(30 days)
The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.
The QuikPass Catheter is comprised of a proximal end containing a Luer connection and hub, a single-lumen shaft with radiopaque markers at the distal end, and a tapered distal tip with oval ports at 60° intervals. The single-lumen shaft of the QuikPass Catheter is constructed of two polymer layers that encapsulate a braid and coil affording increased tensile strength and torque transmission. The distal 40cm of the catheter has a hydrophilic coating to aid in navigating the device through the vasculature to the target location. The QuikPass Catheter is available in both 3 French and 4 French outer diameter sizes. Each version is available in 135cm and 150cm lengths, providing a total of four models. All models of the QuikPass Catheter are sold sterile. Sterility is achieved using ethylene oxide.
The provided text is a 510(k) summary for the QuikPass Catheter, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device (Turnpike® Catheter) rather than proving the device meets specific acceptance criteria through a clinical study involving AI or human reader performance.
Therefore, the information required to answer your questions regarding acceptance criteria and a study that proves the device meets them (especially those related to AI, human reader performance, ground truth, and expert adjudication) is not present in the provided document.
The document primarily describes:
- Device description and indications for use: The QuikPass Catheter is for accessing coronary/peripheral vasculature, facilitating guidewire placement/exchange, and delivering contrast media.
- Comparison to a predicate device: It highlights similarities in design, materials, and intended use, arguing that differences do not raise new questions of safety or effectiveness.
- Non-clinical performance data: It lists various bench tests (biocompatibility, sterilization, shelf-life, packaging, and general catheter performance like kink resistance, lubricity, radiopacity) that were performed to support substantial equivalence. These are standard engineering and material tests for medical devices, not clinical effectiveness studies.
In summary, there is no discussion of an AI algorithm, human-in-the-loop performance, expert readers, ground truth establishment for a test set, or MRMC studies in this regulatory filing. The acceptance criteria mentioned are related to engineering and material performance specifications for the catheter itself, not diagnostic performance based on AI or human interpretation of images.
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January 28, 2022
Traverse Vascular, Inc. % Prithul Bom Most Repsonsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K214106
Trade/Device Name: QuikPass Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: December 28, 2021 Received: December 29, 2021
Dear Prithul Bom:
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 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
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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 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.
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices 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) K214106
Device Name QuikPass™ Catheter
Indications for Use (Describe)
The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.
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
510(k) Number: K214106
Date Prepared: December 24, 2021
Table 1. Submitter Information
| Manufacturer of Record: | Manufacturer's Contact Person: |
|---|---|
| Traverse Vascular, Inc.535 Stevens Ave. WestSolana Beach, CA 92075 | Greg GeissingerRegulatory Affairs Consultant |
| Phone: (858) 349-8839 | |
| Email: GJGeissinger@hotmail.com |
| Trade Name: | QuikPass™ Catheter |
|---|---|
| Device Common Name: | Catheter, Percutaneous |
| Classification Name: | Percutaneous Catheter |
| Regulatory Classification: | Class II |
| Device Panel: | Cardiovascular |
| Regulation Number | 21 CFR 870.1250 |
| Product Code: | DQY |
Table 2. Device Information
The QuikPass Catheter is comprised of similar materials and is of similar design to the corresponding components of the previously cleared predicate, Turnpike® Catheter (Table 3). The subject and predicate devices share similar technical requirements, perform as intended, and present no unacceptable risks to the intended patient population or end user.
Table 3. Predicate Device
| Predicate Device | Manufacturer | FDA 510(k) |
|---|---|---|
| Turnpike® Catheter | Vascular Solutions, Inc.(now Teleflex, Inc.) | K142065 |
1 Device Description
The QuikPass Catheter is comprised of a proximal end containing a Luer connection and hub, a single-lumen shaft with radiopaque markers at the distal end, and a tapered distal tip with oval ports at 60° intervals.
The single-lumen shaft of the QuikPass Catheter is constructed of two polymer layers that encapsulate a braid and coil affording increased tensile strength and torque transmission. The distal 40cm of the catheter has a hydrophilic coating to aid in navigating the device through the vasculature to the target location.
The QuikPass Catheter is available in both 3 French and 4 French outer diameter sizes. Each version is available in 135cm and 150cm lengths, providing a total of four models. A list of available model numbers is provided in Table 4 below.
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| Model Number | Size | Working Length |
|---|---|---|
| 135-03 | 3 Fr | 135 cm |
| 135-04 | 4 Fr | 135 cm |
| 150-03 | 3 Fr | 150 cm |
| 150-04 | 4 Fr | 150cm |
Table 4. Available Model Numbers
All models of the QuikPass Catheter are sold sterile. Sterility is achieved using ethylene oxide. An image of the QuikPass Catheter is provided in Figure 1.
Image /page/4/Picture/5 description: The image shows a close-up of a metallic, cylindrical object, possibly a pipe or a rod. The object has a smooth, reflective surface with some dark markings or indentations along its length. The object appears to be slightly bent or curved, and the lighting suggests a studio or controlled environment.
