Headway 27 Microcatheter

K142449 · MicroVention, Inc. · DQY · Mar 26, 2015 · Cardiovascular

Device Facts

• Record ID: K142449
• Device Name: Headway 27 Microcatheter
• Applicant: MicroVention, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 26, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro 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 navigation through small, tortuous vasculature over steerable guidewire. Features semi-rigid proximal section transitioning to flexible distal tip; dual radiopaque markers for fluoroscopic visualization. Supplied with introducer sheath and shaping mandrel. Used by physicians in clinical settings (e.g., interventional radiology/cardiology). Physician manually shapes distal tip via steam; advances catheter under fluoroscopic guidance. Infuses contrast media or therapeutic agents (occlusion coils) to treat vascular conditions. Benefits include access to distal, complex anatomy for targeted delivery of diagnostic or therapeutic materials.

Clinical Evidence

Bench testing only. Testing included surface contamination, dimensional attributes, force at break, leakage (liquid/air), burst pressure, coating durability/lubricity, tip shape retention, simulated use, flow rate, kink resistance, and fatigue testing. Biocompatibility testing performed per ISO 10993 standards (cytotoxicity, sensitization, irritation, hemocompatibility, systemic toxicity, pyrogenicity). All tests passed.

Technological Characteristics

Single lumen catheter; materials: polyurethane elastomer (polyblend/Pellethane), Pebax, polyamide (Grilamid), stainless steel braid/coil, PTFE, polyolefin elastomer. Marker: Platinum/Iridium. Hub: Nylon. Hydrophilic coating (Hydak). Sterilization: Ethylene Oxide. Dimensions: 156 cm length, .0278" ID. Connectivity: None (manual).

Indications for Use

Indicated for patients requiring intravascular infusion of diagnostic agents (contrast media) or therapeutic agents (occlusion coils) within peripheral, coronary, or neuro vasculature.

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

• Headway 27 Microcatheter (K110813)

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

March 26, 2015

MicroVention, Inc. Ms. Cynthia Valenzuela Sr. International Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780

Re: K142449 Trade/Device Name: Headway 27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 19, 2015 Received: February 27, 2015

Dear Ms. Valenzuela,

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

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the quality systems (OS) 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 -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) K142449

Device Name Headway 27 Microcatheter

Indications for Use (Describe)

The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro 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> <input checked="true" type="checkbox"/> Research Use (Part 21 CFR 312) or Screening Purposes </div> |
|------------------------------------------------------------------------------------------------------------------|
| <div> <input type="checkbox"/> Compassionate Use (21 CFR 312.310) </div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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#### 1.3. 510(k) Summary

| Trade Name: | Headway 27 Microcatheter |
|-------------------|-------------------------------------------------------------------------|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc.<br>1311 Valencia Avenue<br>Tustin, California U.S.A. |
| Contact: | Cynthia Valenzuela [phone] or [phone] |
| Date: | 2014 AUG 06 |
| Predicate Device: | Headway 27 Microcatheter (K110813) |

## 510(k) Summary

### Device Description:

The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.

### Indications For Use:

The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.

| | Headway 27 (predicate) | Headway 27 (proposed) |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
| Intended Use | The Headway microcatheter is intended<br>for general intravascular use, including the<br>peripheral, coronary and neurovasculature-<br>for the infusion of diagnostic and<br>therapeutic agents. | Same |
| Material | | Same |
| | Catheter Body<br>Outer layer of polyurethane elastomer<br>(Polyblend and Pellethane), polyether block<br>amide (Pebax) and polyamide (Grilamid); inner<br>layer of stainless steel braid/coil, PTFE and<br>polyolefin elastomer | |
| | Marker<br>Platinum/Iridium | |
| | Hub<br>Nylon | |
| | Strain Relief<br>Pebax | |
| | Introducer<br>Pebax | |
| Shaping Mandrel | Stainless steel | |

#### Technological Comparison:

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| Proximal ID/OD | ID = .027" min<br>OD = .040" | ID = .0278" min<br>OD = .040" |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Distal ID/OD | ID = .027" min<br>OD = .034" | ID = .027" min<br>OD = .035" |
| Effective Length | 150 cm | 156 cm |
| Coating | Hydrophilic coating<br>(Hydak® - same) | Same |
| Tip Configuration | Straight - Steam Shapeable by physician<br>prior to use | Same |
| Guidewire Compatibility | 0.018" wires or smaller | 0.014"/0.016"/0.018"/0.021" |
| Accessories | Introducer sheath and shaping mandrel | Same |
| Method of Supply | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging Configuration | Catheter placed into a HDPE dispenser tube.<br>Dispenser tube, introducer and shaping mandrel<br>placed on a polyethylene packaging card that is<br>inserted into a Tyvek® pouch. Pouch and IFU<br>placed in bleached sulfate carton box. | Same |

