Who is the manufacturer of BOBBY Balloon Guide Catheter?

MicroVention, Inc. filed the 510(k) submission for BOBBY Balloon Guide Catheter (K193607).

What is the FDA product code for BOBBY Balloon Guide Catheter?

DQY. It is classified under 21 CFR 870.1250 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for BOBBY Balloon Guide Catheter?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like BOBBY Balloon Guide Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BOBBY Balloon Guide Catheter

Q: What are the predicate devices for BOBBY Balloon Guide Catheter?

Concentric Medical, FlowGate2™ (K153729).

K193607 · MicroVention, Inc. · DQY · Jul 21, 2020 · Cardiovascular

Device Facts

Record ID	K193607
Device Name	BOBBY Balloon Guide Catheter
Applicant	MicroVention, Inc.
Product Code	DQY · Cardiovascular
Decision Date	Jul 21, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The BOBBY Balloon Guide Catheter is intended: 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 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.

Device Story

BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter; features distal compliant polyurethane balloon, radiopaque markers, and proximal bifurcated luer hub. Used in peripheral and neurovascular procedures; operated by clinicians. Input: guidewire/catheter through inner lumen; contrast media via syringe through outer lumen for balloon inflation. Output: temporary vascular occlusion; conduit for retrieval devices. Hydrophilic coating on distal end enhances lubricity for advancement. Radiopaque markers facilitate fluoroscopic visualization of balloon position. Distal air-purging system removes air from inflation lumen. Benefits: enables controlled vascular access and occlusion during angiography and interventional procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies were required. Performance testing included conditioning/aging, visual inspection, dimensional attributes, inflation volume/diameter, burst volume, tip stiffness, torque, force at break, connector compliance, radiopacity, particulate matter, leakage, fatigue, simulated use, kink resistance, lubricity, and lumen collapse. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, and hemocompatibility (hemolysis, complement activation, thrombogenicity, PTT).

Technological Characteristics

Co-axial, braid-and-coil reinforced catheter; materials include medical-grade plastics (nylon, PTFE, polyethylene, polyolefin) and stainless steel. Features compliant polyurethane balloon, distal hydrophilic coating, and Pt-Ir radiopaque marker bands. Dimensions: 8Fr (0.110" OD, 0.086" ID), 95 cm length. Sterilized via EtO (SAL 10^-6).

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into peripheral and neurovascular blood vessels, providing temporary vascular occlusion during angiographic procedures, and serving as a conduit for retrieval devices.

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

Concentric Medical, FlowGate2™ (K153729)

