Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical characteristics and mechanical performance of a catheter, with no mention of AI or ML capabilities.

Therapeutic

No
This device is a support catheter used to introduce other interventional devices; it does not directly treat a medical condition.

Diagnostic

No

The device description and intended use indicate that the Navien™ Intracranial Support Catheter is used for introducing other interventional devices into the vasculature, not for diagnosing conditions. It is a tool for accessing anatomical sites, not for providing diagnostic information.

SaMD (Software as a Medical Device)

No

The device description clearly details a physical catheter with a luer hub, shaft, hydrophilic coating, and marker, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is "for the introduction of interventional devices into the peripheral and neurovasculature." This describes a device used within the body for a procedural purpose, not a device used to examine specimens outside the body to provide diagnostic information.
Device Description: The description details a catheter designed for insertion into blood vessels to facilitate other procedures. It doesn't mention any components or functions related to analyzing biological samples.
Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Reagents, calibrators, or controls
- Measurement of analytes

The Navien™ Intracranial Support Catheter is a medical device used in interventional procedures, specifically for accessing and navigating within blood vessels. It is not designed to perform diagnostic tests on samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Product codes

DQY

Device Description

The Navien™ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien™ Intracranial Support Catheter has a marker on the distal tip that is visible under fluoroscopy. The dimensions are included in the Navien™ Intracranial Support Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has both straight and pre-shaped tips.

The proximal end of the Navier™ Intracranial Support Catheter has a Luer fitting to allow attachment of accessories and infusion of liquids through the system. The Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neurovasculature

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The following testing was performed to support the coating change to the Navien™ Intracranial Support Catheter with new coating to establish substantial equivalence to the Navien™ Intracranial Support Catheter with old coating:
Visual/Dimensional Inspection Torque Strength Coating Lubricity Catheter Leakage Test (Liquid) Dynamic Pressure Test Distal Tip Buckling Particulate Testing Physician Usability Testing

The following testing was leveraged from the predicate device due to sufficiency of the existing testing record and justification for adoption:
System Dimensional- Length Kink Resistance Flow Rate During Continuous Flush (for information only) Leakage (Static Burst Test)
Aspiration
Labeling
Catheter Hub (ISO 594-1)
Tensile Srength
Corrosion Resistance
Tip Configuration
Radiopacity

A Design Validation study was performed on a bench model to assess the substantial equivalence and usability of Navien™ Intracranial Support Catheter with new coating compared to the previously cleared Navien™ Intracranial Support Catheter with old coating. Biocompatibility testing, sterilization, and a 2-year accelerated aging study were also performed. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

Conclusion: The Navien™ Intracranial Support Catheter with new coating is substantially equivalent to the currently cleared Navien™ Intracranial Support Catheter with old coating based on the successful completion of non-clinical bench and design validation testing as well as identical principles of design, operation and indications for use.

Biocompatibility testing:
Plastics (USP) - Passes physical chemical characteristics.
L929 MEM Elution Test - ISO - Non-cytotoxic
Klingman Maximization Test – ISO (Guinea Pig Sensitization) - Non-sensitizer
Intracutaneous Injection Test - ISO - Non-irritant
Acute Systemic Injection Test – ISO - Non-cytotoxic
Materials Mediated Rabbit Pyrogen - ISO - Non-pyrogenic
Hemolysis: Direct Contact / Indirect Extract - Non-hemolytic
Complement activation C3a and SC5b-9 - Levels of the compliments C3a and SC5b complements were similar for Navien and control device
Thrombosis (in vivo) – Canine (Navien) - Acceptable, expected to be equivalent to Navien in clinical use
in vitro Hemocompatibility Assay - No adverse effect on platelet and leukocyte counts
Partial Thromboplastin Time - No adverse effect on prothrombin coagulation time of human plasma.
Ames bacterial Mutagenicity 4 salmonella+1e. coli - Non-mutagenic
in vitro Mouse Lymphoma Assay with Extended Treatment - Non-mutagenic (non-genotoxic and non-clastogenic) in this test system.
in vivo Mouse Micronucleus Assay - Non-mutagenic in this test system.

