Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter

K150107 · Micro Therapeutics Inc Dba Ev3 Neurovascular · DQY · Jul 29, 2015 · Cardiovascular

Device Facts

• Record ID: K150107
• Device Name: Arc Intracranial Support Catheter, Arc Mini Intracranial Support Catheter
• Applicant: Micro Therapeutics Inc Dba Ev3 Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 29, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Story

The Arc and Arc Mini are single-lumen, flexible, variable-stiffness composite catheters featuring a Nitinol structure and a radiopaque distal marker band for fluoroscopic visualization. The distal sections include a hydrophilic coating to reduce frictional force during intravascular navigation. Used by physicians in clinical settings, the catheters are navigated through the vasculature to facilitate the delivery of interventional devices. The device is supplied sterile for single-use. By providing a stable conduit, the catheter assists in reaching target sites within the neurovasculature, potentially improving procedural outcomes for patients undergoing interventional neurovascular procedures.

Clinical Evidence

No clinical studies were performed. Substantial equivalence was established through extensive non-clinical bench testing and design validation. Bench testing included lumen patency, dimensional inspection, distal tip buckling, injection/suction flow rates, vacuum resistance, tensile strength, coating integrity/lubricity, kink resistance, leakage, burst pressure, and torque-to-failure. Biocompatibility was confirmed per ISO 10993-1, including cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, hemolysis, and mutagenicity. Physician usability testing in a tortuous benchtop model confirmed compatibility and performance.

Technological Characteristics

Single-lumen, variable-stiffness composite catheter; Nitinol support structure; PTFE-lined polymer shaft; hydrophilic coating; platinum radiopaque marker band. Dimensions vary by model. Sterilized via ethylene oxide per ISO 11135-1:2007. Biocompatibility per ISO 10993-1. Standalone device.

Indications for Use

Indicated for the introduction of interventional devices into the peripheral and neurovasculature for patients requiring such procedures.

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

• ReFlex™ Guide Catheter (K110055)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem that resembles an abstract representation of an eagle or a similar bird, with stylized feathers or wings.

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

July 29, 2015

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ms. Phuong Chau Senior Regulatory Affairs Product Specialist 9775 Toledo Way Irvine, California 92618

Re: K150107

Trade/Device Name: Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 26, 2015 Received: June 29, 2015

Dear Ms. Phuong Chau:

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 device

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related 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.

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 நி/Δ

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) K150107

#### Device Name

ArcTM Intracranial Support Catheter and ArcTM Mini Intracranial Support Catheter

Indications for Use (Describe)

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Type of Use (Select one or both, as applicable)

| <label><input checked="true" type="checkbox"/> For Activities Related to CA SB1383 (Organic Waste)</label> |
|------------------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> For Other Composting Activities</label> |

X | Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary – K150107

| 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: | Phuong Chau<br>Senior Regulatory Affairs Product Specialist<br>Telephone: [phone]<br>E-mail: [e-mail] | | | |
| Date Summary<br>Prepared: | June 25, 2015 | | | |
| Trade Name of<br>Device: | Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial<br>Support Catheter | | | |
| Common Name of<br>Device: | Catheter, Percutaneous | | | |
| Classification of<br>Device: | 21 CFR 870.1250 – Class II | | | |
| Product Code: | DQY | | | |
| Predicate Device: | ReFlex™ Guide Catheter, 510(k)#: K110055 | | | |
| Performance Data: | The following bench testing was performed in support of the Arc™ and<br>Arc™ Mini Intracranial Support Catheter and to establish substantial<br>equivalence to the ReFlex™ Guide Catheter: | | | |
| | • Lumen Patency | | | |
| | • Dimensional Inspection | | | |
| | • Distal Tip Buckling | | | |
| | • Catheter Injection Flow Rate | | | |
| | • Catheter Suction Flow Rate | | | |
| | • Vacuum Resistance | | | |
| | • Hub Air Aspiration Leak | | | |
| | • Shaft Peak Tensile Force | | | |
| | • Hub Peak Tensile Force | | | |
| | • Coating Integrity – Baseline | | | |
| | • Coating Lubricity/Durability | | | |
| | | | | |

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- . Particulate Testing
- Coating Integrity Simulated Use .
- . Kink Resistance
- Liquid Leakage .
- Static/Dynamic Burst .
- . Torque to Failure

A Design Validation study was performed on a bench model to assess the usability of the Arc™ and ArcTM Mini Intracranial Support Catheter compared to the previously cleared ReFlex™ Guide Catheter. Biocompatibility testing, sterilization, and a 6-month 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 ArcTM Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are substantially equivalent to the currently cleared ReFlex™ Guide Catheter based on the successful completion of nonclinical bench and design validation testing as well as similar principles of design, operation and indications for use.
#### Device Description:

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are designed for the introduction of interventional devices into the peripheral and neurovasculature. The Arc™ Mini are a single lumen, flexible, variable stiffness composite catheters with a Nitinol structure. A radiopaque marker band on the distal tip of the devices is used for visualization under fluoroscopy. The distal sections of both catheters are coated with a hydrophilic coating, which is used to reduce the overall frictional force during intravascular use. The Arc™ and Arc™ Mini dimensions are included in the individual device label. The devices are supplied sterile and are intended for single-use only.

