091 Balloon Guide Catheter

{0}------------------------------------------------ October 31, 2023 Image /page/0/Picture/1 description: The image contains 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. EOSolutions, Corp. % Garry Koroshec Senior Design Quality Engineer / Regulatory Affairs InNeuroCo, Inc. 19700 Sterling Road, Suite 1 Pembroke Pines, Florida 33332 Re: K231629 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: October 3, 2023 Received: October 5, 2023 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 (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. 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). {1}------------------------------------------------ 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 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-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 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. 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-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 -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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231629 Device Name 091 Balloon Guide Catheter #### Indications for Use (Describe) The 091 Balloon Guide Catheter is infacilitating 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) | |-------------------------------------------------| |-------------------------------------------------| | <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">☐</span> 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 | October 30, 2023 | |-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter | InNeuroCo Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332<br>On behalf of:<br>EOSolutions, Corp.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332 | | Primary Submission Contact | Garry Koroshec<br>Staff Design Quality Engineer / Regulatory Affairs<br>InNeuroCo Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332<br>Telephone: 1-954-254-5003<br>Facsimile: 1-954-742-5989<br>E-Mail: garry@inneuroco.com | | Secondary Submission Contacts | Marianne Grunwaldt<br>Senior Director of Quality Assurance and Requlatory Affairs<br>InNeuroCo Inc.<br>19700 Stirling Road, Suite 1<br>Pembroke Pines, FL 33332<br>Telephone: 1-954-703-5271<br>Facsimile: 1-954-742-5989<br>E-Mail: marianne@inneuroco.com<br>Ming-Cheng Chew<br>Regulatory Consultant<br>RQM+<br>8401 73rd Avenue North, Suite 63<br>Brooklyn Park, MN 55428<br>Telephone: 763-232-3701<br>E-Mail: mchew@rqmplus.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 Code | DQY, QJP | | Predicate Device | 091 Balloon Guide Catheter (K220331) | | Reference Device | 091 Long Sheath (K172468) | {4}------------------------------------------------ #### 6.1 Device Description The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a balloon at the distal end. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A compliant balloon is flush mounted on the catheter to provide temporary vascular occlusion during angiographic procedures. 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, dilator, and one-way luer valve accessory are included within the packaging. A similar dilator was cleared as part of the reference device under K172468. The 091 Balloon Guide Catheter is supplied sterile, non- pyrogenic, and is intended for single use only. #### 6.2 Indications for Use 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. ### 6.3 Technological Characteristics and Basis for Substantial Equivalence #### Table 6.1 Technological Comparison between the subject 091 Balloon Guide Catheter and 091 Balloon Guide Catheter (K220331) | Parameter | Predicate Device<br>091 Balloon Guide Catheter (K220331) | Subject Device<br>091 Balloon Guide Catheter (K231629) | |------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------| | Indications for<br>Use | The 091 Balloon Guide Catheter is<br>indicated for use in facilitating the insertion<br>and guidance of intravascular catheters<br>into a selected blood vessel in the<br>peripheral and neuro vascular systems.