#### Technological Comparison (conti.):

## Verification and Test Summary:

| Bench Testing | Acceptance Criteria | Result | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Surface Contamination | • Liquid on surface<br>• Particulate on external<br>surface<br>• Surface defects/sharp<br>edges | • Free from uncured<br>hydrophilic coating.<br>• No surface<br>particulate > .02 mm²<br>per tappi chart<br>• Free from surface<br>defect/no sharp edges<br>• Embedded particulate<br>acceptable if OD is in<br>specification<br>• Free from damage | Passed |
| Dimensional Attributes | • Catheter effective<br>length<br>• Catheter lumen<br>• Catheter outer<br>diameter<br>• Length of distal OD<br>(2.2Fr section) | • 150 ± 2 cm<br>• .027" (0.69 mm)<br>• nominal .040"/.034-<br>.028" (1.0/.86--.71<br>mm)<br>• ≥ 6cm | Passed |
| Force at break | Device shall not break<br>during use | ≥ 1.12 lbs (5.0 N) for<br>outer diameters from<br>.030" to .045" (.76 to<br>1.1 mm) | Passed |

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| Bench Testing | Acceptance Criteria | Result | |
|-----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------|
| Freedom from Leakage<br>(Liquid) | (low pressure - long<br>duration)<br>Device shall not leak<br>fluids | No liquid leaking from<br>hub and catheter shaft at<br>46 psi (317.2 kPa) for<br>30 second duration | Passed |
| Freedom from Leakage<br>(air) | (high pressure - short<br>time)<br>Device shall not leak<br>fluids | No liquid leaking from<br>hub and catheter shaft at<br>300 psi/2068 kPa (rated<br>burst pressure) for 10<br>second duration | Passed |
| Burst Pressure of Catheter | Air shall not leak into<br>device | No air leaking into<br>syringe for 15 seconds | Passed |
| Dynamic Burst Pressure | Microcatheter will not<br>burst statically below<br>rated burst pressure. | Microcatheter: will not<br>burst below 300 psi<br>(2068 kPa) | Passed |
| Durability and Lubricity of Hydrophilic Coating-<br>Verification that hydrophilic coating does not delaminate<br>during use | | Rated 3 or higher<br>(simulated use) | Passed |
| Tip Shape and Tip Retention | | Tip retain better than<br>55% of its original<br>shape | Passed |
| Simulated Use | | Rated 3 or higher in<br>tested categories | Passed |
| Compatibility with agents | | Rated 3 or higher in<br>tested applicable<br>categories | Passed |
| Flow Rate | Reference data | N/A | |
| Kink Resistance | | Equivalent to or better<br>kink resistance than<br>competitive | Passed |
| Catheter Stiffness | | Document stiffness<br>using Tinius Olsen -<br>reference data only | N/A |
| Catheter Flexural Fatigue | The catheter must have<br>acceptable results per<br>the following<br>conditions:<br>- Flexural fatigue:<br>simulated use, tip<br>shaping testing<br>- Hoop stress fatigue:<br>flow rate, dynamic<br>burst, liquid leakage, | Passed | |

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| Bench Testing | Acceptance Criteria | Result |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------|
| Catheter Particle Testing | Per USP <788> - less<br>than 25 particles greater<br>than 10 microns and less<br>than 3 particles greater<br>than 25 micron | Passed |
| Dead Space | Reference data | N/A |
| Torque Test | 50 rotations without<br>catheter breakage or<br>equivalent to<br>competitive product<br>catheters. | Passed |
| DMSO Test | Functional performance<br>and chemical stability | Passed |

| Biocompatibility | Results | Conclusion |
|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------|
| Cvtotoxicity ISO 10993-5<br>MEM Elution Test | Cell culture tested with test article<br>exhibited slight reactivity (Grade 1) | Non-toxic |
| Cytotoxicity ISO 10993-5<br>Cell Culture Agar Overlay | Grade 2: zone limited to under<br>specimen | Non-toxic |
| Sensitization ISO 10993-10<br>Guinea Pig Maximization Test | Grade 0: No visible change | Non-irritant |
| Irritation ISO 10993-10<br>Intracutaneous Reactivity Evaluation<br>Test | Comparative between control and test<br>article <1.0 | Non-irritant |
| Hemocompatibility - Rabbit Blood<br>Direct Contact (ISO10993-4) | 0.1% hemolysis | Non-hemolytic |
| Hemocompatibility - Unactivated<br>Partial Thromboplastin Time Assay<br>Direct Contact (ISO10993-4) | Test article = 12.6 seconds<br>(Normal PT clotting range = 10-14<br>seconds) | No effect on coagulation |
| Hemocompatibility - Complement<br>Activation Assay (ISO10993-4) | C3a = 17.7%<br>SC5b-9= 1.6 % | No effect on<br>complement activation |
| Hemocompatibility -<br>Thrombogenicity Study in Dogs<br>(ISO10993-4) | Minimal to moderate thrombus<br>formation, clotting ability was not<br>compromised | Similar<br>thromboresistance<br>compared to control |
| Systemic toxicity - Systemic Injection<br>Test<br>(ISO10993-11) | No decrease in body weight of >10%.<br>No reaction found. | Non-toxic effects |
| Systemic toxicity - Rabbit Pyrogen<br>Test (ISO10993-11) | Temperature increases was 0.0℃ from<br>baseline. | Non-pyrogenic |

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### Summary of Substantial Equivalence:

The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 27 Microcatheter when compared with the predicate device, Headway 27 Microcatheter (K110813).

The devices,

- " Have the same intended use,
- Use the same operating principle,
- Incorporate the same basic design,
- . Are packaged and sterilized using same methods.

In summary, the Headway 27 Microcatheter described in this submission was found to have a safety and effectiveness profile that is similar to the predicate devices.