#### Indications for Use:

The Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are 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 Arc™ Intracranial Support Catheter and Arc M Mini Intracranial Support Catheter and the currently cleared ReFlex (M Guide Catheter.

| | ReFlex™ Guide<br>Catheter<br>(K110055) | Arc™ Intracranial<br>Support Catheter | Arc™ Mini<br>Intracranial<br>Support Catheter | Rationale for<br>Difference (If<br>Present) |
|-----------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------|
| Indication for<br>Use | The ReFlex™<br>Guide Catheter is<br>indicated for the<br>introduction of | The Arc Intracranial<br>Support Catheter is<br>indicated for the<br>introduction of | The Arc Mini<br>Intracranial Support<br>Catheter is indicated<br>for the introduction | N/A |

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| | ReFlex™ Guide<br>Catheter<br>(K110055) | Arc™ Intracranial<br>Support Catheter | Arc™ Mini<br>Intracranial<br>Support Catheter | Rationale for<br>Difference (If<br>Present) |
|--------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | interventional<br>devices into the<br>peripheral and<br>neurovasculature. | interventional<br>devices into the<br>peripheral and<br>neurovasculature. | of interventional<br>devices into the<br>peripheral and<br>neurovasculature. | |
| Materials | | | | |
| Catheter<br>Shaft<br>Materials | PTFE lined<br>polymeric catheter,<br>with hydrophilic<br>coating | PTFE lined<br>polymeric catheter,<br>with hydrophilic<br>coating | PTFE lined<br>polymeric catheter,<br>with hydrophilic<br>coating | The material used<br>for the Arc and<br>Arc Mini catheters<br>were shown to be<br>biocompatible per<br>ISO 10993 testing.<br>Materials of this<br>type are widely<br>used in similar<br>medical devices. |
| Catheter<br>Shaft<br>Support | Nitinol | Same | Same | N/A |
| Marker<br>band | Platinum | Same | Same | N/A |
| Dimensions | | | | |
| Usable Length | 90 – 130 cm | 132 – 135 cm | 160 – 163 cm | Longer lengths<br>provided for<br>additional<br>navigability<br>options to user. |
| Distal ID | 0.046" – 0.072" | 0.061" | 0.035" | Smaller distal ID<br>provided for<br>improved<br>trackability over<br>guide wire to<br>smaller vessels. |
| Distal OD<br>(Max) | 0.058"–0.084" max | 0.071" max | 0.049" | Smaller distal<br>ID/OD provided<br>for improved<br>distal flexibility. |
| Proximal ID | 0.046" – 0.072" | 0.069" | 0.044" | Smaller proximal<br>ID provided for<br>improved<br>trackability over<br>guide wire to |

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| | ReFlex™ Guide<br>Catheter<br>(K110055) | Arc™ Intracranial<br>Support Catheter | Arc™ Mini<br>Intracranial<br>Support Catheter | Rationale for<br>Difference (If<br>Present) |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------|
| | | | | smaller vessels. |
| Proximal OD<br>(Max) | 0.058"–0.084" max | 0.0825" max | 0.0620" | N/A |
| Tip<br>Configuration | Single, straight<br>flexible tip | Same | Same | N/A |
| Guidewire<br>Compatibility | Can be navigated<br>over a guidewire<br>with a maximum<br>OD of 0.038 in. | Same | Can be navigated<br>over a guidewire<br>with a maximum<br>OD of 0.032 in. | Largest<br>compatible<br>guidewire size<br>dependent on<br>smallest ID. |
| Sterilization<br>Method | Ethylene Oxide | Same | Same | N/A |
| Packaging | Catheter in<br>polyethylene hoop<br>attached to<br>packaging card<br>inside<br>PET/PE/Tyvek<br>pouch inside SBS<br>carton | Same | Same | N/A |

#### Sterilization and Shelf Life

The packaged Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter are 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-s 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 Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter devices have established the product and packaging remain functional and maintain sterility for up to 6 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) 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.

