087 Balloon Guide Catheter System

K192525 · Q'Apel Medical, LLC · DQY · Oct 31, 2019 · Cardiovascular

Device Facts

• Record ID: K192525
• Device Name: 087 Balloon Guide Catheter System
• Applicant: Q'Apel Medical, LLC
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 31, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 087 Balloon Guide Catheter System is indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

Device Story

Sterile, single-use 8Fr intravascular catheter; variable stiffness shaft with stainless steel coil reinforcement; bifurcated dual-port luer hub; distal hydrophilic coating; dual radiopaque marker bands. Used in peripheral and neurovasculature to facilitate catheter guidance and provide temporary vascular occlusion via an inflatable balloon. Operated by clinicians under fluoroscopic guidance. System includes inflation syringe, peel-away introducer, hub extension, and three-way stopcock. Provides a conduit for interventional retrieval devices. Benefits include improved navigation through tortuous anatomy and temporary flow arrest during procedures.

Clinical Evidence

Bench testing only. No clinical or animal studies were required. Testing included physical integrity, functionality, and performance: packaging strength (ASTM F88, F2096), visual surface requirements (ISO 10555-1), dimensional inspection, balloon burst/inflation volume (ISO 10555-4), torque, tensile strength, flow rate, connector compliance (ISO 80369-7), corrosion resistance, radiopacity (ASTM F640-12), leakage, particulate/coating integrity (AAMI TIR42, USP 788), fatigue, and kink resistance (DIN EN 13868).

Technological Characteristics

8Fr variable stiffness catheter; stainless steel coil reinforced shaft; low durometer urethane compliant balloon; distal hydrophilic coating; bifurcated dual-port luer hub; dual radiopaque marker bands. Sterilized via EtO. Complies with ISO 10555-1, ISO 10555-4, ISO 80369-7, and ASTM F640-12.

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into peripheral and neurovascular blood vessels; provides temporary vascular occlusion; serves 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)

Reference Devices

• 087 Balloon Guide Catheter System (K190749)

Submission Summary (Full Text)

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Image /page/0/Picture/0 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 31, 2019

Q'Apel Medical LLC % Michele Lucey President Lakeshore Medical Device Consulting LLC 128 Blye Hill Landing Newbury, New Hampshire 03255

Re: K192525

Device Name: 087 Balloon Guide Catheter System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 12, 2019 Received: September 13, 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D. 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

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# Indications for Use

510(k) Number (if known) K192525

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 intravasular catheter into a selected blood vessel in the peripheral and neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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### 510(k) Summary Traditional 510(k) As required by 21 CFR 807.92

### Submitter Information:

| Submitter's Name: | Q'Apel Medical LLC |
|-----------------------|-------------------------------------------------|
| Address: | 330 Wilshire Boulevard<br>Santa Monica CA 90401 |
| Telephone: | 310-395-3950 |
| Fax: | 310-395-3950 |
| Contact Person: | Michele Lucey |
| Telephone: | 603-748-1374 |
| Date Prepared: | October 17, 2019 |
| Device Trade Name: | 087 Balloon Guide Catheter System |
| Classification: | Class II |
| Classification Name: | Percutaneous Catheter |
| Product Code(s): | DQY |
| Regulation Number(s): | 870.1250 |
| Predicate Device: | Concentric Medical, FlowGate2TM, K153729 |
| Reference Device: | 087 Balloon Guide Catheter System K190749 |

#### 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 neurovasculature. The balloon provides temporary vascular occlusion during such procedures. The 087 Balloon Guide Catheter System is also indicated for use as a conduit for retrieval devices.

#### 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

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- 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 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 Balloon Guide Catheter uses a distal hydrophilic coating to reduce friction between the catheter shaft and the vessel wall.

