(30 days)
Not Found
No
The description focuses on the physical construction and intended use of a catheter, with no mention of AI, ML, or any computational analysis of data.
No.
The device description and intended use indicate it is an access and delivery tool (for guidewires and contrast media), not a device that directly treats a medical condition.
No
The QuikPass Catheter is intended to access vasculature, facilitate guidewire placement, exchange, and deliver contrast media. These are interventional and delivery functions, not diagnostic.
No
The device description clearly outlines a physical catheter with specific material composition, dimensions, and features, indicating it is a hardware medical device.
Based on the provided information, the QuikPass Catheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to access and facilitate procedures within the coronary and/or peripheral vasculature. This involves direct interaction with the patient's body for diagnostic or therapeutic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The description details a catheter designed for insertion into blood vessels, with features like a lumen, radiopaque markers, and a hydrophilic coating to aid in navigation within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to provide information about a person's health status.
IVD devices are typically used to perform tests on samples taken from the body, such as blood glucose meters, pregnancy tests, or diagnostic kits for infectious diseases. The QuikPass Catheter is a medical device used for interventional procedures within the body.
N/A
Intended Use / 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.
Product codes
DQY
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.
All models of the QuikPass Catheter are sold sterile. Sterility is achieved using ethylene oxide.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or peripheral vasculature
Indicated Patient Age Range
greater than 21 years of age
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
The following performance data were provided in support of the substantial equivalence determination.
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.
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).
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
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
1
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
2
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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3
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. West | |
| Solana Beach, CA 92075 | Greg Geissinger |
| Regulatory 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.
5
| 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 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. | The Turnpike 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 to | |||
| subselectively infuse/deliver | |||
| diagnostic and therapeutic agents. | Similar; the subject device | ||
| indications for use are | |||
| narrower than those of the | |||
| predicate. There are | |||
| therefore no new questions | |||
| of safety or effectiveness. | |||
| Catheter | |||
| Components | Proximal hub with Luer connection | Proximal hub with Luer connection | Identical |
| Single-lumen shaft constructed of | |||
| two polymer layers encapsulating a | |||
| braid and coil and having a | |||
| hydrophilic coating | Single-lumen shaft constructed of | ||
| two polymer layers encapsulating a | |||
| braid and coil and having a | |||
| hydrophilic coating | Identical | ||
| Radiopaque distal markers and ports | |||
| for guidewire passage and solution | |||
| infusion | Radiopaque distal tip with outlet for | ||
| guidewire passage and solution | |||
| infusion | Similar; minor design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Available | |||
| Models, Sizes, | |||
| and Working | |||
| Length | Model #135-03: 3 Fr; 135cm | ||
| Model #135-04: 4 Fr; 135cm | |||
| Model #150-03: 3 Fr; 150cm | |||
| Model #150-04: 4 Fr; 150cm | Model #5642: 3 Fr; 135cm | ||
| Model #5643: 3 Fr; 150cm | Similar; minor design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Labeled Shaft | |||
| Outer 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 design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Labeled Shaft | |||
| Inner 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 design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Distal Tip Shape | Smooth, Rounded, Tapered | Smooth, Rounded, Tapered | Identical |
| Description | Subject Device | Predicate Device (K142065) | Conclusion |
| Distal Tip | |||
| Length | 4-6mm | 8-10mm | Similar; minor design |
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Distal Tip | |||
| Inner/Outer | |||
| Diameter | 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 design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Hydrophilic | |||
| Coating | |||
| Material, | |||
| Location, | |||
| Length, and | |||
| Function | Hydrogel polymer, distal shaft, | ||
| 40cm in length, lubricious coating | Hydrogel polymer, distal shaft, | ||
| 60cm in length, lubricious coating | Similar; minor design | ||
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Intended Patient | |||
| Population | Intended for use in adults (greater | ||
| than 21 years of age) | Intended for use in adults (greater | ||
| than 21 years of age) | Identical | ||
| Compatible | |||
| Guidewire | |||
| Diameter | 0.014" | ≤ 0.014" | Similar; compatible |
| guidewire diameter for the | |||
| subject device falls within | |||
| the labeled range for the | |||
| predicate device | |||
| Compatible | |||
| Guide Catheter | |||
| Size | ≥ 6 Fr (≥ 1.78mm ID) | ≥ 5 Fr (≥ 1.42mm ID) | Similar; compatible guide |
| catheter diameter for the | |||
| subject device falls within | |||
| the labeled range for the | |||
| predicate device | |||
| Catheter Images | Image: 3FR CATHETERS | Image: Catheter | Similar; minor design |
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Materials of | |||
| Construction | |||
| (Patient | |||
| Contacting) | Pebax Shaft | ||
| Metallic Braid & Coil | |||
| Polycarbonate Luer | |||
| Loctite Adhesive | Pebax Shaft | ||
| Metallic Braid & Coil | |||
| Polycarbonate Luer | |||
| Loctite Adhesive | Similar (exact predicate | ||
| formulations unknown); | |||
| minor design differences do | |||
| not raise new questions of | |||
| safety or effectiveness | |||
| Distal Tip | |||
| Material | Tungsten-loaded 35D Pebax | Tungsten loaded polymer (exact | |
| composition and durometer | |||
| unknown) | Similar (exact predicate | ||
| formulations unknown); | |||
| minor design differences do | |||
| not raise new questions of | |||
| safety or effectiveness | |||
| Shaft Material | Pebax 72D = proximal | ||
| Pebax 45D = mid shaft | |||
| Pellethane 80A = distal shaft | Polymer jacket (exact composition | ||
| and durometer unknown) | Similar (exact predicate | ||
| formulations unknown); | |||
| minor design differences do | |||
| not raise new questions of | |||
| safety or effectiveness | |||
| Description | Subject Device | Predicate Device (K142065) | Conclusion |
| Braid and Coil | |||
| Materials | Braid: stainless steel | ||
| Coil: tungsten | Braid and coil material unknown | Similar (exact predicate | |
| materials unknown); minor | |||
| design differences do not | |||
| raise new questions of | |||
| safety or effectiveness | |||
| Proximal Hub | |||
| Material | Polycarbonate | Polymer (exact composition | |
| unknown) | Similar (exact predicate | ||
| materials unknown); minor | |||
| design differences do not | |||
| raise new questions of | |||
| safety or effectiveness | |||
| Radiopaque | |||
| Material | Platinum/Iridium | None | The addition of radiopaque |
| materials meets state of the | |||
| art and does not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Distal Side Ports | 3 Fr: 3 side ports | ||
| 4 Fr: 4 side ports | None | Similar; minor design | |
| differences do not raise new | |||
| questions of safety or | |||
| effectiveness | |||
| Package | |||
| Contents | • 1 Catheter | ||
| • 1 Dispenser coil | • 1 Catheter | ||
| • 1 Dispenser coil | Identical | ||
| Additional | |||
| Accessories | |||
| Supplied | None | None | Identical |
| Sterilization | |||
| Method / SAL | Ethylene Oxide (EO) / 10-6 | Ethylene Oxide (EO) / 10-6 | Identical |
| Single-Use | |||
| Devices? | Yes | Yes | Identical |
| Shelf-Life | 6 months | ≥ 12 months | Similar; shelf life for the |
| subject device falls within | |||
| the labeled range for the | |||
| predicate device | |||
| Over-the-Wire | |||
| Delivery? | Yes | Yes | Identical |
Table 5. Substantial Equivalence Comparison
6
7
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.
8
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.
9
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.