PATH BGC

K242392 · Crossroads Neurovascular, Inc. · QJP · May 9, 2025 · Cardiovascular

Device Facts

• Record ID: K242392
• Device Name: PATH BGC
• Applicant: Crossroads Neurovascular, Inc.
• Product Code: QJP · Cardiovascular
• Decision Date: May 9, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

Device Story

PATH BGC is a dual coaxial lumen catheter used in neurovascular angiographic procedures. It features an inner coil-reinforced and outer braid-reinforced variable stiffness lumen, a compliant polyurethane balloon at the distal end for temporary vascular occlusion, and a bifurcated luer hub for flushing and inflation. Radiopaque markers are located at the tip and balloon ends. The device is operated by a physician in a clinical setting. It is inserted into the neurovascular system to guide other catheters; the balloon is inflated to occlude blood flow, facilitating procedures. The device is provided sterile via Ethylene Oxide. It is a mechanical device; no software or AI/ML algorithms are involved.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including visual/dimensional inspection, simulated use, kink resistance, coating lubricity, radiopacity, delivery/retrieval forces, balloon deflation time, tip stiffness, coating integrity, torque strength, tensile strength, leak testing (liquid/air), hub compatibility, burst testing (static/dynamic), lumen collapse resistance, corrosion resistance, particulate evaluation, balloon fatigue, and shelf-life/transit testing. Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-irritant, non-sensitizing, non-toxic, non-pyrogenic, and thromboresistant properties.

Technological Characteristics

Dual coaxial lumen catheter; inner coil-reinforced and outer braid-reinforced variable stiffness lumens. Materials: Neusoft UR862A Pebax (jackets), polyurethane (tip/balloon), stainless steel (braid), platinum/iridium (marker bands), polycarbonate (hub). Sterilization: Ethylene Oxide (ISO 11135). Connectivity: None. Software: None. Standards: ISO 10555-1 (leak/burst/corrosion), ISO 80369-7 (luer), ISO 10993 (biocompatibility).

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into neurovascular blood vessels and providing temporary vascular occlusion during angiographic procedures.

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

• Modified FlowGate Balloon Guide Catheter (K131492)

Submission Summary (Full Text)

{0}

FDA U.S. FOOD & DRUG ADMINISTRATION

May 9, 2025

Crossroads Neurovascular, Inc.
% Ryan Breckenridge
QA/RA Consultant
M4D LLC
105 North Pointe Drive, Suite D
Lake Forest, California 92630

Re: K242392
Trade/Device Name: PATH BGC
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP
Dated: March 28, 2025
Received: April 07, 2025

Dear Ryan Breckenridge:

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K242392 - Ryan Breckenridge
Page 2

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).

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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

{2}

K242392 - Ryan Breckenridge
Page 3

assistance/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,

Naira Muradyan -S

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}

FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K242392 | |
| Device Name PATH BGC | |
| Indications for Use (Describe) PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures. | |
| 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) | |
| 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." | |

{4}

510(k) Summary – K242392
As required by 21 CFR 807.92

| Applicant: | Crossroads Neurovascular, Inc.
105 North Pointe Drive, Suite D
Lake Forest, CA 92630 |
| --- | --- |
| Contact: | Ryan Breckenridge
Telephone: [phone]
Email: [e-mail] |
| Date Prepared: | May 07, 2025 |
| Device Trade Name: | PATH BGC |
| Device Common Name: | Balloon Guide Catheter |
| Classification Name: | Catheter, Percutaneous |
| Regulation Number: | 21 CFR 870.1250 |
| Product Code: | QJP |
| Predicate Device: | Modified FlowGate Balloon Guide Catheter, K131492 |

## Device Description

The PATH Balloon Guide Catheter (PATH BGC) is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. The catheter has hydrophilic coating at the distal and proximal end. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation.

## Indications For Use

PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures.

## Comparison of Predicate and Subject Devices

The table below provides the comparison of technological characteristics and indications for use of the subject device with the predicate device.

