EMBOGUARD Balloon Guide Catheter

K233924 · Neuravi Limited · QJP · Apr 18, 2024 · Cardiovascular

Device Facts

• Record ID: K233924
• Device Name: EMBOGUARD Balloon Guide Catheter
• Applicant: Neuravi Limited
• Product Code: QJP · Cardiovascular
• Decision Date: Apr 18, 2024
• Decision: SESE
• Submission Type: Special
• 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 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.

Device Story

The EMBOGUARD Balloon Guide Catheter is a dual-lumen, braid-reinforced, variable-stiffness catheter designed for neurovascular procedures. It features a compliant balloon at the distal end for temporary vascular occlusion and a hydrophilic coating on the distal shaft to facilitate navigation. The device is operated by a physician in a clinical setting (e.g., interventional suite) to guide intravascular catheters to target vessels or serve as a conduit for retrieval devices. The physician monitors the device's position via radiopaque markers under fluoroscopy. By providing a stable, occluded pathway, the device assists in complex neurovascular interventions, potentially improving procedural success and patient outcomes.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence is supported by bench testing, including biocompatibility (ISO 10993), balloon performance (inflation/deflation, fatigue, burst, compliance), and mechanical integrity (tensile strength, kink resistance, torque, deliverability). All tests met predetermined acceptance criteria.

Technological Characteristics

Dual-lumen, braid-reinforced (stainless steel) catheter; variable stiffness; compliant balloon; hydrophilic coating. Materials: Pebax 35D/55D/72D, PTFE, stainless steel, Pt-Ir marker. Sterilization: EtO (SAL 10^-6). Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring neurovascular intravascular catheter guidance and temporary vascular occlusion during angiographic procedures, or 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

• EMBOGUARD Balloon Guide Catheter (K212340)

Submission Summary (Full Text)

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April 18, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K233924

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: March 22, 2024 Received: March 22, 2024

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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

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

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

Sincerely,

# Naira Muradyan -S

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

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## Indications for Use

510(k) Number (if known) K233924

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 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.

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

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# 510(k) Summarv

# K233924

#### SUBMITTER: l.

510(k) Owner: Neuravi Ltd.

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

Contact Person: Niall Fox

Director of Regulatory Affairs

Tel: [phone]

E-mail: [e-mail]

Date Prepared: April 16th 2024

#### II. DEVICE

Trade Name of Device: EMBOGUARD™ Balloon Guide Catheter

Common Name of Device: Catheter, Percutaneous, Neurovasculature

Classification Name: 21 CFR 870.1250 - Class II

Product Code: QJP

#### III. PREDICATE DEVICES

EMBOGUARD™ Balloon Guide Catheter (K212340)

#### 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.

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

A summary of the technological characteristics of the EMBOGUARD™ Balloon Guide Catheter device in comparison to those of the predicate device is presented below. The device specifications are unchanged in comparison to the predicate devices. There is a change in the shafts' Pebax jacket materials blend of Pebax, colorant mix and addition of colorant carrier. The forming process of the catheter inner lumen liner material has also changed.

