EMBOGUARD Balloon Guide Catheter

K212340 · Neuravi Limited · QJP · Dec 17, 2021 · Cardiovascular

Device Facts

• Record ID: K212340
• Device Name: EMBOGUARD Balloon Guide Catheter
• Applicant: Neuravi Limited
• Product Code: QJP · Cardiovascular
• Decision Date: Dec 17, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

Device Story

The EMBOGUARD Balloon Guide Catheter is a dual-lumen, braid-reinforced, variable-stiffness catheter designed for neurovascular procedures. It features a compliant polyblend balloon at the distal end for temporary vascular occlusion and a hydrophilic coating on the distal shaft to enhance lubricity. The device is operated by a physician in a clinical setting (e.g., angiography suite). The catheter is inserted into the neurovascular system to guide other intravascular devices and acts as a conduit for retrieval devices. The balloon is inflated via a non-coaxial inflation lumen to occlude blood flow, aiding in the performance of angiographic procedures. The device includes a bifurcated luer hub for connection to inflation/aspiration equipment. By providing stable access and temporary occlusion, the device facilitates the navigation and deployment of retrieval tools, potentially improving clinical outcomes in neurovascular interventions.

Clinical Evidence

No clinical studies were performed. Evidence consists of bench testing (dimensional verification, torque, tensile strength, flexibility, kink resistance, lubricity, particulate analysis, radiopacity, simulated use, and balloon performance) and an acute animal study in a swine model. The animal study confirmed comparable usability, effectiveness, and tissue response (histology) to the predicate device.

Technological Characteristics

Dual-lumen, braid-reinforced (stainless steel) catheter with variable stiffness. Materials: nylon, PTFE, polycarbonate, polyurethane, polyolefin, polyblend, stainless steel. Features: compliant polyblend balloon, distal hydrophilic coating, Pt-Ir radiopaque marker. Sterilization: EtO (SAL 10^-6). Connectivity: manual luer-lock connections. Dimensions: 8F shaft, 6.6F inner diameter.

Indications for Use

Indicated for facilitating insertion and guidance of intravascular catheters into 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

• 8F FlowGate Balloon Guide Catheter (K153729)

Submission Summary (Full Text)

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December 17, 2021

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Neuravi Ltd. Niall Fox Director of Regulatory Affairs Block 3, Ballybrit Business Park Galway, H91 K5YD Ireland

Re: K212340

Trade/Device Name: EMBOGUARD Balloon Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP Dated: November 16, 2021 Received: November 17, 2021

Dear Niall Fox:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K212340

Device Name EMBOGUARD™ Balloon Guide Catheter

### Indications for Use (Describe)

EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during 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> <span> <svg height="16" width="16"> <path d="M2 2 L14 14 M2 14 L14 2" stroke="black" stroke-width="2"></path> </svg> </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

# K212340

#### l. SUBMITTER:

510(k) Owner: Neuravi Ltd.

Block 3, Ballybrit Business Park, Galway H91 K5YD, Ireland

Contact Person: Niall Fox

Director Regulatory Affairs

Tel: [phone]

E-mail: [e-mail]

Date Prepared: December 17, 2021

#### II. DEVICE

Trade Name of Device: EMBOGUARD™ Balloon Guide Catheter

Common Name of Device: Catheter, Percutaneous

Classification Name: 21 CFR 870.1250 - Class II

Product Code: QJP

#### PREDICATE DEVICE III.

8F FlowGate Balloon Guide Catheter (K153729)

#### IV. DEVICE DESCRIPTION

EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.

#### V. INDICATIONS FOR USE

EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

A summary of the technological characteristics of the EMBOGUARD Balloon Guide Catheter device in comparison to those of the predicate device is presented below.

