Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a physical medical device (catheter) and its performance characteristics, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
The device is a guide catheter that facilitates the insertion and guidance of an intravascular catheter and provides temporary vascular occlusion, rather than directly treating a disease or condition.

Diagnostic

No

The device is a Balloon Guide Catheter used to facilitate insertion and guidance of an intravascular catheter and provide temporary vascular occlusion. Its function is interventional, not diagnostic.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical catheter with a balloon, lumens, and a hub. It also mentions biocompatibility testing, sterilization, and bench testing, all indicative of a hardware medical device.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes a device used within the body to facilitate the insertion and guidance of catheters and provide temporary vascular occlusion. This is an in vivo application.
Device Description: The description details a physical catheter with a balloon, designed for insertion into blood vessels. This is a medical device used directly on a patient.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) outside the body to provide diagnostic information. IVDs are used to examine specimens in vitro (in glass or in a lab setting).

The device described is a medical device used for interventional procedures within the neurovascular system.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

QJP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

neurovascular system

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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 pre-determined acceptance criteria as specified in the test protocol and in accordance with the requirements of the applicable standards.

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.

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. Bench testing included: Visual Inspection and Dimensional Verification, Visual Surface Inspection, Torque Durability, Torque to Failure (characterization only), Torque Transmission (characterization only), Tensile Strength, Flexibility and Kink Resistance, Kink to Failure (characterization only), Catheter Lubricity and Durability, Coating Length and Location, Particulates (characterization only), Coating Integrity (characterization only), Radiopacity, Simulated Use, Simulated Clot Retrieval Testing, User Evaluation, Catheter Deliverability and Withdrawal Force, Cather Luer Hub Dimensional and Performance Testing, Inner Lumen Integrity - Pressure, Inner Lumen Integrity - Aspiration, Hub Shaft Pressure Integrity, Introducer Sheath Compatibility (Insertion and Withdrawal), Introducer Sheath Compatibility (Re-insertion and Re-withdrawal), Tip Stiffness, Balloon Location, Balloon Inflation / Deflation, Balloon Fatigue, Balloon OD and Compliance, Balloon Concentricity, Balloon Burst, Conditioning, Distribution, and Shelf Life Aging - Device, Conditioning, Distribution, and Shelf Life Aging - Packaging, Visual Inspection Packaging and Labeling, System Visual Inspection, Effective Length Outer Diameter Inner Diameter Taper Diameter, Tensile Strength, Kink Resistance, Dilator Hub Luer Dimensional & Performance Requirements, Luer Dimensional, Fluid Leakage by Pressure Decay, Sub-atmospheric Pressure Air Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Torque Durability, Luer Activated Valve (LAV), Visual Inspection, Leak Test, Activation, LAV Luer Dimensional & Performance Requirements, LAV Male & Female Luer Dimensional, Fluid Leakage by Pressure Decay Sub-atmospheric Pressure Air Leakage, Stress Cracking, Resistance to Separation from Axial Load, Resistance to Separation from Unscrewing, Resistance to Overriding, Rotating Hemostasis Valve (RHV), Visual Inspection, ID (Male Luer), ID (Compression Seal), ID (Side Port), Seal Integrity (Pressure), Seal Integrity (Aspiration), RHV Hub Luer Dimensional & Performance, Gauging, Liquid Leakage, Air Leakage, Separation Force Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking. All samples met the pre-determined acceptance criteria for these tests.

An acute animal study was performed to assess the usability, effectiveness and safety of the EMBOGUARD Balloon Guide Catheter device compared to the predicate device in the swine model. Acute performance evaluated on Day 0 showed that the usability and performance of the EMBOGUARD Balloon Guide Catheter device was equivalent to that of the predicate device tested. Histological evaluation performed on treated vessels after 2-3 days demonstrated that the local and end organ tissue response was comparable between the EMBOGUARD Balloon Guide Catheter and the predicate device tested.

No clinical studies were performed to demonstrate substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K153729

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

0

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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

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: +353-91-394123

E-mail: nfox5@its.jnj.com

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.

