091 Balloon Guide Catheter

{0}------------------------------------------------ July 29, 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 the FDA logo, which 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. InNeuroCo, Inc. Garry Koroshec Senior Design Quality Engineer / Regulatory Affairs 19700 Stirling Road, Suite 1 Pembroke Pines, Florida 33332 # Re: K220331 Trade/Device Name: 091 Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 30, 2022 Received: July 1, 2022 # Dear Garry Koroshec: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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 medical devices and radiation-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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220331 Device Name 091 Balloon Guide Catheter Indications for Use (Describe) The 091 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 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. 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) | |----------------------------------------------|---------------------------------------------| | <span style="font-size: 20px;">☑</span> | <span style="font-size: 20px;">☐</span> | > 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." {3}------------------------------------------------ # 510(k) Summary | Date Summary Prepared | July 21, 2022 | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | InNeuroCo, Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332 | | Primary Submission Contact | Garry Koroshec<br>Senior Design Quality Engineer / Regulatory Affairs<br><br>InNeuroCo, Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332<br><br>Telephone: 1-954-254-5003<br>Facsimile: 1-954-742-5989<br>E-Mail: garry@inneuroco.com | | Secondary Submission Contacts | Ming Cheng Chew<br>Regulatory Consultant<br><br>Libra Medical Inc.<br>8401 73rd Avenue North, Suite 63<br>Brooklyn Park, MN 55428<br><br>Telephone: 763-232-3701<br>E-Mail: mcchew@libramed.com<br><br>Marianne Grunwaldt<br>Senior Director of Regulatory Affairs and Quality Assurance<br><br>InNeuroCo, Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332<br><br>Telephone: 1-954-703-5271<br>Facsimile: 1-954-742-5989<br>E-Mail: marianne@inneuroco.com | | Trade Name | 091 Balloon Guide Catheter | | Regulation Number | 21 CFR 870.1250 | | Device Common or Classification<br>Name | Percutaneous Catheter, Neurovasculature | | Product Class | Class II | | Product Panel | Cardiovascular, Neurology | | Product Codes | DQY, QJP | | Predicate Device | Concentric Balloon Guide Catheter<br>K112404 | {4}------------------------------------------------ ## 6.1 Device Description The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed 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 dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only. #### 6.2 Indications for Use The 091 Balloon Guide Catheter is in facilitating the insertion and quidance of intravascular catheters 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. #### 6.3 Technological Characteristics and Basis for Substantial Equivalence | Parameter | Predicate Device<br>Concentric Balloon Guide Catheter<br>(K112404) | Subject Device<br>091 Balloon Guide Catheter<br>(K220331) | |---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | The Concentric Balloon Guide Catheter is<br>indicated for use in facilitating the insertion<br>and guidance of an intravascular catheter<br>into a selected blood vessel in the<br>peripheral and neuro vascular systems. The<br>balloon provides temporary vascular<br>occlusion during these and other<br>angiographic procedures. The Balloon<br>Guide Catheter is also indicated for use as<br>a conduit for Retrieval devices. | The 091 Balloon Guide Catheter is indicated<br>for use in facilitating the insertion and<br>guidance of intravascular catheters into a<br>selected blood vessel in the peripheral and<br>neuro vascular systems. The balloon provides<br>temporary vascular occlusion during these<br>and other angiographic procedures. The<br>Balloon Guide Catheter is also indicated for<br>use as a conduit for Retrieval devices. | | Anatomical<br>Location | Peripheral and neuro vasculature | Peripheral and neuro vasculature | | Product Code | DQY | DQY, QJP | | Classification | Class II | Class II | | Regulation<br>Number | 870.1250 | 870.1250 | | Catheter<br>Material | Outer Jacket: Pebax<br>Inner Lumen: PTFE and Pebax<br>Distal Tip: Pebax | Outer Jacket: PTFE and Polyethylene<br>Inner Lumen: PTFE, Pebax, and Nylon<br>Distal Tip: Chronoflex and Polyolefin | | Reinforcement<br>Layer | Stainless Steel Braid | Stainless Steel Coil | | Radiopaque<br>Marker Band | Platinum/Iridium | Platinum/Iridium | ## Table 6.1 Technological Comparison of the 091 Balloon Guide Catheter and Concentric Balloon Guide Catheter (K112404) {5}------------------------------------------------ | Parameter | Predicate Device<br>Concentric Balloon Guide Catheter<br>(K112404) | Subject Device<br>091 Balloon Guide Catheter<br>(K220331) | |--------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------| | Coating | None | None | | Internal<br>Construction | Co-axial Lumen | Co-axial Lumen | | Hub | Polyurethane | Polycarbonate | | Strain Relief | Polyolefin | Silicone | | Balloon Material | Silicone | Polyurethane elastomer | | Working Length | 80cm, 95cm | 95cm | | Max Outer<br>Diameter | 0.088, 0.104, and 0.116 inches | 0.125 inches | | Shaft Inner<br>Diameter | 0.059, 0.078, and 0.085 inches | 0.0905 inches | | Accessories<br>Supplied | Dilator | Peel Away Introducer | | Packaging | Polyethylene Tube and HDPE Packaging<br>Card<br>Tyvek/PE/PET Pouch | Polyethylene Tube and HDPE Packaging<br>Card<br>Tyvek/PE/PET Pouch | | Sterilization | Ethylene Oxide | Ethylene Oxide | | Number of Uses | Single Use | Single Use | ## 6.4 Performance Data Design verification and validation were performed to ensure that the 091 Balloon Guide Catheter meets its performance specifications and demonstrates substantial equivalence to the predicate device. The list of the performance testing conducted is presented below in Table 6.2. Some of the tests were also conducted on the predicate device to