Related Devices

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K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254 · Concentric Medical, Inc. · Nov 21, 2012
K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER · Concentric Medical, Inc. · Oct 3, 2013
K220331 — 091 Balloon Guide Catheter · Inneuroco, Inc. · Jul 29, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. July 21, 2020 MicroVention, Inc. Stephanie Onstot Senior Regulatory Affairs Specialist 1311 Valencia Avenue Tustin, CA 92780 Re: K193607 Trade/Device Name: BOBBY Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, QJP Dated: June 25, 2020 Received: June 26, 2020 ## Dear Stephanie Onstot: 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ 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 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 (Acting) 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) K193607 Device Name BOBBY Balloon Guide Catheter Indications for Use (Describe) The BOBBY Balloon Guide Catheter is intended: 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 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) | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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 ## 510(k) Owner Information: | 510(k) Owner: | MicroVention, Inc. | | |----------------|-------------------------|------------------------------------------| | Address: | 1311 Valencia Ave | | | | Tustin, California, USA | | | Telephone: | 714-247-8000 | | | Fax: | 714-247-8014 | | | Contact Person | Stephanie Onstot | | | Telephone | 714-247-8000 x 8317 | | | Date Prepared: | | June 25, 2020 | | | Device Trade Name: | BOBBY™ Balloon Guide Catheter | | | Classification: | Class II | | | Classification Name: | Percutaneous Catheter | | | Product Code(s): | DQY, QJP | | | Regulation Number(s) | 870.1250 | | | Predicate Devices: | Concentric Medical, FlowGate2™ (K153729) | | | | | #### Indication for Use: The BOBBY Balloon Guide Catheter is intended: 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 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. ## Device Description The BOBBY Balloon Guide Catheter is a co-axial, braid-reinforced, variable stiffness catheter with an external hydrophilic coating. The BOBBY Balloon Guide Catheter incorporates a compliant balloon, radiopaque markers, and a bifurcated luer hub on the proximal end. The BOBBY Balloon Guide Catheter has an inner lumen through which a guidewire and catheter can be inserted, and a co-axial outer lumen that is used to inflate and deflate the balloon with a syringe filled with contrast media. A bifurcated luer hub is attached to the proximal end of the balloon guide catheter to provide access to both the inner and outer lumens. In addition, a hydrophilic coating is applied to the distal end of the balloon guide catheter to provide a lubricious outer surface for catheter advancement in the vasculature. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic {4}------------------------------------------------ procedures. The balloon incorporates a distal air-purging system to purge air from the inflation lumen prior to use. The balloon catheter also incorporates radiopaque markers to facilitate fluoroscopic visualization and indication of the balloon position. ## Performance Testing Summary: The BOBBY Balloon Guide Catheter has successfully completed the following relevant performance testing demonstrating that the device is suitable for its intended use. | Performance Test Summary | | | | |---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | Study Name | Description | Reference Standard | Results | | Conditioning, Distribution, and Shelf Life Aging Verification | To demonstrate that the product meets the packaging strength and packaging integrity following accelerated aging to a 1-year shelf life equivalent | ASTM F88 Seal Strength of Flexible Barrier materials ASTM F2096 Standard Test Method for Detecting Gross Leaks in Medical Packaging | Pass All samples met the pre- determined acceptance criteria | | Packaging Visual Inspection | To demonstrate that the product meets the packaging visual inspection requirements given | N/A | Pass All samples met the pre- determined acceptance criteria | | Visual Surface Requirements | To demonstrate the product satisfies the visual surface requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Dimensional/Physical Attributes Inspection | To demonstrate that the product meets the dimensional specifications | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Inflation Volume vs Balloon Diameter | To demonstrate that the product meets the inflation volume vs balloon diameter specifications | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single- Use Catheters - Part 4: Balloon Dilation Catheters | Pass All samples met the pre- determined acceptance criteria | | Balloon Burst Volume | To demonstrate that the Balloon is capable of withstanding an injection volume above the maximum fill volume. | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single- Use Catheters - Part 4: Balloon Dilation Catheters | Pass All samples met the pre- determined acceptance criteria | | Tip Stiffness | To demonstrate that the stiffness of the distal end of the product is similar to other