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| | Predicate Device | Subject Device | |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | 8F FlowGate Balloon<br>Guide Catheter<br>(K153729) | EMBOGUARD™<br>Balloon Guide Catheter<br>(K212340) | Comparison |
| Classification | Class II (21CFR<br>870.1250) | Class II (21CFR<br>870.1250) | Same |
| Device Classification<br>Name | Catheter, Percutaneous | Catheter, Percutaneous | Same |
| Classification<br>Product Code | DQY | QJP | Similar |
| Indications for Use | FlowGate Balloon Guide<br>Catheters are<br>indicated for use in<br>facilitating the insertion<br>and guidance of an<br>intravascular catheter<br>into a selected blood<br>vessel in the peripheral<br>and neuro vascular<br>systems. The balloon<br>provides temporary<br>vascular occlusion<br>during these and other<br>angiographic procedures.<br>The Balloon Guide<br>Catheter is also indicated<br>for use as a conduit for<br>Retrieval<br>devices. | EMBOGUARD<br>Balloon Guide<br>Catheters are indicated<br>for use in facilitating the<br>insertion and<br>guidance of an<br>intravascular catheter<br>into a selected blood<br>vessel in the<br>neurovascular system.<br>The balloon provides<br>temporary vascular<br>occlusion during<br>angiographic<br>procedures. The Balloon<br>Guide Catheter is also<br>indicated for use as a<br>conduit for<br>Retrieval Devices. | Similar<br>The subject device is<br>indicated for use only<br>in the<br>neurovasculature. |
| Material | Commonly used medical<br>grade plastics (nylon,<br>PTFE, polyolefin,<br>polyamide) and stainless<br>steel | Commonly used medical<br>grade plastics (nylon,<br>PTFE, polycarbonate,<br>polyurethane,<br>polyolefin, polyblend)<br>and stainless steel | Similar<br>The differences do<br>not raise new<br>questions of safety<br>and effectiveness.<br>This is confirmed<br>through<br>biocompatibility<br>and performance<br>testing. |
| Reinforced Catheter<br>Shaft | Stainless steel braid | Stainless steel braid | Same |
| Radiopaque Marker<br>Band | Distal tip Pt-Ir marker<br>band | Distal tip Pt-Ir marker<br>band | Same |
| Radiopaque Marker<br>location from Distal<br>Tip | 0.75mm | 1.3mm | Similar<br>Differences do not raise<br>new questions of safety<br>and effectiveness, and do<br>not impact visibility<br>under fluoroscopy. This is<br>confirmed through<br>radiopaque marker<br>visualization as part of<br>performance testing. |
| Radiopaque Marker<br>Length | 0.020" | 0.031" | Similar<br>Differences do not raise<br>new questions of safety<br>and effectiveness, and do<br>not impact visibility<br>under fluoroscopy. This is<br>confirmed through<br>radiopaque marker<br>visualization as part of<br>performance testing. |
| Compliant Balloon | Yes, silicone | Yes, polyblend | Similar<br>Differences do not raise<br>new questions of safety<br>and effectiveness. Both<br>materials are used for<br>compliant balloons for<br>intravascular use. |
| Effective Length | 85 cm<br>95 cm | 85 cm<br>95 cm | Same |
| Labelled Shaft Outer<br>Diameter | 8F (2.7 mm) | 8F (2.8 mm) | Similar<br>The differences do not<br>raise new questions of<br>safety and effectiveness.<br>Compatibility with |
| | | | ancillary devices has<br>been verified through |
| | | | the performance testing. |
| Labelled Shaft Inner<br>Diameter | 6.4F (0.084") | 6.6F (0.087") | Similar<br>The differences do not<br>raise new questions of<br>safety and effectiveness.<br>Compatibility with<br>ancillary devices has<br>been verified through<br>the performance testing. |
| Tip Shape | Straight | Straight | Same |
| Outer Coating | Not applicable | Hydrophilic Coating –<br>Distal portion of the<br>shaft | The difference does not<br>raise new questions of<br>safety and effectiveness.<br>Hydrophilic coatings are<br>commonly used to<br>enhance lubricity of<br>intravascular catheters. |
| Balloon Inflation<br>Lumen | Coaxial | Non-coaxial | The difference does not<br>raise new questions on<br>safety and effectiveness.<br>The balloon inflation<br>lumen design and<br>balloon performance<br>have been evaluated<br>through<br>performance testing. |
| Accessory Devices<br>Provided | Dilator (1)<br>Rotating Hemostasis<br>Valve (1)<br>Tuohy Borst Valve with<br>Sideport (1)<br>Peel Away Sheath (1)<br>Luer-Activated Valve (1)<br>Extension Tubing (1) | Dilator (1)<br>Rotating Hemostasis<br>Valve (1)<br>Tuohy Borst Valve with<br>Sideport (1)<br>Peel Away Sheath (1)<br>Luer-Activated Valve<br>(1) | Similar<br>The differences do not<br>raise new questions of<br>safety and effectiveness. |
| How Supplied | Sterile, Single Use | Sterile, Single Use | Same |
| Sterilization Method | EtO | EtO | Same |
| Sterility Assurance<br>Level | 10-6 | 10-6 | Same |

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# VII. PERFORMANCE DATA Biocompatibility Testing:

The biocompatibility evaluation for the EMBOGUARD Balloon Guide Catheter device was conducted in accordance with ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process" and FDA biocompatibility guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"."

