(127 days)
Not Found
No
The summary describes a physical medical device (catheter) and its performance characteristics. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on material properties, mechanical function, and biocompatibility.
No
The device is a guide catheter used to facilitate the insertion and guidance of other catheters and retrieval devices, and to provide temporary vascular occlusion. It does not directly treat a disease or condition.
No
The device is a guide catheter used to facilitate the insertion and guidance of other intravascular catheters and to provide temporary vascular occlusion. It is a tool for interventional procedures, not for diagnosing conditions.
No
The device description clearly outlines a physical catheter with a balloon, lumens, and other hardware components. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used in vivo (within the body) to facilitate the insertion and guidance of catheters and provide temporary vascular occlusion during angiographic procedures in the neurovascular system. This is a therapeutic and interventional use, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a physical catheter with a balloon, lumens, and a hub, designed for insertion into blood vessels. This aligns with an in vivo medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the EMBOGUARD Balloon Guide Catheter is an invasive medical device used for interventional procedures, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
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
Biocompatibility Testing: The biocompatibility evaluation for the EMBOGUARD Balloon Guide Catheter device was conducted in accordance with ISO 10993-1 and FDA biocompatibility guidance. The device is categorized as an external communicating device with limited exposure with circulating blood (
§ 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).
0
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).
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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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3
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: +353-91-394123
E-mail: nfox5@its.jnj.com
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.
4
| Characteristics | Predicate Device:
EMBOGUARD™ Balloon Guide
Catheter | Subject Device:
EMBOGUARD™ Balloon Guide
Catheter |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212340 | K233924 |
| Classification | Class II, 21 CFR 870.1250 | Same as Predicate Device |
| Device
Classification
Name | Catheter, Percutaneous,
Neurovasculature | Same as Predicate Device |
| Classification
Product Code | QJP | Same as Predicate Device |
| 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. | Same as Predicate Device |
| Materials | Commonly used medical grade
plastics (nylon, PTFE,
polycarbonate, polyurethane,
polyolefin, polyblend) and stainless
steel | Same as Predicate Device |
| Shaft Outer Jacket
Distal Segment (1)
Pebax 35D Jacket
0.004" W/T | Pebax 3533 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Pebax 3533 SA01 MED
Pebax 5533 SA01 MED
(colorant carrier)
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7
Irganox 1010
Tinuvin 622 |
| Shaft Outer Jacket
Distal Segment (2)
Pebax 35D Jacket
0.005" W/T | Pebax 3533 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Pebax 3533 SA01 MED
Pebax 5533 SA01 MED
(colorant carrier)
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7
Irganox 1010
Tinuvin 622 |
| Shaft Outer Jacket
Distal Segment (3)
Pebax 35/40D
Jacket | Pebax 4033 SA01 MED
Pebax 3533 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Pebax 5533 SA01 MED
Pebax 3533 SA01 MED
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7 |
| Characteristics | Predicate Device:
EMBOGUARD™ Balloon Guide
Catheter | Subject Device:
EMBOGUARD™ Balloon Guide
Catheter |
| Shaft Outer Jacket
Distal Segment (4)
Pebax 40D Jacket | Pebax 4033 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Irganox 1010
Tinuvin 622
Pebax 5533 SA01 MED
Pebax 3533 SA01 MED
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7
Irganox 1010
Tinuvin 622 |
| Shaft Outer Jacket
Distal Segment (5)
Pebax 55D Jacket | Pebax 5533 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Pebax 5533 SA01 MED
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7
Irganox 1010
Tinuvin 622 |
| Shaft Outer Jacket
Distal Segment (6)
Pebax 72D Jacket | Pebax 7233 SA01 MED
Techmer Blue/Black (PM50167E1)
Irganox 1010
Tinuvin 622 | Pebax 7233 SA01 MED
Pebax 5533 SA01 MED
(colorant carrier)
CSRM016 Pigment Blue 36
CSRM037 Pigment Violet 23
CSRM035 Pigment Green 7
Irganox 1010
Tinuvin 622 |
| Inner Lumen Liner | RAM extruded forming process;
method by which the liner is formed
into its tubular shape | Film cast forming process; method by
which the liner is formed into its
tubular shape |
| Reinforced
Catheter Shaft | Stainless steel braid | Same as Predicate Device |
| Radiopaque
Marker Band | Distal tip Pt-Ir marker band | Same as Predicate Device |
