Branchor Balloon Guide Catheter
Device Facts
| Record ID | K203723 |
|---|---|
| Device Name | Branchor Balloon Guide Catheter |
| Applicant | Asahi Intecc Co., Ltd. |
| Product Code | QJP · Cardiovascular |
| Decision Date | Dec 10, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.1250 |
| Device Class | Class 2 |
Indications for Use
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.
Device Story
Variable stiffness, braid-reinforced coaxial lumen catheter; distal polyurethane balloon for temporary vascular occlusion; proximal branched connector. Used in neurovascular procedures; operated by trained physicians. Input: manual inflation via syringe/stopcock; output: vascular access/occlusion. Hydrophilic outer coating and PTFE-coated shaft lumen enhance lubricity and device passage. Fluoroscopic visualization via distal radiopaque marker. Benefits: facilitates navigation, contrast delivery, and retrieval device deployment in neurovasculature.
Clinical Evidence
Bench testing only. Testing included air leakage, balloon pressure/diameter/inflation/deflation, burst pressure, kink resistance, tensile strength, torque, and lumen collapse. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility) confirmed safety. Sterilization validated per ISO 11135-1.
Technological Characteristics
Materials: Polyurethane elastomer, Polyamide 12, Stainless steel, PTFE. Coaxial lumen, braid-reinforced. Hydrophilic coating. Dimensions: 9F OD, 6.84F ID. Sterilization: Ethylene Oxide (SAL 10^-6). Radiopaque marker for fluoroscopy. Manual operation.
Indications for Use
Indicated for patients requiring neurovascular catheterization, contrast media injection, temporary vascular occlusion, or retrieval device conduit. No specific age or gender contraindications stated.
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
Submission Summary (Full Text)
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December 10, 2021
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ASAHI INTECC Co., Ltd % Cynthia Valenzuela Director, Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue. Suite 212 Tustin, California 92780
Re: K203723
Trade/Device Name: Branchor Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: November 4, 2021 Received: November 8, 2021
Dear Cynthia Valenzuela:
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 (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 located 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.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
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# Indications for Use
510(k) Number (if known) K203723
Device Name Branchor Balloon Guide Catheter
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|---------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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## 510(K) K203723
| DATE PREPARED: | 10 December 2021 |
|------------------------|--------------------------------------------------|
| SUBMITTER: | ASAHI INTECC CO., LTD |
| | 3-100 Akatsuki-cho, Seto |
| | Aichi 489-0071, Japan |
| | Telephone: +81 561 48 5551 |
| PRIMARY CONTACT: | Mrs. Cynthia Valenzuela |
| | Director, Global Regulatory Affairs |
| | ASAHI INTECC USA, INC. |
| | 3002 Dow Avenue, Suite 212 |
| | Tustin, California 92780 |
| | Phone: (714) 442 0575 |
| | Email: cynthiav@asahi-intecc-us.com |
| TRADE NAME: | Branchor Balloon Guide Catheter |
| DEVICE CLASSIFICATION: | Class II, 21 CFR §870.1250 |
| CLASSIFICATION NAME: | Percutaneous Catheter |
| PRODUCT CODE: | QJP, Catheter, Percutaneous, Neurovasculature |
| | DQY, Catheter, Percutaneous |
| PREDICATE DEVICE: | Primary Predicate Device: |
| | CELLO Balloon Guide Catheter (K120781; August 9, |
| | 2012) |
| | Reference Predicate Device: |
| | 8F FlowGate Balloon Guide Catheter (K153729; |
| | January 27, 2016) |
## Device Description:
This balloon guide catheter is a variable stiffness catheter that has a radio-opaque marker at the distal end of the balloon and 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 the recommended balloon injection volume are indicated on the product label. The balloon guide catheter is provided sterile, using ethylene oxide, and is intended for single use only by physicians who have been adequately trained in neurointerventional procedures.
The outer surface of this balloon guide catheter is coated with a hydrophilic coating in order to enhance lubricity when the surface is wet. The shaft lumen is provided with PTFE coating, except the connector part, to facilitate the passage of the guidewire and other devices through the section.
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## Accessories
The Branchor Balloon Guide Catheter is packaged with a peel-away to protect the balloon during catheter introduction, a syringe for balloon inflation, and a three-way stopcock to connect the syringe for inflation and deflation of the balloon.
#### Intended Use/Indications for Use
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.
#### Comparison of Technological Characteristics:
The Branchor Balloon Guide Catheter has similar
- Indications for use, .
- Fundamental scientific technology, .
- Fundamental design, .
- Packaging and sterilization of devices .
as the marketed predicate devices. A tabular comparison of the specific technological characteristics between the predicate devices and the subject device is provided below. The technological differences do not raise new questions of safety and effectiveness.
