(30 days)
Not Found
No
The device description and performance studies focus on the physical and mechanical properties of a steerable sheath, dilator, and guidewire. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is described as an introducer for catheters, not a device that directly treats a condition.
No
The device is indicated for introducing various cardiovascular catheters to the heart, which is a procedural/interventional function, not a diagnostic one.
No
The device description clearly details multiple physical components including a steerable sheath, transseptal dilator, and guidewire, made of materials like stainless steel, nylon, Pebax, HDPE, and PTFE. Performance studies also focus on physical and mechanical properties, packaging, and sterilization, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to introduce cardiovascular catheters to the heart. This is a procedural device used in vivo (within the body) to facilitate a medical procedure.
- Device Description: The description details a physical device (sheath, dilator, guidewire) designed for mechanical manipulation and access within the heart.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing. IVDs typically involve reagents, calibrators, controls, and analytical procedures performed in vitro.
This device is clearly a medical device used for interventional cardiology procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
Product codes (comma separated list FDA assigned to the subject device)
DYB
Device Description
The VersaCross Steerable Sheath kit is a sterile, single-use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The VersaCross Steerable Sheath kit is comprised of a steerable sheath, a transseptal dilator and a J-tip guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a Pebax distal tip. The sheath has a platinum/iridium marker band positioned near the distal tip to facilitate tracking and placement of the sheath under fluoroscopy during procedures. The sheath is finished at the proximal end with a hemostatic valve and two distal side ports and has a 3-way stopcock to facilitate the injection or aspiration of fluids. The sheath is available in three curve options (i.e. small, medium, and large) that can be deflected 90° counter-clockwise and 180° clockwise. The transseptal dilator is comprised of a high density polyethylene (HDPE) tube and a stainless steel hypotube. The dilator also has a tungsten coil positioned near the distal tip to facilitate tracking and placement of the dilator under fluoroscopy during procedures. The dilator has a tapered tip and a male luer hub connector at the proximal end for connection to the sheath. The Itip guidewire is comprised of stainless steel coated with polytetrafluoroethylene (PTFE).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopy
Anatomical Site
heart, including the left side of the heart through the interatrial septum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 VersaCross Steerable Sheath kit to support its safety and effectiveness with regards to the intended use as well as substantial equivalence to the predicate device. The following verifications and validations were completed to support the changes incorporated in the proposed device: Biocompatibility Verification, General Physical Verification, Mechanical Verification, Packaging Verification, Sterilization Verification, Bench Validation. The VersaCross Steerable Sheath kit met all requirements as specified by the test protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 17, 2019
Baylis Medical Company Inc. May Tsai Regulatory Affairs Manager 2580 Matheson Blvd. E Mississauga, Ontario L4W 4J1 Canada
Re: K190688
Trade/Device Name: VersaCross Steerable Sheath, VersaCross Transseptal Dilator Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: March 15, 2019 Received: March 18, 2019
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 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 medical devices and radiation-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 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190688
Device Name VersaCross Steerable Sheath VersaCross Transseptal Dilator
Indications for Use (Describe)
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
| 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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7. 510(k) Summary
7.1 Submitter Information
| A. Company Name: | Baylis Medical Company Inc. |
|---|---|
| B. Company Address: | 2580 Matheson Blvd. East |
| Mississauga, Ontario L4W 4J1 | |
| Canada | |
| C. Company Phone: | (905)602-4875 |
| D. Company Facsimile: | (905)602-5671 |
| E. Contact Person: | May Tsai |
| F. Summary Prepared on: | 15-Mar-2019 |
7.2 Device Identification
| A. Device Trade Name: | VersaCross Steerable Sheath
VersaCross Transseptal Dilator |
|-------------------------|---------------------------------------------------------------|
| B. Device Common Name: | Catheter introducer |
| C. Classification Name: | 21 CFR 870.1340, Catheter introduce r |
| D. Product Code: | DYB |
| E. Device Class: | Class II |
7.3 Identification of Predicate Device
The predicate for the VersaCross Steerable Sheath kit is listed in Table 1.
| Predicate Device | Manufacturer | Intended Use | 510(k) |
|---|---|---|---|
| SureFlex Steerable Guiding Sheath | Baylis Medical Company Inc. | Indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum | K122926 |
Table 1: Legally Marketed Predicate Device
4
7.4 Indications for Use
The VersaCross Steerable Sheath and VersaCross Transseptal Dilator is indicated for introducing various cardiovascular catheters to the heart, including the left side of the heart through the interatrial septum.