The EMBOGUARD Balloon Guide Catheter device is categorized as an external communicating device with limited exposure with circulating blood (≤ 24 hours) per ISO 10993-1.

| Test Name | Test Method | Results |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | Tested in accordance with ISO 10993-5, Biological Evaluation of Medical<br>Devices - Part 5: Tests for in vitro<br>cytotoxicity. | Pass<br>Non-cytotoxic according to the<br>pre-determined acceptance<br>criteria. |
| Sensitization | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical<br>Devices – Part 10: Tests for Irritation<br>and Skin Sensitization. Kligman and<br>Magnusson Maximisation Test. | Pass<br>Did not elicit a sensitization<br>response according to the<br>pre-determined acceptance<br>criteria. |
| Intracutaneous<br>Irritation | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical<br>Devices - Part 10: Tests for Irritation<br>and Skin Sensitization. | Pass<br>Test requirements for<br>intracutaneous reactivity<br>were met according to the<br>pre-determined acceptance<br>criteria. |
| Systemic Toxicity:<br>Systemic Injection<br>Test | Tested in accordance with ISO 10993-11, Biological Evaluation of Medical<br>Devices – Part 11: Tests for Systemic<br>Toxicity. | Pass<br>Test requirements for<br>systemic toxicity were met,<br>according to the<br>pre-determined acceptance<br>criteria. |
| Systemic Toxicity:<br>Material<br>Mediated<br>Pyrogenicity | Tested in accordance with ISO 10993-11, Biological Evaluation of Medical<br>Devices – Part 11: Tests for Systemic<br>Toxicity, and USP <151> Pyrogen Test. | Pass<br>Non-pyrogenic, met the<br>pre-determined acceptance<br>criteria. |
| | | |
| <b>Hemocompatibility:</b><br><b>Hemolysis Study</b> | Tested in accordance with ASTM F756-<br>17, Standard Practice for Assessment<br>of Hemolytic Properties of Materials<br>and ISO 10993-4, Biological Evaluation<br>of Medical Devices – Part 4: Selection<br>of Tests for Interactions with Blood.<br>Tests for Hemolytic Properties, Direct<br>and Indirect Methods. | Pass<br>Non-hemolytic, met the<br>pre-determined acceptance<br>criteria. |
| <b>Hemocompatibility:</b><br><b>Complement<br/>Activation Study</b> | Tested in accordance with ISO 10993-<br>4, Biological Evaluation of Medical<br>Devices - Part 4: Selection of Tests<br>for Interactions with Blood. SC5b-9<br>Complement Activation. | Pass<br>Does not activate the<br>complement system, met the<br>pre-determined acceptance<br>criteria. |
| <b>Hemocompatibility:</b><br><b>Thrombogenicity<br/>Study</b> | Tested in accordance with ISO 10993-<br>4, Biological Evaluation of Medical<br>Devices - Part 4: Selection of Tests<br>for Interactions with Blood. | Pass<br>Demonstrates similar<br>thromboresistance<br>characteristics as the control<br>device, met the<br>pre-determined acceptance<br>criteria. |
| <b>Genotoxicity:</b><br><b>Bacterial Reverse<br/>Mutation Study</b> | Tested in accordance with ISO 10993-<br>3, Biological Evaluation of Medical<br>Devices - Part 3: Tests for<br>Genotoxicity, Carcinogenicity and<br>Reproductive Toxicity, and OECD 471,<br>Guideline for Testing of Chemicals,<br>Bacterial Reverse Mutation Test. | Pass<br>Non-mutagenic according to<br>the<br>pre-determined acceptance<br>criteria. |
| <b>Genotoxicity:</b><br><b>Mouse Lymphoma<br/>Assay</b> | Tested in accordance with ISO 10993-<br>3, Biological Evaluation of Medical<br>Devices - Part 3: Tests for<br>Genotoxicity, Carcinogenicity and<br>Reproductive Toxicity, and OECD<br>Guideline for the Testing of<br>Chemicals. | Pass<br>Non-mutagenic according to<br>the<br>pre-determined acceptance<br>criteria. |

The biocompatibility evaluation included the following tests:

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All biocompatibility tests completed met the pre-determined acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards.