# Nonclinical Performance Testing Summary:

Determination of substantial equivalence is based on an assessment of non-clinical performance bench test data. The 087 Balloon Guide Catheter System has successfully completed the following relevant performance testing to demonstrate substantial equivalence. Testing was performed to evaluate physical integrity, functionality, and performance of the 087 Balloon Guide Catheter. A summary of the tests performed is provided in the table below:

| Performance Test Summary | | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Study Name | Description | Reference Standard | Results |
| Conditioning.<br>Distribution, and Shelf<br>Life Aging Verification | To demonstrate that the product<br>meets the packaging strength and<br>packaging integrity following<br>accelerated aging to a 6-month<br>shelf life equivalent | ASTM F88 Seal<br>Strength of Flexible<br>Barrier materials<br>ASTM F2096 Standard<br>Test Method for<br>Detecting Gross Leaks<br>in Medical Packaging | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Packaging Visual<br>Inspection | To demonstrate that the product<br>meets the packaging visual<br>inspection requirements given | N/A | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Visual Surface<br>Requirements | To demonstrate the product<br>satisfies the visual surface<br>requirements | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Dimensional Inspection | To demonstrate that the product<br>meets the dimensional<br>specifications | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Inflation Volume vs<br>Balloon Diameter | To demonstrate that the product<br>meets the inflation volume vs<br>balloon diameter specifications | In consideration of ISO<br>10555-4:2013<br>Intravascular Catheters<br>- Sterile and Single-Use<br>Catheters - Part 4:<br>Balloon Dilatation<br>Catheters | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Balloon Burst Volume, | To demonstrate that the Balloon<br>is capable of withstanding an<br>injection volume of 1.0CC. | In consideration of ISO<br>10555-4:2013<br>Intravascular Catheters<br>- Sterile and Single-Use<br>Catheters - Part 4:<br>Balloon Dilatation<br>Catheters | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Tip Deflection, FG 00100 | To demonstrate that the stiffness<br>of the distal end of the product is<br>similar to other marketed devices. | N/A | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Torque Testing | To demonstrate that the product is<br>capable of 720 degrees of rotation<br>about the central lumen axis<br>without failure. | N/A | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Peak Tensile | To demonstrate the product<br>satisfies the peak tensile<br>requirements | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Flow Rate | To demonstrate that the flow rate<br>is comparable to the predicate<br>device. | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Small Bore Connector<br>Compliance with<br>Standard | To demonstrate that the product<br>meets the requirements | ISO 80369-7 2016,<br>Small-bore connectors<br>for liquids and gases in<br>healthcare applications<br>- Part 7, Connectors<br>for intravascular or<br>hypodermic<br>applications. | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Corrosion Resistance | To demonstrate the product<br>satisfies the corrosion resistance<br>requirements | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Radiopacity | To determine the radiopaque<br>characteristics of the device. | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements<br>ASTM F640-12<br>Standard Test Methods<br>for Determining<br>Radiopacity for<br>Medical Use | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Hub Extension Liquid<br>Leakage Under Pressure | To demonstrate that the product<br>meets the liquid leakage<br>requirements | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Hub Extension Hub<br>Aspiration Air Leakage | To demonstrate that the product<br>meets the liquid leakage<br>requirements | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Particulates, Coating<br>Integrity | This study was conducted to<br>determine the quantity and size of<br>particles generated during<br>simulated use, including use with<br>stent retrievers | AAMI TIR42:10<br>Evaluation of<br>particulates associated<br>with vascular medical<br>devices<br>USP <788> Particulate<br>Matter in Injections<br>FDA CTQ: Hydrophilic<br>Coated and<br>Hydrophobic Coated<br>Vascular and<br>Neurological Devices,<br>August 2015 | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Liquid Leakage Under<br>Pressure | To demonstrate that the product<br>meets the liquid leakage<br>requirements given in ISO 10555-<br>1. | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Hub Aspiration Air<br>Leakage | To demonstrate that the product<br>meets the hub aspiration air<br>leakage requirements given in<br>ISO 10555-1. | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Balloon Inflation Fatigue | To demonstrate that there is no<br>degradation of the Balloon after<br>20 inflation cycles. | In consideration of ISO<br>10555-4:2013<br>Intravascular Catheters<br>- Sterile and Single-Use<br>Catheters - Part 4:<br>Balloon Dilatation<br>Catheters | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Flex Fatigue | To demonstrate that the product<br>does not loose structural integrity<br>when used in the tortuous path<br>model. | ISO 10555-1:2013<br>Intravascular catheters -<br>Sterile and single-use<br>catheters - Part 1:<br>General requirements | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Performance Test Summary | | | |
| Study Name | Description | Reference Standard | Results |
| Kink Resistance | To demonstrate that the product<br>has acceptable kink resistance | DIN EN 13868:2002,<br>Test methods for<br>kinking of single lumen<br>catheters and medical<br>tubing | Pass<br>All samples met<br>the pre-determined<br>acceptance criteria |
| Simulated Use | Evaluation of device performance<br>under simulated use conditions,<br>including stent retrievers<br>compared to the predicate device | In consideration of ISO<br>10555-4:2013<br>Intravascular Catheters<br>- Sterile and Single-Use<br>Catheters - Part 4:<br>Balloon Dilatation<br>Catheters | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria |

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The results of these tests provide reasonable assurance that the 087 Balloon Guide Catheter System has been designed and tested to assure conformance to the requirements for its intended use and indications for use. No new safety or performance issues were raised during the testing; therefore, this device is considered to be substantially equivalent to the predicate device.

Animal or Clinical Testing: No animal or clinical studies were required to demonstrate substantial equivalence.

### Biocompatibility Testing Summary

The device is categorized as Externally Communicating Device, Circulating Blood, Limited Contact (< 24 hours), per ISO 10993-1. There are no changes to the device materials or manufacturing processes, no additional biocompatibility testing was deemed necessary to implement this change.

#### 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 of the Subject Device with the Predicate Device | | | |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | Subject Device<br>087 Balloon Guide<br>Catheter System | Predicate device<br>FlowGate2 Balloon<br>Guide Catheter | Comparison |
| Regulatory Clearance/<br>Approval Reference | K192525 | 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 |
| Indications for Use | The 087 Balloon Guide<br>Catheter System is<br>indicated for use in<br>facilitating the insertion and<br>guidance of an intravascular<br>catheter into a selected | FlowGate™ Balloon<br>Guide Catheters are<br>indicated for use in<br>facilitating the insertion<br>and guidance of an<br>intravascular catheter into | Intended Use is the<br>same, the subject device<br>does not include an<br>indication for use in<br>angiographic<br>procedures. This |
| Comparison of the Subject Device with the Predicate Device | | | |
| Feature | Subject Device<br>087 Balloon Guide<br>Catheter System | Predicate device<br>FlowGate2 Balloon<br>Guide Catheter | Comparison |
| | blood vessel in the<br>peripheral and<br>neurovasculature. The<br>balloon provides temporary<br>vascular occlusion during<br>such procedures. The 087<br>Balloon Guide Catheter<br>System is also indicated for<br>use as a conduit for<br>retrieval devices. | a selected blood vessel in<br>the peripheral and neuro<br>vascular systems. The<br>balloon provides<br>temporary vascular<br>occlusion during these<br>and other angiographic<br>procedures. The Balloon<br>Guide Catheter is also<br>indicated for use as a<br>conduit for Retrieval<br>devices. | difference does not<br>raise new questions of<br>safety and efficacy, |
| Anatomical Locations | Peripheral and neuro<br>vasculature | Peripheral and neuro<br>vasculature | Same |
| Material | Commonly used medical<br>grade plastics and stainless<br>steel, | Commonly used medical<br>grade plastics and<br>stainless steel, | Same |
| Reinforced Catheter Shaft<br>Reinforcement | Stainless steel coil<br>reinforced | Stainless Steel braid<br>reinforced | Similar, minor<br>difference does not<br>raise new questions<br>regarding safety and<br>efficacy, both devices<br>have reinforced catheter<br>walls, same as reference<br>device |
| Injection Port | Yes | Yes | Same |
