(144 days)
Not Found
No
The description focuses on the mechanical components and intended use of a standard introducer sheath and does not mention any AI/ML capabilities or image processing beyond standard imaging modalities.
No
The device is described as an introducer catheter that facilitates the delivery of other catheters and guidewires into the heart chambers. It does not actively treat a disease or condition itself.
No
Explanation: The device is an introducer sheath used for the percutaneous introduction of other cardiovascular catheters and guidewires. Its function is to facilitate access to heart chambers for procedures, not to diagnose medical conditions.
No
The device description clearly states it is comprised of a sheath, dilator, and guidewire, which are physical components, not software. The performance studies also focus on mechanical and physical testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The VersaCross Transseptal Sheath is described as a device for the introduction of catheters and guidewires into the heart chambers. It is a tool used during a medical procedure to access anatomical locations. It does not perform any tests on bodily samples.
- Procedure Type: The procedures described are catheterization and angiography, which are interventional procedures performed directly on the patient, not laboratory tests on samples.
Therefore, the VersaCross Transseptal Sheath is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VersaCross Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
Product codes
DYB
Device Description
The VersaCross™ Transseptal Sheath is a sterile, single-use introducer catheter The device is comprised of a sheath (VersaCross™ Sheath), a dilator device. (VersaCross™ Dilator) and a j-tipped quidewire.
The VersaCross™ Transseptal Sheath is designed for catheterization and angiography of specific heart chambers and locations. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
all heart chambers, including the left atrium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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.
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
Bench-top Validation: Bench-top validation testing was conducted to assess valve durability of the sheath, radiopacity, compatibility with other devices and to evaluate the design and function.
Mechanical Testing: Performed to ensure compliance with ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. Tests included Torque Transmission, Shaft Stiffness Bend, Tip Stiffness, Air and Liquid Leakage (Sheath and Hemostasis Valve), Tensile Tests, Cap Integrity Tests, Valve Insertion Force, Snap Force, Strength of Union Torque Withstand, Strength of Union Pull Test Hub to Body, and Flexural Rigidity.
General Physical Testing: Performed to ensure compliance with ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. Tests included Curve Relaxation, Surface Defects, Corrosion Resistance, Shaft Lubricity, Coating Particulate, Air Leakage, Liquid Leakage, Shapeability, Luer Tests, and Corrosion Resistance.
Biocompatibility Verification: Verified in accordance with ISO 10993-1:2009/Cor.1:2010 and the June 16, 2016 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".
Sterilization Verification: Completed to the requirements of ISO 11135-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008/Cor.1:2009.
Packaging: Ship testing performed to ensure integrity of device packaging. Seal strength and sterile barrier integrity validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over proposed shelf life.
Pyrogen Testing: LAL testing using the Kinetic Chromogenic method conducted to ensure the device meets current FDA and USP pyrogen limit specifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 20, 2019
Baylis Medical Company Inc. Meghal Khakhar VP, Regulatory and Scientific 2645 Matheson Blvd. East Mississauga, L4W 4J1 Canada
Re: K183655
Trade/Device Name: VersaCross Transseptal Sheath Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 24, 2019 Received: April 25, 2019
Dear Ms. Khakhar:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Nicole Ibrahim 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) K183655
Device Name VersaCross Transseptal Sheath
Indications for Use (Describe)
The VersaCross Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
| 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) |
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510(K) SUMMARY
Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 2580 Matheson Blvd. East |
| Mississauga, Ontario, L4W 4J1 | |
| Canada | |
| C. Company Phone: | +1 (905) 602-4875 |
| D. Company Facsimile: | +1 (905) 602-5671 |
| E. Contact Person: | Meghal Khakhar |
| VP, Regulatory & Scientific Affairs | |
| F. Summary Prepared on: | 19-DEC-2018 |
Device Identification
| A. Device Trade Name: | VersaCross™ Transseptal Sheath |
|---|---|
| B. Device Common Name: | Introducer Sheath kit |
| C. Classification Name: | Introducer, Catheter (21 CFR 870.1340) |
| D. Product Code: | DYB |
| E. Review Panel: | Cardiovascular |
| F. Device Class: | Class II |
Identification of Legally Marketed Device
| A. Predicate Device: | TorFlex Transseptal Guiding Sheath |
|---|---|
| B. Manufacturer: | Baylis Medical Company Inc. |
| C. 510(k) | K102948 |
| D. Indications for Use | The TorFlex™ Transseptal Guiding Sheath is used for |
| the percutaneous introduction of various types of | |
| cardiovascular catheters to all heart chambers | |
| including the left atrium via transseptal perforation / |
puncture.