marketed devices. | N/A | Pass All samples met the pre- determined acceptance criteria | | Torque Testing | To demonstrate that the product is capable of 720 degrees of rotation about the central lumen axis without failure. | N/A | Pass All samples met the pre- determined acceptance criteria | | Performance Test Summary | | | | | Study Name | Description | Reference Standard | Results | | Force at Break | To demonstrate the product satisfies the force at break requirements | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Small Bore Connector Compliance with Standard | To demonstrate that the product meets the requirements | ISO 80369-7 2016, Small-bore connectors for liquids and gases in healthcare applications - Part 7, Connectors for intravascular or hypodermic applications. | Pass All samples met the pre- determined acceptance criteria | | Radiopacity | To determine the radiopaque characteristics of the device. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements ASTM F640-12 Standard Test Methods for Determining Radiopacity for Medical Use | Pass All samples met the pre- determined acceptance criteria | | Particulate, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use | USP <788> Particulate Matter in Injections | Pass All samples met the pre- determined acceptance criteria | | Freedom from Liquid Leakage | To demonstrate that the product meets the liquid leakage requirements given in ISO 10555- 1. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Hub Aspiration Air Leakage | To demonstrate that the product meets the hub aspiration air leakage requirements given in ISO 10555-1. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Balloon Fatigue Test | To demonstrate that there is no degradation of the Balloon after repetitive inflation cycles. | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single- Use Catheters - Part 4: Balloon Dilation Catheters | Pass All samples met the pre- determined acceptance criteria | | Simulated Use | Simulated use under in vitro conditions in a cerebral vascular model | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single- Use Catheters - Part 4: Balloon Dilation Catheters | Pass All samples met the pre- determined acceptance criteria | | Performance Test Summary | | | | | Study Name | Description | Reference Standard | Results | | Flexural Fatigue | To demonstrate that the product does not lose structural integrity when used in the tortuous path model. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Kink Resistance | To demonstrate that the device has similar kink resistance compared to the predicate device. | N/A | Pass All samples met the pre- determined acceptance criteria | | Lubricity and durability of the hydrophilic coating | To demonstrate that the hydrophilic coating is lubricious and durable. | N/A | Pass All samples met the pre- determined acceptance criteria | | Guidewire lumen burst pressure (Static, dynamic) | To demonstrate that the device does not burst below rated burst pressure. | ISO 10555-1:2013 Intravascular catheters - Sterile and single-use catheters - Part 1: General requirements | Pass All samples met the pre- determined acceptance criteria | | Balloon Deflation Time | To demonstrate that the device has similar balloon deflation time compared to the predicate device. | ISO10555-4:2013 Intravascular catheters - Sterile and single-use catheters – Part 4: Balloon dilation catheters | Pass All samples met the pre- determined acceptance criteria | | Lumen Collapse | To demonstrate that the guidewire lumen does not collapse under aspiration. | N/A | Pass All samples met the pre- determined acceptance criteria | {5}------------------------------------------------ {6}------------------------------------------------ No animal or clinical studies were required to demonstrate substantial equivalence. ## Biocompatibility Testing Summary Categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1, the following testing was conducted: | Test Name | Test Method | Results | | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices – Part 5: Tests for in vitro cytotoxicity | Pass Noncytotoxic according to the predetermined acceptance criteria | | | | Sensitization | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices – Part 10 Tests for Irritation and Skin Sensitization, Kligman Maximization Test | Pass Did not elicit a sensitization response according to the predetermined acceptance criteria | | Intracutaneous Irritation | | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization | Pass Test requirements for intracutaneous reactivity were met according to the predetermined acceptance criteria | {7}------------------------------------------------ | Test Name | Test Method | Results | |---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------| | Systemic Toxicity: Systemic Injection Test | Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity | Pass Test requirements for systemic toxicity were met according to the predetermined acceptance criteria | | Systemic Toxicity: Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices – Part 11: Tests for Systemic Toxicity and USP NF 36:2018 <151> Pyrogen Test | Pass Non-pyrogenic, met the predetermined acceptance criteria | | Hemocompatibility: Hemolysis | Tested in accordance