Performance Testing – Bench:
Dimensional Inspection - All device met acceptance criteria.
Torque to Failure - Torque to failure testing met acceptance criteria.
Coating Lubricity/Durability - Coating lubricity and durability testing met acceptance criteria.
Liquid Leakage - Liquid leakage met acceptance criteria.
Dynamic Burst - Dynamic burst testing met acceptance criteria.
Tip Buckling - Tip buckling force met acceptance criteria.
Particulate Testing - Number of particulates generated met acceptance criteria.
Physician Usability Testing - All test results met the acceptance criteria.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

Navien™ Intracranial Support Catheter, 510(k)#: K110055

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

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three figures in profile, representing the department's focus on people and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 12, 2016

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Jennifer Correa Sr. Product Specialist/Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K161152

Trade/Device Name: Navien Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: September 6, 2016 Received: September 8, 2016

Dear Ms. Correa:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -SA

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161152

Device Name

Navien™ Intracranial Support Catheter

Indications for Use (Describe)

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration No. 2029214 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Correa
Senior Regulatory Affairs Specialist
Telephone: (949) 297-9563
E-mail: jennifer.l.correa@medtronic.com |
| Date Summary Prepared: | September 6, 2016 |
| Trade Name of Device: | Navien™ Intracranial Support Catheter |
| Common Name of Device: | Catheter, Percutaneous |
| Classification of Device: | 21 CFR 870.1250 – Class II |
| Product Code: | DQY |
| Predicate Device: | Navien™ Intracranial Support Catheter, 510(k)#: K110055
Originally cleared under trade name: ReFlex™ Guide Catheter |
| Performance Data: | The following testing was performed to support the coating change to the Navien™ Intracranial Support Catheter with new coating to establish substantial equivalence to the Navien™ Intracranial Support Catheter with old coating:
Visual/Dimensional Inspection Torque Strength Coating Lubricity Catheter Leakage Test (Liquid) Dynamic Pressure Test Distal Tip Buckling Particulate Testing Physician Usability Testing The following testing was leveraged from the predicate device due to sufficiency of the existing testing record and justification for adoption: System Dimensional- Length Kink Resistance Flow Rate During Continuous Flush (for information only) Leakage (Static Burst Test) |

4

Aspiration ●
Labeling ●
Catheter Hub (ISO 594-1) ●
Tensile Srength
Corrosion Resistance ●
Tip Configuration ●
Radiopacity ●

A Design Validation study was performed on a bench model to assess the substantial equivalence and usability of Navien™ Intracranial Support Catheter with new coating compared to the previously cleared Navien™ Intracranial Support Catheter with old coating. Biocompatibility testing, sterilization, and a 2-year accelerated aging study were also performed. No clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology of the device.

The Navien™ Intracranial Support Catheter with new coating is Conclusion: substantially equivalent to the currently cleared Navien™ Intracranial Support Catheter with old coating based on the successful completion of non-clinical bench and design validation testing as well as identical principles of design, operation and indications for use.

Device Description:

The Navien™ Intracranial Support Catheter is a single lumen, flexible, variable stiffness composite catheter which has a luer hub on the proximal end. The catheter shaft has a hydrophilic coating to reduce friction during use. The Navien™ Intracranial Support Catheter has a marker on the distal tip that is visible under fluoroscopy. The dimensions are included in the Navien™ Intracranial Support Catheter inner lumen can accommodate guidewires up to 0.038 inches in diameter to aid in placement of the catheter system. The catheter has both straight and pre-shaped tips.

The proximal end of the Navier™ Intracranial Support Catheter has a Luer fitting to allow attachment of accessories and infusion of liquids through the system. The Catheter is offered in various sizes to accommodate physician preferences and anatomical variations. The catheter is provided sterile, nonpyrogenic, and is intended for single use only.