<br>The 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. | Same | | Anatomical<br>Location | Peripheral and Neuro Vasculature | Same | | Product Code | DQY, QJP | Same | | Classification | Class II | Same | | Requlation<br>Number | 870.1250 | Same | | Catheter<br>Material | Outer Jacket: PTFE and Polyethylene<br>Inner Member: PTFE, Pebax, and Nylon<br>Distal Tip: Chronoflex and Polyolefin | Same | {5}------------------------------------------------ | Parameter | Predicate Device<br>091 Balloon Guide Catheter (K220331) | Subject Device<br>091 Balloon Guide Catheter (K231629) | |---------------------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------| | Reinforcement<br>Layer | Stainless Steel Coil | Same | | Radiopaque<br>Marker Band | Platinum/Iridium | Same | | Coating | None | Same | | Internal<br>Construction | Co-axial Lumen | Same | | Hub | Polycarbonate | Same | | Strain Relief | Silicone | Same | | Balloon<br>Material | Polyurethane Elastomer | Same | | Working<br>Length | 95 cm | 75, 85, 95 cm | | Max Outer<br>Diameter | 0.125 inches | Same | | Shaft Inner<br>diameter | 0.0905 inches | Same | | Accessories<br>supplied | Peel Away Introducer | Dilator, One-Way Valve, Peel Away<br>Introducer | | Dilator | None | Working Length: 88, 98, 108 cm<br>Inner/Outer Diameter: 0.038 in max/0.087 in | | Packaging | Polyethylene Tube and HDPE Packaging<br>Card<br>Tyvek/PE/PET Pouch | Same | | Sterilization | Ethylene Oxide | Same | | Number of<br>Uses | Single Use | Same | ### 6.4 Performance Data The list of the performance testing conducted to demonstrate that the subject 091 Balloon Guide Catheter meets its performance specifications is presented below in Table 6.2. Verification test data from testing done on previously cleared version of the 091 Balloon Guide Catheter (K220331) were also used to support the new 091 Balloon Guide Catheter. | Test performed | Test Summary | Results | |--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Design Verification and Validation Testing | | | | Catheter Tensile Strength | The catheter must meet tensile strength specifications. | Pass | | Catheter Burst | The catheter must meet catheter burst specification. | Pass | | Particulate | The catheters were tested in comparison to the predicate device for all<br>particle sizes including the<br>large particles to establish substantial equivalence to the predicate<br>device. | Pass | | Dilator Working Length | The dilator must meet working length specification. | Pass | | Dilator Inner Diameter (ID) | The dilator must meet inner diameter (ID) specification. | Pass | | Dilator Outer Diameter (OD) | The dilator must meet outer diameter (OD) specification. | Pass | | Dilator Hub Compatibility | The hub luer shall meet the applicable criteria for each test as defined<br>by ISO 594-1 and ISO 594-2. | Pass | | Dilator Radiopacity | The dilator shall be visible under fluoroscopic imaging. | Pass | | Dilator Tensile Strength | The dilator must meet tensile strength specifications. | Pass | | Dilator Visual Inspection | Samples were visually inspected under 2.5X magnification to ensure<br>acceptance criteria were met. | Pass | | Label Content | The label and directions for use (DFU) must meet content specifications. | Pass | | Usability - Simulated Use Testing | Simulated use testing was conducted utilizing all accessory devices<br>expected to be used during a clinical procedure. | Pass | Table 6.2 – Performance Bench Tests Performed on the 091 Balloon Guide Catheter {6}------------------------------------------------ #### 6.5 Biocompatibility Testing The 091 Balloon Guide Catheter and the dilator were assessed for biocompatibility in accordance with ISO 10993-1, "Biological evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process," as part of predicate and reference device submissions. There are no material or contact duration changes of these components in the current submission. The subject device an externally communicating medical device with circulating blood contact for less than 24 hours. The results of the prior testing demonstrate the biocompatibility of the 091 Balloon Guide Catheter and the dilator for their indicated use. #### 6.6 Sterilization Validation A sterilization validation adoption assessment was conducted to verify that the subject device can be adopted into the previously validated ethylene oxide (EO) sterilization cycle. It concluded that the subject 091 Balloon Guide Catheter will likely present an equal or lesser challenge to the sterilization cycle than the existing products. EO residual testing and bioburden testing of the existing 091 Balloon Guide Catheter and dilator products are deemed applicable to the subject device. #### 6.7 Clinical Data and Animal Study No clinical data or animal study were deemed necessary to support the subject device submission. #### 6.8 Conclusion The review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the 091 Balloon Guide Catheter, is substantially equivalent to the predicate 091 Balloon Guide Catheter (K220331). The differences between the subject and the predicate devices do not raise new questions of safety and effectiveness.