Branchor Balloon Guide Catheter

{0}------------------------------------------------ October 11, 2022 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ASAHI INTECC Co., Ltd % Cynthia Valenzuela Director, Global Regulatory Affairs ASAHI INTECC USA, Inc. 3002 Dow Avenue, Suite 212 Tustin, California 92780 Re: K221951 Trade/Device Name: Branchor Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: September 7, 2022 Received: September 13, 2022 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K221951 Device Name Branchor Balloon Guide Catheter The Branchor Balloon Guide Catheter is indicated for use to facilitate the insertion and guidance of an intravasular 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) 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. 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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ #### 510(K) Summary [as required by 21 CFR §807.92(c)] # 510(K) K221951 | DATE PREPARED: | 11 OCT 2022 | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SUBMITTER: | ASAHI INTECC CO., LTD<br>3-100 Akatsuki-cho, Seto<br>Aichi 489-0071, Japan<br>Telephone: +81 561 48 5551 | | PRIMARY CONTACT: | Mrs. Cynthia Valenzuela<br>Director, Global Regulatory Affairs<br>ASAHI INTECC USA, INC.<br>3002 Dow Avenue, Suite 212<br>Tustin, California 92780<br>Phone: (949) 413 0071<br>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 | | PREDICATE DEVICE: | Branchor Balloon Guide Catheter (K203723) | ### Device Description: The Branchor Balloon Guide Catheter has the same design, materials and accessories as the predicate device (K203723). The change to the subject device includes performance testing and labeling to allow use with a power injector. This balloon guide catheter is a variable stiffness catheter that has a radiopaque 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 quide 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 quide 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 quidewire and other devices through the section. {4}------------------------------------------------ #### Accessories The Branchor Balloon Guide Catheter is packaged with a peel-away to protect the balloon during catheter introduction, a 1mL 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 Indications for Use and Technological Characteristics: The Branchor Balloon Guide Catheter has identical - Indications for use, . - Fundamental principles of operation, . - . Fundamental design and materials, - Packaging and sterilization of devices as the marketed predicate device. A tabular comparison of the specific technological characteristics between the predicate device and subject device is provided below. The labeling changes to allow the use of power injectors with the subject device do not raise new questions of safety and effectiveness. {5}------------------------------------------------ Table 1: Comparison Table | Name of Device | Branchor Balloon Guide Catheter | Branchor Balloon Guide Catheter | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Predicate | Subject Device | | 510(K) Number: | K203723 | K221951 | | Indications for Use | 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. | 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. | | | The balloon provides temporary<br>vascular occlusion during these<br>procedures. | The balloon provides temporary<br>vascular occlusion during these<br>procedures. | | | The Branchor Balloon Guide Catheter<br>can also be used as a conduit for<br>retrieval devices. | The Branchor Balloon Guide<br>Catheter can also be used as a<br>conduit for retrieval devices. | | Device Description | This balloon guide catheter is a<br>variable stiffness catheter that has a<br>radio-opaque marker at the distal end<br>of the balloon to facilitate fluoroscopic<br>visualization and indicate the balloon<br>position, a branched connector at the<br>proximal end, and is equipped with a<br>braid reinforced coaxial lumen. A<br>balloon is attached to the distal end,<br>and the dimensions of this balloon<br>guide catheter and recommended<br>balloon injection volume are provided<br>on the product label.<br>The outer surface of this balloon guide<br>catheter is coated with a hydrophilic<br>coating for enhanced lubricity when the<br>surface is wet.<br>The shaft lumen is provided with PTFE<br>coating, with the exception of the<br>connector section to facilitate the<br>passage of the guidewire and other<br>devices through the section. | This balloon guide catheter is a<br>variable stiffness catheter that has a<br>radio-opaque marker at the distal end<br>of the balloon to facilitate fluoroscopic<br>visualization and indicate the balloon<br>position, a branched connector at the<br>proximal end, and is equipped with a<br>braid reinforced coaxial lumen. A<br>balloon is attached to the distal end,<br>and the dimensions of this balloon<br>guide catheter and recommended<br>balloon injection volume are provided<br>on the 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.<br>The shaft lumen is provided with<br>PTFE coating, with the exception of<br>the connector section to facilitate<br>the passage of the guidewire and<br>other devices through the section. | {6}------------------------------------------------ | Name of Device | Branchor Balloon Guide Catheter | Branchor Balloon Guide Catheter | |----------------------------|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------| | 510(K) Number: | K203723 | K221951 | | Regulation<br>Number: | 21 CFR § 870.1250 | 21 CFR § 870.1250 | | Regulation<br>Description: | Catheter, Percutaneous,<br>Neurovasculature | Catheter, Percutaneous,<br>Neurovasculature | | Regulatory Class: | II | II | | Product Code: | QJP | QJP | | Size | Shaft OD: 3.00 mm<br>Shaft ID: 2.28 mm | Shaft OD: 3.00 mm<br>Shaft ID: 2.28 mm | | Effective Length | 90 cm, 100 cm | 90 cm, 100 cm | | Balloon Material | Polyurethane elastomer | Polyurethane elastomer | | Shaft Material | Polyurethane Elastomer<br>Polyamide 12 Elastomer<br>Polyamide 12<br>Stainless Steel<br>Polytetrafluoroethylene | Polyurethane Elastomer<br>Polyamide 12 Elastomer<br>Polyamide 12<br>Stainless Steel<br>Polytetrafluoroethylene | | Accessories | Peel-away<br>Syringe<br>Three way stopcock | Peel-away<br>Syringe<br>Three way stopcock | | Sterilization Method | Ethylene Oxide | Ethylene Oxide | | Sterility Level | SAL10-6 | SAL10-6 | | Single Use | Yes | Yes | | Radiopaque Markers | Yes | Yes | | Anatomical Sites | Neuro vascular | Neuro vascular | {7}------------------------------------------------ #### PERFORMANCE TESTING: Non-clinical bench testing was performed on the Branchor Balloon Guide Catheter to allow use with power injectors. The following testing was performed: ## Table 2: Performance Testing | Test | Result | |---------------------------------------|--------| | Burst Pressure under static condition | Pass | | Power Injection | Pass | | Flow Rate | Pass | The testing of non-aged and aged devices was performed. The in vitro bench tests demonstrated that the Branchor Balloon Guide Catheter met all acceptance criteria. Performance data demonstrates that the device functions as intended and has a safety and effectiveness profile that is similar to the predicate device. # BIOCOMPATIBILITY, STERILIZATION and SHELF LIFE: The change to the subject device does not impact biocompatibility, sterilization, and shelf life, as compared to the predicate device. ### CONCLUSION: The Branchor Balloon Guide Catheter has similar intended use, same technological characteristics, such as components, design, materials, sterilization method, shelf life and operating principles, as the predicate device. Performance data demonstrate that the subject 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 device.