(59 days)
No.
Reasoning: The device description and performance studies do not mention any AI, machine learning, or deep neural network components. The device is a physical catheter used for medical procedures.
No.
This device is an accessory (guide catheter) used to facilitate the insertion and guidance of other catheters and devices. It does not directly provide therapy.
No
This device is a guide catheter used to facilitate the insertion of other intravascular catheters and for temporary vascular occlusion. Its function is interventional, not diagnostic.
No
The device description, intended use, and performance studies clearly indicate that the Branchor X Balloon Guide Catheter is a physical medical device (catheter with a balloon) used in neurovascular procedures. It involves physical components, material coatings, and mechanical properties, not solely software.
No
The device is a catheter used for physical guidance, occlusion, and retrieval during medical procedures, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.
Product codes
QJP
Device Description
The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section.
The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neurovascular
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
Non-clinical bench testing was performed on the Branchor X Balloon Guide Catheter to determine substantial equivalence. The following testing/assessments were performed: Dimensional Verification, Distal Tip Visual Inspection, Surface Visual Inspection, Radio-Detectability, Balloon Diameter to Inflation Pressure, Freedom from Leakage and Damage on Inflation, Balloon Maximum Diameter, Liquid Leakage under Pressure, Air Leakage into Hub Assembly during Aspiration, Peak Tensile Strength, Kink Resistance, Tip Flexibility, Flow Rate, Burst Pressure under Static Condition, Power Injection, Torque Strength, Coating Integrity/Particulate, Simulated Use, and Connector testing. All samples met the acceptance criteria for these tests.
Biocompatibility testing was conducted in accordance with ISO 10993 series, including: Cytotoxicity (MEM Elution Test), Sensitization (Maximization Test), Irritation or Intracutaneous Reactivity (Intracutaneous Injection Test), Acute Systemic Toxicity (Systemic Injection), Material Mediated Pyrogenicity (Rabbit Pyrogen Test), Hemocompatibility (Hemolysis, Complement Activation (SC5b-9), Unactivated Partial Thromboplastin Time Assay (UPTT), and Thrombogenicity). Cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis, complement activation, and UPTT tests concluded non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, non-activator, and non-activator respectively. Thrombogenicity was comparable to commercially available comparator devices.
The sterilization process has been validated in accordance with ISO 11135-1:2014 to achieve a sterility assurance level (SAL) of 10⁻⁶. EO and ECH residuals were below limits specified in ISO 10993-7:2008. Bacterial Endotoxin Levels were below 2.15 EU/device.
Baseline and accelerated shelf-life testing demonstrated the device performs as intended for a proposed 6 months shelf-life.
Animal and clinical studies were not deemed necessary.
Key Metrics
Not Found
Predicate Device(s)
Branchor Balloon Guide Catheter (K221951)
Reference Device(s)
Branchor Balloon Guide Catheter (K203723), CELLO Balloon Guide Catheter (K120781)
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).
FDA 510(k) Clearance Letter - Branchor X Balloon Guide Catheter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
ASAHI INTECC Co., Ltd.
℅ Esther Kim
Quality System and Regulatory Affairs Associate
ASAHI INTECC USA, Inc.
3002 Dow Avenue, Suite 212
Tustin, California 92780
Re: K251240
Trade/Device Name: Branchor X Balloon Guide Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: QJP
Dated: April 21, 2025
Received: April 22, 2025
Dear Esther Kim:
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
K251240 - Esther Kim
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
K251240 - Esther Kim
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
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 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)
K251240
Device Name
Branchor X Balloon Guide Catheter
Indications for Use (Describe)
The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.
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
PRAStaff@fda.hhs.gov
"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."
Page 5
510(k) Summary
(as required by 21 CFR § 807.92)
K251240
Page 1 of 8
Global Headquarters and R&D Center
3-100 Akatsuki-cho, Seto-shi, Aichi 489-0071 Japan
TEL : +81-561-48-5551 FAX : +81-561-48-5552
http://www.asahi-intecc.co.jp/
Branchor X Balloon Guide Catheter
K251240
Date Prepared: 11 June 2025
Applicant: ASAHI INTECC CO., LTD.
3-100 Akatsuki-cho,
Seto, Aichi 489-0071 Japan
Contact: Esther Kim
Quality System and Regulatory Affairs Associate
ASAHI INTECC USA, Inc.
