Reverse 021 Micro Catheter, Reverse 027 Micro Catheter

K171268 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQY · May 31, 2017 · Cardiovascular

Device Facts

• Record ID: K171268
• Device Name: Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: May 31, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reverse™ Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

Device Story

Single-lumen microcatheter; designed for access to small, tortuous vasculature. Introduced over steerable guidewire; semi-rigid proximal section transitions to flexible distal tip for navigation. Features PTFE liner for device passage; dual radiopaque markers for fluoroscopic visualization; hydrophilic coating for lubricity. Available in 0.021" and 0.027" ID models. Used in clinical settings (neuro, peripheral, coronary) by physicians. Provides pathway for delivery of diagnostic/therapeutic agents; facilitates vessel navigation; improves procedural outcomes by enabling access to difficult anatomy.

Clinical Evidence

No clinical data. Substantial equivalence based on non-clinical performance evaluations, including bench-top verification (physical integrity, lubricity, simulated use, shelf-life) and biocompatibility testing per ISO 10993-1.

Technological Characteristics

Single-lumen catheter; PTFE liner; hydrophilic coating (Serene®); dual radiopaque markers. Materials identical to predicate except for coating. Sterilization: Ethylene Oxide (ISO 11135-1, SAL 10^-6). Dimensions: 150 cm length; 0.021" or 0.027" ID. Accessories: steam shaping mandrel, peel-away introducer sheath.

Indications for Use

Indicated for use in neuro, peripheral, and coronary vasculature for infusion of diagnostic agents (e.g., contrast media) and therapeutic agents (e.g., occlusion coils).

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

• Reverse™ Medical Microcatheter (K130858)

Reference Devices

• Navien™ Intracranial Catheter (K161152)
• Arc™ Intracranial Catheter (K150107)

Submission Summary (Full Text)

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

Mav 31. 2017

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Eric Elliott Principal Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618

Re: K171268

Trade/Device Name: Reverse Micro Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA, DQO Dated: April 28, 2017 Received: May 1, 2017

Dear Mr. Elliott:

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 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,

Carlos L. Pena -S- ¯

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)

K171268

Device Name

Reverse™ Micro Catheter

Indications for Use (Describe)

The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

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

| <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|---------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

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# 510(k) Summary per 21 CFR 807.92

| Submitter's<br>Name and<br>Address | Micro Therapeutics, Inc.<br>d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618 U.S.A. | | |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|----------------------------|
| Contact Name<br>and Information | Eric Elliott<br>Principal Regulatory Affairs Specialist<br>Tel: [phone]<br>E-mail: [e-mail] | | |
| Date Prepared | April 28, 2017 | | |
| Trade Name | Reverse™ Micro Catheter | | |
| Common Name | Catheter Percutaneous, Catheter Infusion, Catheter<br>Diagnostic | | |
| Classification<br>Name | Catheter, Percutaneous (DQY) has been classified as Class II per 21 CFR 870.1250 | | |
| | Catheter, Infusion (KRA) has been classified as Class II per 21 CFR 870.1210 | | |
| | Catheter, Intravascular Diagnostic (DQO) has been classified as Class II per 21 CFR 870.1200 | | |
| Predicate<br>Device | Reverse™ Medical<br>Microcatheter | K130858 | 11-Oct-2013 |
| Reference<br>Device(s) | Navien™ Intracranial Catheter<br>Arc™ Intracranial Catheter | K161152<br>K150107 | 12-Oct-2016<br>29-Jul-2015 |
| Description of<br>Device | The Reverse™ Micro Catheter is a single lumen catheter<br>designed to be introduced over a steerable guide wire to<br>access small, tortuous vasculature. The semi-rigid proximal<br>section transitions to a flexible distal tip to facilitate vessel<br>navigation. The micro catheter incorporates a PTFE liner to<br>facilitate movement or introduction of devices passed<br>through its lumen. Dual radiopaque markers at the distal end | | |

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Device facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance Description, lubricity and promote deliverability. continued The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID. The Reverse™ Micro Catheter is intended for use in neuro, Intended peripheral, and coronary vasculature for the infusion of Use/Indications diagnostic agents, such as contrast media, and therapeutic for Use agents, such as occlusion coils.

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Device Technology Characteristics and Comparison to Predicate Device

The Reverse™ Micro Catheter maintains the same fundamental scientific technology and operating principles as the predicate Reverse™ Medical Microcatheter (K130858). Furthermore, dimensions, materials of construction (excluding hydrophilic coating), sterilization method, and indications for use remain unchanged.

The primary difference between the subject and predicate device is the utilization of Serene® hydrophilic coating. This is the same coating as previously cleared with Medtronic's more recent intracranial support catheters, Navien™ (K161152) and Arc™ (K150107). Serene® will replace the predicate's legacy hydrophilic coating, thereby improving consistency across Medtronic Neurovascular's product portfolio and reducing manufacturing redundancy across the organization.

The only remaining design difference between subject and predicate is the elimination of yellow colorant from the split sheath introducer, an accessory packaged with the catheter. Even though the colorant is no longer utilized, the overall design and base formulation remains unchanged. With the two exceptions listed above, all raw materials utilized by the Reverse™ Micro Catheter are identical to those of the predicate (K130858).

