Navien Intracranial Support Catheter

K161152 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQY · Oct 12, 2016 · Cardiovascular

Device Facts

• Record ID: K161152
• Device Name: Navien Intracranial Support Catheter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Oct 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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

Device Story

Navien Intracranial Support Catheter is a single-lumen, flexible, variable-stiffness composite catheter; features luer hub for accessory attachment and liquid infusion; includes hydrophilic coating to reduce friction; distal tip marker visible under fluoroscopy. Used in neurovascular and peripheral procedures to facilitate placement of interventional devices (e.g., guidewires up to 0.038 inches). Operated by physicians in clinical settings. Device provides a pathway for interventional tools; aids in navigating tortuous anatomy. Benefits include atraumatic access to target vasculature.

Clinical Evidence

No clinical data. Substantial equivalence established via non-clinical bench testing and design validation comparing the new coating to the predicate device. Bench testing included dimensional inspection, torque strength, coating lubricity/durability, leakage, dynamic burst, tip buckling, and particulate testing per USP <788>.

Technological Characteristics

Single-lumen, variable-stiffness composite catheter; PTFE-lined polymer shaft; Nitinol support; platinum marker band; hydrophilic coating. Dimensions: 90-130 cm length; 0.046"-0.072" ID; 0.058"-0.084" OD. Sterilized via Ethylene Oxide per ISO 11135-1:2007. Biocompatibility per ISO 10993-1. Luer hub per ISO 594-1.

Indications for Use

Indicated for introduction of interventional devices into peripheral and neurovasculature. No specific patient population, age, or gender restrictions provided.

Regulatory Classification

Identification

A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.

Predicate Devices

• Navien™ Intracranial Support Catheter (K110055)

Submission Summary (Full Text)

{0}------------------------------------------------

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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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.

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 [e-mail]

"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

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration No. 2029214 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer Correa<br>Senior Regulatory Affairs Specialist<br>Telephone: [phone]<br>E-mail: [e-mail] |
| 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<br>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:<br>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.

{5}------------------------------------------------

| | Navien™ Intracranial Support<br>Catheter with old coating<br>(K110055) | Navien™ Intracranial Support<br>Catheter with new coating |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|
| Indication for<br>Use | The Navien™ Intracranial Support<br>Catheter is indicated for the<br>introduction of interventional devices<br>into the peripheral and<br>neurovasculature. | Same |
| Catheter Shaft<br>Materials | PTFE lined polymeric catheter, with<br>hydrophilic coating | Same |
| Catheter Shaft<br>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<br>Configuration | Single, straight flexible tip | Same |
| Sterilization<br>Method | Ethylene Oxide | Same |
| Packaging | Catheter in polyethylene hoop<br>attached to packaging card inside<br>PET/PE/Tyvek pouch inside SBS<br>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)

{6}------------------------------------------------

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

{7}------------------------------------------------

### 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,<br>proximal and distal inner<br>and outer diameters were<br>measured and recorded. | Usable length, proximal<br>and distal inner and outer<br>diameters must meet all<br>inspection criteria | All device met<br>acceptance criteria. |
| Torque to Failure | Device was tested for full-<br>length torque strength to<br>determine number of<br>rotations to failure. | The catheter must<br>withstand multiple<br>revolutions without failure | Torque to failure testing<br>met acceptance criteria. |
| Coating<br>Lubricity/Durability | Device coating was<br>evaluated for average<br>frictional force and<br>durability. | Average Friction Force<br>must be comparable to the<br>predicate device | Coating lubricity and<br>durability testing met<br>acceptance criteria. |
| Liquid Leakage | Device was tested for ISO<br>10555-1, Annex C liquid<br>leakage testing. | Catheter shall not leak per<br>ISO 10555-1 | Liquid leakage met<br>acceptance criteria. |
| Dynamic Burst | Device was tested under<br>full-length static<br>conditions to burst and at<br>pressures experienced<br>during worst-case dynamic<br>injections. | Catheter shall not burst or<br>leak during a dynamic<br>pressure test | Dynamic burst testing<br>met acceptance criteria. |
| Tip Buckling | Repeated distal tip<br>buckling force under<br>compressive load was<br>evaluated for stiffness. | Compressive load shall not<br>be statistically<br>significantly different to<br>comparable and/or the<br>predicate device | Tip buckling force met<br>acceptance criteria. |
| Particulate Testing | Device was evaluated for<br>particulate generation<br>under simulated use in a<br>representative tortuous<br>anatomical model per<br>USP<788> | Particulate must be within<br>limits per USP<788> | Number of particulates<br>generated met<br>acceptance criteria. |
| Physician Usability<br>Testing | The device was navigated<br>through a tortuous<br>benchtop model to assess<br>accessibility and the tip<br>atraumatic profile. | Assess navigation of<br>Navien™ with new<br>coating to the ICA and<br>comparing Navien™ with<br>new to Navien™ with old<br>coating with regards to tip<br>atraumaticity. | All test results met the<br>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

{9}------------------------------------------------

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.