Figure 1. QuikPass Catheter
2 Indications for Use
The QuikPass Catheter is intended to be used to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and is also intended to assist in the delivery of contrast media into the coronary and/or peripheral vasculature.
3 Comparison of Technological Characteristics with the Predicate Device
The subject and predicate devices are based on the same technological elements of using a single-lumen catheter to achieve the desired vascular access to place or exchange guidewires and to deliver diagnostic agents such as contrast media. The catheter designs are similar, come in identical working lengths, and have similar outer diameter models available.
The subject and predicate devices are both compatible with ≥ 6 French guide catheters and 0.014" guidewires. The subject and predicate devices are both sold sterile and have similar indications for use. A detailed summary of substantial equivalence between the subject and predicate devices is provided in Table 5 below.
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| Description | Subject Device | Predicate Device (K142065) | Conclusion |
|---|---|---|---|
| Product Name | QuikPass Catheter | Turnpike® Catheter | |
| Manufacturer | Traverse Vascular, Inc. | Vascular Solutions, Inc.(now Teleflex, Inc.) | |
| 510(k) Number | To be determined | K142065 | |
| Classification | Class II | Class II | Identical |
| Product Code /Regulation | DQY / 21 CFR 870.1250 | DQY / 21 CFR 870.1250 | Identical |
| Indications forUse | The QuikPass Catheter is intended tobe used to access discrete regions ofthe coronary and/or peripheralvasculature. It may be used tofacilitate placement and exchange ofguidewires and is also intended toassist in the delivery of contrastmedia into the coronary and/orperipheral vasculature. | The Turnpike catheter isintended to be used to accessdiscrete regions of the coronaryand/or peripheral vasculature. Itmay be used to facilitate placementand exchange of guidewires and tosubselectively infuse/deliverdiagnostic and therapeutic agents. | Similar; the subject deviceindications for use arenarrower than those of thepredicate. There aretherefore no new questionsof safety or effectiveness. |
| CatheterComponents | Proximal hub with Luer connection | Proximal hub with Luer connection | Identical |
| Single-lumen shaft constructed oftwo polymer layers encapsulating abraid and coil and having ahydrophilic coating | Single-lumen shaft constructed oftwo polymer layers encapsulating abraid and coil and having ahydrophilic coating | Identical | |
| Radiopaque distal markers and portsfor guidewire passage and solutioninfusion | Radiopaque distal tip with outlet forguidewire passage and solutioninfusion | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness | |
| AvailableModels, Sizes,and WorkingLength | Model #135-03: 3 Fr; 135cmModel #135-04: 4 Fr; 135cmModel #150-03: 3 Fr; 150cmModel #150-04: 4 Fr; 150cm | Model #5642: 3 Fr; 135cmModel #5643: 3 Fr; 150cm | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Labeled ShaftOuter Diameter | Model #135-03: 2.95 Fr (0.98mm)Model #135-04: 3.95 Fr (1.32mm)Model #150-03: 2.95 Fr (0.98mm)Model #150-04: 3.95 Fr (1.32mm) | Model #5642: 2.9 Fr (0.97mm)Model #5643: 2.9 Fr (0.97mm) | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Labeled ShaftInner Diameter | Model #135-03: 2.10 Fr (0.70mm)Model #135-04: 3.10 Fr (1.04mm)Model #150-03: 2.10 Fr (0.70mm)Model #150-04: 3.10 Fr (1.04mm) | Model #5642: 1.26 Fr (0.42mm)Model #5643: 1.26 Fr (0.42mm) | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Distal Tip Shape | Smooth, Rounded, Tapered | Smooth, Rounded, Tapered | Identical |
| Description | Subject Device | Predicate Device (K142065) | Conclusion |
| Distal TipLength | 4-6mm | 8-10mm | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Distal TipInner/OuterDiameter | OD: 1.8 Fr (0.6mm)ID: 1.2 Fr (0.4mm) | OD: 1.6 Fr (0.53mm)ID: 1.25 Fr (0.42mm) | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| HydrophilicCoatingMaterial,Location,Length, andFunction | Hydrogel polymer, distal shaft,40cm in length, lubricious coating | Hydrogel polymer, distal shaft,60cm in length, lubricious coating | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Intended PatientPopulation | Intended for use in adults (greaterthan 21 years of age) | Intended for use in adults (greaterthan 21 years of age) | Identical |
| CompatibleGuidewireDiameter | 0.014" | ≤ 0.014" | Similar; compatibleguidewire diameter for thesubject device falls withinthe labeled range for thepredicate device |
| CompatibleGuide CatheterSize | ≥ 6 Fr (≥ 1.78mm ID) | ≥ 5 Fr (≥ 1.42mm ID) | Similar; compatible guidecatheter diameter for thesubject device falls withinthe labeled range for thepredicate device |
| Catheter Images | Image: 3FR CATHETERS | Image: Catheter | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| Materials ofConstruction(PatientContacting) | Pebax ShaftMetallic Braid & CoilPolycarbonate LuerLoctite Adhesive | Pebax ShaftMetallic Braid & CoilPolycarbonate LuerLoctite Adhesive | Similar (exact predicateformulations unknown);minor design differences donot raise new questions ofsafety or effectiveness |
