(28 days)
The VersaCross Connect™ Transseptal Dilator is indicated for use in procedures where access to the left atrium via the transseptal technique is desired.
The subject VersaCross Connect™ Transseptal Dilator is a single-use device that is supplied sterile to the user. 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 guidewire 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. The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). 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 provided document is an FDA 510(k) clearance letter for the VersaCross Connect™ Transseptal Dilator. It primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Crucially, this document does not describe a study involving "acceptance criteria" for an AI/ML powered device, nor does it detail a study proving such a device meets these criteria.
The device in question, the VersaCross Connect™ Transseptal Dilator, is a mechanical medical device (a vessel dilator), not an AI/ML-powered one. The testing described is typical for a mechanical device and includes:
- Mechanical Testing: Torque Transmission, Torque Withstand, Flexural Rigidity, Shapeability, Curve Retention, Hub-Shaft Tensile, Tip to Tip Cap Cantilever and Tensile, Clamshell Tensile, Clamshell Cantilever.
- General Physical Testing: Luer Tests, Air and Liquid Leakage Tests, Corrosion Test.
- System Verification Testing: Compatibility Test, Snap Force Test.
- Biocompatibility Verification: Evaluated through adopted biological data of the predicate device (K220414).
- Sterilization Verification: Ethylene Oxide sterilization to a SAL of 10-6.
- Pyrogen Testing: Limulus Amoebocyte Lysate (LAL) testing.
- Packaging Verification: Ship testing and sterile barrier integrity.
- Benchtop Validation: To validate performance during normal intended use.
Therefore, I cannot extract the information required to populate the requested table and answer the questions about AI/ML device acceptance criteria and study details from the provided text.
The document states: "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." This is the general statement of compliance, but it does not provide specific acceptance criteria values or performance metrics in a tabulated format that would be relevant for an AI/ML device.
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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.
July 12, 2024
Baylis Medical Company, Inc. Ezgi Tas Regulatory Affairs Specialist, III 5825 Explorer Drive Mississauga, ON L4W5P6 Canada
Re: K241720
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: June 13, 2024 Received: June 14, 2024
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"
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(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 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 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-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
Katherine Trivedi Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241720
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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13. 510(K) SUMMARY
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: | Ezgi TasRegulatory Affairs Specialist, III |
| E. Date Summary Prepared: | 13-June-2024 |
Device Identification
| A. Device Trade Name: | VersaCross Connect™ TM 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 |
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Identification of Legally Marketed Device
| PredicateDevice | Manufacturer | 510(k) | Indications for Use |
|---|---|---|---|
| VersaCrossConnect™TransseptalDilator | Baylis MedicalCompany Inc. | K220414 | The VersaCross Connect™Transseptal Dilator is indicatedfor use in procedures whereaccess to the left atrium via thetransseptal technique is desired. |
| Table 13.1: Predicate Device | ||
|---|---|---|
| -------------------------------- | -- | -- |
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 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 guidewire 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.
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The dilator can be used with separately cleared compatible access sheaths such as CARTO VIZIGO™ Bi-Directional Guiding Sheath (K231412). 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.
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.
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.
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| Characteristic | Subject DeviceCompared to PredicateVersaCross Connect™Transseptal Dilator(K220414) | Comment |
|---|---|---|
| IntendedUse/Indicationsfor Use | Identical | Both subject and predicate device areindicated for use in procedures whereaccess to the left atrium via thetransseptal technique is desired. |
| Fundamentalscientifictechnology | Identical | Both subject and predicate device relyon transfer of mechanical force toachieve tissue dilation. |
| Operatingprinciples | Identical | The principles of operation for bothsubject and predicate device is thetransfer of mechanical force to achievetissue dilation. |
| Mechanism ofaction | Identical | Both subject and predicate devicedilate tissue to achieve its intendeduse. |
| Environment ofUse | Identical | Both the predicate and subject deviceare used in facilities equipped withstaff to perform diagnostic andinterventional procedures. |
| Technologicalcharacteristics(Material,dimensions,design) | Similar | Both the predicate and subject deviceshare the same fundamental design.The subject device differs from thepredicate device as follows:• Dilator shaft extrusion material• Dilator shaft and tip taperdimensions• Only D1 curve option; changesto curve radius/angle and reach |
| Snap fit hub geometry and hub length No guidewire supplied with dilator | ||
| 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 |
Table 13.2: Comparison of Subject and Predicate Device
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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 safety and effectiveness of the subject device:
Mechanical Testing
Mechanical verification was conducted for the subject device to ensure compliance with the of ISO 11070:2014/Amd.1:2018 and Baylis Medical Company Inc. requirements. The following mechanical tests were performed:
- . Torque Transmission
- . Torque Withstand
- Flexural Rigidity ●
- . Shapeability
- . Curve Retention
- Hub-Shaft Tensile ●
- . Tip to Tip Cap Cantilever and Tensile
- Clamshell Tensile
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- . Clamshell Cantilever
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 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 10993-1:2018 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 (K220414).
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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 BS EN 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 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 BS EN 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.
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
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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.
§ 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).