Indications for Use
The VersaCross™ Transseptal Sheath is used for the percutaneous introduction of various types of cardiovascular catheters and guidewires to all heart chambers, including the left atrium via transseptal perforation / puncture.
4
Device Description
The VersaCross™ Transseptal Sheath is a sterile, single-use introducer catheter The device is comprised of a sheath (VersaCross™ Sheath), a dilator device. (VersaCross™ Dilator) and a j-tipped quidewire.
The VersaCross™ Transseptal Sheath is designed for catheterization and angiography of specific heart chambers and locations. 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 for the VersaCross™ Transseptal Sheath remains unchanged from the predicate TorFlex™ Transseptal Guiding Sheath (K102948). The indications for use of the subject device is identical to that of the predicate except for the addition of quidewires in addition to cardiovascular catheters as devices that can be introduced to the heart. This difference provides clarification only and does not change the intended use of the subject device as compared to the predicate device.
The proposed and predicate devices share the same fundamental scientific technology, including principles of operation and mechanism of action (see Table 11.1 below). The differences in design and technological characteristics between the proposed and predicate devices do not raise different questions of safety and effectiveness. The results of verification and validation testing provide reasonable assurance of substantial equivalence of the VersaCross™ Transseptal Sheath with the predicate device.
| Characteristic | Comparison Results |
|---|---|
| Intended Use | Identical |
| Indications for Use | Similar |
| Fundamental Scientific Technology | Identical |
| Operating Principles | Identical |
| Mechanism of Action | Identical |
| Materials | Similar |
| Technological Aspects | Similar |
| Packaging and Sterilization | Identical |
Table 11.1: Comparison of Subject and Predicate Device
Performance Testing Summary
Performance Testing has been completed to demonstrate substantial equivalence of the subject device and predicate device. All test requirements were met as specified by applicable standards and the test protocols. The device was subjected to the following verification and validation activities.
Mechanical Testing
Mechanical verification testing was conducted for the subject VersaCross™ Transseptal Sheath to ensure compliance with the requirements of ISO
5
11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following tests were performed:
- . Sheath Mechanical Tests:
- Torque Transmission + Hub to Shaft Joint Torque o
- Shaft Stiffness Bend O
- Tip Stiffness o
- Air and Liquid Leakage Sheath o
- Air and Liquid Leakage Hemostasis Valve O
- Tensile Tests O
- Cap Integrity Tests O
- Valve Insertion Force O
- Snap Force O
- Dilator Mechanical Tests: .
- o Torque Transmission
- Strength of Union Torque Withstand O
- Strength of Union Pull Test Hub to Body о
- o Flexural Rigidity
General Physical Testing
General physical verification testing was conducted for the subject VersaCross™ Transseptal Sheath to ensure compliance with ISO 11070:2014 and Baylis Medical Company Inc. self-enforced requirements. The following tests were performed:
- . Sheath General Physical Tests:
- o Curve Relaxation
- Surface Defects o
- o Corrosion Resistance
- Shaft Lubricity o
- Coating Particulate O
- Dilator General Physical Tests:
- Air Leakage O
- Liquid Leakage O
- Shapeability O
- O Luer Tests
- Corrosion Resistance O
Biocompatibility Verification
The biological safety of the subject VersaCross™ Transseptal Sheath was verified in accordance with the requirements of ISO 10993-1:2009/Cor.1:2010 and the June 16, 2016 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".
Sterilization Verification
Sterilization verification was completed for the subject VersaCross™ Transseptal Sheath to the requirements of ISO 11135-1:2014. Sterilization is performed with Ethylene Oxide to a Sterility Assurance Level (SAL) of 10-6. Residual limits are in accordance with ISO 10993-7:2008/Cor.1:2009.
.
6
Packaging
Ship testing was performed to ensure the integrity of the device packaging through the rigors of shipping and handling. The seal strength and sterile barrier integrity was validated per ANSI/AAMI/ISO 11607:2006 (Parts 1 and 2) over the proposed shelf life of the device.
Pyrogen Testing
The subject VersaCross™ Transseptal Sheath is supplied non-pyrogenic. LAL testing using the Kinetic Chromogenic method was conducted to ensure the device meets current FDA and USP pyrogen limit specifications.
Bench-top Validation
Bench-top validation testing was conducted to assess valve durability of the sheath, radiopacity, compatibility with other devices and to evaluate the design and function.
Conclusion
The intended use and fundamental scientific technology, including principles of operation and mechanism of action, of the subject VersaCross™ Transseptal Sheath remain unchanged from the predicate TorFlex™ Transseptal Guiding Sheath (K102948). Differences in design and technological characteristics do not raise any different questions of safety and effectiveness. The results of verification and validation activities support the substantial equivalence of the subject VersaCross™ Transseptal Sheath to the predicate device.