4

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

5

6

7

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
Devices - Part 5: Tests for in vitro
cytotoxicity.	Pass
Non-cytotoxic according to the
pre-determined acceptance
criteria.
Sensitization	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
Did not elicit a sensitization
response according to the
pre-determined 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
pre-determined acceptance
criteria.
Systemic Toxicity:
Systemic Injection
Test	Tested in accordance with ISO 10993-11, Biological Evaluation of Medical
Devices – Part 11: Tests for Systemic
Toxicity.	Pass
Test requirements for
systemic toxicity were met,
according to the
pre-determined acceptance
criteria.
Systemic Toxicity:
Material
Mediated
Pyrogenicity	Tested in accordance with ISO 10993-11, Biological Evaluation of Medical
Devices – Part 11: Tests for Systemic
Toxicity, and USP Pyrogen Test.	Pass
Non-pyrogenic, met the
pre-determined acceptance
criteria.

Hemocompatibility:
Hemolysis Study	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
pre-determined acceptance
criteria.
Hemocompatibility:
Complement
Activation Study	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
pre-determined acceptance
criteria.
Hemocompatibility:
Thrombogenicity
Study	Tested in accordance with ISO 10993-
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
pre-determined acceptance
criteria.
Genotoxicity:
Bacterial Reverse
Mutation Study	Tested in accordance with ISO 10993-
3, Biological Evaluation of Medical
Devices - Part 3: Tests for
Genotoxicity, Carcinogenicity and
Reproductive Toxicity, and OECD 471,
Guideline for Testing of Chemicals,
Bacterial Reverse Mutation Test.	Pass
Non-mutagenic according to
the
pre-determined acceptance
criteria.
Genotoxicity:
Mouse Lymphoma
Assay	Tested in accordance with ISO 10993-
3, Biological Evaluation of Medical
Devices - Part 3: Tests for
Genotoxicity, Carcinogenicity and
Reproductive Toxicity, and OECD
Guideline for the Testing of
Chemicals.	Pass
Non-mutagenic according to
the
pre-determined acceptance
criteria.

The biocompatibility evaluation included the following tests:

8

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.

9

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
Inspection
and
Dimensional
Verification	To demonstrate that
the product meets
the visual and
dimensional
specifications.	ISO 10555-1:2013, Intravascular
catheters - Sterile and single-use
catheters - Part 1: General
requirements
ISO 10555-4:2013, Intravascular
catheters - Sterile and single-use
catheters - Part 4: Balloon
dilatation catheters
ISO 11070:2014/AMD 1:2018,
Sterile Single-Use Intravascular
Introducers, Dilators and
Guidewires	Pass
All samples met
the pre-
determined
acceptance
criteria.
Visual Surface
Inspection	To demonstrate the
product satisfies the
visual surface
requirements.	ISO 10555-1:2013
ISO 10555-4:2013
ISO 11070:2014/AMD 1:2018	Pass
All samples met
the pre-
determined
acceptance
criteria.
Torque	To demonstrate		Pass
Torque
Durability	To demonstrate
that the product is
capable of 360
degrees of
rotation of the hub
while the distal tip
is fixed in position.	FDA guidance for Certain
Percutaneous Transluminal
Coronary Angioplasty (PTCA)
Catheters:2010; §VIII.A.10
Torque Strength	All samples met
the pre-
determined
acceptance
criteria.
Torque to
Failure	The number of
rotations of the
proximal hub
required to initiate
device failure,
including
separation, when
the distal end is
held stationary.	Characterization only
FDA guidance Certain PTCA
Catheters:2010 §VIII.A.10
Torque Strength	Pass
The test
samples met
the pre-
determined
acceptance
criteria.
Torque
Transmission	To determine the
torque
transmission ratio.	Characterization only
FDA guidance Certain PTCA
Catheters:2010 §VIII.A.10
Torque Strength	The torque
transmission at
the tip has been
characterized
successfully after
a minimum 720°
hub rotation.
Tensile
Strength	To demonstrate the
product satisfies the
tensile strength
requirements for
bonds
and tip pull test.	ISO 10555-1:2013
ISO 11070:2014/AMD 1:2018
FDA guidance Certain PTCA
Catheters:2010 §VIII.A.7, Catheter
Bond Strength, A.8, Tip Pull Test	Pass
All samples met
the pre-
determined
acceptance
criteria.
Flexibility and
Kink
Resistance	To demonstrate that
the product has
acceptable
flexibility and kink
resistance
when wrapped
around a series of
mandrels	FDA guidance Certain PTCA
Catheters:2010
§VIII.A.9 Flexibility and Kink Test	Pass
All samples met
the pre-
determined
acceptance
criteria.