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# Sterilization and Shelf Life:

The EMBOGUARD Balloon Guide Catheter device is labelled as a single-use, sterile device, with a shelf life of 1 year. The sterilization process for the EMBOGUARD Balloon Guide Catheter device has been successfully validated and process monitoring controls are in place to assure that the device is EO-sterilized to achieve a minimum SAL of 10-6.

Shelf life studies have been conducted for the EMBOGUARD Balloon Guide Catheter device and establish that the product and packaging remain functional and sterile for the shelf life period of 1 year.

## Bench Testing:

The results of design verification and validation testing conducted on the EMBOGUARD Balloon Guide Catheter device demonstrate that it performs as designed, fulfils all pre-determined product performance specification requirements, and is suitable for its intended use. The verification and validation test results demonstrate that EMBOGUARD Balloon Guide Catheter is substantially equivalent to the predicate device.

| Performance Bench Testing Summary | | | |
|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Study Name | Description | Reference Standard | Results |
| Visual<br>Inspection<br>and<br>Dimensional<br>Verification | To demonstrate that<br>the product meets<br>the visual and<br>dimensional<br>specifications. | ISO 10555-1:2013, Intravascular<br>catheters - Sterile and single-use<br>catheters - Part 1: General<br>requirements<br>ISO 10555-4:2013, Intravascular<br>catheters - Sterile and single-use<br>catheters - Part 4: Balloon<br>dilatation catheters<br>ISO 11070:2014/AMD 1:2018,<br>Sterile Single-Use Intravascular<br>Introducers, Dilators and<br>Guidewires | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Visual Surface<br>Inspection | To demonstrate the<br>product satisfies the<br>visual surface<br>requirements. | ISO 10555-1:2013<br>ISO 10555-4:2013<br>ISO 11070:2014/AMD 1:2018 | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Torque | To demonstrate | | Pass |
| Torque<br>Durability | To demonstrate<br>that the product is<br>capable of 360<br>degrees of<br>rotation of the hub<br>while the distal tip<br>is fixed in position. | FDA guidance for Certain<br>Percutaneous Transluminal<br>Coronary Angioplasty (PTCA)<br>Catheters:2010; §VIII.A.10<br>Torque Strength | All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Torque to<br>Failure | The number of<br>rotations of the<br>proximal hub<br>required to initiate<br>device failure,<br>including<br>separation, when<br>the distal end is<br>held stationary. | Characterization only<br>FDA guidance Certain PTCA<br>Catheters:2010 §VIII.A.10<br>Torque Strength | Pass<br>The test<br>samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Torque<br>Transmission | To determine the<br>torque<br>transmission ratio. | Characterization only<br>FDA guidance Certain PTCA<br>Catheters:2010 §VIII.A.10<br>Torque Strength | The torque<br>transmission at<br>the tip has been<br>characterized<br>successfully after<br>a minimum 720°<br>hub rotation. |
| Tensile<br>Strength | To demonstrate the<br>product satisfies the<br>tensile strength<br>requirements for<br>bonds<br>and tip pull test. | ISO 10555-1:2013<br>ISO 11070:2014/AMD 1:2018<br>FDA guidance Certain PTCA<br>Catheters:2010 §VIII.A.7, Catheter<br>Bond Strength, A.8, Tip Pull Test | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Flexibility and<br>Kink<br>Resistance | To demonstrate that<br>the product has<br>acceptable<br>flexibility and kink<br>resistance<br>when wrapped<br>around a series of<br>mandrels | FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.A.9 Flexibility and Kink Test | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| | | | |
| Kink to Failure | To determine the<br>bend radius at which<br>catheter kink occurs,<br>as it is bent around<br>mandrels of<br>decreasing radii. | Characterization only<br><br>FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.A.9 Flexibility and Kink Test | The kink to<br>failure has been<br>characterized at<br>different<br>sections down to<br>a 2.5mm<br>mandrel. |