1

{5}

Table 1: Comparison of Predicate and Subject Devices

| Feature | Predicate Device Modified FlowGate Balloon Guide Catheter | Subject Device PATH BGC |
| --- | --- | --- |
| | K131492 | K242392 |
| Indications for Use | The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices. | PATH BGC is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during these and other angiographic procedures. |
| Device Description | The FlowGate Balloon Guide Catheter is a coaxial-lumen, braided shaft, variable stiffness catheter with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on the product label. | The PATH BGC is a dual coaxial lumen catheter consisting of an inner coil reinforced variable stiffness lumen and an outer braid reinforced variable stiffness lumen. A radiopaque marker is included at the tip of the catheter and at the distal and proximal ends of the balloon. A compliant balloon is mounted near the distal end of the catheter to provide vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing and balloon inflation. |
| Outer Jacket | Pebax | Neusoft UR862A Pebax |
| Inner Jacket | Pebax | Neusoft UR862A Pebax |
| Distal Tip | Pebax | Polyurethane |

{6}

| Feature | Predicate Device Modified FlowGate Balloon Guide Catheter | Subject Device PATH BGC |
| --- | --- | --- |
| | K131492 | K242392 |
| Balloon Material | Silicone | Polyurethane |
| Braid | Stainless Steel | Stainless Steel |
| Braid Distal End Securement | Cyanoacrylate | Cyanoacrylate |
| Marker Band | Platinum/Iridium | Platinum/Iridium |
| Catheter Hub | Polyurethane | Polycarbonate |
| Strain Relief | Polyolefin/Pebax | Polyurethane |
| Labeled Shaft Inner/Outer Diameter (Nominal) | Inner Diameter: 0.084in
Outer Diameter: 0.106in | Inner Diameter: 0.070in
Outer Diameter: 0.0965in |
| Maximum Outer Diameter Along Effective Length | 0.1080in | 0.0965in |
| Effective Lengths | 85cm and 95cm | 90cm, 95cm, 100cm, and 105cm |
| Distal Tip Length | 0.75mm | 2cm |
| Radiopaque Marker Length (Nominal) | 0.020in | 0.035in |
| Accessory Devices Provided | Dilator
Peel Away Sheath
Rotating Hemostatic Valve
Tuohy Borst Valve with Sideport
Luer Activated Valve
Extension Tubing | Peel Away Sheath
Rotating Hemostatic Valve with Sideport
Luer Activated Valve |
| Packaging Materials & Configuration | Polyethylene Tube and HDPE Packaging Card
Tyvek/LLDPE Pouch | Polyethylene Tube and HDPE Packaging Card
Tyvek/LLDPE Pouch |

3

{7}

To establish substantial equivalence of the subject device and ensure the device meets the design specifications and requirements, non-clinical bench performance and biocompatibility testing were conducted per the risk analysis. The testing performed and results are summarized below.

# Design Verification Testing - Bench

Performance testing was conducted to support the PATH BGC submission. The results of the design verification and validation testing (Table 2) confirm that the subject device conforms to the pre-defined specifications and test acceptance criteria are met.

Table 2: PATH BGC Bench Testing Summary

| Test | Description | Results |
| --- | --- | --- |
| Visual Inspection | To verify the visual surface requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Dimensional Inspection | To verify the dimensional specifications are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Simulated Use | To evaluate the performance of the device and accessories in simulated anatomy model. | Pass – all samples met the pre-determined acceptance criteria. |
| Kink Resistance | To evaluate the device around bends of clinically relevant radii and verify kink resistance requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Coating Lubricity | To evaluate frictional forces and verify coating lubricity requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Radiopacity | To evaluate marker band visibility under fluoroscopy. | Pass – all samples met the pre-determined acceptance criteria. |
| Delivery/Retrieval | To evaluate the device in an anatomical model and determine the maximum forces required to completely deliver and retrieve the PATH BGC. | Pass – all samples met the pre-determined acceptance criteria. |
| Balloon Deflation Time | To verify balloon deflation time requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Distal Tip Stiffness | To evaluate distal tip deflection force and verify distal tip stiffness requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Coating Integrity | To evaluate device pre- and post-insertion and retrieval through a simulated vascular model and verify coating integrity requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |

{8}

| Torque Strength | To evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| --- | --- | --- |
| Shaft & Hub Tensile | To verify tensile strength requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Liquid Leak | To verify liquid leak requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Air Leak | To verify air leak requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Hub Compatibility | To verify BGC bifurcated luer hub requirements per ISO 80369-7 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| RHV Luer | To verify RHV luer requirements per ISO 80369-7 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Static Burst | To verify static burst requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Dynamic Burst | To verify dynamic burst requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Resistance to Lumen Collapse | To demonstrate that the main lumen does not collapse under aspiration. | Pass – all samples met the pre-determined acceptance criteria. |
| Corrosion Resistance | To verify corrosion resistance requirements per ISO 10555-1 are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Particulate | To evaluate the device within a simulated anatomy model and verify particulate count is similar to the comparator device. | Pass – all samples met the pre-determined acceptance criteria. |
| Balloon Fatigue | To evaluate repetitive balloon inflation and deflation cycles and verify fatigue requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Balloon Burst Volume | To verify balloon burst volume requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Balloon Diameter to Inflation Volume (Compliance) | To characterize balloon diameter for pre-defined balloon inflation volumes. | All samples were characterized. |
| Shelf Life | To verify device performance after accelerated aging. | Pass – all samples met the pre-determined acceptance criteria. |
| Transit Testing | To subject the device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Packaging – Bubble Leak | To evaluate packaging per ASTM F2096-11 and verify requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
| Packaging – Pouch Seal Strength | To evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |

