Support Catheter

K200317 · Qxmedical, LLC · DQY · May 14, 2020 · Cardiovascular

Device Facts

• Record ID: K200317
• Device Name: Support Catheter
• Applicant: Qxmedical, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: May 14, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Support Catheter is a single-lumen catheter designed for use in the vascular system and intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

Device Story

Over-the-wire (OTW) single-lumen catheter; tapered atraumatic tip; distal radiopaque markers for fluoroscopic guidance; hydrophilic coating on distal end for tracking. Used in vascular system during coronary/peripheral interventions. Operated by physicians. Input: guidewire (0.014", 0.018", 0.035"). Function: provides conduit for guidewire passage/exchange and infusion of saline, contrast, or therapeutic agents; supports guidewire advancement. Output: physical access to vasculature. Benefits: facilitates navigation through discrete vascular portions and procedural fluid delivery.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including visual/dimensional inspection, leakage, luer compatibility, guidewire compatibility, sheath/guiding catheter compatibility, simulated use, coating integrity, fluoroscopic visualization, corrosion resistance, fluid flow, shipping/distribution, stiffness/flexibility, kink resistance, fatigue, tensile strength, markerband retention, particulate evaluation, torque strength, burst pressure, and shelf life.

Technological Characteristics

Single-lumen catheter; tapered distal tip; hydrophilic coating; three distal radiopaque markers. Available in lengths 65-180cm; compatible with 0.014", 0.018", 0.035" guidewires. Proximal molded manifold with female luer. Sterilized via ethylene oxide (EO). Mechanical design for percutaneous vascular access.

Indications for Use

Indicated for use in patients undergoing coronary and peripheral interventional procedures requiring guidewire support, vascular navigation, guidewire exchange, or infusion of saline, contrast, or therapeutic agents.

Regulatory Classification

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.

Predicate Devices

• Access and Support Catheter (K123311)

Submission Summary (Full Text)

{0}------------------------------------------------

May 14, 2020

Image /page/0/Picture/1 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 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.

QXMedical, LLC Fernando Di Caprio Chief Technology Officer 2820 Patton Road Roseville, Minnesota 55113

### Re: K200317

Trade/Device Name: Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 15, 2020 Received: April 16, 2020

## Dear Fernando Di Caprio:

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-regulatory-assistance/contact-usdivision-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

for 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) K200317

Device Name Support Catheter

Indications for Use (Describe)

The support catheter is intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

Type of Use (*Select one or both, as applicable*)

| <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary QXMédical Support Catheter (K200317)

# Date Prepared: May 14, 2020

# Submitter Information:

| Submitter's Name/Address | Contact Person |
|--------------------------|----------------------------------------|
| QXMédical, LLC | Fernando Di Caprio |
| 2820 Patton Road | Chief Technical Officer |
| Roseville, MN 55113 | Phone: [phone] |
| | Email: [e-mail] |

# De vice Information:

| Device Classification Name | Catheter, Percutaneous |
|-----------------------------|------------------------|
| Common Name | Support Catheter |
| Trade Name | Support Catheter |
| Regulatory Class | Class 2 |
| Regulation Number | 21 CFR 870.1250 |
| Regulation Name | Percutaneous Catheter |
| Classification Product Code | DQY |
| 510(k) Review Panel | Cardiovascular |

### Performance Standards :

No performance standards applicable to this product have been developed under Section 514 of the Act.

# Predicate Device:

| Predicate Device | 510(k) Status |
|-----------------------------|---------------|
| Access and Support Catheter | K123311 |

{4}------------------------------------------------

### De vice Description:

The subject Support Catheter is an over-the-wire (OTW) single-lumen catheter with a tapered atraumatic tip. The catheter is available in fifteen (15) size models compatible with standard 0.014", 0.018" and 0.035" diameter guidewires and with effective lengths of 65 cm, 90 cm, 135 cm, 150 cm and 180 cm. The distal end of the catheter incorporates three (3) distal radiopaque markers to assist with fluoroscopic guidance and estimating distances. A hydrophilic coating on the distal end assists with catheter advancement. The proximal end of the catheter has a molded manifold with a female luer connection in fluid communication with the catheter lumen. The catheter lumen is used for guidewire passage and exchanges as well as fluid infusion. The catheter guidewire size and length are printed on the strain relief. The device is supplied sterile and intended for single use only.