| Marker Band Locations | 0.06-in (1.5mm) from the<br>distal tip edge (distal of the<br>balloon)<br>0.66-in (16.8mm) from the<br>distal tip edge (proximal of<br>the balloon) | 0.08-in (2mm) from the<br>distal tip edge | Similar, minor<br>difference does not<br>raise new questions<br>regarding safety and<br>efficacy, both devices<br>utilize radiopaque<br>marker bands, same as<br>reference device |
| Compliant Balloon | Yes, low durometer<br>urethane | Yes, silicone | Similar, material<br>differences do not raise<br>new questions of safety<br>and efficacy, both<br>materials are used for<br>compliant balloons for<br>intravascular use, same<br>as the reference device |
| Labeled Shaft Outer<br>Diameter | 0.110-in (max)<br>(2.79mm)<br>8.4Fr | 0.106-in (max)<br>(2.7mm)<br>8Fr | Similar, minor<br>differences do not raise<br>new questions of safety<br>and efficacy, same as<br>the reference device |
| Comparison of the Subject Device with the Predicate Device | | | |
| Feature | Subject Device<br>087 Balloon Guide<br>Catheter System | Predicate device<br>FlowGate2 Balloon<br>Guide Catheter | Comparison |
| Labelled Shaft Inner<br>Dimension | .087-in<br>(2.21mm)<br>6.6Fr | .084-in<br>(2.21mm)<br>6.4Fr | Similar, minor<br>differences do not raise<br>new questions of safety<br>and efficacy, same as<br>the reference device |
| Effective length | 90, 95, 100 cm<br>(35.4, 37.4, 39.4 in) | 90cm, 100 cm<br>(35.4, 39.4 in) | Same |
| Tip Shape | Straight | Straight | Same |
| Maximum Balloon<br>Volume | 0.6ml | 0.6ml | Same |
| Radiopaque | Distal Tip has radiopaque<br>marker bands, stainless<br>steel reinforcement in the<br>catheter shaft renders the<br>shaft visible on fluoroscopy | Distal Tip has radiopaque<br>marker bands, stainless<br>steel reinforcement in the<br>catheter shaft renders the<br>shaft visible on<br>fluoroscopy | Same |
| Coating | Hydrophilic Coating –<br>Proximal to the balloon, on<br>the distal portion | None | Difference does not<br>raise new questions of<br>safety and efficacy.<br>Hydrophillic coatings<br>are commonly used to<br>lubricate vascular<br>catheters. Both devices<br>do not have coating on<br>the balloon region,<br>same as the reference<br>device |
| Internal Construction | Multi Lumen catheter wall | Coaxial Lumen | Differences do not raise<br>new questions of safety<br>and efficacy. Both<br>designs are intended to<br>create a pathway to the<br>side arm for balloon<br>inflation, same as the<br>reference device |
| Reinforced Shaft | Stainless steel reinforced<br>shaft | Stainless steel reinforced<br>shaft | Same |
| Accessories Supplied | 3-Way Stopcock, Peel<br>Away Sheath, Hub<br>extension, 1ml Syringe | Dilator, Rotating<br>Hemostasis Valve, Tuohy<br>Borst Valve with<br>Sideport, Peel Away<br>Sheaths, Luer-Activated<br>Valves | Similar, minor<br>differences do not raise<br>new questions of safety<br>and efficacy., same as<br>the reference device |
| How Supplied | Sterile, single use | Sterile, single use | Same |
| Sterilization Method | $EtO$ | $EtO$ | Same |

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# Conclusion:

Q'Apel Medical LLC concludes through a review of the benchtop assessments, the comparison of the device classification, intended use, operating principle, technological characteristics, sterility, and biocompatibility that the 087 Balloon Guide Catheter System is substantially equivalent to the predicate device.