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| Characteristics | Predicate Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter | Subject Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212340 | K233924 |
| Classification | Class II, 21 CFR 870.1250 | Same as Predicate Device |
| Device<br>Classification<br>Name | Catheter, Percutaneous,<br>Neurovasculature | Same as Predicate Device |
| Classification<br>Product Code | QJP | Same as Predicate Device |
| Indications for Use | EMBOGUARD Balloon Guide<br>Catheters are indicated for use in<br>facilitating the insertion and<br>guidance of an intravascular<br>catheter into a selected blood<br>vessel in the neurovascular system.<br>The balloon provides temporary<br>vascular occlusion during<br>angiographic procedures. The<br>Balloon Guide Catheter is also<br>indicated for use as a conduit for<br>Retrieval Devices. | Same as Predicate Device |
| Materials | Commonly used medical grade<br>plastics (nylon, PTFE,<br>polycarbonate, polyurethane,<br>polyolefin, polyblend) and stainless<br>steel | Same as Predicate Device |
| Shaft Outer Jacket<br>Distal Segment (1)<br>Pebax 35D Jacket<br>0.004" W/T | Pebax 3533 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Pebax 3533 SA01 MED<br>Pebax 5533 SA01 MED<br>(colorant carrier)<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7<br>Irganox 1010<br>Tinuvin 622 |
| Shaft Outer Jacket<br>Distal Segment (2)<br>Pebax 35D Jacket<br>0.005" W/T | Pebax 3533 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Pebax 3533 SA01 MED<br>Pebax 5533 SA01 MED<br>(colorant carrier)<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7<br>Irganox 1010<br>Tinuvin 622 |
| Shaft Outer Jacket<br>Distal Segment (3)<br>Pebax 35/40D<br>Jacket | Pebax 4033 SA01 MED<br>Pebax 3533 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Pebax 5533 SA01 MED<br>Pebax 3533 SA01 MED<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7 |
| Characteristics | Predicate Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter | Subject Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter |
| Shaft Outer Jacket<br>Distal Segment (4)<br>Pebax 40D Jacket | Pebax 4033 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Irganox 1010<br>Tinuvin 622<br>Pebax 5533 SA01 MED<br>Pebax 3533 SA01 MED<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7<br>Irganox 1010<br>Tinuvin 622 |
| Shaft Outer Jacket<br>Distal Segment (5)<br>Pebax 55D Jacket | Pebax 5533 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Pebax 5533 SA01 MED<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7<br>Irganox 1010<br>Tinuvin 622 |
| Shaft Outer Jacket<br>Distal Segment (6)<br>Pebax 72D Jacket | Pebax 7233 SA01 MED<br>Techmer Blue/Black (PM50167E1)<br>Irganox 1010<br>Tinuvin 622 | Pebax 7233 SA01 MED<br>Pebax 5533 SA01 MED<br>(colorant carrier)<br>CSRM016 Pigment Blue 36<br>CSRM037 Pigment Violet 23<br>CSRM035 Pigment Green 7<br>Irganox 1010<br>Tinuvin 622 |
| Inner Lumen Liner | RAM extruded forming process;<br>method by which the liner is formed<br>into its tubular shape | Film cast forming process; method by<br>which the liner is formed into its<br>tubular shape |
| Reinforced<br>Catheter Shaft | Stainless steel braid | Same as Predicate Device |
| Radiopaque<br>Marker Band | Distal tip Pt-Ir marker band | Same as Predicate Device |
| Radiopaque<br>Marker Location<br>from Distal Tip | 1.3 mm | Same as Predicate Device |
| Radiopaque<br>Marker Length | 0.031 | |
| Characteristics | Predicate Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter | Subject Device:<br>EMBOGUARD™ Balloon Guide<br>Catheter |
| Balloon Inflation<br>Lumen | Non-coaxial | Same as Predicate Device |
| Accessory Devices<br>Provided | Dilator (1)<br>Rotating Hemostasis Valve (1)<br>Peel Away Sheath (1)<br>Luer-Activated Valve (1) | Same as Predicate Device |
| How Supplied | Sterile, Single Use | Same as Predicate Device |
| Sterilization<br>Method | EtO | Same as Predicate Device |
| Sterility Assurance<br>Level | $10^{-6}$ | Same as Predicate Device |
| Shelf Life | 1 year | 1 year |

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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. All biocompatibility tests completed met the predetermined acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards. The biocompatibility evaluation included the following tests.

