(182 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter and delivery system, with no mention of software, algorithms, or AI/ML capabilities.
No.
The device description and intended use primarily describe its function in facilitating the insertion and guidance of other interventional devices, rather than directly treating a condition or disease.
No
The device is described as facilitating the insertion and guidance of interventional devices, not for diagnosing medical conditions.
No
The device description clearly outlines a physical catheter with hardware components (lumen, radiopaque marker band, luer hub, hydrophilic coating) and is packaged with other physical devices (Delivery Assist Catheter, RHVs, introducer sheaths). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside the body (in vitro).
- Device Description and Intended Use: The Broadway 8 Catheter is a device used within the body (in vivo) to facilitate the insertion and guidance of other interventional devices into blood vessels in the neurovascular system. It is a tool for a medical procedure, not a test performed on a sample.
The description clearly indicates a device used for navigation and delivery within the circulatory system, which is a therapeutic or interventional purpose, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
Product codes
QJP
Device Description
The Broadway 8 Catheter is a single lumen, flexible, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The Broadway 8 Catheter shaft has a lubricious hydrophilic coating at the distal end to reduce friction during use. It is packaged with a FastPass Delivery Assist Catheter, two rotating hemostasis valves (RHVs) and two peel-away introducer sheaths.
The FastPass Delivery Assist Catheter may be used in conjunction with the Broadway 8 Catheter to facilitate the introduction of the Broadway 8 Catheter into distal vasculature and aid in navigation to distal anatomy. The FastPass Delivery Assist Catheter has a lubricious hydrophilic coating at the distal end to reduce friction during use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurovascular system
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
Performance Data - Bench: The results of design verification and design validation testing conducted on the Broadway 8 Catheter demonstrate that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate Device. Tests included: Dimensional Verification, Tensile Strength, Torsional Bond Strength, Particulate, Coating Integrity, Liquid Leak, Air Leak, Kink Resistance, Burst Pressure, Liner Lamination, Chemical Compatibility, Tip Buckling, Product Integrity Post-Removal, Simulated Use Testing, and Friction Force Testing. All tests met established acceptance criteria or were comparable to the predicate device.
Performance Data - Animal Study: An animal study was conducted in compliance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) at 3-day and 30-day timepoints to assess the navigation to the target artery (3 passes in each artery), angiography, necropsy, and histopathology of the Subject Device, Broadway 8 Catheter, compared to the Predicate Device, AXS Vecta 74 Catheter. The vessels evaluated in the swine model included the ascending pharyngeal artery (APA), internal maxillary artery (IMAX), internal mammary artery (IMA), superficial cervical artery (SCA), and axillary artery. All study endpoints were met and the Broadway 8 Catheter (Test Article) performed as well as or better than the AXS Vecta 74 catheter (Control Article), with no vessel damage observed at the treatment or terminal procedures. The study results demonstrated vascular safety of the Broadway 8 Catheter. This study supports substantial equivalence of the Broadway 8 Catheter to the Predicate Device as evidenced by the absence of vascular damage at the treatment sites during the GLP safety study.
Performance Data - Clinical: No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Key Metrics
Not Found
Predicate Device(s)
AXS Vecta Intermediate Catheter (AXS Vecta 74), K200206
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
December 19, 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 the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Stryker Neurovascular Shazia Hakim Principal Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K241768
Trade/Device Name: Broadway 8 Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: November 19, 2024 Received: November 20, 2024
Dear Shazia Hakim:
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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Sara S. Thompson -S
for Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional, and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241768
Device Name Broadway 8 Catheter
Indications for Use (Describe)
The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(k) Summary
| Submitter | Stryker Neurovascular
47900 Bayside Parkway
Fremont, CA 94538
Phone: 510-413-2500 |
|-----------------------|--------------------------------------------------------------------------------------------|
| Contact | Shazia Hakim |
| Date Prepared | June 19, 2024 |
| Device Name | Broadway 8 Catheter |
| Common Name | Percutaneous Catheter |
| Classification Name | Catheter, Percutaneous, Neurovasculature (21 CFR 870.1250) |
| Product Code | QJP |
| Device Classification | Class II |
| Predicate Device | AXS Vecta Intermediate Catheter (AXS Vecta 74), K200206 |
Device Description
The Broadway 8 Catheter is a single lumen, flexible, variable stiffness catheter designed for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system. It has a radiopaque marker band on the distal end and a luer hub at the proximal end. The Broadway 8 Catheter shaft has a lubricious hydrophilic coating at the distal end to reduce friction during use. It is packaged with a FastPass Delivery Assist Catheter, two rotating hemostasis valves (RHVs) and two peel-away introducer sheaths.
The FastPass Delivery Assist Catheter may be used in conjunction with the Broadway 8 Catheter to facilitate the introduction of the Broadway 8 Catheter into distal vasculature and aid in navigation to distal anatomy. The FastPass Delivery Assist Catheter has a lubricious hydrophilic coating at the distal end to reduce friction during use.