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Table 1: Comparison Table
| Name of Device | CELLO Balloon Guide Catheter | 8F FlowGate Balloon Guide Catheter | Branchor Balloon Guide Catheter |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| 510(K) Number: | K120781 | K153729 | SUBJECT DEVICE<br>K203723 |
| Intended Use<br>and Indications | The CELLO Balloon Guide Catheter<br>is indicated for use in facilitating the<br>insertion and guidance of<br>intravascular catheters into a<br>selected blood vessel in the<br>peripheral and neuro vasculature<br>systems. The balloon provides<br>temporary vascular occlusion during<br>these and other angiographic<br>procedures. | FlowGate Balloon Guide Catheters are<br>indicated for use in facilitating the<br>insertion and guidance of an<br>intravascular catheter into a selected<br>blood vessel in the peripheral and neuro<br>vascular systems. The balloon provides<br>temporary vascular occlusion during<br>these and other angiographic<br>procedures. The Balloon Guide Catheter<br>is also indicated for use as a conduit for<br>Retrieval devices. | The Branchor Balloon Guide<br>Catheter is indicated for use to<br>facilitate the insertion and<br>guidance of an intravascular<br>catheter into a selected blood<br>vessel in the neuro vasculature,<br>and injection of contrast media.<br>The balloon provides temporary<br>vascular occlusion during these<br>procedures.<br>The Branchor Balloon Guide<br>Catheter can also be used as a<br>conduit for retrieval devices. |
| Device Description | The CELLO Balloon Guide Catheter<br>is a coaxial-lumen, braid-reinforced,<br>variable stiffness catheter with two<br>radiopaque markets on both the<br>distal and proximal ends of the<br>balloon and a bifurcated luer hub on<br>the proximal end. A compliant<br>silicone balloon is mounted on the<br>distal end. Balloon Guide Catheter<br>dimensions and the recommended<br>balloon inflation volumes are<br>indicated on product label. | The FlowGate Balloon Guide Catheter<br>are coaxial-lumen, braid- reinforced,<br>variable stiffness catheters designed for<br>use in facilitating the insertion and<br>guidance of an intravascular catheter<br>into a selected blood vessel in the<br>peripheral and neuro vascular systems.<br>A radiopaque market is included on the<br>distal end for angiographic visualization.<br>A compliant balloon is mounted on the<br>distal end to provide temporary vascular<br>occlusion during angiographic<br>procedures. A bifurcated luer hub on the<br>proximal end allows attachments for<br>flushing, inflation and aspiration. Balloon<br>Guide Catheter dimensions and<br>maximum recommended balloon inflation<br>volume are indicated on product label. | This balloon guide catheter is a<br>variable stiffness catheter that has<br>a radio-opaque marker at the<br>distal end of the balloon to<br>facilitate fluoroscopic visualization<br>and indicate the balloon position,<br>a branched connector at the<br>proximal end, and is equipped with<br>a braid reinforced coaxial lumen. A<br>balloon is attached to the distal<br>end, and the dimensions of this<br>balloon guide catheter and<br>recommended balloon injection<br>volume are provided on the<br>product label.<br>The outer surface of this balloon<br>guide catheter is coated with a<br>hydrophilic coating for enhanced<br>lubricity when the surface is wet. |
| Name of Device | CELLO Balloon Guide<br>Catheter | 8F FlowGate Balloon Guide<br>Catheter | Branchor Balloon Guide Catheter |
| | | | The shaft lumen is provided with<br>PTFE coating, with the exception<br>of the connector section to<br>facilitate the passage of the<br>guidewire and other devices<br>through the section. |
| Regulatory Status: | | | |
| Regulation Number: | 21 CFR § 870.1250 | 21 CFR § 870.1250 | 21 CFR § 870.1250 |
| Regulation<br>Description: | Percutaneous Catheter | Percutaneous Catheter | Catheter, Percutaneous,<br>Neurovasculature |
| Regulatory Class: | II | II | II |
| Product Code: | DQY | DQY | QJP<br>DQY |
| Product Information: | | | |
| Size | 6F, 7F, 8F, 9F | Shaft OD: 8F; Shaft ID: 6.4F | Shaft OD: 9F; Shaft ID: 6.84F |
| Effective Length | 92cm to 102cm | 95cm and 85cm | 90cm, 100cm |
| Balloon Material | Silicone Rubber | Silicone Elastomer | Polyurethane Elastomer |
| Shaft Material | Polyurethane<br>Polyamide<br>Stainless Steel<br>PFA | Pebax<br>Polyamide<br>Stainless Steel<br>PTFE | Polyurethane Elastomer<br>Polyamide 12 Elastomer<br>Polyamide 12<br>Stainless Steel<br>Polytetrafluoroethylene |
| Accessories | Unknown | Dilator<br>Peel-away Sheath<br>Rotating Hemostatic Valve<br>Tuohy Borst Valve with Sideport<br>Lure-Activated Valve | Peel-away<br>Syringe<br>Three-way Stopcock |