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| 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 Dyson catheter are comparable<br>to the ReFlex and less than that of<br>the positive control. | Levels of the compliments C3a<br>and SC5b complements were<br>similar for Arc and control<br>device |
| Thrombosis (in vivo) — Canine<br>(Arc / ReFlex) | The thromboresistance properties<br>of the Arc and Arc Mini<br>Intracranial Support Catheters are<br>acceptable in clinical use. | Acceptable, expected to be<br>equivalent to ReFlex in clinical<br>use |
| in vitro Hemocompatibility<br>Assay | Neither the Arc nor the ReFlex<br>Guide Catheter resulted in a<br>decrease in any blood component | No adverse effect on platelet<br>and leukocyte counts |

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| Test | Result | Conclusion |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|
| | as compared to the reference<br>material. These results indicate that<br>the cause of thrombi is not related<br>to the materials exposed to human<br>blood during use. | |
| Partial Thromboplastin Time | Clotting times for Arc and the<br>ReFlex (predicate device) test arms<br>were similar to the negative control<br>and 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 |

## Performance Testing – Bench

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

| Test | Method | Conclusions |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Lumen Patency | The total length of the device<br>must pass a mandrel of the<br>required size from the proximal<br>hub to distal tip. | All devices met acceptance<br>criteria. |
| Dimensional Inspection | The usable length, proximal and<br>distal inner and outer diameters<br>were measured and recorded. | All device met acceptance<br>criteria. |
| Distal Tip Buckling | Repeated distal tip buckling force<br>under compressive load was<br>evaluated for stiffness. | Distal tip buckling force met<br>acceptance criteria. |
| Catheter Injection Flow Rate | Device flow rate was measured<br>using ISO 10555-1, Annex E test<br>methods with injection through<br>proximal hub. | Injection flow rate met<br>acceptance criteria. |
| Test | Method | Conclusions |
| Catheter Suction Flow Rate | Device flow rate was measured<br>using ISO 10555-1, Annex E test<br>methods with injection through<br>distal tip. | Suction flow rate met acceptance<br>criteria. |
| Vacuum Resistance | Device was evaluated for<br>resistance to vacuum collapse<br>under static conditions with a<br>60cc syringe. | Device was resistant to vacuum<br>collapse under static conditions. |
| Hub Air Aspiration Leak | Device was tested for ISO<br>10555-1, Annex D hub air<br>aspiration leak. | Hub air aspiration test met<br>acceptance criteria. |
| Shaft Peak Tensile Force | Shaft peak tensile strength was<br>tested to failure for each joint<br>using ISO 10555-1, Annex B test<br>methods. | Shaft joint peak tensile force met<br>acceptance criteria. |
| Hub Peak Tensile Force | Hub-shaft joint peak tensile<br>strength was tested to failure<br>using ISO 10555-1, Annex B test<br>methods | Hub-shaft joint peak tensile force<br>met acceptance criteria. |
| Coating Integrity - Baseline | Fully assembled devices were<br>inspected under a minimum 2.5x<br>magnification for worst-case<br>coating defects. | Baseline coating integrity<br>characterized with worst-case<br>defect images. Data collected as<br>engineering reference. |
| Coating Lubricity/Durability | Device coating was evaluated for<br>average frictional force and<br>durability. | Coating lubricity and durability<br>testing met acceptance criteria. |
| Particulate Testing | Device was evaluated for<br>particulate generation under<br>simulated use in a representative<br>tortuous anatomical model. | Number of particulates generated<br>met acceptance criteria. |
| Coating Integrity - Simulated<br>Use | Fully assembled devices were<br>pre-conditioned under simulated<br>use conditions in a representative<br>tortuous anatomical model.<br>Coating was inspected under a<br>minimum 2.5x magnification and<br>subsequently tested for average<br>frictional force. | Post-simulated use coating<br>integrity characterized with<br>worst-case defect images. |
| Kink Resistance | Device was wrapped around a<br>rod of known radius and<br>inspected in-place for any kinks. | Device was resistant to kinking<br>around small radii. |
| Liquid Leakage | Device was tested for ISO | Liquid leakage met acceptance |
| Test | Method | Conclusions |
| | 10555-1, Annex C liquid leakage<br>testing. | criteria. |
| Static/Dynamic Burst | Device was tested under full-<br>length static conditions to burst<br>and at pressures experienced<br>during worst-case dynamic<br>injections. | Static/dynamic burst testing met<br>acceptance criteria. |
| Torque to Failure | Device was tested for full-length<br>torque strength to determine<br>number of rotations to failure. | Torque to failure testing met<br>acceptance criteria. |
| Physician Usability Testing | The device was navigated<br>through a tortuous benchtop<br>model to assess compatibility<br>with accessories, device stability,<br>ability to aspirate, ability to inject<br>saline or contrast, and the user's<br>ability to navigate to the M1 and<br>M2 segment of the MCA and<br>retrieve a mechanical<br>thrombectomy device. | All test results met the<br>acceptance criteria. |

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#### 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 devices. Substantial equivalence of the Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter has been established to the predicate device through the results of bench testing.

### Performance Testing - Clinical

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 Arc™ Intracranial Support Catheter and Arc™ Mini Intracranial Support Catheter has been established to the predicate device through the results of bench and design validation testing.