Indications for Use:

The Navien™ Intracranial Support Catheter is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Comparison

The table below provides a comparison of the technological characteristics of the Navien™ Intracranial Support Catheter with old coating and the currently cleared Navien™ Intracranial Support Catheter.

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| | Navien™ Intracranial Support
Catheter with old coating
(K110055) | Navien™ Intracranial Support
Catheter with new coating |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indication for
Use | The Navien™ Intracranial Support
Catheter is indicated for the
introduction of interventional devices
into the peripheral and
neurovasculature. | Same |
| Catheter Shaft
Materials | PTFE lined polymeric catheter, with
hydrophilic coating | Same |
| Catheter Shaft
Support | Nitinol | Same |
| Marker band | Platinum | Same |
| Usable Length | 90 - 130 cm | Same |
| Distal ID | 0.046" – 0.072" | Same |
| Distal OD | 0.058"–0.084" max | Same |
| Proximal ID | 0.046" – 0.072" | Same |
| Proximal OD | 0.058"–0.084" max | Same |
| Tip
Configuration | Single, straight flexible tip | Same |
| Sterilization
Method | Ethylene Oxide | Same |
| Packaging | Catheter in polyethylene hoop
attached to packaging card inside
PET/PE/Tyvek pouch inside SBS
carton | Same |

Sterilization and Shelf Life

The packaged Navien™ Intracranial Support Catheter with new coating is sterilized using a validated ethylene oxide (EO) sterilization cycle at the Sterigenics US; LLC facility located at 4900 Gifford Avenue, Los Angeles, CA. The sterilization cycle has been validated to ensure a sterility assurance level (SAL) of 10° in accordance with ISO 11135-1:2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Aging studies for the Navien™ Intracranial Support Catheter with new coating device has established the product and packaging remain functional and maintain sterility for up to 24 months. Aging studies for packaging integrity, seal strength, and device functionality were performed and met all acceptance criteria.

Biocompatibility

Biocompatibility testing was performed in compliance with the FDA consensus standard, recognition number 2-156, AAMI/ANSI/ISO 10993-1: 2009, Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process and U.S. Food and Drug Administration (FDA)

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Blue Book Memorandum G95-1 (1995) guidelines. All studies were conducted in compliance with U.S. Food and Drug Administration Good Laboratory Practice (GLP) regulations set forth in 21 CFR Part 58.

Test	Result	Conclusion
Plastics (USP)	Meets USP Physicochemical
extraction parameters.	Passes physical chemical
characteristics.
L929 MEM Elution Test - ISO	The test article scored "0" at 24, 48
and 72 ± 4 hours and is considered
non-cytotoxic under the conditions
of this test.	Non-cytotoxic
Klingman Maximization Test –
ISO (Guinea Pig Sensitization)	Under the conditions of this
protocol, the test article did not
elicit a sensitization response.	Non-sensitizer
Intracutaneous Injection Test -
ISO	The differences in the mean test
and control scores of the extract
dermal observations were less than
1.0, indicating that the requirements
of the ISO Intracutaneous
Reactivity Test have been met by
the test article.	Non-irritant
Acute Systemic Injection Test –
ISO	None of the test article extract
treated animals were observed with
clinical signs consistent with
toxicity at any of the observation
periods.	Non-cytotoxic
Materials Mediated Rabbit
Pyrogen - ISO	This response did not exceed the
USP limit and meets the
requirements for this test. Therefore
these results indicate that the test
article was determined to be non-
pyrogenic.	Non-pyrogenic
Hemolysis: Direct Contact /
Indirect Extract	There were no significant
differences between the test article
extract and negative control article
results. The test article is
considered non-hemolytic	Non-hemolytic
Complement activation C3a and
SC5b-9	The levels of C3a and SC5b-9 of
the NavienTM catheter with new
coating are comparable to the
NavienTM with old coating and less
than that of the positive control.	Levels of the compliments C3a
and SC5b complements were
similar for Navien and control
device
Thrombosis ( in vivo ) – Canine
(Navien)	The thromboresistance properties
of the NavienTM Intracranial
Support Catheters are acceptable in
clinical use.	Acceptable, expected to be
equivalent to Navien in clinical
use
Test	Result	Conclusion
in vitro Hemocompatibility
Assay	The Navien Guide Catheter did not
result in a decrease in any blood
component as compared to the
reference material. These results
indicate that the cause of thrombi is
not related to the materials exposed
to human blood during use.	No adverse effect on platelet
and leukocyte counts
Partial Thromboplastin Time	Clotting times for the Navien
(predicate device) test arms were
similar to the negative control and
the reference material (HDPE),
indicating that the device materials
are not an activator of the intrinsic
coagulation pathway.	No adverse effect on
prothrombin coagulation time
of human plasma.
Ames bacterial Mutagenicity 4
salmonella+1e. coli	Based on the criteria and conditions
of the study protocol, the test article
is considered non-mutagenic.	Non-mutagenic
in vitro Mouse Lymphoma Assay
with Extended Treatment	The test article is considered to be
non-mutagenic (non-genotoxic and
non-clastogenic) in this test system.	Non-mutagenic
in vivo Mouse Micronucleus
Assay	Based on the criteria of the assay,
the test article is considered non-
mutagenic in this test system.	Non-mutagenic