| Catheter<br>Lubricity and<br>Durability | To demonstrate that<br>the product meets<br>coating lubricity and<br>durability<br>specifications. | N/A | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Coating Length<br>and Location | To demonstrate that<br>the product meets<br>coating length and<br>location<br>specifications. | N/A | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Particulates | This study was<br>conducted to<br>determine the<br>quantity and size of<br>particles generated<br>during simulated use. | Characterization only<br><br>AAMI TIR42:2010, Evaluation of<br>Particulates Associated with<br>Vascular Medical Devices<br><br>ASTM F2743-11: 2010, Standard<br>Guide for Coating Inspection and<br>Acute Particulate<br>Characterization of Coated Drug-<br>Eluting Vascular Stent Systems<br><br>USP <788> Particulate Matter in<br>Injections | Pass<br>The particulates<br>from the subject<br>device and<br>cleared controls<br>were evaluated<br>and found<br>comparable. |
| Coating<br>Integrity | To characterize the<br>coating under<br>specified<br>magnification pre-<br>and post-simulated<br>use. | Characterization only<br><br>FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.A.12 Coating Integrity | Coating has been<br>characterized<br>under specified<br>magnification<br>pre- and post-<br>simulated use. |
| Radiopacity | To determine the<br>radiopaque<br>characteristics of the<br>device and dilator. | ASTM F640-20, Standard Test<br>Methods for Determining<br>Radiopacity for Medical Use | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| | | | |
| Simulated Use | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | Pass<br>All samples met the pre-determined acceptance criteria. |
| Simulated<br>Clot Retrieval<br>Testing | To evaluate device performance (including clot retrieval performance) in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | Pass<br>All samples met the pre-determined acceptance criteria. |
| User<br>Evaluation | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | Pass<br>All samples met the pre-determined acceptance criteria. |
| Catheter<br>Deliverability<br>and<br>Withdrawal<br>Force | To demonstrate that the device meets the required tracking force specification. | N/A | Pass<br>All samples met the pre-determined acceptance criteria. |
| Cather Luer<br>Hub<br>Dimensional<br>and<br>Performance<br>Testing | To demonstrate that the product meets the requirements for small bore connectors. | ISO 80369-7:2016, Small-bore connectors for liquids and gases in healthcare applications — Part 7, Connectors for intravascular or hypodermic applications<br>ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods<br>ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements<br>ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings | Pass<br>All samples met the pre-determined acceptance criteria. |
| Inner Lumen<br>Integrity -<br>Pressure | To demonstrate that<br>the product meets<br>the pressure<br>requirements. | ISO 10555-1:2013<br><br>FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.B.1 Catheter Body Burst<br>Pressure | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Inner Lumen<br>Integrity -<br>Aspiration | To demonstrate that<br>the product meets<br>the aspiration air<br>leakage<br>requirements and<br>will not collapse<br>under aspiration. | ISO 10555-1:2013 | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Hub Shaft<br>Pressure<br>Integrity | To demonstrate that<br>the device shaft<br>meets the<br>minimum inner<br>diameter<br>specification up to<br>1138kPa internal<br>pressure through<br>hub's inflation luer. | ISO 10555-1:2013<br><br>FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.B.1 Catheter Body Burst<br>Pressure | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Introducer<br>Sheath<br>Compatibility<br>(Insertion<br>and<br>Withdrawal) | To demonstrate that<br>the product meets<br>the required<br>insertion and<br>withdrawal force<br>without product<br>damage. | N/A | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Introducer<br>Sheath<br>Compatibility<br>(Re-insertion<br>and Re-<br>withdrawal) | To demonstrate<br>device integrity is<br>maintained post re-<br>insertion and re-<br>withdrawal. | N/A | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Tip Stiffness | To demonstrate that<br>the stiffness of the<br>distal end of the | N/A | Pass<br>All samples met<br>the pre- |
| | product is similar to<br>predicate device. | | determined<br>acceptance<br>criteria. |
| Balloon<br>Location | To demonstrate<br>balloon meets the<br>balloon location<br>specification. | ISO 10555-4:2013 | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Balloon<br>Inflation /<br>Deflation | To demonstrate<br>balloon meets the<br>inflation and<br>deflation time<br>specifications. | ISO 10555-4:2013<br>FDA guidance Certain PTCA<br>Catheters:2010<br>§VIII.A.6 Balloon Inflation<br>and Deflation Time | Pass<br>All samples met<br>the pre-<br>determined<br>acceptance<br>criteria. |
| Balloon<br>Fatigue | To demonstrate that<br>there is no<br>degradation of the<br>balloon after 20<br>inflation cycles.…