| Biocompatibility Testing | | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Test | Test Method Summary | Results |
| Cytotoxicity Study | Tested in accordance with ISO 10993-5, Biological Evaluation of Medical Devices - Part 5: Tests for in vitro Cytotoxicity. | Pass<br>Non-cytotoxic according to the pre-determined acceptance criteria. |
| Sensitization<br>Study | Tested in accordance with ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization, Kligman and Magnusson Maximisation Test. | Pass,<br>Did not elicit a sensitization response according to the pre-determined acceptance criteria. |
| Intracutaneous<br>Irritation | Tested in accordance with ISO 10993-10,<br>Biological Evaluation of Medical Devices -<br>Part 10: Tests for Irritation and Skin<br>Sensitization. | Pass<br>Test requirements for<br>intracutaneous reactivity were<br>met according to the pre-<br>determined acceptance<br>criteria. |
| Acute Systemic<br>Toxicity | Tested in accordance with ISO 10993-11,<br>Biological Evaluation of Medical Devices -<br>Part 11: Tests for Systemic Toxicity. | Pass<br>Test requirements for systemic<br>toxicity were met according to<br>the pre-determined acceptance<br>criteria. |
| Pyrogenicity -<br>Material-Mediated<br>Rabbit Pyrogen | Tested in accordance with ISO 10993-11,<br>Biological Evaluation of Medical Devices -<br>Part 11: Tests for Systemic Toxicity and<br>USP <151> Pyrogen Test. | Pass<br>Non-pyrogenic, met the pre-<br>determined acceptance<br>criteria. |
| Hemolysis Study | Tested in accordance ASTM F756-17,<br>Standard Practice for Assessment of<br>Hemolytic Properties of Materials and ISO<br>10993-4, Biological Evaluation of Medical<br>Devices - Part 4: Selection of Tests for<br>Interactions with Blood, Tests for<br>Hemolytic Properties, Direct and Indirect<br>Methods. | Pass<br>Non-hemolytic, met the pre-<br>determined acceptance<br>criteria. |
| SC5b-9 Complement<br>Activation Study | Tested in accordance with ISO 10993-4,<br>Biological Evaluation of Medical Devices -<br>Part 4: Selection of Tests for Interactions<br>with Blood, SC5b-9 Complement<br>Activation. | Pass<br>Does not activate the<br>complement system, met the<br>pre-determined acceptance<br>criteria. |
| ASTM Partial<br>Thromboplastin Time<br>(PTT) | Tested in accordance with ISO 10993-4,<br>Biological Evaluation of Medical Devices -<br>Part 4: Selection of Tests for Interactions<br>with Blood. | Pass<br>Demonstrates similar<br>thromboresistance<br>characteristic as the control<br>device, met the pre-<br>determined acceptance<br>criteria. |
| Platelet and<br>Leukocyte Count | Tested in accordance with ISO 10993-4,<br>Biological Evaluation of Medical Devices -<br>Part 4: Selection of Tests for Interactions<br>with Blood. | Pass<br><br>Demonstrates similar<br>thromboresistance<br>characteristic as the control<br>device, met the pre-<br>determined acceptance<br>criteria. |

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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. Previous testing with the predicate device has demonstrated that 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 sterility assurance level (SAL) of 10-6. The changes made to the EMBOGUARD Balloon Guide Catheter do not impact its sterilization.

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

## In Vitro (Bench) Testing:

Performance bench testing was conducted according to existing test methods previously reviewed by FDA in the predicate submission (K212340). A description of each performance test used to support substantial equivalence determination is presented below.