| Distal TipMaterial | Tungsten-loaded 35D Pebax | Tungsten loaded polymer (exactcomposition and durometerunknown) | Similar (exact predicateformulations unknown);minor design differences donot raise new questions ofsafety or effectiveness |
| Shaft Material | Pebax 72D = proximalPebax 45D = mid shaftPellethane 80A = distal shaft | Polymer jacket (exact compositionand durometer unknown) | Similar (exact predicateformulations unknown);minor design differences donot raise new questions ofsafety or effectiveness |
| Description | Subject Device | Predicate Device (K142065) | Conclusion |
| Braid and CoilMaterials | Braid: stainless steelCoil: tungsten | Braid and coil material unknown | Similar (exact predicatematerials unknown); minordesign differences do notraise new questions ofsafety or effectiveness |
| Proximal HubMaterial | Polycarbonate | Polymer (exact compositionunknown) | Similar (exact predicatematerials unknown); minordesign differences do notraise new questions ofsafety or effectiveness |
| RadiopaqueMaterial | Platinum/Iridium | None | The addition of radiopaquematerials meets state of theart and does not raise newquestions of safety oreffectiveness |
| Distal Side Ports | 3 Fr: 3 side ports4 Fr: 4 side ports | None | Similar; minor designdifferences do not raise newquestions of safety oreffectiveness |
| PackageContents | • 1 Catheter• 1 Dispenser coil | • 1 Catheter• 1 Dispenser coil | Identical |
| AdditionalAccessoriesSupplied | None | None | Identical |
| SterilizationMethod / SAL | Ethylene Oxide (EO) / 10-6 | Ethylene Oxide (EO) / 10-6 | Identical |
| Single-UseDevices? | Yes | Yes | Identical |
| Shelf-Life | 6 months | ≥ 12 months | Similar; shelf life for thesubject device falls withinthe labeled range for thepredicate device |
| Over-the-WireDelivery? | Yes | Yes | Identical |
Table 5. Substantial Equivalence Comparison
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4 Performance Data
The following performance data were provided in support of the substantial equivalence determination.
4.1 Biocompatibility
Biocompatibility testing for the QuikPass Catheter was completed in accordance with ISO 10993-1:2018, Biological evaluation of medical devices (FR #2-258). The QuikPass Catheter was tested for cytotoxicity, hemocompatibility, irritation, sensitization, pyrogenicity, and acute systemic toxicity. The QuikPass Catheter biocompatibility testing met all requirements.
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4.2 Sterilization, Shelf-Life and Packaging
The QuikPass Catheter is subjected to ethylene oxide (EO) sterilization to meet a sterility assurance level (SAL) of 10 . Testing was performed to demonstrate that the devices have acceptable levels of EO residuals, bioburden, and endotoxin.
Accelerated aging was performed per ASTM F1980. Standard Guide for Accelerated Aging of Sterile Barrier Systems of Medical Devices (FR #14-497) to validate package sterility and device performance after 6-months of accelerated aging shelf life.
Device packaging was validated in accordance with ASTM D4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems (FR #14-499) for simulated distribution testing, with ASTM D4332-14, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing (FR #5-99) followed for environmental conditioning. Package integrity was validated per ASTM F1886, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection (FR #14-501), ASTM F2096, Standard Test Method for Determining Gross Leaks in Packaging by Internal Pressurization (FR #14-359), and ASTM F88, Standard Test Method for Seal Strength of Flexible Barrier Materials (FR #14-482).
4.3 Bench Testing
Performance of the QuikPass Catheter was assessed via design verification testing performed in accordance with ISO 10555-1:2013, Intravascular catheters - Sterile and single-use catheters -Part 1: General requirements (FR #6-408). Aged and non-aged samples were tested for a variety of characteristics, including visual defects, appropriate dimensions, compatibility with guidewires and guide catheters, pressurization, vacuum, tracking, kink resistance, coating lubricity, coating durability, torsion, bend, tensile strength, coating integrity, particulate, radiopacity, and corrosion.
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5 Conclusions
The QuikPass Catheter is comprised of similar materials and is of similar design to the corresponding components of the predicate device. The subject and predicate devices share similar technical requirements, perform as intended, and present no unacceptable risks to the intended patient population or end user. The non-clinical bench data support the safety of the device and demonstrate that the QuikPass Catheter performs as intended in the specified use conditions. The non-clinical testing demonstrates that the device is as safe, as effective, and performs as well as or better than the predicate device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).