| Radiopaque
Marker Location
from Distal Tip | 1.3 mm | Same as Predicate Device |
| Radiopaque
Marker Length | 0.031 | |
| Characteristics | Predicate Device:
EMBOGUARD™ Balloon Guide
Catheter | Subject Device:
EMBOGUARD™ Balloon Guide
Catheter |
| Balloon Inflation
Lumen | Non-coaxial | Same as Predicate Device |
| Accessory Devices
Provided | Dilator (1)
Rotating Hemostasis Valve (1)
Peel Away Sheath (1)
Luer-Activated Valve (1) | Same as Predicate Device |
| How Supplied | Sterile, Single Use | Same as Predicate Device |
| Sterilization
Method | EtO | Same as Predicate Device |
| Sterility Assurance
Level | $10^{-6}$ | Same as Predicate Device |
| Shelf Life | 1 year | 1 year |
5
6
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 |
| Non-cytotoxic according to the pre-determined acceptance criteria. | ||
| Sensitization | ||
| 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, |
| 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. | ||
| Acute Systemic | ||
| Toxicity | Tested in accordance with ISO 10993-11, | |
| Biological Evaluation of Medical Devices - | ||
| Part 11: Tests for Systemic Toxicity. | Pass | |
| Test requirements for systemic | ||
| toxicity were met according to | ||
| the pre-determined acceptance | ||
| criteria. | ||
| Pyrogenicity - | ||
| Material-Mediated | ||
| Rabbit Pyrogen | 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. | ||
| Hemolysis Study | Tested in accordance 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. | ||
| SC5b-9 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. | ||
| ASTM Partial | ||
| Thromboplastin Time | ||
| (PTT) | 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 | ||
| characteristic as the control | ||
| device, met the pre- | ||
| determined acceptance | ||
| criteria. | ||
| Platelet and | ||
| Leukocyte Count | 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
characteristic as the control
device, met the pre-
determined acceptance
criteria. |
7
8
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 | |||
| Concentricity | To demonstrate that the | ||
| product meets the balloon | |||
| diameter specification on | |||
| each side at the | |||
| recommended inflation | |||
| volume when rotated 360°. | FDA guidance Certain PTCA | ||
| Catheters:2010; §VIII.A5 Balloon | |||
| Compliance (Diameter vs. Pressure) | 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. | N/A | 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. | |||
| Inner Lumen | |||
| Integrity - Pressure | To demonstrate that the | ||
| product meets the pressure | |||
| requirements. | ISO 10555-1:2013 Intravascular catheters |
- Sterile and single-use catheters - Part 1:
General requirements
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 Intravascular catheters - Sterile and single-use catheters - Part 1:
General requirements
FDA guidance Certain PTCA
Catheters:2010; §VIII.B.1 Catheter Body
Burst Pressure | Pass
All samples met the
pre-determined
acceptance criteria. |
| Catheter
Deliverability
and
Withdrawal Force | To demonstrate that device
meets the required tracking
force specification. | N/A | 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 | Pass
All samples met the
pre-determined
acceptance criteria. |
| 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 Certain PTCA
Catheters:2010; §VIII.A.10 Torque
Strength
FDA guidance "Coronary, Peripheral
and Neurovascular Guidewires -
Performance Tests and Recommended
Labeling":2019 | Pass
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. | FDA guidance "Coronary, Peripheral and
Neurovascular Guidewires – Performance
Tests and Recommended Labeling":2019
FDA guidance Certain PTCA
Catheters:2010; §VIII.A.10 Torque
Strength | Pass
All samples met the
pre-determined
acceptance criteria. |
| Visual Inspection | To demonstrate the product
satisfies the visual surface
requirements. | ISO 10555-1:2013 Intravascular Catheters-
Sterile and single-use catheters - Part 1:
General requirements | Pass
All samples met the
pre-determined
acceptance criteria. |
| Particulates | This study was conducted to
determine the quantity and
size of particles generated
during simulated use. | Characterization only | Pass
The particulates from
the subject device
and the predicate
were evaluated and
found comparable. |
| Tensile Strength | To demonstrate the product
satisfies the tensile strength
requirements for bonds and
tip pull test. | ISO 10555-1:2013 Intravascular Catheters-
Sterile and single-use catheters - Part 1:
General requirements.
FDA guidance Certain PTCA Catheters:2010;
§VIII.A.7 Catheter Bond Strength, §VIII.A.8
Tip Pull Test | Pass
All samples met the
predetermined
acceptance criteria. |
| Tip Stiffness | To demonstrate that the
stiffness of the distal end of
the product is similar to
predicate device. | N/A | Pass
The tip deflection
force of the subject
device was
evaluated and
found comparable
to the predicate |
9
10
11
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.