with ASTM F756-17, Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood. Tests for Hemolytic Properties, Direct and Indirect Methods | Pass Non-hemolytic, met the predetermined acceptance criteria | | Hemocompatibility: Complement Activation | Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, SC5b-9 Complement Activation | Pass Does not activate the complement system, met the predetermined acceptance criteria | | Hemocompatibility: Thrombogenicity | Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, and ASTM F2888-19, Standard Practice for Platelet Leukocyte Count-An In Vitro Measure for Hemocompatibility Assessment of Cardiovascular Materials | Pass Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria | | Hemocompatibility: In Vitro Hemocompatibility | Tested in accordance with ISO 10993-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood, Hemocompatibility, Direct Contact Method | Pass Not expected to result in adverse effects in vivo, met the predetermined acceptance criteria | | Hemocompatibility: Partial Thromboplastin Time | Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood and ASTM F2382- 18, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT) | Pass Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria | ## Predicate Device Comparison The following table provides a comparison of the key characteristics of the BOBBY Balloon Guide Catheter to the predicate device. | Comparison Chart | | | | | |---------------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | Feature | Subject Device | Predicate device | Comparison | | | | BOBBY Balloon Guide Catheter K193607 | 8F FlowGate2™ Balloon Guide Catheter K153729 | | | | FDA Classification | Class II | Class II | Same | | | Product Code(s) | DQY, QJP | DQY | Same | | | Regulation Number | 870.1250 | 870.1250 | Same | | | Regulation Name | Percutaneous Catheter | Percutaneous Catheter | Same | | | Anatomical Locations | Peripheral and neuro vasculature | Peripheral and neuro vasculature | Same | | | Comparison Chart | | | | | | Feature | Subject Device BOBBY Balloon Guide Catheter K193607 | Predicate device 8F FlowGate™ Balloon Guide Catheter K153729 | Comparison | | | Material | Commonly used medical grade plastics (e.g. nylon, PTFE, polyethylene, polyolefin) and stainless steel | Commonly used medical grade plastics (e.g. nylon, PTFE, polyethylene, polyolefin) and stainless steel | Similar, minor differences do not raise new questions of safety and efficacy, confirmed through biocompatibility and performance testing | | | Reinforced Catheter Shaft | Stainless steel braid and coil reinforced shaft | Stainless steel braid reinforced shaft | Similar, minor differences do not raise new questions of safety and efficacy | | | Injection Port | Yes | Yes | Same | | | Radiopacity | Yes, shaft is visible due to distal tip Pt-Ir marker bands | Yes, shaft material contains barium sulfate, distal tip Pt-Ir marker band | Similar, minor difference does not raise new questions regarding safety and efficacy, both devices are radiopaque | | | Radiopaque Marker Bands | 2 | 1 | Similar, minor difference does not raise new questions regarding safety and efficacy, both devices utilize radiopaque marker bands | | | Compliant Balloon | Yes, polyurethane | Yes, silicone | Similar, material differences do not raise new questions of safety and efficacy, both materials are used for compliant balloons for intravascular use | | | Labeled Shaft Outer Diameter | 0.110 in (2.8 mm) 8Fr | 0.106 in (2.7 mm) 8Fr | Similar, minor differences do not raise new questions of safety and efficacy | | | Comparison Chart | | | | | | Feature | Subject Device BOBBY Balloon Guide Catheter K193607 | Predicate device 8F FlowGate2™ Balloon Guide Catheter K153729 | Comparison | | | Labeled Shaft Inner Diameter | 0.086 in (2.18 mm) 6.5Fr | 0.084 in (2.1 mm) 6.4Fr | Similar, minor differences do not raise new questions of safety and efficacy | | | Effective length | 95 cm (37.4 in) | 85 cm, 95cm (33.5, 37.4 in) | Similar, minor differences do not raise new questions of safety and efficacy | | | Tip Shape | Straight | Straight | Same | | | Coating | Hydrophilic Coating - Distal portion of shaft | None | Difference does not raise new questions of safety and efficacy. Hydrophilic coatings are commonly used to lubricate vascular catheters. | | | Internal Construction | Coaxial lumen | Coaxial lumen | Same | | | Accessories Supplied | Peel Away Sheath | Dilator, Rotating Hemostasis Valve, Tuohy Borst Valve with sideport, Peel Away Sheaths, Luer- Activated Valves | Similar, minor differences do not raise new questions of safety and efficacy. | | | How Supplied | Sterile, single use | Sterile, single use | Same | | | Sterilization Method | EtO | EtO | Same | | | Sterility Assurance Level | 10-6 | 10-6 | Same | | {8}------------------------------------------------ {9}------------------------------------------------ ## Conclusion: MicroVention, Inc. concludes through a review of the benchtop assessments, the comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility that the BOBBY Balloon Guide Catheter is substantially equivalent to the predicate device, FlowGate2™ Balloon Guide Catheter. Any differences are minor and do not raise different questions of safety and effectiveness.