Cordis BRITECROSS Support Catheter

K233637 · Cordis US Corp · DQY · Jun 28, 2024 · Cardiovascular

Device Facts

• Record ID: K233637
• Device Name: Cordis BRITECROSS Support Catheter
• Applicant: Cordis US Corp
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Cordis BRITECROSS Support Catheters are indicated to guide and support a guide wire during access to the peripheral vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

Device Story

Flexible single-lumen support catheter; used in peripheral vascular interventions. Clinician introduces device over guidewire through existing guide catheter or introducer sheath; advanced under fluoroscopic guidance. Radiopaque distal tip and two shaft marker bands provide visualization and lesion length approximation. Proximal hub features integrated strain relief and female luer for syringe connection. Facilitates guidewire exchange and infusion of saline or contrast agents. Used in clinical settings by physicians. Benefits include improved access to tortuous peripheral anatomy and accurate placement relative to lesions.

Clinical Evidence

Bench testing only. No clinical or animal data required. Performance verified via dimensional, mechanical, and in-vitro testing including kink, 3-point bend, tensile strength, leak, bend failure, trackability, and fluid delivery. Biocompatibility per ISO 10993-1 and sterilization per ISO 11137-1.

Technological Characteristics

Flexible single-lumen catheter; lubricious coating; radiopaque distal tip and two marker bands. Materials biocompatible per ISO 10993-1. Manual operation; fluoroscopic visualization. Compatible with 0.014", 0.018", and 0.035" guidewires. Max injection pressure 300 psi. Sterile, single-use.

Indications for Use

Indicated for patients requiring peripheral vascular access to guide/support guidewires, perform guidewire exchanges, and receive saline or diagnostic contrast 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

• Spectranetics Quick-Cross Support Catheters (K072750)

Reference Devices

• Terumo Medical R2P Navicross (K231044)

Submission Summary (Full Text)

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June 28, 2024

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 the FDA logo, which consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below that.

Cordis US Corp. Linda Ruedy Senior Director, Global Regulatory Affairs 14201 NorthWest 60th Avenue Miami Lakes. Florida 33014

Re: K233637

Trade/Device Name: Cordis BRITECROSS Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: November 13, 2023 Received: November 13, 2023

Dear Linda Ruedy:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Samuel G. Raben -S

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

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## Indications for Use

510(k) Number (if known) K233637

Device Name Cordis BRITECROSS Support Catheter

Indications for Use (Describe)

The Cordis BRITECROSS Support Catheters are indicated to guide and support a guide wire during access to the peripheral vasculature, allow for exchange of guide wires, and provide a conduit for the delivery of saline solutions or diagnostic contrast agents.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Traditional 510(k)

# 510(K) SUMMARY

| Sponsor/Submitter: | Cordis US Corp<br>14201 North West 60th Avenue<br>Miami Lakes, Florida 33014, USA |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Linda Ruedy<br>Senior Director, Global Regulatory Affairs<br>Phone: [phone] |
| Date Prepared: | November 09, 2023 |
| Device Trade Name: | Cordis BRITECROSS™ Support Catheter |
| Common Name: | Peripheral Support Catheter |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 870.1250 |
| Classification Name: | Catheter, Percutaneous |
| Product Code: | DQY |
| Predicate Device: | Spectranetics Quick-Cross Support Catheters (K072750) |
| Device Description: | The BRITECROSS Support Catheter is a flexible single lumen<br>catheter that is intended to cross lesions to facilitate guidewire<br>access and/or the delivery of saline/contrast during peripheral<br>vascular interventions. The subject device is designed to allow for<br>fluoroscopic visualization of the catheter. The radiopaque distal<br>tip allows for accurate placement of the tip relative to the lesion.<br>Further, there are two (2) radiopaque marker bands incorporated<br>along the shaft to provide the clinician with a length reference<br>facilitating approximation of the lesion length. On the proximal<br>end, the hub has an integrated strain relief and a standard female<br>luer to connect with a standard syringe. The BRITECROSS<br>Catheter is available in various lengths and diameters and the size<br>is printed on the hub for quick identification. The device is sterile<br>and is for single use. |
| Device Operation: | Through a previously inserted guide catheter or introducer sheath,<br>the clinician introduces the BRITECROSS Support Catheter over<br>the guidewire and advances the subject device under fluoroscopy<br>to the desired location within the vasculature in the peripheral<br>vessels. The radiopaque distal tip and two (2) marker bands allow<br>for the clinician to visualize the distal end of the subject device as<br>well as provide an approximation of lesion length. The<br>BRITECROSS Catheter facilitates guidewire exchange and allows<br>for infusion of either sterile saline or contrast. |
| Indications for Use: | The Cordis BRITECROSS Support Catheters are indicated to<br>guide and support a guide wire during access to the peripheral<br>vasculature, allow for exchange of guide wires, and provide a<br>conduit for the delivery of saline solutions or diagnostic contrast<br>agents. |
| Technological<br>Characteristics: | The BRITECROSS Support Catheter can be introduced over the<br>guidewire and advanced under fluoroscopy to the desired location<br>within the vasculature and navigating tortuous anatomy in the<br>peripheral vessels. The radiopaque distal tip and two (2)<br>radiopaque marker bands allow for the clinician to visualize the<br>distal end of the subject device as well as provide an<br>approximation of lesion length. The BRITECROSS Catheter<br>facilitates guidewire exchange and allows for infusion of either<br>sterile saline or contrast at specified injection pressures. |
| Performance Data: | The function of the BRITECROSS Support Catheter has been<br>verified through:<br>Performance Testing (dimensional, mechanical, in-vitro<br>testing) Dimensional measurements Kink test testing 3-point bend testing Tensile strength testing Leak testing Bend failure testing Hydrophilic coating length Coating friction Torque testing Coating integrity testing Particulate testing Trackability testing Ability to deliver fluids Biocompatibility (ISO 10993-1) Cytotoxicity Irritation Sensitization Acute systemic toxicity Material mediated pyrogen Hemolysis Hemocompatibility Sterilization (ISO 11137-1) |

