Who is the manufacturer of 087 Balloon Guide Catheter System?

Q'Apel filed the 510(k) submission for 087 Balloon Guide Catheter System (K190749).

What is the FDA product code for 087 Balloon Guide Catheter System?

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

What is the regulatory pathway for 087 Balloon Guide Catheter System?

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

Who can help prepare an FDA 510(k) submission like 087 Balloon Guide Catheter System?

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.

087 Balloon Guide Catheter System

Q: What are the predicate devices for 087 Balloon Guide Catheter System?

Concentric Medical, FlowGate2™ (K153729).

K190749 · Q'Apel · DQY · Jul 15, 2019 · Cardiovascular

Device Facts

Record ID	K190749
Device Name	087 Balloon Guide Catheter System
Applicant	Q'Apel
Product Code	DQY · Cardiovascular
Decision Date	Jul 15, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1250
Device Class	Class 2

Intended Use

The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures.

Device Story

The 087 Balloon Guide Catheter System is a sterile, single-use, 8Fr intravascular catheter designed for peripheral and neurovascular procedures. It features a stainless steel coil-reinforced shaft, a bifurcated dual-port luer hub, and a distal compliant balloon. The device is operated by a physician in a clinical setting. The central lumen allows for the introduction of interventional devices, while the inflation port, used with an included 1cc syringe, enables balloon inflation/deflation for temporary vascular occlusion. A distal hydrophilic coating reduces friction during navigation. Radiopaque marker bands on either side of the balloon facilitate visualization under fluoroscopy. The device assists clinicians in navigating tortuous vasculature and provides temporary flow arrest, potentially improving the safety and efficacy of interventional procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies were required. Performance testing included packaging integrity, visual surface requirements, dimensional inspection, inflation volume/diameter, balloon burst volume, tip deflection, torque, peak tensile strength, flow rate, small-bore connector compliance, corrosion resistance, radiopacity, leakage/aspiration testing, balloon inflation fatigue, simulated use in a cerebral vascular model, and flex fatigue. Biocompatibility testing confirmed the device is non-cytotoxic, non-pyrogenic, non-hemolytic, and does not activate the complement system or affect coagulation.

Technological Characteristics

8Fr variable stiffness catheter; stainless steel coil-reinforced shaft; compliant urethane balloon; distal hydrophilic coating; bifurcated dual-port luer hub; radiopaque Pt-Ir marker bands. Sterilized via Ethylene Oxide (EtO) to a 10^-6 SAL. Complies with ISO 10555-1, ISO 10555-4, ISO 80369-7, and ASTM F640-12 standards.

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into peripheral and neuro vasculature; provides temporary vascular occlusion.

