(228 days)
No
The device description and performance studies focus on the physical and mechanical properties of the catheter, with no mention of AI or ML capabilities.
No.
The primary functions of the device are to guide and support guide wires, facilitate their exchange, and provide a conduit for fluid delivery during peripheral vascular interventions, not to treat a disease or condition itself.
No
The device is primarily intended to guide and support a guidewire, allow for guidewire exchange, and provide a conduit for delivery of saline or contrast agents during peripheral vascular interventions. While it can deliver diagnostic contrast agents, its main function is interventional support, not the diagnosis of a disease or condition itself.
No
The device description clearly describes a physical catheter with a lumen, radiopaque markers, a hub, and strain relief, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used 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." This describes a device used within the body for procedural support and delivery, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter designed for insertion into the peripheral vasculature, with features for visualization and fluid delivery. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to test biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on the analysis of such samples.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Cordis BRITECROSS Support Catheter does not fit this description.
N/A
Intended Use / Indications for 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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic visualization
Anatomical Site
Peripheral Vasculature
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The function of the BRITECROSS Support Catheter has been verified through: Performance Testing (dimensional, mechanical, in-vitro 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)
Clinical Data: No clinical data was required.
Animal Data: No animal performance data was required.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
2
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Traditional 510(k)
510(K) SUMMARY
| Sponsor/Submitter: | Cordis US Corp
14201 North West 60th Avenue
Miami Lakes, Florida 33014, USA |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Linda Ruedy
Senior Director, Global Regulatory Affairs
Phone: (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 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. |
| Device Operation: | Through a previously inserted guide catheter or introducer sheath,
the clinician introduces the BRITECROSS Support Catheter over
the guidewire and advances the subject device under fluoroscopy
to the desired location within the vasculature in the peripheral
vessels. The radiopaque distal tip and two (2) marker bands allow
for the clinician to visualize the distal end of the subject device as
well as provide an approximation of lesion length. The
BRITECROSS Catheter facilitates guidewire exchange and allows
for infusion of either sterile saline or contrast. |
| Indications for 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. |
| Technological
Characteristics: | The BRITECROSS Support Catheter can be introduced over the
guidewire and advanced under fluoroscopy to the desired location
within the vasculature and navigating tortuous anatomy in the
peripheral vessels. The radiopaque distal tip and two (2)
radiopaque marker bands allow for the clinician to visualize the
distal end of the subject device as well as provide an
approximation of lesion length. The BRITECROSS Catheter
facilitates guidewire exchange and allows for infusion of either
sterile saline or contrast at specified injection pressures. |
| Performance Data: | The function of the BRITECROSS Support Catheter has been
verified through:
Performance Testing (dimensional, mechanical, in-vitro
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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5
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
Cordis
BRITECROSS™
Support Catheter | Primary Predicate Device
Spectranetics Quick-
Cross Support Catheter | Reference Device
Terumo Medical R2P
Navicross |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | TBD | K072750 | K231044 |
| Clearance Date | TBD | December 4, 2007 | July 27, 2023 |
| Attribute | Subject Device
Cordis
BRITECROSS™
Support Catheter | Primary Predicate Device
Spectranetics Quick-
Cross Support Catheter | Reference Device
Terumo Medical R2P
Navicross |
| Manufacturer | Cordis US Corp | Spectranetics Corp | Terumo Medical |
| Trade Name | BRITECROSS™
Support Catheter | Quick-Cross Support
Catheter | Navicross Support Catheter |
| Common
Name | Support Catheter | Same, Support Catheter | Same, Support Catheter |
| Class | II | Same, II | Same, II |
| Product Code | DQY | Same, DQY | Same, DQY |
| Classification
Section | 870.1250 | Same, 870.1250 | Same, 870.1250 |
| Indications for
Use | 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. | Intended to support a guide
wire during access to the
vasculature, allow for
exchange of guidewires,
and provide a conduit for
the delivery of saline
solutions or diagnostic
contrast agents. | Indicated to guide and
support a guidewire during
access of the peripheral
vasculature through an
access site, including but not
limited to the radial artery,
allow for wire exchanges,
and provide a conduit for the
delivery of saline or
diagnostic contrast agents |
| Intended
Region | Peripheral Vasculature | Same, Peripheral
Vasculature | Same, Peripheral
Vasculature |
| Intended Use | To support guide wire
access and deliver
saline and/or contrast | Same, To support guide
wire access and deliver
saline and/or contrast | Same, To support guide wire
access and deliver saline
and/or contrast |
| Operating
Principle | Manual | Same, Manual | Same, Manual |
| Technological
Characteristics | Flexible catheter with
lubricious coating,
radiopaque markers,
and hub | Same, Flexible catheter
with lubricious coating,
radiopaque markers, and
hub | Same, Flexible catheter with
lubricious coating,
radiopaque markers, and hub |
| Anatomical
Access | Peripheral Vasculature | Same, Peripheral
Vasculature | Same, Peripheral
Vasculature |
| Single Use? | Yes | Same, Yes | Same, Yes |
| Provided
Sterile? | Yes | Same, Yes | Same, Yes |
| Guidewire
Compatibility | 014", 018", and 035" | Same, 014", 018", and 035" | Same, 014", 018", and 035" |
| Effective
Lengths (cm) | 65, 90, 135, 150, 190,
200 | Same
014": 135, 150
018": 90, 135, 150
035": 65, 90, 135, 150 | Same, 200 |
| # Radiopaque
Markers | 3 (including tip) | Same, 3 | Same, 3 |
| Attribute | Subject Device
Cordis
BRITECROSS™
Support Catheter | Primary Predicate Device
Spectranetics Quick-
Cross Support Catheter | Reference Device
Terumo Medical R2P
Navicross |
| Marker
Spacing (mm) | 014: 15mm
018: 15mm
035: 50mm | Same,
014: 15mm
018: 15mm
035: 50mm | 40mm, 60mm |
| Sheath
Compatibility | 4F, 5F | Same, 4F, 5F | 4.5F |
| Single
Lumen? | Yes | Same, Yes | Same, Yes |
| Maximum
Injection
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.