7.5 Device Description
The VersaCross Steerable Sheath kit is a sterile, single-use device designed for safe and easy catheterization and angiography of specific heart chambers and locations. The VersaCross Steerable Sheath kit is comprised of a steerable sheath, a transseptal dilator and a J-tip guidewire. The steerable sheath is comprised of a stainless steel braided nylon tube with a Pebax distal tip. The sheath has a platinum/iridium marker band positioned near the distal tip to facilitate tracking and placement of the sheath under fluoroscopy during procedures. The sheath is finished at the proximal end with a hemostatic valve and two distal side ports and has a 3-way stopcock to facilitate the injection or aspiration of fluids. The sheath is available in three curve options (i.e. small, medium, and large) that can be deflected 90° counter-clockwise and 180° clockwise. The transseptal dilator is comprised of a high density polyethylene (HDPE) tube and a stainless steel hypotube. The dilator also has a tungsten coil positioned near the distal tip to facilitate tracking and placement of the dilator under fluoroscopy during procedures. The dilator has a tapered tip and a male luer hub connector at the proximal end for connection to the sheath. The Itip guidewire is comprised of stainless steel coated with polytetrafluoroethylene (PTFE).
7.6 Comparison to Predicate Device
The characteristics of the proposed and predicate devices are compared in Table 2.
| Characteristic | Status |
|---|---|
| Intended Use | Identical |
| Indications for Use | Identical |
| Fundamental scientific technology | Identical |
| Operating principles | Identical |
| Mechanism of action | Identical |
| Materials | Similar |
| Key technological characteristics (e.g. dimensions) | Similar |
| Accessory devices | Identical |
| Packaging configuration | Similar |
| Environment of use | Identical |
| Sterility and Reusability | Identical |
| Sterilization method | Identical |
Table 2: Comparison between Characteristics of Proposed and Predicate Devices
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Performance Testing 7.7
Non-clinical performance testing was completed for the VersaCross Steerable Sheath kit to support its safety and effectiveness with regards to the intended use as well as substantial equivalence to the predicate device. The following verifications and validations were completed to support the changes incorporated in the proposed device:
-
- Biocompatibility Verification: The biological safety of the VersaCross Steerable Sheath kit was verified as per the requirements of ISO 10993-1:2009/Cor.1:2010 and FDA's modified ISO guidelines in accordance with the 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".
-
- General Physical Verification: General physical verification was performed to verify compliance of the VersaCross Steerable Sheath kit with ISO 11070:2014. ISO 594-1:1986, ISO 594-2:1998 and specified Baylis Medical requirements.
-
- Mechanical Verification: Mechanical verification was performed to verify compliance of the VersaCross Steerable Sheath kit with ISO 11070:2014 and specified Baylis Medical requirements.
-
- Packaging Verification: Ship testing verification was performed to ensure the integrity of the packaging of VersaCross Steerable Sheath kit through the rigors of shipping and handling. Stability testing was also completed to demonstrate the integrity of the primary packaging (i.e. sterile barrier) as per ANSI/AAMI/ISO 11607-1:2006 and ANSI/AAMI/ISO 11607-2:2006 over the proposed device shelf life.
-
- Sterilization Verification: Sterilization verification was performed to verify that the VersaCross Steerable Sheath kit is sterilized as per ISO 11135:2014 to a sterility assurance level of 10-6 and meets the requirements of ISO 10993-7:2008/Cor.1:2009.
-
- Bench Validation: Validation testing was completed to evaluate the performance of the kit during normal use as per specified Baylis Medical requirements. Testing was also completed to validate the radiopacity of the kit as per ISO 11070:2014.
The VersaCross Steerable Sheath kit met all requirements as specified by the test protocols.
l This document uses the term "substantial equivalence" as defined in 21 CFR 807.100 and not as defined in Title 35 of the U.S. Code. Any statement made in conjunction with this submission regarding substantial equivalence as well as any reference to features being "identical" with respect to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, ". . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without premarket approval or reclassification. The determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42.520 et seg. (1977).
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7.8 Conclusion
The proposed and predicate devices share the same intended use and fundamental scientific technology, including principles of operation and mechanism of action. Design and technological differences between the proposed and predicate devices do not raise any new concerns of safety and effectiveness. The results of verification and validation testing demonstrate that the VersaCross Steerable Sheath kit is as safe, as effective, and performs in a manner that is substantially equivalent to the predicate device.