Indications for Use
The Broadway 8 Catheter is indicated for use in facilitating the insertion and guidance of appropriately sized interventional devices into a selected blood vessel in the neurovascular system.
5
Technological Characteristics and Product Feature Comparison
Stryker Neurovascular has demonstrated the Broadway 8 Catheter is substantially equivalent to the Predicate Device, AXS Vecta Intermediate Catheter based on the same or similar materials, similar design, and the same fundamental operating principles. A comparison of the Subject Device with the Predicate Device is summarized in Table 1 below.
| Detail | Broadway 8 Catheter
(Subject Device) | AXS Vecta Intermediate Catheter
(AXS Vecta 74)
(Predicate Device) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 870.1250 | Same |
| Classification | II | Same |
| FDA Product Code | QJP | QJP, DQY |
| 510(k) Number | K241768 | K200206 |
| Indications for Use | The Broadway 8 Catheter is indicated
for use in facilitating the insertion and
guidance of appropriately sized
interventional devices into a selected
blood vessel in the neurovascular
system. | The AXS Vecta Intermediate Catheter is
indicated for use in facilitating the
insertion and guidance of appropriately
sized interventional devices into a
selected blood vessel in the peripheral
and neurovascular systems. The AXS
Vecta Intermediate Catheter is also
indicated for use as a conduit for
retrieval devices. |
| Materials | Commonly used medical grade plastics
& metals with hydrophilic coating. | Same |
| Strain Relief | None | Polyolefin |
| Reinforcement | Stainless Steel | Stainless Steel/Nitinol |
| Coating | Hydrophilic Coating | Hydrophilic Coating |
| Outer Diameter | 0.098 in. | Distal OD:
AXS Vecta 71: 0.082 in.
AXS Vecta 74: 0.083 in.
Proximal OD:
AXS Vecta 71: 0.085 in.
AXS Vecta 74: 0.087 in. |
| Inner Diameter | 0.084 in. | AXS Vecta 71: 0.071 in.
AXS Vecta 74: 0.074 in. |
| Effective Length(s) | 132 cm | 115, 125, 132 cm |
| Sterilization Method | EO Sterilization | Same |
| How Supplied | Single Use/Sterile | Same |
| Detail | Broadway 8 Catheter
(Subject Device) | AXS Vecta Intermediate Catheter
(AXS Vecta 74)
(Predicate Device) |
| Accessory Devices Provided | 2 Hemostasis Valves, 2 Peel-Away
Introducers
FastPass Delivery Assist Catheter
(ID: 0.016"; Distal OD: 0.033"; Bulb
OD: 0.075", Length: 156cm) | Hemostasis Valve, 2 Peel-Away
Introducers
Scout Introducer |
Table 1: Substantial Equivalence Comparison
6
Risk Assessment
Risk assessment of the Broadway 8 Catheter has been conducted in accordance with EN ISO 14971 and Stryker Neurovascular risk management procedures. Stryker Neurovascular has determined that the Broadway 8 Catheter raises no new questions of safety or effectiveness. The risk assessment conducted on the Subject Device did not result in any new hazards or harms, and no significant changes to the occurrences of harm were identified when compared with the Predicate Device.
Testing Summary
Performance Data - Bench
The results of design verification and design validation testing conducted on the Broadway 8 Catheter demonstrate that it performs as designed, is suitable for the indication for use, and is substantially equivalent to the legally marketed Predicate Device. The design verification and design validation bench testing are summarized in Table 2 below:
| Test | Test Method Summary | Conclusions |
|---|---|---|
| Dimensional Verification | Verification of critical dimensions. | Pass - Samples met established |
| acceptance criteria. | ||
| Tensile Strength | Tensile strength tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria. | ||
| Torsional Bond Strength | The test specimens were rotated to evaluate | |
| integrity after rotation. | Pass - Samples met established | |
| acceptance criteria |
| Table 2: Performance Data - Bench Testing | ||
|---|---|---|
| Test | Test Method Summary | Conclusions |
| Particulate | Particulate was collected from simulated use | |
| in a tortuous model, characterized by size | ||
| and particulate type, and compared to | ||
| commercially available product. | Pass - Device comparable to | |
| predicate. | ||
| Coating Integrity | Hydrophilic coating was inspected before | |
| and after simulated use in a tortuous model. | Pass – Device comparable to | |
| predicate | ||
| Liquid Leak | Liquid leak tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria. | ||
| Air Leak | Air leak tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria. | ||
| Kink Resistance | Measurement of catheter kink radius | Pass - Samples met established |
| acceptance criteria | ||
| Burst Pressure | Burst Pressure was tested per ISO 10555-1. | Pass - Samples met established |
| acceptance criteria | ||
| Liner Lamination | Verification of inner liner adherence following | |
| simulated use. | Pass - Samples met established | |
| acceptance criteria | ||
| Chemical Compatibility | Catheter was measured and visually | |
| inspected before and after exposure to | ||
| various clinically relevant chemicals. | Pass - Samples met established | |