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Performance Testing – Bench

A summary of the pre-clinical bench testing performed for the Navien™ Intracranial Support Catheter is presented in the table below.

8

Test	Method	Acceptance Criteria	Conclusions
Dimensional Inspection	The usable length,
proximal and distal inner
and outer diameters were
measured and recorded.	Usable length, proximal
and distal inner and outer
diameters must meet all
inspection criteria	All device met
acceptance criteria.
Torque to Failure	Device was tested for full-
length torque strength to
determine number of
rotations to failure.	The catheter must
withstand multiple
revolutions without failure	Torque to failure testing
met acceptance criteria.
Coating
Lubricity/Durability	Device coating was
evaluated for average
frictional force and
durability.	Average Friction Force
must be comparable to the
predicate device	Coating lubricity and
durability testing met
acceptance criteria.
Liquid Leakage	Device was tested for ISO
10555-1, Annex C liquid
leakage testing.	Catheter shall not leak per
ISO 10555-1	Liquid leakage met
acceptance criteria.
Dynamic Burst	Device was tested under
full-length static
conditions to burst and at
pressures experienced
during worst-case dynamic
injections.	Catheter shall not burst or
leak during a dynamic
pressure test	Dynamic burst testing
met acceptance criteria.
Tip Buckling	Repeated distal tip
buckling force under
compressive load was
evaluated for stiffness.	Compressive load shall not
be statistically
significantly different to
comparable and/or the
predicate device	Tip buckling force met
acceptance criteria.
Particulate Testing	Device was evaluated for
particulate generation
under simulated use in a
representative tortuous
anatomical model per
USP	Particulate must be within
limits per USP	Number of particulates
generated met
acceptance criteria.
Physician Usability
Testing	The device was navigated
through a tortuous
benchtop model to assess
accessibility and the tip
atraumatic profile.	Assess navigation of
Navien™ with new
coating to the ICA and
comparing Navien™ with
new to Navien™ with old
coating with regards to tip
atraumaticity.	All test results met the
acceptance criteria.

Performance Testing - Animal

No animal study was performed as there is no change to the indications for use or the fundamental scientific technology for the new device. Substantial equivalence of the Navien™ Intracranial Support Catheter with new coating has been established to the predicate device through the results of bench testing.

Performance Testing – Clinical

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No clinical study was performed as there is no change to the indications for use or the fundamental scientific technology for the new devices. Substantial equivalence of the Navien™ Intracranial Support Catheter with new coating has been established to the predicate device through the results of bench and design validation testing.