2018 and the September 8, 2023 FDA guidance document, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Biocompatibility verification of the subject VersaCross Connect™ Transseptal Dilator was conducted through adopted biological data of the predicate device VersaCross Connect™ Transseptal Dilator (K241720).
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/A1:2018 and ISO 10993-7:2008/A1:2019. 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 guidance 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 ISO 11607-1:2019 over the proposed intended shelf life of the subject device.
Page 10
VersaCross Connect™ Transseptal Dilator
Baylis Medical Company Inc.
Special 510(k)
013-Page 6
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.
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 effectiveness, 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. Technological 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.