Kink to Failure	To determine the
bend radius at which
catheter kink occurs,
as it is bent around
mandrels of
decreasing radii.	Characterization only

FDA guidance Certain PTCA
Catheters:2010
§VIII.A.9 Flexibility and Kink Test | The kink to
failure has been
characterized at
different
sections down to
a 2.5mm
mandrel. |
| Catheter
Lubricity and
Durability | To demonstrate that
the product meets
coating lubricity and
durability
specifications. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Coating Length
and Location | To demonstrate that
the product meets
coating length and
location
specifications. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Particulates | This study was
conducted to
determine the
quantity and size of
particles generated
during simulated use. | Characterization only

AAMI TIR42:2010, Evaluation of
Particulates Associated with
Vascular Medical Devices

ASTM F2743-11: 2010, Standard
Guide for Coating Inspection and
Acute Particulate
Characterization of Coated Drug-
Eluting Vascular Stent Systems

USP Particulate Matter in
Injections | Pass
The particulates
from the subject
device and
cleared controls
were evaluated
and found
comparable. |
| Coating
Integrity | To characterize the
coating under
specified
magnification pre-
and post-simulated
use. | Characterization only

FDA guidance Certain PTCA
Catheters:2010
§VIII.A.12 Coating Integrity | Coating has been
characterized
under specified
magnification
pre- and post-
simulated use. |
| Radiopacity | To determine the
radiopaque
characteristics of the
device and dilator. | ASTM F640-20, Standard Test
Methods for Determining
Radiopacity for Medical Use | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| | | | |
| Simulated Use | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | Pass
All samples met the pre-determined acceptance criteria. |
| Simulated
Clot Retrieval
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
All samples met the pre-determined acceptance criteria. |
| User
Evaluation | To evaluate device performance in simulated anatomy in relation to the key steps involved in the clinical procedure. | N/A | Pass
All samples met the pre-determined acceptance criteria. |
| Catheter
Deliverability
and
Withdrawal
Force | To demonstrate that the device meets the required tracking force specification. | N/A | Pass
All samples met the pre-determined acceptance criteria. |
| Cather Luer
Hub
Dimensional
and
Performance
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
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications — Part 20: Common test methods
ISO 594-1:1986, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 1: General requirements
ISO 594-2:1998, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings | Pass
All samples met the pre-determined acceptance criteria. |
| Inner Lumen
Integrity -
Pressure | To demonstrate that
the product meets
the pressure
requirements. | ISO 10555-1:2013

FDA guidance Certain PTCA
Catheters:2010
§VIII.B.1 Catheter Body Burst
Pressure | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Inner Lumen
Integrity -
Aspiration | To demonstrate that
the product meets
the aspiration air
leakage
requirements and
will not collapse
under aspiration. | ISO 10555-1:2013 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Hub Shaft
Pressure
Integrity | To demonstrate that
the device shaft
meets the
minimum inner
diameter
specification up to
1138kPa internal
pressure through
hub's inflation luer. | ISO 10555-1:2013

FDA guidance Certain PTCA
Catheters:2010
§VIII.B.1 Catheter Body Burst
Pressure | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Introducer
Sheath
Compatibility
(Insertion
and
Withdrawal) | To demonstrate that
the product meets
the required
insertion and
withdrawal force
without product
damage. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Introducer
Sheath
Compatibility
(Re-insertion
and Re-
withdrawal) | To demonstrate
device integrity is
maintained post re-
insertion and re-
withdrawal. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Tip Stiffness | To demonstrate that
the stiffness of the
distal end of the | N/A | Pass
All samples met
the pre- |
| | product is similar to
predicate device. | | determined
acceptance
criteria. |
| Balloon
Location | To demonstrate
balloon meets the
balloon location
specification. | ISO 10555-4:2013 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Balloon
Inflation /
Deflation | To demonstrate
balloon meets the
inflation and
deflation time
specifications. | ISO 10555-4:2013
FDA guidance Certain PTCA
Catheters:2010
§VIII.A.6 Balloon Inflation
and Deflation Time | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Balloon
Fatigue | To demonstrate that
there is no
degradation of the
balloon after 20
inflation cycles. | ISO 10555-4:2013
FDA guidance Certain
PTCA Catheters:2010
§VIII.A.4 Balloon Fatigue | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Balloon
OD and
Compliance | To demonstrate that
the product meets
the maximum
recommended
inflation volume vs
balloon diameter
specifications. | ISO 10555-4:2013
FDA guidance Certain PTCA
Catheters:2010
§VIII.A.5 Balloon Compliance | Pass
All samples met the
pre- determined
acceptance criteria. |
| Balloon
Concentricity | To demonstrate that
the product meets
the balloon diameter
specifications on
each side at the
recommended
inflation volume
when rotated 360°. | ISO 10555-4:2013 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Balloon Burst | To demonstrate that
the balloon is
capable of
withstanding an
injection volume of
2x and 2.5x
recommended
inflation volume. | ISO 10555-4:2013 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Conditioning,
Distribution,
and Shelf Life
Aging