5

{9}

# Animal Study

Animal study was not deemed necessary to demonstrate substantial equivalence.

# Sterilization and Shelf Life

The subject device is sterilized using an Ethylene Oxide (EtO) sterilization cycle. The sterilization cycle was verified to ensure a sterility assurance level (SAL) of $10^{-6}$ in accordance with ISO 11135:2014, "Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation, and routine control of a sterilization process for medical devices."

Shelf-life studies for the subject device have demonstrated that the subject device and packaging remain functional for the labeled use by date. Shelf-life studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.

# Biocompatibility

Biocompatibility evaluation for the subject device was performed in accordance with ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and Good Laboratory Practice (GLP). Biocompatibility testing completed on the PATH Balloon Guide Catheter and tissue-contacting accessories (Luer Activated Valve, Peel-Away Sheath, and RHV) is summarized in Table 3.

Table 3: Biocompatibility Testing

| Test | Standard | Results | Conclusion |
| --- | --- | --- | --- |
| Minimum Essential Medium (1X MEM) Cytotoxicity (GLP) | ISO 10993-5 | Test article scored 0 at 48 hours. 1X MEM test extract showed no cytotoxic potential to L-929 mouse fibroblast cells undiluted or at any dilution. | Non-cytotoxic |
| Intracutaneous Irritation (GLP - 2 Extracts) | ISO 10993-23 | The delta between the average scores of the extract of the test article and the vehicle control are 0.0; 0.2. | Non-irritant |
| Guinea Pig Maximization Sensitization (GLP - 2 Extracts) | ISO 10993-10 | Test and control animal's response not greater than “0”. | Non- sensitizing |
| Acute Systemic Toxicity (GLP - 2 Extracts) | ISO 10993-11 | None of the animals were observed with abnormal clinical signs indicative of toxicity for 72 hours. All were alive at the end of 72 hours and body weight changes were within acceptable parameters. | Non-toxic |
| Material-Mediated Rabbit Pyrogen (GLP) | ISO 10993-11, USP <151> | No rabbit temperature rise ≥0.5°C. | Non-pyrogenic |
| Complement Activation Assay with Comparison Article (GLP) | ISO 10993-4, ASTM F756, ASTM 2382, ASTM F2888 | Results were within acceptable range and not statistically different than | Not an activator of the complement system |
| | | the control animal was not observed. | |

{10}

| | | activated normal human serum (NHS) control or negative control. | |
| --- | --- | --- | --- |
| Hemolysis – Direct Contact and Extract Method (GLP) | | Direct Contact Blank corrected hemolytic index: -0.3.
Extract Blank corrected hemolytic index: -0.4. | Non-hemolytic |
| A GLP 4-Hour Thrombogenicity Study in Ovine | | Test articles were compared to the comparator. | Thromboresistance of the test device is similar to the comparator. |
| Partial Thromboplastin Time (PTT) (GLP) | | Test article was found to be 90.3% of the negative control and not statistically different from the comparator. | |
| Heparinized Blood Platelet and Leukocyte Count Assay | | Test article was found to be 108.0% and 90.4% of the negative control (for platelet and leukocyte cell, respectively) and not statistically different from the comparator. | |

Clinical Study

Clinical study was not deemed necessary to demonstrate substantial equivalence.

Conclusion

The PATH BGC and the predicate device, Modified FlowGate Balloon Guide Catheter (K131492), have similar intended use, device operating principle, technological characteristics, and indications for use. The differences in technological characteristics do not raise new questions of safety or effectiveness. Successful completion of non-clinical bench performance testing, biocompatibility, sterility, and shelf-life testing demonstrates that the subject device meets the design specifications and functions as intended. Based on the information provided in this submission, the PATH BGC is substantially equivalent to the predicate, Modified FlowGate Balloon Guide Catheter (K131492).