| Sterilization Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
| Sterility Level | SAL10-6 | SAL10-6 | SAL10-6 |
| Single Use | Yes | Yes | Yes |
| Radiopaque Markers | Yes | Yes | Yes |
| Anatomical Sites | Peripheral and neuro vascular | Peripheral and neuro vascular | Neuro vascular |
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# NON-CLINICAL TESTING / PERFORMANCE DATA:
Non-clinical bench testing was performed on the Branchor Balloon Guide Catheter to determine substantial equivalence. The following testing was performed:
| Test | Result |
|-------------------------------------------------|-------------------------|
| Air Leakage Into Hub Assembly During Aspiration | Pass |
| Balloon Diameter to Inflation Pressure | Pass |
| Balloon Inflation and Deflation Times | Pass |
| Balloon Maximum Diameter | Pass |
| Burst Pressure | Pass |
| Coating Integrity/Particulate Evaluation | (Characterization Only) |
| Design Verification – Simulated Use | Pass |
| Dimensional Analysis | Pass |
| Freedom from Leakage and Damage on Inflation | Pass |
| Kink Resistance Test | Pass |
| Liquid Leakage Under Pressure | Pass |
| Lumen Collapse Under Maximum Aspiration | Pass |
| Luer Hub Testing | Pass |
| Peak Tensile Strength - Tip | Pass |
| Peak Tensile Strength - Tube Junction | Pass |
| Radio-detectability | Pass |
| Tip Flexibility | Pass |
| Torque Strength | Pass |
| Visual Inspection - Distal Tip | Pass |
| Visual Inspection - Surface | Pass |
# Table 2: Performance Testing
The in vitro bench tests demonstrated that the Branchor Balloon Guide Catheter met all acceptance criteria and performed similarly to the predicate devices. Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate devices.
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## BIOCOMPATIBILITY:
The Branchor Balloon Guide Catheter was tested in accordance with ISO 10993-1, and found to be biocompatible. The following tests were performed:
| Test | Test Summary | Conclusion |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Systemic Toxicity - ISO<br>10993-11 Rabbit Pyrogen Test<br>(material mediated) | The test article should not increase the rectal<br>temperature of any of the animals by more than<br>0.5 °C. | Non-pyrogenic |
| Systemic Toxicity - ISO<br>10993-11 Systemic Injection | The test article must not show significantly<br>greater biological activity than the control. | No acute systemic toxicity |
| Cytotoxicity - ISO 10993-5<br>L929 cells/MEM Elution Test | The test system is considered suitable if no signs<br>of cellular reactivity (Grade 0) are noted for both<br>the negative control article and the medium<br>control. | Non-cytotoxic |
| Sensitization - ISO 10993-<br>10 Guinea Pig Maximization<br>Test | The extracts should show no evidence of<br>causing delayed dermal contact sensitization in<br>the guinea pig. | Non-sensitizing |
| Irritation - ISO 10993-10<br>Intracutaneous Injection<br>Test | The test extract and the negative control must<br>exhibit similar edema and erythema scores. | Non-irritant |
| Hemocompatibility - ISO<br>10993-4 Hemolysis | Test article in direct contact with blood and test<br>article extract must be non-hemolytic. | Non-hemolytic |
| Hemocompatibility - ISO<br>10993-4 Partial<br>Thromboplastin Time Assay<br>(PTT) | The PTT of the plasma exposed to test article<br>extract should not significantly decreased when<br>compared to untreated and negative controls. | Minimal Activator |
| Hemocompatibility - ISO<br>10993-4<br>Complement Activation<br>Assay (SC5b-9) | The plasma exposed to test article must exhibit<br>no significant increase in SC5b-9 when<br>compared to activated NHS and negative control<br>after 60 minutes exposure. | Non-Potential Activator |
| Hemocompatibility –<br>ISO 10993-4<br>Thrombogenicity | Compare results of test article to predicate<br>control Thrombogenicity response in NAVI<br>model.<br>Determine acceptability of results as part of risk<br>management. | No Thrombosis |
## Table 2: Biocompatibility Results
## STERILIZATION and SHELF LIFE:
The Branchor 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 ° 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 3 year shelf-life
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# CONCLUSION:
The Branchor Balloon Guide Catheter has similar technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles, as the predicate devices. Performance data demonstrate that the device functions as intended. The conclusions drawn from the nonclinical tests demonstrate that the Branchor Balloon Guide Catheter is substantially equivalent to the legally marketed predicate devices.