| acceptance criteria | ||
| Tip Buckling | Measurement of distal catheter buckling | |
| force. | Pass - Samples met established | |
| acceptance criteria | ||
| Product Integrity Post-Removal | Catheter and accessories were inspected | |
| following removal from packaging. | Pass - Samples met established | |
| acceptance criteria. | ||
| Simulated Use Testing | Simulated use testing in a bench anatomical | |
| model using worst-case interventional devices | ||
| with femoral artery access. | Pass - Samples met established | |
| acceptance criteria. | ||
| Friction Force Testing | Coating lubricity measured by a pinch test and | |
| compared to predicate device. | Pass – Device comparable to | |
| predicate |
7
8
Performance Data - Animal Study
An animal study was conducted in compliance with FDA Good Laboratory Practice (GLP) Regulation (21 CFR Part 58) at 3-day and 30-day timepoints to assess the navigation to the target artery (3 passes in each artery), angiography, necropsy, and histopathology of the Subject Device, Broadway 8 Catheter, compared to the Predicate Device, AXS Vecta 74 Catheter. The vessels evaluated in the swine model included the ascending pharyngeal artery (APA), internal maxillary artery (IMAX), internal mammary artery (IMA), superficial cervical artery (SCA), and axillary artery. All study endpoints were met and the Broadway 8 Catheter (Test Article) performed as well as or better than the AXS Vecta 74 catheter (Control Article), with no vessel damage observed at the treatment or terminal procedures. The study results demonstrated vascular safety of the Broadway 8 Catheter. This study supports substantial equivalence of the Broadway 8 Catheter to the Predicate Device as evidenced by the absence of vascular damage at the treatment sites during the GLP safety study.
Performance Data - Clinical
No clinical study was conducted as bench testing was determined sufficient for verification and validation purposes.
Sterilization and Shelf Life
The Broadway 8 Catheter and all device accessories are sterilized with 100% Ethylene Oxide to a sterility assurance level (SAL) of 106. The Subject Device and accessories meet the requirements for EO residuals per EN ISO 10993-7 for a limited contact delivery system - externally communicating. The Broadway 8 Catheter and accessories are provided for single use only.
The labeled shelf life for the Broadway 8 Catheter is 1-year. Shelf-life testing (product and packaging) and Distribution Shipping Challenge Conditioning testing were performed on the Subject Device, and the results met established criteria.
Biocompatibility
The Broadway 8 Catheter is categorized as a limited exposure (≤24 hours), externally communicating device with circulating blood contact in accordance with ISO 10993-1 and FDA Guidance, "Use of International ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation of testing within a risk management process." All patient contacting components used in the Broadway 8 Catheter have a history of safe clinical use throughout the medical device industry and/or within Stryker Neurovascular and have supporting biocompatibility data. The results of the biocompatibility testing are summarized in Table 3 below.
9
| Test | Test Method Summary | Conclusion |
|---|---|---|
| Extract and Direct Hemolysis | ISO 10993-4 | Non-hemolytic |
| Thromboresistance | ISO 10993-4 | Non-thrombogenic |
| SC5b-9 Complement Activation Assay | ISO 10993-4 | Non-activator |
| ASTM Partial Thromboplastin Time | ISO 10993-4 | No enhancement or inhibition |
| of coagulation system | ||
| Cytotoxicity Study Using the ISO Elution | ||
| Method | ISO 10993-5 | Non-cytotoxic |
| ISO Maximization Sensitization Study | ISO 10993-10 | No evidence of sensitization |
| ISO Acute Systemic Toxicity Study – | ||
| Extract | ISO 10993-11 | No mortality or evidence of |
| acute systemic toxicity | ||
| Material Mediated Pyrogenicity | USP | Non-pyrogenic reactivity |
| ISO Intracutaneous Reactivity Study – | ||
| Extract | ISO 10993-23 | Non-irritant |
| Table 3: Biocompatibility Tests and Results | |||||
|---|---|---|---|---|---|
| -- | -- | --------------------------------------------- | -- | -- | -- |
Conclusions
The Broadway 8 Catheter is substantially equivalent to the Predicate Device based on similar intended use / indications for use, same or similar materials, same fundamental design, and the same operating principles. The conclusions drawn from risk assessments, the bench testing conducted using the Subject Device compared to the Predicate Device, and an animal safety study demonstrate that the Subject Device is suitable for the indication for use with the associated QJP Product Code. Additionally, the testing results summarized above along with the risk assessment demonstrate that the benefits of the device outweigh any residual risks when used in accordance with device Instructions for Use. Stryker Neurovascular has demonstrated that the Broadway 8 Catheter is substantially equivalent to the legally marketed Predicate Device.