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

K192525 — 087 Balloon Guide Catheter System · Q'Apel Medical, LLC · Oct 31, 2019
K203840 — BOSS 8F Balloon Guide Catheter · Marblehead Medical, LLC · Jan 28, 2021
K153729 — 8F FlowGate2 Balloon Guide Catheter · Concentric Medical · Jan 27, 2016
K220331 — 091 Balloon Guide Catheter · Inneuroco, Inc. · Jul 29, 2022
K200910 — BOSS Balloon Guide Catheter · Marblehead Medical · May 2, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font. July 15, 2019 Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255 Re: K190749 Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, MJN Dated: June 12, 2019 Received: June 14, 2019 Dear Michele Lucey: 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, Xiaolin Zheng, 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) K190749 Device Name 087 Balloon Guide Catheter System #### Indications for Use (Describe) The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### 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 As required by 21 CFR 807.92 #### Submitter Information: | Submitter's Name: | Q'Apel Medical LLC | |-----------------------|------------------------------------------| | Address: | 330 Wilshire Boulevard | | | Santa Monica CA 90401 | | Telephone: | 310-395-3950 | | Fax: | 310-395-3950 | | Contact Person: | Michele Lucey | | Telephone: | 603-748-1374 | | Date Prepared: | July 15, 2019 | | Device Trade Name: | 087 Balloon Guide Catheter System | | Classification: | Class II | | Classification Name: | Percutaneous Catheter | | Product Code(s): | DQY, MJN | | Regulation Number(s): | 870.1250 | | Predicate Devices: | Concentric Medical, FlowGate2™ (K153729) | ### Indication for Use: The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vasculature. The balloon provides temporary vascular occlusion during such procedures. ### Device Description The 087 Balloon Guide Catheter System is a sterile, single-use intravascular catheter. The system consists of: - 087 Balloon Guide Catheter ● - 1cc Inflation Syringe ● - 8Fr Peel Away Introducer ● - Hub Extension ● - Three Way Stopcock ● The 087 Balloon Guide Catheter is offered in three effective lengths, 90, 95, and 100 cm. The 087 Balloon Guide Catheter is an 8 French variable stiffness catheter utilizing a bifurcated dual port luer hub on the proximal end and dual radiopaque distal marker bands on each side of the balloon. The catheter shaft is stainless steel coil reinforced. The hub central port is positioned {4}------------------------------------------------ coaxial to the central lumen to facilitate introduction of interventional devices through the central lumen. The inflation port is positioned at an angle to the central port and is used with the accessory Inflation Syringe to facilitate inflating and deflating the balloon. The 087 Neurovascular Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall. ## Performance Testing Summary: The 087 Balloon Guide Catheter System 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 6-month 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 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 Dilatation 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 of 1.0 CC. | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | Tip Deflection, FG 00100 | 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 | | Performance Test Summary | | | | | Study Name | Description | Reference Standard | Results | | 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 | | Peak Tensile | To demonstrate the product satisfies the peak tensile 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 | | Flow Rate | To demonstrate that the flow rate is comparable to the predicate device. | 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 | | Corrosion Resistance | To demonstrate the product satisfies the corrosion resistance 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 | | 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 | | Hub Extension Liquid Leakage Under Pressure | To demonstrate that the product meets the liquid leakage 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 | | Hub Extension Hub Aspiration Air Leakage | To demonstrate that the product meets the liquid leakage 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 | | Performance Test Summary | | | | | Study Name | Description | Reference Standard | Results | | Particulates, Coating Integrity | This study was conducted to determine the quantity and size of particles generated during simulated use | AAMI TIR42:10 Evaluation of particulates associated with vascular medical devices USP <788> Particulate Matter in Injections FDA CTQ: Hydrophilic Coated and Hydrophobic Coated Vascular and Neurological Devices, August 2015 | Pass All samples met the pre-determined acceptance criteria | | Liquid Leakage Under Pressure | 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 Inflation Fatigue | To demonstrate that there is no degradation of the Balloon after 20 inflation cycles. | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | Simulated Use | Evaluation of device performance under simulated use conditions compared to the predicate device | In consideration of ISO 10555-4:2013 Intravascular Catheters - Sterile and Single-Use Catheters - Part 4: Balloon Dilatation Catheters | Pass All samples met the pre-determined acceptance criteria | | Flex Fatigue | To demonstrate that the product does not loose 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 | | Simulated Use Evaluation of the Q'Apel Balloon Guide Catheter | Simulated use under invitro conditions in a cerebral vascular model | N/A | Pass All samples met the pre-determined acceptance criteria | {5}------------------------------------------------ {6}------------------------------------------------ No animal or clinical studies were required to demonstrate substantial equivalence. {7}------------------------------------------------ # 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 toxicity, Neutral Red Uptake Method | Pass Noncytotoxic 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 | | 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 | | Systemic Toxicity | 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 | | Material Mediated Pyrogenicity | Tested in accordance with ISO 10993-11, Biological Evaluation of Medical Devices - Part 11: Tests for Systemic Toxicity and USP 40 <151> Pyrogen Test | Pass Nonpyrogenic, met the predetermined acceptance criteria | | 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 | | 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 | | 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 | | Un-activated 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- 04, Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (UPTT) | Pass Does not have an effect on coagulation of human plasma, met the predetermined acceptance criteria | | Thrombogenicity | Tested in accordance with ISO 10994-4, Biological Evaluation of Medical Devices - Part 4: Selection of Tests for Interactions with Blood | Pass Demonstrates similar thromboresistance characteristics as the control device, met the predetermined acceptance criteria | {8}------------------------------------------------ ## Predicate Device Comparison The following table provides a comparison of the key characteristics of the 087 Balloon Guide Catheter System to the predicate device. | Comparison Chart | | | | |---------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Subject Device 087 Balloon Guide Catheter System | Predicate device the 8F FlowGate2TM Balloon Guide Catheter | Comparison | | Regulatory Clearance/ Approval Reference | K190749 | K153729 | NA | | FDA Classification | Class II | Class II | Same | | Product Code(s) | DQY | 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 | | Material | Commonly used medical grade plastics and stainless steel, | Commonly used medical grade plastics and stainless steel | Similar, difference does not raise new questions regarding safety and efficacy, confirmed through biocompatibility and performance testing | | Reinforced Catheter Shaft Reinforcement | Stainless steel coil reinforced | Stainless steel braid reinforced | Similar, minor difference does not raise new questions regarding safety and efficacy, both devices have reinforced catheter walls | | Injection Port | Yes | Yes | Same | | Radiopacity | Yes, shaft is visible due to coil reinforcement, 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 | | Marker Band Locations | 0.06-in (1.5mm) from the distal tip edge (distal of the balloon) 0.66-in (16.8mm) from the distal tip edge (proximal of the balloon) | .08-in (2mm) from the distal tip edge | Similar, minor difference does not raise new questions regarding safety and efficacy, both devices utilize radiopaque marker bands | | Compliant Balloon | Yes, low durometer urethane | Yes, silicone | Similar, material differences do not | | Comparison Chart | | | | | Feature | Subject Device 087 Balloon Guide Catheter System | Predicate device the 8F FlowGate2TM Balloon Guide Catheter | Comparison | | | | | raise new questions of safety and efficacy, both materials are used for compliant balloons for intravascular use | | Labeled Shaft Outer Diameter | 0.110-in (max) (2.79mm) 8Fr | 0.106 in (2.7mm) 8Fr | Similar, minor differences do not raise new questions of safety and efficacy | | Labelled Shaft Inner Dimension | .087-in (2.21mm) 6.6Fr | 0.084-in (2.11mm) 6.4Fr | Similar, minor differences do not raise new questions of safety and efficacy | | Effective length | 90, 95, 100 cm (35.4, 37.4, 39.4 in) | 90cm, 100cm (35.4, 39.4 in) | Same | | Tip Shape | Straight | Straight | Same | | Maximum Balloon Volume | 0.6ml | 0.6ml | Same | | Injection Port | Yes | Yes | Same | | Radiopaque | Distal Tip has radiopaque marker bands, stainless steel reinforcement in the catheter shaft renders the shaft visible on fluoroscopy | Distal Tip has a radiopaque marker band, stainless steel reinforcement in the catheter shaft renders the shaft visible on fluoroscopy | Same | | Coating | Hydrophilic Coating – Proximal to the balloon, on the distal Portion | None | Difference does not raise new questions of safety and efficacy. Hydrophilic coatings are commonly used to lubricate vascular catheters. Both devices do not have coating on the balloon region | | Internal Construction | Multi Lumen catheter wall | Coaxial lumen | Differences do not raise new questions of safety and efficacy | | Comparison Chart | | | | | Feature | Subject Device 087 Balloon Guide Catheter System | Predicate device the 8F FlowGate2TM Balloon Guide Catheter | Comparison | | Reinforced Shaft | Stainless steel reinforced shaft | Stainless steel reinforced shaft | Same | | Accessories Supplied | 3-Way Stopcock, Peel Away Sheath, Hub extension, 1ml Syringe | 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 | | | | | efficacy. Both designs are intended to create a pathway to the side arm for balloon inflation | {9}------------------------------------------------ {10}------------------------------------------------ ### Conclusion: Q'Apel Medical LLC 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 087 Balloon Guide Catheter System is substantially equivalent to the predicate device, the FlowGate2™ Balloon Guide Catheter. Any differences are minor and do not raise different questions of safety and effectiveness.