Device | To demonstrate the
device met all
specifications at both
baseline and
following accelerated
aging to a 1-year
shelf life equivalent. | Evaluation of device
following accelerated
aging to a 1-year shelf life
equivalent | Pass
All samples met the
pre- determined
acceptance criteria. |
| Conditioning,
Distribution,
and Shelf Life
Aging

Packaging | Evaluation of
packaging strength
and integrity at both
baseline and
following accelerated
aging to a 1-year
shelf life equivalent. | ASTM D4169-16, Standard
Practice for Performance
Testing of Shipping
Containers and Systems
ASTM F88/F88M-15,
Standard Test Method for
Seal Strength of Flexible
Barrier Materials
ASTM F1929-15, Standard
Test Method for Detecting
Seal Leaks in Porous Medical
Packaging by Dye
Penetration | Pass
All samples met the
pre- determined
acceptance criteria. |
| Visual
Inspection
Packaging and
Labeling | To demonstrate that
the product meets
the packaging and
labeling visual and
adherence
Requirements. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| System Visual
Inspection | To demonstrate that
the product meets
the visual and
dimensional.
specifications. | Dilator
ISO 10555-1
ISO 10555-4 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| | | | |
| Effective
Length
Outer Diameter
Inner Diameter
Taper Diameter | To demonstrate that
the product meets
the visual and
dimensional
specifications. | ISO 11070 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Tensile
Strength | To demonstrate that
the dilator
withstands peak
tensile strength. | ISO 10555-1
ISO 11070
FDA guidance Certain PTCA
Catheters:2010 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Kink Resistance | To demonstrate that
there are no kinks,
defects or damage. | FDA guidance Certain PTCA
Catheters:2010 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Dilator Hub Luer Dimensional & Performance Requirements | | | |
| Luer
Dimensional | To demonstrate that
the product meets
the
dimensional
specifications. | ISO 80369-7 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Fluid Leakage
by Pressure
Decay | To demonstrate that
the luer lock
connector does not
leak while subjected
to applied pressure. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Sub-
atmospheric
Pressure Air
Leakage | | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Stress Cracking | To demonstrate that
the luer lock
connector does not
crack when subjected
to axial force and
torque. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Resistance to
Separation
from Axial Load | To demonstrate that
the luer lock connector
does not separate from
the reference
connector while
subjected to a
disconnection applied
axial force | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| | To demonstrate that | | Pass |
| Resistance to
Separation
from
Unscrewing | the luer lock
connector does not
override the threads
of a reference
connector while
subjected to
unscrewing torque. | ISO 80369-20 | All samples met
the pre-
determined
acceptance
criteria. |
| Resistance to
Overriding | To demonstrate that
the luer lock
connector does not
override the threads
of a reference
connector while
subjected to applied
torque. | ISO 80369-20 | All samples met
the pre-
determined
acceptance
criteria. |
| Torque
Durability | To demonstrate that
there is no
separation of the
dilator hub from the
shaft or embolization
after one complete
rotation of the hub. | FDA guidance Certain PTCA
Catheters:2010
Coronary, Peripheral, and
Neurovascular Guidewires –
Performance Tests and
Recommended Labeling | All samples met
the pre-
determined
acceptance
criteria. |
| Luer Activated Valve (LAV) | | | |
| Visual
Inspection | To demonstrate that
the LAV meets
the visual
specifications. | ISO 10555-1
ISO 10555-4
ISO 11070 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Leak Test | To demonstrate that
the LAV does not
leak when used to
inflate/deflate the
balloon. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Activation | To demonstrate that
that the LAV allows
flow and does not
leak when activated.
To demonstrate that
the LAV prevents
flow and maintains
balloon inflation
when the syringe is
removed. | N/A | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| LAV Luer Dimensional & Performance Requirements | | | |