3002 Dow Avenue, Suite 212
Tustin, CA 92780
Office: (949) 756-8901 ext 508
e-mail: aiu_ra@asahi-intecc-us.com
Trade/Device Name: Branchor X Balloon Guide Catheter
Regulation Number: 21 CFR § 870.1250
Classification Name: Percutaneous Catheter
Device Classification: Class II
Product Code: QJP – Catheter, Percutaneous, Neurovasculature
Predicate Device: Branchor Balloon Guide Catheter (K221951)
Reference Devices: Branchor Balloon Guide Catheter (K203723)
CELLO Balloon Guide Catheter (K120781)
Page 6
I. DEVICE DESCRIPTION
The Branchor X Balloon Guide Catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of the balloon guide catheter and recommended balloon injection volume are provided on the product label.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section. This allows the guidewire and other devices to easily move through the section.
The Branchor X Balloon Guide Catheter is packaged with a luer-activated valve, a syringe, a three-way stopcock, a rotating hemostasis valve (RHV), and a peel-away accessories.
II. INDICATIONS FOR USE
The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices.
III. COMPARISON OF INDICATIONS FOR USE AND TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE
The comparison of the Branchor X Balloon Guide Catheter and the predicate Branchor Balloon Guide Catheter (K221951) shows that the devices have the same intended use and same or similar technological characteristics, such as components, design, materials, sterilization method, and operating principle. The technological differences do not raise new questions of safety and effectiveness.
A tabular comparison of the intended use and specific technological characteristics between the subject, predicate and reference devices is provided below:
Page 2 of 8
Page 7
| Name of Devices | Branchor X Balloon Guide Catheter (subject) | Branchor Balloon Guide Catheter (predicate) | Branchor Balloon Guide Catheter (reference) |
|---|---|---|---|
| 510(k) | K251240 | K221951 | K203723 |
| Indications for Use | The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media. |
The balloon provides temporary vascular occlusion during these procedures.
The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices. | The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices. | The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices. |
Page 3 of 8
Page 8
| Name of Devices | Branchor X Balloon Guide Catheter (subject) | Branchor Balloon Guide Catheter (predicate) | Branchor Balloon Guide Catheter (reference) | CELLO Balloon Guide Catheter (reference) |
|---|---|---|---|---|
| 510(k) | K251240 | K221951 | K203723 | K120781 |
| Indications for Use | The Branchor X Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media. |
The balloon provides temporary vascular occlusion during these procedures.
The Branchor X Balloon Guide Catheter can also be used as a conduit for retrieval devices. | The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices. | The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravascular catheter into a selected blood vessel in the neuro vasculature, and injection of contrast media.
The balloon provides temporary vascular occlusion during these procedures.
The Branchor Balloon Guide Catheter can also be used as a conduit for retrieval devices. | The CELLO Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vasculature systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. |
| Device Description | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label. The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label. The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label. The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | |
| Regulation Number | 21 CFR § 870.1250 | 21 CFR § 870.1250 | 21 CFR § 870.1250 | |
| Regulation Description | Catheter, Percutaneous, Neurovasculature | Catheter, Percutaneous, Neurovasculature | Catheter, Percutaneous, Neurovasculature | |
Page 9
| Branchor X Balloon Guide Catheter (subject) | Branchor Balloon Guide Catheter (predicate) | Branchor Balloon Guide Catheter (reference) | CELLO Balloon Guide Catheter (reference) | |
|---|---|---|---|---|
| Device Description | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label. |
The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet.
The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet.
The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | This balloon guide catheter is a variable stiffness catheter that has a radiopaque marker at the distal end of the balloon to facilitate fluoroscopic visualization and indicate the balloon position, a branched connector at the proximal end, and is equipped with a braid reinforced coaxial lumen. A balloon is attached to the distal end, and the dimensions of this balloon guide catheter and recommended balloon injection volume are provided on the product label.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating for enhanced lubricity when the surface is wet.
