(270 days)
Not Found
No
The provided text describes a physical medical device (a catheter with a balloon) and its performance during bench testing, with no mention of software, algorithms, or any form of artificial intelligence.
No
The device facilitates the insertion and guidance of a catheter and provides temporary vascular occlusion, but it does not directly treat a disease or condition. It is an accessory device used during a procedure.
No
The device is described as a catheter that facilitates insertion and guidance of another catheter and provides temporary vascular occlusion. Its function is interventional, not diagnostic.
No
The device description details a physical catheter with multiple hardware components (lumens, balloon, radiopaque markers, hub, etc.), and the performance studies focus on bench testing of these physical characteristics. There is no mention of software as the primary mechanism of action or a significant component of the device's functionality.
No.
The device is an intravascular catheter used for guiding and occluding blood vessels, not for testing samples from the human body.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
QJP
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (All tests passed, meaning all samples met the pre-determined acceptance criteria)
Test: Visual Inspection, Description: To verify the visual surface requirements are met.
Test: Dimensional Inspection, Description: To verify the dimensional specifications are met.
Test: Simulated Use, Description: To evaluate the performance of the device and accessories in simulated anatomy model.
Test: Kink Resistance, Description: To evaluate the device around bends of clinically relevant radii and verify kink resistance requirements are met.
Test: Coating Lubricity, Description: To evaluate frictional forces and verify coating lubricity requirements are met.
Test: Radiopacity, Description: To evaluate marker band visibility under fluoroscopy.
Test: Delivery/Retrieval, Description: To evaluate the device in an anatomical model and determine the maximum forces required to completely deliver and retrieve the PATH BGC.
Test: Balloon Deflation Time, Description: To verify balloon deflation time requirements are met.
Test: Distal Tip Stiffness, Description: To evaluate distal tip deflection force and verify distal tip stiffness requirements are met.
Test: Coating Integrity, Description: To evaluate device pre- and post-insertion and retrieval through a simulated vascular model and verify coating integrity requirements are met.
Test: Torque Strength, Description: To evaluate device integrity after applied hub rotations with distal end held stationary and verify torque strength requirements are met.
Test: Shaft & Hub Tensile, Description: To verify tensile strength requirements are met.
Test: Liquid Leak, Description: To verify liquid leak requirements per ISO 10555-1 are met.
Test: Air Leak, Description: To verify air leak requirements per ISO 10555-1 are met.
Test: Hub Compatibility, Description: To verify BGC bifurcated luer hub requirements per ISO 80369-7 are met.
Test: RHV Luer, Description: To verify RHV luer requirements per ISO 80369-7 are met.
Test: Static Burst, Description: To verify static burst requirements per ISO 10555-1 are met.
Test: Dynamic Burst, Description: To verify dynamic burst requirements per ISO 10555-1 are met.
Test: Resistance to Lumen Collapse, Description: To demonstrate that the main lumen does not collapse under aspiration.
Test: Corrosion Resistance, Description: To verify corrosion resistance requirements per ISO 10555-1 are met.
Test: Particulate, Description: To evaluate the device within a simulated anatomy model and verify particulate count is similar to the comparator device.
Test: Balloon Fatigue, Description: To evaluate repetitive balloon inflation and deflation cycles and verify fatigue requirements are met.
Test: Balloon Burst Volume, Description: To verify balloon burst volume requirements are met.
Test: Balloon Diameter to Inflation Volume (Compliance), Description: To characterize balloon diameter for pre-defined balloon inflation volumes. (All samples were characterized.)
Test: Shelf Life, Description: To verify device performance after accelerated aging.
Test: Transit Testing, Description: To subject the device, accessories, and packaging to environmental conditioning and shipping simulation and verify performance requirements are met.
Test: Packaging – Bubble Leak, Description: To evaluate packaging per ASTM F2096-11 and verify requirements are met.
Test: Packaging – Pouch Seal Strength, Description: To evaluate packaging per ASTM F88 Technique A (unsupported peel) and verify requirements are met.
Test: Sterility, Description: To subject the device, accessories, and packaging to sterilization and verify the requirements are met.
Animal study was not deemed necessary to demonstrate substantial equivalence.
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 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: Minimum Essential Medium (1X MEM) Cytotoxicity (GLP), Standard: ISO 10993-5, Results: 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., Conclusion: Non-cytotoxic
Test: Intracutaneous Irritation (GLP – 2 Extracts), Standard: ISO 10993-23, Results: The delta between the average scores of the extract of the test article and the vehicle control are 0.0; 0.2., Conclusion: Non-irritant
Test: Guinea Pig Maximization Sensitization (GLP – 2 Extracts), Standard: ISO 10993-10, Results: Test and control animal's response not greater than "0"., Conclusion: Non-sensitizing
Test: Acute Systemic Toxicity (GLP – 2 Extracts), Standard: ISO 10993-11, Results: 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., Conclusion: Non-toxic
Test: Material-Mediated Rabbit Pyrogen (GLP), Standard: ISO 10993-11, USP , Results: No rabbit temperature rise ≥0.5°C., Conclusion: Non-pyrogenic
Test: Complement Activation Assay with Comparison Article (GLP), Standard: ISO 10993-4, ASTM F756, ASTM 2382, ASTM F2888, Results: Results were within acceptable range and not statistically different than activated normal human serum (NHS) control or negative control., Conclusion: Not an activator of the complement system
Test: Hemolysis – Direct Contact and Extract Method (GLP), Results: Direct Contact Blank corrected hemolytic index: -0.3. Extract Blank corrected hemolytic index: -0.4., Conclusion: Non-hemolytic
Test: A GLP 4-Hour Thrombogenicity Study in Ovine, Results: Test articles were compared to the comparator., Conclusion: Not Found
Test: Partial Thromboplastin Time (PTT) (GLP), Results: Test article was found to be 90.3% of the negative control and not statistically different from the comparator., Conclusion: Thromboresistance of the test device is similar to the comparator.
Test: Heparinized Blood Platelet and Leukocyte Count Assay, Results: 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., Conclusion: Not Found
Clinical study was not deemed necessary to demonstrate substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Modified FlowGate Balloon Guide Catheter, K131492
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
510(k) Clearance Letter for PATH BGC
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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.
Page 2
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-
Page 3
K242392 - Ryan Breckenridge Page 3
assistance/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,
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
Page 4
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)
[X] 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:
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
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: 760-917-1294
Email: ryan.breckenridge@m4dllc.com
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.
Page 6
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 |
Page 7
| 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 |
| Sterilization Method | EtO | EtO |
| How Supplied | Sterile, Single Use | Sterile, Single Use |
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.
Page 8
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. |
Page 9
| Test | Description | Results |
|---|---|---|
| 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. |
Page 10
| Test | Description | Results |
|---|---|---|
| Sterility | To subject the device, accessories, and packaging to sterilization and verify the requirements are met. | Pass – all samples met the pre-determined acceptance criteria. |
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 | 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 |
Page 11
| 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. | ||
| Partial Thromboplastin Time (PTT) (GLP) | Test article was found to be 90.3% of the negative control and not statistically different from the comparator. | Thromboresistance of the test device is similar to 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).