(84 days)
No
The device description and performance studies focus on mechanical and physical properties, and there is no mention of AI or ML in the document.
No.
The device is designed to facilitate access to the left atrium and dilate an atrial septal defect, which are procedural steps, not a treatment for a disease or condition itself.
No
Explanation: The device is a transseptal dilator used to facilitate access to the left atrium and dilate the atrial septal defect. It is an interventional tool used during a procedure, not for diagnosing conditions.
No
The device description explicitly states it is comprised of physical components (Dilator and J-tipped Guidewire) and describes their physical properties and functions. The performance studies also focus on mechanical and physical testing.
Based on the provided information, the VersaCross Connect™ Transseptal Dilator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to facilitate access to the left atrium via a transseptal technique during medical procedures. This involves physically manipulating and dilating tissue within the body.
- Device Description: The device is a physical tool (dilator and guidewire) used for mechanical manipulation and guidance within the cardiovascular system.
- Mechanism of Action: The device works by providing support, guiding wires, and physically dilating the atrial septum. It does not analyze biological samples or provide diagnostic information based on in vitro testing.
- Anatomical Site: The device is used directly within the heart chambers and atrial septum. IVD devices typically interact with samples taken from the body (blood, urine, tissue, etc.).
In summary, the VersaCross Connect™ Transseptal Dilator is an invasive medical device used for a procedural purpose, not for diagnosing a condition by testing samples outside the 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 device is comprised of the following components, which are single-use and supplied sterile to the user:
- One Dilator
- One J-tipped Guidewire
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire).
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.
The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
imaging equipment, including fluoroscopy and echocardiography
Anatomical Site
left atrium, atrial septum, heart chambers
Indicated Patient Age Range
Not Found
Intended User / Care Setting
catheterization procedures primarily by Electrophysiologists and Interventional Cardiologists. 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)
Non-clinical performance testing was completed for the subject device to demonstrate its safety and effectiveness for its intended use and to support substantial equivalence to the predicate device. The following verification and validation activities were completed to support the device modifications:
Mechanical Testing: Mechanical verification was conducted for the subject device to verify with the compliance ISO 11070:2014/Amd.1:2018 and Baylis self-enforced 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
- Clamshell Tensile
- Clamshell Cantilever
General Physical Testing: General physical verification was conducted for the subject device to verify compliance with the applicable requirements of ISO 11070:2014/Amd.1:2018, ISO 80369-7, and Baylis self-enforced requirements. The following general physical tests were 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 guidewires, 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 self-enforced 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 4, 2020 FDA guidance document. Biocompatibility verification of the subject device was performed through adoption of biological data from Baylis Medical Company Inc.'s legally marketed devices; the predicate device ExpanSure Large Access Transseptal Dilator (K201288), reference devices VersaCross® Transseptal Sheath, dilator component (VCD) (K183655) and Portage Knot Pusher (component of legally marketed Portage System (K161878)).
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 and ISO 10993-7:2008/Cor.1:2009. Sterilization was performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6.
Pyrogen Testing: Limulus Amoebocyte Lysate (LAL) testing was evaluated using the Kinetic Chromogenic method, as per ANSI/AAMI ST72:2011/(R)2016 and the FDA guidance document, 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 seal strength and 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 11070:2014/Amd.1:2018 and Baylis self-enforced requirements.
The VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities 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
§ 870.1340 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 9, 2022
Baylis Medical Company Inc. May Tsai Director of Regulatory Affairs 5825 Explorer Dr. Mississauga, Ontario L4W 5P6 Canada
Re: K220414
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 11, 2022 Received: April 13, 2022
Dear May Tsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
2
Indications for Use
510(k) Number (if known) K220414
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)
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3
13. 510(K) SUMMARY (K220414)
Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 5825 Explorer Drive |
| Mississauga, Ontario L4W 5P6 | |
| Canada | |
| C. Company Phone: | (905) 602-4875 |
| D. Contact Person: | May Tsai |
| Director, Regulatory Affairs | |
| E. Date Summary Prepared: | 21-April-2022 |
Device Identification
| A. Device Trade Name: | VersaCross Connect™ Transseptal Dilator |
|---|---|
| B. Device Common Name: | Dilator, Vessel, For Percutaneous Catheterization |
| C. Classification Name: | CFR, 870.1310 - Dilator, Vessel, For |
| Percutaneous Catheterization | |
| D. Product Code: | DRE |
| E. Device Class: | Class II |
Identification of Legally Marketed Device
| Predicate Device | Manufacturer | 510(k) | Indications for Use |
|---|---|---|---|
| ExpanSure™ Large | |||
| Access Transseptal | |||
| Dilator | Baylis Medical | ||
| Company Inc. | K201288 | The ExpanSure Large Access | |
| Transseptal Dilator is indicated for | |||
| use in procedures where access to | |||
| the left atrium via the | |||
| transseptal technique is desired. |
Table 13.1: Predicate Device
4
This 510(k) is also citing the legally marketed VersaCross Transseptal Sheath, dilator component (VCD) (K183655) and Portage System, Portage Knot Pusher component (K161878) as reference devices to support material modifications in the subject device.
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 device is comprised of the following components, which are single-use and supplied sterile to the user:
- One Dilator
- One J-tipped Guidewire
The subject VersaCross Connect™ Transseptal Dilator represents modifications made to the legally marketed ExpanSure™ Large Access Transseptal Dilator (K201288) (comprising a dilator and J-tipped Guidewire).
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.
The dilator can be used with separately cleared compatible introducer/access sheaths such as WATCHMAN™ Access sheaths. 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. It is used in catheterization procedures primarily by Electrophysiologists and Interventional Cardiologists. Procedures using the devices are performed in fully equipped catheter labs with imaging equipment, including fluoroscopy and echocardiography under sterile technique.
Comparison to Predicate Device
The intended use and indications for use of the of the VersaCross Connect™ Transseptal Dilator remains unchanged from the ExpanSure™ Large Access Transseptal Dilator (K201288).
The subject and predicate devices also share the same fundamental scientific technology, including principles of operation and mechanism of action.
5
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 provide reasonable assurance of substantial equivalence of the VersaCross Connect™ Transseptal Dilator with the predicate device.
| Characteristic | Subject Device Compared to
Predicate ExpanSure™ Large
Access Transseptal
Dilator (K201288) |
|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended Use | Identical |
| Indications for Use | Identical |
| Fundamental scientific technology | Identical |
| Operating principles | Identical |
| Mechanism of action | Identical |
| Technological characteristics
(Materials, dimensions, design) | Similar |
| Packaging configuration | Identical |
| Sterilization method | Identical |
Table 13.2: Comparison of Subject and Predicate Device
Performance Testing
Non-clinical performance testing was completed for the subject device to demonstrate its safety and effectiveness for its intended use and to support substantial equivalence to the predicate device. The followinq verification and validation activities were completed to support the device modifications:
Mechanical Testing
Mechanical verification was conducted for the subject device to verify with the compliance ISO 11070:2014/Amd.1:2018 and Baylis self-enforced 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 .
- Clamshell Tensile ●
- . Clamshell Cantilever
6
General Physical Testing
General physical verification was conducted for the subject device to verify compliance with the applicable requirements of ISO 11070:2014/Amd.1:2018, ISO 80369-7, and Baylis self-enforced requirements. The following general physical tests were 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 selfenforced 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 4, 2020 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." Biocompatibility verification of the subject device was performed through adoption of biological data from Baylis Medical Company Inc.'s legally marketed devices; the predicate device ExpanSure Large Access Transseptal Dilator (K201288), reference devices VersaCross® Transseptal Sheath, dilator component (VCD) (K183655) and Portage Knot Pusher (component of legally marketed Portage System (K161878)).
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 and ISO 10993-7:2008/Cor.1:2009. 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 ST72:2011/(R)2016 and the FDA guidance document, "Guidance for Industry – Pyrogens and Endotoxins Testing: Questions and
7
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 seal strength and 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 11070:2014/Amd.1:2018 and Baylis self-enforced requirements.
The VersaCross Connect™ Transseptal Dilator met all test requirements as specified by applicable standards and test protocols. The verification and validation activities 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 in technological characteristics 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 VersaCross Connect™ Transseptal Dilator to the predicate device.