The shaft lumen is provided with PTFE coating, with the exception of the connector section to facilitate the passage of the guidewire and other devices through the section. | The CELLO Balloon Guide Catheter is a coaxial-lumen, braid- reinforced, variable stiffness catheter with two radiopaque markers on both the distal and proximal ends of the balloon and a bifurcated luer hub on the proximal end. A compliant silicone balloon is mounted on the distal end. Balloon Guide Catheter dimensions and the recommended balloon inflation volumes are indicated on product label. |
| Regulation Number | 21 CFR § 870.1250 | 21 CFR § 870.1250 | 21 CFR § 870.1250 | 21 CFR § 870.1250 |
| Regulation Description | Catheter, Percutaneous, Neurovasculature | Catheter, Percutaneous, Neurovasculature | Catheter, Percutaneous, Neurovasculature | Percutaneous Catheter |
Page 4 of 8
Page 10
| Branchor X Balloon Guide Catheter (subject) | Branchor Balloon Guide Catheter (predicate) | Branchor Balloon Guide Catheter (reference) | CELLO Balloon Guide Catheter (reference) | |
|---|---|---|---|---|
| Regulatory Class | II | II | II | II |
| Product Code | QJP | QJP | QJP, DQY | DQY |
| Size | Shaft OD: 2.70 mm, 3.00 mm | |||
| Shaft ID: 2.19 mm, 2.42 mm | Shaft OD: 3.00 mm | |||
| Shaft ID: 2.28 mm | Shaft OD: 3.00 mm | |||
| Shaft ID: 2.28 mm | 6 Fr, 7 Fr, 8 Fr, 9 Fr | |||
| Effective Length | 90 cm, 95 cm, 97 cm | 90 cm, 100 cm | 90 cm, 100 cm | 92 cm to 102 cm |
| Balloon Material | Polyurethane elastomer | Polyurethane elastomer | Polyurethane elastomer | Silicone rubber |
| Shaft Materials | Polyurethane Elastomer | |||
| Polyamide 12 elastomer | ||||
| Polyamide 12 | ||||
| Stainless steel | ||||
| Tungsten | ||||
| Polytetrafluoroethylene | Polyurethane Elastomer | |||
| Polyamide 12 elastomer | ||||
| Polyamide 12 | ||||
| Stainless steel | ||||
| Polytetrafluoroethylene | Polyurethane Elastomer | |||
| Polyamide 12 elastomer | ||||
| Polyamide 12 | ||||
| Stainless steel | ||||
| Polytetrafluoroethylene | Polyurethane | |||
| Polyamide | ||||
| Stainless steel | ||||
| PFA | ||||
| Accessories | Luer-activated valve | |||
| RHV | ||||
| Peel-away | ||||
| Syringe | ||||
| Three-way stopcock | Peel-away | |||
| Syringe | ||||
| Three-way stopcock | Peel-away | |||
| Syringe | ||||
| Three-way stopcock | Dilator | |||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility Level | SAL10⁻⁶ | SAL10⁻⁶ | SAL10⁻⁶ | SAL10⁻⁶ |
| Shelf Life | 0.5 years | 3 years | 3 years | Unknown |
| Single Use | Yes | Yes | Yes | Yes |
| Radiopaque Markers | Yes | Yes | Yes | Yes |
| Anatomical Sites | Neurovascular | Neurovascular | Neurovascular | Peripheral and neurovascular |
Page 5 of 8
Page 11
K251240
Page 6 of 8
IV. TESTING SUMMARY
Non-Clinical Testing / Performance Data
Non-clinical bench testing was performed on the Branchor X Balloon Guide Catheter to determine substantial equivalence. The following testing/assessments were performed:
| Test | Test Method Summary | Results/Conclusion |
|---|---|---|
| Dimensional Verification | The device dimensions were measured to confirm they meet design specifications. | All samples met the acceptance criteria. |
| Distal Tip Visual Inspection | The distal tip was visually inspected for appropriate shape and smoothness. | All samples met the acceptance criteria. |
| Surface Visual Inspection | The catheter surface was checked for cleanliness and absence of defects. | All samples met the acceptance criteria. |
| Radio-Detectability | The device was evaluated for visibility under X-ray imaging. | All samples met the acceptance criteria. |
| Balloon Diameter to Inflation Pressure | The balloon was inflated and its diameter was measured at various inflation levels. | All samples met the acceptance criteria. |
| Freedom from Leakage and Damage on Inflation | The balloon was repeatedly inflated and deflated to check for leakage or damage. | All samples met the acceptance criteria. |
| Balloon Maximum Diameter | The balloon was inflated to its maximum volume and checked for integrity. | All samples met the acceptance criteria. |
| Liquid Leakage under Pressure | The catheter was pressurized with liquid and checked for leaks. | All samples met the acceptance criteria. |
| Air Leakage into Hub Assembly during Aspiration | The hub was aspirated and checked for air ingress. | All samples met the acceptance criteria. |
| Peak Tensile Strength | Tensile force was applied to joints to assess mechanical strength. | All samples met the acceptance criteria. |
| Kink Resistance | The catheter was bent to assess resistance to kinking. | All samples met the acceptance criteria. |
| Tip Flexibility | The flexibility of the distal tip was measured. | All samples met the acceptance criteria. |
| Flow Rate | The flow rate through the catheter was measured. | All samples met the acceptance criteria. |
| Burst Pressure under Static Condition | The device was pressurized until failure to assess burst strength. | All samples met the acceptance criteria. |
| Power Injection | The device was tested for performance during high-pressure injection. | All samples met the acceptance criteria. |
| Torque Strength | The device was rotated to assess resistance to torsional stress. | All samples met the acceptance criteria. |
| Coating Integrity/Particulate | The device was tracked in a simulated anatomical model to evaluate coating integrity and particulate release. | All samples met the acceptance criteria. |
| Simulated Use | The device was used in simulated anatomical model to assess overall performance. | All samples met the acceptance criteria. |
| Connector | The connector was tested for leakage, mechanical integrity, and compatibility. | All samples met the acceptance criteria. |
Page 12
K251240
Page 7 of 8
Non-clinical bench testing demonstrated that the Branchor X Balloon Guide Catheter met all pre-established acceptance criteria, functions as intended, and has a safety and effectiveness profile that is similar to the predicate device and the reference devices.