| LAV Male & Female Luer | | | |
| Dimensional | To demonstrate that
the LAV meets
the
dimensional
specifications. | ISO 80369-7 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Fluid Leakage
by Pressure
Decay
Sub-
atmospheric
Pressure Air
Leakage | To demonstrate that
the LAV connector
does not leak under
applied pressure. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Stress Cracking | To demonstrate the
LAV connector does
not crack under
specified axial force
and torque. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Resistance to
Separation
from Axial Load | To demonstrate the
LAV connector does
not separate from
the reference
connector while
subjected to a
disconnection
applied axial force. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Resistance to
Separation
from
Unscrewing | To demonstrate the
LAV connector does
not separate from
the reference
connector while
subjected to
specified unscrewing
torque. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Resistance to
Overriding | To demonstrate that
the luer lock
connector does not
override the threads
of a reference
connector while
subjected to an
applied torque. | ISO 80369-20 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Rotating Hemostasis Valve (RHV) | | | |
| Visual | To demonstrate that | | Pass |
| Inspection | | | |
| Inspection | the RHV meets
the visual
specifications. | ISO 10555-1
ISO 10555-4
ISO 11070 | All samples met
the pre-
determined
acceptance
criteria. |
| ID (Male Luer) | To demonstrate the
RHV meets the ID
specification of the
rigid male luer. | ISO 10555-1
ISO 10555-4
ISO 11070 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| ID (Compression
Seal) | To demonstrate the
RHV meets the ID
specification of the
compression seal. | ISO 10555-1
ISO 10555-4
ISO 11070 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| ID (Side Port) | To demonstrate the
RHV meets the ID
specification of the
side port. | ISO 10555-1
ISO 10555-4
ISO 11070 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Seal Integrity
(Pressure) | To demonstrate the
RHV does not leak or
collapse under
pressure. | ISO 10555-1 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Seal Integrity
(Aspiration) | To demonstrate the
RHV does not leak or
collapse under
aspiration. | ISO 10555-1 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| RHV Hub Luer Dimensional & Performance | | | |
| Gauging | To demonstrate that
RHV product meets
the conical part of
the lock fitting. | ISO 594-1 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Liquid Leakage | To demonstrate that
there is no leakage
sufficient to form a
falling drop | | |
| Air Leakage | To demonstrate that
there is no sign of
continued formation
of air bubbles. | ISO 594-2 | Pass
All samples met
the pre-
determined
acceptance
criteria. |
| Separation
Force
Unscrewing
Torque | To demonstrate that
the product fitting
remains attached to
the reference fitting. | | |
| Ease of
Assembly | To demonstrate that
the RHV meets the
requirements for
small bore
connectors. | | |
| Resistance to
Overriding | To demonstrate the
RHV fitting does not
override the threads
or lugs of the fitting. | | |
| Stress Cracking | To demonstrate that
the RHV withstands
stress cracking of the
fitting. | ISO 594-2 | Pass
All samples met
the pre-
determined
acceptance
criteria. |

Specifically, the following bench tests were performed on the subject device:

10

11

12

13

14

15

16

17

18

19

20

Animal Studies:

Acute animal study has been performed to assess the usability, effectiveness and safety of the EMBOGUARD Balloon Guide Catheter device compared to the predicate device in the swine model. Acute performance evaluated on Day 0 showed that the usability and performance of the EMBOGUARD Balloon Guide Catheter device was equivalent to that of the predicate device tested. Histological evaluation performed on treated vessels after 2-3 days demonstrated that the local and end organ tissue response was comparable between the EMBOGUARD Balloon Guide Catheter and the predicate device tested.

Clinical Studies:

No clinical studies were performed to demonstrate substantial equivalence.

CONCLUSIONS

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