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Traditional 510(k)

# BRITECROSS™ Support Catheter

#### Clinical Data: No clinical data was required.

Animal Data: No animal performance data was required.

Predicate Device Comparison

| Attribute | Subject Device<br>Cordis<br>BRITECROSS™<br>Support Catheter | Primary Predicate Device<br>Spectranetics Quick-<br>Cross Support Catheter | Reference Device<br>Terumo Medical R2P<br>Navicross |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K072750 | K231044 |
| Clearance Date | TBD | December 4, 2007 | July 27, 2023 |
| Attribute | Subject Device<br>Cordis<br>BRITECROSS™<br>Support Catheter | Primary Predicate Device<br>Spectranetics Quick-<br>Cross Support Catheter | Reference Device<br>Terumo Medical R2P<br>Navicross |
| Manufacturer | Cordis US Corp | Spectranetics Corp | Terumo Medical |
| Trade Name | BRITECROSS™<br>Support Catheter | Quick-Cross Support<br>Catheter | Navicross Support Catheter |
| Common<br>Name | Support Catheter | Same, Support Catheter | Same, Support Catheter |
| Class | II | Same, II | Same, II |
| Product Code | DQY | Same, DQY | Same, DQY |
| Classification<br>Section | 870.1250 | Same, 870.1250 | Same, 870.1250 |
| Indications for<br>Use | Indicated to guide and<br>support a guide wire<br>during access to the<br>peripheral vasculature,<br>allow for exchange of<br>guide wires, and<br>provide a conduit for<br>the delivery of saline<br>solutions or diagnostic<br>contrast agents. | Intended to support a guide<br>wire during access to the<br>vasculature, allow for<br>exchange of guidewires,<br>and provide a conduit for<br>the delivery of saline<br>solutions or diagnostic<br>contrast agents. | Indicated to guide and<br>support a guidewire during<br>access of the peripheral<br>vasculature through an<br>access site, including but not<br>limited to the radial artery,<br>allow for wire exchanges,<br>and provide a conduit for the<br>delivery of saline or<br>diagnostic contrast agents |
| Intended<br>Region | Peripheral Vasculature | Same, Peripheral<br>Vasculature | Same, Peripheral<br>Vasculature |
| Intended Use | To support guide wire<br>access and deliver<br>saline and/or contrast | Same, To support guide<br>wire access and deliver<br>saline and/or contrast | Same, To support guide wire<br>access and deliver saline<br>and/or contrast |
| Operating<br>Principle | Manual | Same, Manual | Same, Manual |
| Technological<br>Characteristics | Flexible catheter with<br>lubricious coating,<br>radiopaque markers,<br>and hub | Same, Flexible catheter<br>with lubricious coating,<br>radiopaque markers, and<br>hub | Same, Flexible catheter with<br>lubricious coating,<br>radiopaque markers, and hub |
| Anatomical<br>Access | Peripheral Vasculature | Same, Peripheral<br>Vasculature | Same, Peripheral<br>Vasculature |
| Single Use? | Yes | Same, Yes | Same, Yes |
| Provided<br>Sterile? | Yes | Same, Yes | Same, Yes |
| Guidewire<br>Compatibility | 014", 018", and 035" | Same, 014", 018", and 035" | Same, 014", 018", and 035" |
| Effective<br>Lengths (cm) | 65, 90, 135, 150, 190,<br>200 | Same<br>014": 135, 150<br>018": 90, 135, 150<br>035": 65, 90, 135, 150 | Same, 200 |
| # Radiopaque<br>Markers | 3 (including tip) | Same, 3 | Same, 3 |
| Attribute | Subject Device<br>Cordis<br>BRITECROSS™<br>Support Catheter | Primary Predicate Device<br>Spectranetics Quick-<br>Cross Support Catheter | Reference Device<br>Terumo Medical R2P<br>Navicross |
| Marker<br>Spacing (mm) | 014: 15mm<br>018: 15mm<br>035: 50mm | Same,<br>014: 15mm<br>018: 15mm<br>035: 50mm | 40mm, 60mm |
| Sheath<br>Compatibility | 4F, 5F | Same, 4F, 5F | 4.5F |
| Single<br>Lumen? | Yes | Same, Yes | Same, Yes |
| Maximum<br>Injection<br>Pressure | 300psi | Same, 300psi | 600psi |

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Summary of Substantial Equivalence:

The Cordis BRITECROSS Support Catheter is substantially equivalent to the predicate device as confirmed through relevant performance tests and attributes.