| Performance Bench Testing | | | |
|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Test | Description | Reference Standard | Results |
| Balloon Inflation / Deflation Time | To demonstrate the balloon meets the inflation and deflation time specifications. | FDA guidance Certain PTCA Catheters:2010; §VIII.A6 Balloon Inflation and Deflation Time | Pass All samples met the pre-determined acceptance criteria. |
| Balloon Fatigue | To demonstrate that there is no leakage or damage to the balloon after 20 inflation cycles. | FDA guidance Certain PTCA Catheters:2010; §VIII.A4 Balloon Fatigue (Repeat Balloon Inflations) | Pass All samples met the pre-determined acceptance criteria. |
| Balloon Outer Diameter (OD) and Compliance | To demonstrate that the product meets the maximum recommended inflation volume vs. balloon diameter specifications. | FDA guidance Certain PTCA Catheters:2010; §VIII.A5 Balloon Compliance (Diameters vs. Pressure) | Pass All samples met the pre-determined acceptance criteria. |
| Balloon<br>Concentricity | To demonstrate that the<br>product meets the balloon<br>diameter specification on<br>each side at the<br>recommended inflation<br>volume when rotated 360°. | FDA guidance Certain PTCA<br>Catheters:2010; §VIII.A5 Balloon<br>Compliance (Diameter vs. Pressure) | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Balloon Burst | To demonstrate that the<br>balloon is capable of<br>withstanding an injection<br>volume of 2x and 2.5x<br>recommended inflation<br>volume. | N/A | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Introducer Sheath<br>Compatibility<br>(Insertion and<br>Withdrawal) | To demonstrate that<br>the product meets the<br>required insertion and<br>withdrawal force without<br>product damage. | N/A | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Introducer Sheath<br>Compatibility (Re-<br>insertion and Re-<br>withdrawal) | To demonstrate device<br>integrity is maintained post<br>re-insertion and re-<br>withdrawal. | N/A | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Inner Lumen<br>Integrity - Pressure | To demonstrate that the<br>product meets the pressure<br>requirements. | ISO 10555-1:2013 Intravascular catheters<br>- Sterile and single-use catheters - Part 1:<br>General requirements<br>FDA guidance Certain PTCA<br>Catheters:2010; §VIII.B.1 Catheter Body<br>Burst Pressure | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Inner Lumen<br>Integrity -<br>Aspiration | To demonstrate that the<br>product meets the<br>aspiration air leakage<br>requirements and will not<br>collapse under aspiration. | ISO 10555-1:2013 Intravascular catheters<br>- Sterile and single-use catheters - Part 1:<br>General requirements<br>FDA guidance Certain PTCA<br>Catheters:2010; §VIII.B.1 Catheter Body<br>Burst Pressure | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Catheter<br>Deliverability<br>and<br>Withdrawal Force | To demonstrate that device<br>meets the required tracking<br>force specification. | N/A | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Flexibility and<br>Kink Resistance | To demonstrate that<br>the product has<br>acceptable flexibility and<br>kink resistance when<br>wrapped around a series<br>of mandrels. | FDA guidance Certain PTCA<br>Catheters:2010; §VIII.A.9 Flexibility and<br>Kink Test | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Kink to Failure | To determine the bend<br>radius at which catheter<br>kink occurs, as it is bent<br>around mandrels of<br>decreasing radii. | Characterization only<br>FDA guidance Certain PTCA<br>Catheters:2010; §VIII.A.9 Flexibility and<br>Kink Test | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Torque Durability | To demonstrate that<br>the<br>product is capable of<br>360<br>degrees of rotation of the<br>hub while the distal tip is fixed<br>in position. | FDA guidance Certain PTCA<br>Catheters:2010; §VIII.A.10 Torque<br>Strength<br>FDA guidance "Coronary, Peripheral<br>and Neurovascular Guidewires -<br>Performance Tests and Recommended<br>Labeling":2019 | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Torque to failure | The number of rotations of the<br>proximal hub required<br>to<br>initiate device failure, including<br>separation, when the distal end<br>is held stationary. | FDA guidance "Coronary, Peripheral and<br>Neurovascular Guidewires – Performance<br>Tests and Recommended Labeling":2019<br>FDA guidance Certain PTCA<br>Catheters:2010; §VIII.A.10 Torque<br>Strength | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Visual Inspection | To demonstrate the product<br>satisfies the visual surface<br>requirements. | ISO 10555-1:2013 Intravascular Catheters-<br>Sterile and single-use catheters - Part 1:<br>General requirements | Pass<br>All samples met the<br>pre-determined<br>acceptance criteria. |
| Particulates | This study was conducted to<br>determine the quantity and<br>size of particles generated<br>during simulated use. | Characterization only | Pass<br>The particulates from<br>the subject device<br>and the predicate<br>were evaluated and<br>found comparable. |
| Tensile Strength | To demonstrate the product<br>satisfies the tensile strength<br>requirements for bonds and<br>tip pull test. | ISO 10555-1:2013 Intravascular Catheters-<br>Sterile and single-use catheters - Part 1:<br>General requirements.<br>FDA guidance Certain PTCA Catheters:2010;<br>§VIII.A.7 Catheter Bond Strength, §VIII.A.8<br>Tip Pull Test | Pass<br>All samples met the<br>predetermined<br>acceptance criteria. |
| Tip Stiffness | To demonstrate that the<br>stiffness of the distal end of<br>the product is similar to<br>predicate device. | N/A | Pass<br>The tip deflection<br>force of the subject<br>device was<br>evaluated and<br>found comparable<br>to the predicate |

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### Animal Studies:

No animal study was deemed necessary to evaluate the changes to the subject device and demonstrate substantial equivalence to the predicate device.

## Clinical Studies:

No clinical study was deemed necessary to demonstrate substantial equivalence between the subject and predicate device.

## VIII. CONCLUSIONS

The subject device has the same intended use and similar technological characteristics as the predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness. Non-clinical studies conducted demonstrate that the EMBOGUARD™ Balloon Guide Catheter Device is substantially equivalent to the predicate device.