In support of a substantial equivalence determination, Medtronic Neurovascular has compared and evaluated the design differences between the subject and predicate device.

| Technological<br>Characteristic | Subject Device<br>K171268 | Predicate Device<br>K130858 |
|-----------------------------------|------------------------------------------------------|-----------------------------------------|
| Inner Diameter | Reverse 021: 0.021"<br>Reverse 027: 0.027" | Same |
| Guidewire<br>Compatibility | Reverse 021: ≤ 0.018" OD<br>Reverse 027: ≤ 0.025" OD | Same |
| Distal Sheath<br>Outer Diameter | Reverse 021: 2.4 F<br>Reverse 027: 2.8 F | Same |
| Proximal Sheath<br>Outer Diameter | Reverse 021: 2.75 F<br>Reverse 027: 3.1 F | Same |
| Usable Length | 150 cm | Same |
| Coating | Hydrophilic Topcoat w/<br>Polyacrylamide Base | Hydrophilic Topcoat w/<br>Urethane Base |
| Peel Away<br>Introducer<br>Sheath | Yes (Colorless) | Yes (Yellow) |

Non-clinical performance evaluations, as described below, indicate that the subject device is substantially equivalent to. and at least as safe and effective as the predicate device (Reverse™ Medical Microcatheter, K130858).

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### Non-Clinical Performance Data

Modifications to the predicate device were assessed according to risk-based failure mode effects and criticality analysis (FMECA), ensuring that the appropriate verification and validation activities were conducted. Determination of substantial equivalence is based on this assessment of nonclinical verification and validation testing.

Non-clinical data includes bench-top verification and validation, packaging verification, and biological safety.

### Bench Testing:

Bench testing was performed to evaluate physical integrity. functionality, and overall performance of the catheter relative to the design modifications introduced by the subject device. Comprehensive verification and validation activities were successfully completed; raising no new issues of safety or effectiveness. All testing passed the acceptance criteria. Performance testing encompassed:

- surface inspection
- dimensional requirements .
- lubricity/ friction .
- particulates
- coating characterization ●
- . simulated use device compatibility
- simulated use navigation and delivery .
- shelf-life verification (1 year accelerated aging) .

## Biological Safety Testing:

The Reverse™ Micro Catheter was subiected to a series of biocompatibility tests in accordance with FDA Guidance, Use of International Standard ISO 10993-1.

- MEM Elution Cytotoxicity ●
- Guinea Piq Maximization Sensitization .
- Intracutaneous Reactivity ●
- Acute System Injection ●
- Materials Mediated Rabbit Pvrogen ●
- Hemolysis Direct Contact
- Hemolysis Indirect Extract Method
- Complement Activation
- In vivo Thrombogenicity
- Genotoxicity, Ames Assay ●
- Genotoxicity, in vitro Mouse Lymphoma ●
- Genotoxicity, in vivo Mouse Micronucleus ●
- . USP Physicochemical

Testing demonstrated that the Reverse™ Micro Catheter finished device, accessories, and packaging materials have no residual risk of biological hazards; and are therefore considered biocompatible for their intended use.

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| Non-Clinical<br>Performance<br>Data, continued | Microbial assessments included bioburden, endotoxin, and<br>sterility assurance. Sterilization has been validated and is<br>controlled in accordance with ISO 11135-1, Medical Devices –<br>Validation and Routine Control of Ethylene Oxide Sterilization and<br>designed to provide a minimum SAL of 10-6. Validation was<br>conducted using the overkill approach in accordance with ISO<br>11135-1 Annex B (normative), Conservative determination of lethal<br>rate of the sterilization process – Overkill approach. The validated<br>cycle was adopted for the Reverse™ Microcatheter based on<br>fractional results determined from EO comparative resistance<br>testing. |
|------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Packaging Validation: |
| | Visual Inspection, Bubble Leak, and Seal Strength testing<br>was used to evaluate integrity of the packaging configuration.<br>Testing was leveraged from representative product using<br>identical packaging materials after being subjected to<br>Ethylene Oxide sterilization (2x), environmental conditioning,<br>and simulated shipping and distribution. |
| | Conclusion: |
| | Non-clinical performance evaluations, as described above,<br>indicate that the subject device is substantially equivalent to,<br>and at least as safe and effective as the predicate device,<br>(Reverse™ Medical Microcatheter, K130858). |
| Clinical<br>Performance<br>Data | Not applicable; determination of substantial equivalence is<br>based on an assessment of non-clinical performance data. |
| Conclusion | With respect to the predicate, design modifications<br>incorporated by subject device do not alter the fundamental<br>scientific technology or the indications for use. Based on<br>failure mode effects and criticality analysis (FMECA),<br>comprehensive verification and validation activities were<br>successfully completed; raising no new issues of safety or<br>effectiveness. |
| | Non-clinical performance data supports a determination that<br>the subject device, Reverse™ Micro Catheter, is<br>substantially equivalent to the predicate device (Reverse™<br>Medical Microcatheter, K130858); and that it is at least as<br>safe and effective for its intended use. |