Biocompatibility Testing
The biocompatibility evaluation for the Branchor X Balloon Guide Catheter was conducted in accordance with the FDA guidance, "Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process"," and International Standard ISO 10993 series.
The biocompatibility testing included the following tests:
| Test | Test Summary | Conclusion |
|---|---|---|
| Cytotoxicity | ||
| MEM Elution Test | ||
| ISO 10993-5 | Determine the potential cytotoxicity of a mammalian cell culture (L929) in response to the test article extract. | Non-cytotoxic |
| Sensitization | ||
| Maximization Test | ||
| ISO 10993-10 | Allergenic or sensitizing potential of the device was evaluated using polar and non-polar extracts in a guinea pig maximization test. | Non-sensitizing |
| Irritation or Intracutaneous Reactivity | ||
| Intracutaneous Injection Test | ||
| ISO 10993-23 | Potential irritation effect of the extract of the device as a result of intracutaneous injection of polar and non-polar extracts was tested. | Non-irritant |
| Acute Systemic Toxicity | ||
| Systemic Injection | ||
| ISO 10993-11 | Determine the potential toxic effects of the test article extract as a result of a single-dose systemic injection of polar and non-polar extracts in mice. | Non-toxic |
| Material Mediated Pyrogenicity | ||
| Rabbit Pyrogen Test | ||
| ISO 10993-11 | Determine the potential presence of material-mediated pyrogen. | Non-pyrogenic |
| Hemocompatibility | ||
| Hemolysis | ||
| ISO 10993-4 | Determine the potential hemolytic activity, via the induction of increased levels of free plasma hemoglobin in rabbit blood, in response to the test article (direct) and its extract (indirect). | Non-hemolytic |
| Hemocompatibility | ||
| Complement Activation (SC5b-9) | ||
| ISO 10993-4 | Human plasma was exposed to the device (direct contact) to determine the potential activation of the SC5b-9 complement system. | Non-activator |
| Hemocompatibility | ||
| Unactivated Partial Thromboplastin Time Assay (UPTT) | ||
| ISO 10993-4 | Human plasma was exposed to the device (direct contact) to assess any effect on the intrinsic coagulation pathway by measuring clotting time (UPTT). | Non-activator |
| Hemocompatibility | ||
| Thrombogenicity | ||
| ISO 10993-4 | Compared the thrombogenicity properties of direct blood contacting components of the subject and commercially available control devices in vivo. | Comparable thromboresistance to commercially available comparator devices |
Per ISO 10993-1, the Branchor X Balloon Guide Catheter was categorized as an externally communicating device with circulating blood contact for a limited duration of contact (≤ 24 hours).
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Sterilization and Shelf Life
The Branchor X Balloon Guide Catheter sterilization process using Ethylene Oxide (EO) has been validated in accordance with ISO 11135-1:2014 to achieve a sterility assurance level (SAL) of 10⁻⁶. EO and Ethylene Chlorohydrin (ECH) residuals were below the limits specified in ISO 10993-7:2008.
Bacterial Endotoxin Levels were below the level of 2.15 EU/device.
Both baseline and accelerated shelf-life testing were conducted demonstrating the device will perform as intended to support the proposed 6 months shelf-life.
Animal Study
Animal study was not deemed necessary to demonstrate substantial equivalence.
Clinical Study
Clinical study was not deemed necessary to demonstrate substantial equivalence.
V. CONCLUSIONS
The Branchor X Balloon Guide Catheter has the same intended use and similar technological characteristics such as components, design, materials, sterilization method, and operating principles as the predicate device. Performance testing demonstrates that the device functions as intended. The differences between the subject and predicate device do not raise different or new questions of safety or effectiveness. The conclusions drawn from the nonclinical tests demonstrate that the Branchor X Balloon Guide Catheter is substantially equivalent to the predicate device.