help establish substantial equivalence. All predetermined acceptance criteria were met. | Test performed | Test Summary | Results | |-----------------------------|-----------------------------------------------------------------------------------------------------|---------| | Design Verification Testing | | | | Tensile Strength | Testing was completed per ISO 10555-1, Section 4.6 and<br>Annex B. | Pass | | PTFE delamination | PTFE liner was visually inspected to ensure that<br>delamination of the liner was not present. | Pass | | Torque Strength | The device must withstand one turn of the hub. | Pass | | Catheter Burst | Testing was completed per ISO10555-1, Section 4.10<br>and Annex F. | Pass | | Balloon Burst | The constrained balloon must not burst below the<br>specified volume. | Pass | | Visual Inspection | Samples were visually inspected under 2.5X magnification<br>to ensure acceptance criteria were met. | Pass | | Particulates | Testing was completed per USP <788>. Testing was also<br>performed in comparison to the predicate. | Pass | | Liquid Leak Test | Testing was conducted per ISO 10555-1, Section 4.7 and<br>Annex C. | Pass | | Air Leak Test | Testing was conducted per ISO 10555-1 section 4.7.2 and<br>Annex D. | Pass | | Balloon Leak Test | Testing was conducted per ISO 10555-4, section 4.4.2<br>and Annex B. | Pass | Table 6.2 – Performance Bench Tests Performed on the 091 Balloon Guide Catheter {6}------------------------------------------------ InNeuroCo, Inc. 091 Balloon Guide Catheter Traditional 510(k) K220331 | Test performed | Test Summary | Results | |--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Dimensional Verification | The catheter and introducer must meet dimensional specifications. | Pass | | Chemical Compatibility | The device shall withstand exposure to saline, dextrose, heparin, and contrast. | Pass | | Hub Compatibility | Catheter luers shall be tested per ISO 594-1:1986 and ISO 594-2:1998. | Pass | | Kink Resistance | After conditioning, two sections of each test sample were wrapped around progressively smaller diameter mandrels until a kink was observed. | Pass | | Balloon Air Purge Test | The balloon shall be capable of having an acceptable level of air removed. | Pass | | Balloon Fatigue Test | The balloon shall withstand the specified number of inflation/deflation cycles. | Pass | | Balloon Compliance Test | The balloon shall not exceed the specified dimensions for a given inflation volume. | Pass | | Flow Arrest | The balloon was inflated within a clinically relevant flow model and a minimum occlusion time (aka time of effective flow arrest) was confirmed. | Pass | | Balloon Deflation Time | The balloon was inflated within a clinically relevant flow model, the time to restore flow (deflation) was measured. | Pass | | Packaging - Pouch Leak Test | Testing was conducted per ASTM F-1929. | Pass | | Packaging - Pouch Peel Test | Testing was conducted per ASTM F88/F88M. | Pass | | Packaging - Visual Inspection | Packaging was visually inspected to determine if any perforations, nicks, cuts, or punctures on the pouch were present. All pouch seals were also visually inspected to verify that seals were not damaged or peeled, and that all seals were intact. | Pass | | Packaging - Seal Width | The seals should meet the specified width. | Pass | | Design Validation Testing | | | | In-vitro Simulated Use Study – Benchtop | The 091 Balloon Guide Catheter was prepared per the instructions for use (IFU). A simulated interventional procedure was performed by physicians in order to verify the product's performance. | Pass | | Usability Testing | | | | In-vitro Simulated Use Study -<br>Useability<br>(including Label Content -<br>Product IFU) | Evaluators representative of the intended user population shall review the 091 Balloon Guide Catheter IFU and labeling, then attempt to use the catheters and accessories along with the expected compatible products in a simulated use environment, using worst-case neurovascular models | Pass | No clinical studies were required to demonstrate substantial equivalence. #### 6.5 Biocompatibility testing The 091 Balloon Guide Catheter was assessed for biocompatibility in accordance with ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The subject device is considered an externally communicating medical device with circulating blood contact for less than 24 hours. The biological effects tests performed are summarized in Table 6.3. The results of the testing demonstrate the biocompatibility of the 091 Balloon Guide Catheter for its indicated use. {7}------------------------------------------------ | Biological Effect | Test | Results | |-----------------------------------|---------------------------------------------------------------------------|---------| | Cytotoxicity | MEM elution, 48 hr. inc.,<br>triplicate L929, 24 hr. ext.<br>(nonimplant) | Pass | | Sensitization | Magnusson-Kligman<br>Method, 2 extracts | Pass | | Irritation | Intracutaneous Toxicity<br>(ISO), 2 extracts | Pass | | Material mediated<br>pyrogenicity | Material Mediated Pyrogen | Pass | | Acute Systemic Toxicity | Systemic Injection (ISO), 2<br>extracts | Pass | | Hemocompatibility | Hemolysis, ASTM Method,<br>indirect (human blood) | Pass | | | Hemolysis, ASTM Method,<br>direct contact (human blood) | Pass | | | Complement Activation,<br>SC5b-9 | Pass | | | Dog Thrombogenicity | Pass | Table 6.3 Summarv of Biocompatibility Testing # 6.6 Sterilization Validation A confirmatory sterilization study was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide (EO) sterilization cycle. The device passed all sterility, EO residual, limulus amebocyte lysate (LAL), and bioburden testing. ## 6.7 Conclusion The review of the verification and validation test results as well as the comparison of the device classification, indications for use, operating principles, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the 091 Balloon Guide Catheter, is substantially equivalent to the Concentric Balloon Guide Catheter (K112404). The differences between the subject and the predicate devices do not raise new questions of safety and effectiveness.