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 Description

The BRITECROSS Support Catheter is a flexible single lumen catheter that is intended to cross lesions to facilitate guidewire access and/or the delivery of saline/contrast during peripheral vascular interventions. The subject device is designed to allow for fluoroscopic visualization of the catheter. The radiopaque distal tip allows for accurate placement of the tip relative to the lesion. Further, there are two (2) radiopaque marker bands incorporated along the shaft to provide the clinician with a length reference facilitating approximation of the lesion length. On the proximal end, the hub has an integrated strain relief and a standard female luer to connect with a standard syringe. The BRITECROSS Catheter is available in various lengths and diameters and the size is printed on the hub for quick identification. The device is sterile and is for single use.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Cordis BRITECROSS Support Catheter." This is a regulatory filing that aims to demonstrate that a new device is as safe and effective as an already legally marketed device (the predicate device).

Crucially, this document focuses on the substantial equivalence of a new medical device to a predicate device based on performance testing and predicate device comparison, not on the evaluation of an AI/ML algorithm. The provided text does not contain information about an AI/ML device, its acceptance criteria, or a study proving that an AI/ML device meets those criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI/ML device meets the acceptance criteria using the provided text. The device described, the Cordis BRITECROSS Support Catheter, is a physical medical device (a catheter) and not an AI/ML algorithm.

The "Performance Data" section lists various physical, mechanical, and biological tests conducted on the catheter (e.g., dimensional, mechanical, in-vitro testing, biocompatibility, sterilization), which are typical for physical medical devices to demonstrate their safety and efficacy. It explicitly states "No clinical data was required" and "No animal performance data was required," further indicating that this is not an AI/ML study.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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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Traditional 510(k)

510(K) SUMMARY

Sponsor/Submitter:	Cordis US Corp14201 North West 60th AvenueMiami Lakes, Florida 33014, USA
Contact Person:	Linda RuedySenior Director, Global Regulatory AffairsPhone: (408) 857-6754
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 lumencatheter that is intended to cross lesions to facilitate guidewireaccess and/or the delivery of saline/contrast during peripheralvascular interventions. The subject device is designed to allow forfluoroscopic visualization of the catheter. The radiopaque distaltip allows for accurate placement of the tip relative to the lesion.Further, there are two (2) radiopaque marker bands incorporatedalong the shaft to provide the clinician with a length referencefacilitating approximation of the lesion length. On the proximalend, the hub has an integrated strain relief and a standard femaleluer to connect with a standard syringe. The BRITECROSSCatheter is available in various lengths and diameters and the sizeis printed on the hub for quick identification. The device is sterileand is for single use.
Device Operation:	Through a previously inserted guide catheter or introducer sheath,the clinician introduces the BRITECROSS Support Catheter overthe guidewire and advances the subject device under fluoroscopyto the desired location within the vasculature in the peripheralvessels. The radiopaque distal tip and two (2) marker bands allowfor the clinician to visualize the distal end of the subject device aswell as provide an approximation of lesion length. TheBRITECROSS Catheter facilitates guidewire exchange and allowsfor infusion of either sterile saline or contrast.
Indications for Use:	The Cordis BRITECROSS Support Catheters are indicated toguide and support a guide wire during access to the peripheralvasculature, allow for exchange of guide wires, and provide aconduit for the delivery of saline solutions or diagnostic contrastagents.
TechnologicalCharacteristics:	The BRITECROSS Support Catheter can be introduced over theguidewire and advanced under fluoroscopy to the desired locationwithin the vasculature and navigating tortuous anatomy in theperipheral vessels. The radiopaque distal tip and two (2)radiopaque marker bands allow for the clinician to visualize thedistal end of the subject device as well as provide anapproximation of lesion length. The BRITECROSS Catheterfacilitates guidewire exchange and allows for infusion of eithersterile saline or contrast at specified injection pressures.
Performance Data:	The function of the BRITECROSS Support Catheter has beenverified through:Performance Testing (dimensional, mechanical, in-vitrotesting) 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 DeviceCordisBRITECROSS™Support Catheter	Primary Predicate DeviceSpectranetics Quick-Cross Support Catheter	Reference DeviceTerumo Medical R2PNavicross
510(k) number	TBD	K072750	K231044
Clearance Date	TBD	December 4, 2007	July 27, 2023
Attribute	Subject DeviceCordisBRITECROSS™Support Catheter	Primary Predicate DeviceSpectranetics Quick-Cross Support Catheter	Reference DeviceTerumo Medical R2PNavicross
Manufacturer	Cordis US Corp	Spectranetics Corp	Terumo Medical
Trade Name	BRITECROSS™Support Catheter	Quick-Cross SupportCatheter	Navicross Support Catheter
CommonName	Support Catheter	Same, Support Catheter	Same, Support Catheter
Class	II	Same, II	Same, II
Product Code	DQY	Same, DQY	Same, DQY
ClassificationSection	870.1250	Same, 870.1250	Same, 870.1250
Indications forUse	Indicated to guide andsupport a guide wireduring access to theperipheral vasculature,allow for exchange ofguide wires, andprovide a conduit forthe delivery of salinesolutions or diagnosticcontrast agents.	Intended to support a guidewire during access to thevasculature, allow forexchange of guidewires,and provide a conduit forthe delivery of salinesolutions or diagnosticcontrast agents.	Indicated to guide andsupport a guidewire duringaccess of the peripheralvasculature through anaccess site, including but notlimited to the radial artery,allow for wire exchanges,and provide a conduit for thedelivery of saline ordiagnostic contrast agents
IntendedRegion	Peripheral Vasculature	Same, PeripheralVasculature	Same, PeripheralVasculature
Intended Use	To support guide wireaccess and deliversaline and/or contrast	Same, To support guidewire access and deliversaline and/or contrast	Same, To support guide wireaccess and deliver salineand/or contrast
OperatingPrinciple	Manual	Same, Manual	Same, Manual
TechnologicalCharacteristics	Flexible catheter withlubricious coating,radiopaque markers,and hub	Same, Flexible catheterwith lubricious coating,radiopaque markers, andhub	Same, Flexible catheter withlubricious coating,radiopaque markers, and hub
AnatomicalAccess	Peripheral Vasculature	Same, PeripheralVasculature	Same, PeripheralVasculature
Single Use?	Yes	Same, Yes	Same, Yes
ProvidedSterile?	Yes	Same, Yes	Same, Yes
GuidewireCompatibility	014", 018", and 035"	Same, 014", 018", and 035"	Same, 014", 018", and 035"
EffectiveLengths (cm)	65, 90, 135, 150, 190,200	Same014": 135, 150018": 90, 135, 150035": 65, 90, 135, 150	Same, 200
# RadiopaqueMarkers	3 (including tip)	Same, 3	Same, 3
Attribute	Subject DeviceCordisBRITECROSS™Support Catheter	Primary Predicate DeviceSpectranetics Quick-Cross Support Catheter	Reference DeviceTerumo Medical R2PNavicross
MarkerSpacing (mm)	014: 15mm018: 15mm035: 50mm	Same,014: 15mm018: 15mm035: 50mm	40mm, 60mm
SheathCompatibility	4F, 5F	Same, 4F, 5F	4.5F
SingleLumen?	Yes	Same, Yes	Same, Yes
MaximumInjectionPressure	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.

Regulation Number and Section

§ 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).