### Intended Use/Indications for Use :

The Support Catheter is a single-lumen catheter designed for use in the vascular system and intended for use during coronary and peripheral interventional procedures to guide and support guidewires, traverse discrete portions of the vasculature, allow for guidewire exchanges and provide a conduit for infusion of saline solution, diagnostic contrast agents and therapeutic agents.

### Summary of Non-Clinical Testing:

The subject Support Catheter underwent mechanical, performance, and biocompatibility assessments to support a determination of substantial equivalence. These tests provide reasonable assurance that the device meets the established performance criteria and will perform as intended. The testing did not raise any new questions of safety and effectiveness.

| Tests Performed | |
|--------------------------------|----------------------------------|
| Visual/Dimensional inspections | Catheter stiffness & flexibility |
| Freedom from leakage | Kink resistance and radius |
| Luer syringe compatibility | Guidewire support |
| Guidewire compatibility | Catheter fatigue |
| Sheath compatibility | Tensile strength |
| Guiding catheter compatibility | Markerband retention |
| Simulated use | Particulate evaluations |
| Coating integrity | Torque strength |
| Fluoroscopic visualization | Burst pressure |
| Corrosion resistance | Shelf life testing |
| Fluid flow rates | Package integrity |
| Shipping/distribution testing | Environment conditioning |

The mechanical and performance tests performed on the Support Catheter include:

{5}------------------------------------------------

### Clinical Testing

Clinical evaluation was not required for this device.

#### Comparison to Predicate Device

The subject Support Catheter has the same or similar intended use, indications, technological characteristics, and principles of operation as the previously cleared predicate device. Like the predicate device, the subject Support Catheter is a single lumen catheter with a tapered distal tip and three (3) radiopaque markers to assist with fluoroscopic guidance. The catheters have a hydrophilic coating on the distal end to aid with tracking, access and passage. They are available in various sizes (diameters & lengths) to accommodate different guidewires and allow access to various anatomical locations. Like the predicate device, the subject Support Catheter is placed into the patient's vascular system via percutaneous access. The catheters are threaded over a guidewire and through a guiding catheter (or sheath) to access discrete portions of the patient's vasculature. Once the desired placement is achieved, the catheters may provide support for further advancement of the guidewire. Additionally, the guidewire may be removed and exchanged for another guidewire or the guidewire may be removed to allow infusion of saline, contrast or other procedural solutions. Like the predicate device, the subject Support Catheter is a single-use device and sterilized using ethylene oxide (EO).

| Technological<br>Characteristics | Subject Device:<br>Support Catheter | Predicate Device:<br>Access and Support<br>Catheter | Notes |
|----------------------------------|----------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Catheter Effective<br>Lengths | 65cm, 90cm, 135cm,<br>150cm and 180cm | 65cm, 90cm, 135cm and<br>150cm | Subject device includes<br>180cm length models |
| Catheter Tip Design | Distal tip is 1.25mm long<br>and tapered | Distal tip is 2.0mm long<br>and tapered | Subject device has a<br>shorter tip |
| Hydrophilic Coating<br>Length | 40cm coating length on<br>65cm and 90cm models.<br>80cm coating length on<br>135cm, 150cm and 180cm<br>models. | 40cm coating length on all<br>models. | The 135cm, 150cm and<br>180cm effective length<br>models of the subject<br>device have 80cm coated<br>length |

Minor differences between the subject Support Catheter and the previously cleared predicate device are outlined in the following table:

No significant differences impacting safety and effectiveness were identified with respect to intended use, materials, technological characteristics, and principles of operation.

{6}------------------------------------------------

#### Substantial Equivalence Comparison

Based on a comparison of the intended use/indications for use, principle of use, intended anatomical location, and technological characteristics, along with the results from a series of non-clinical tests, the subject Support Catheter has been shown to be substantially equivalent to the predicate device.

The subject Support Catheter raises no new questions of safety or effectiveness compared to the predicate device and is eligible for premarket clearance.

#### Conclusion

Based on the successful results from the Non-Clinical Testing performed and the Substantial Equivalence Comparison, we conclude that the device is as safe and effective as the legally marketed predicate device listed above.