EXCELSIOR XT-27 MICROCATHETER

K113778 · Stryker Neurovascular · DQY · Apr 20, 2012 · Cardiovascular

Device Facts

• Record ID: K113778
• Device Name: EXCELSIOR XT-27 MICROCATHETER
• Applicant: Stryker Neurovascular
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non-liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

Device Story

Sterile, single-lumen microcatheter; 0.027-inch ID; used by physicians to access distal neurovasculature. Operates via tracking over steerable guidewires within a guide catheter. Features graded shaft stiffness and Hydrolene outer coating to reduce friction. Includes radiopaque tip marker for fluoroscopic visualization. Available in 135cm/150cm lengths with straight or pre-shaped tips. Physician uses luer fitting to attach accessories; performs steam shaping as needed. Facilitates delivery of contrast media, therapeutic agents, and stents. Benefits patient by enabling precise navigation to distal neurovascular sites for diagnostic or interventional procedures.

Clinical Evidence

Bench testing only. Testing included visual inspection, dimensional measurements, corrosion resistance, simulated use (introduction, tracking, deployment, detachment), advancement/retraction force, and comprehensive biocompatibility (cytotoxicity, irritation, systemic toxicity, sensitization, hemocompatibility, pyrogenicity). All results met pre-defined acceptance criteria equivalent to predicate devices.

Technological Characteristics

Materials: PTFE, Pebax, stainless steel wire, Nylon, Santoprene. 0.027-inch ID. Features: Hydrolene hydrophilic coating, radiopaque 90%Pt-10%Ir tip marker, graded shaft stiffness (up to 5 zones), double helix winding reinforcement. Dimensions: 135cm/150cm lengths, 2.7F distal OD. Sterilization: Sterile, single-use.

Indications for Use

Indicated for patients requiring delivery of diagnostic or therapeutic agents and non-liquid interventional devices (e.g., stents) into the neurovasculature using a 0.027-inch inner diameter catheter.

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

• Renegade™ Hi-Flo™ Microcatheter (K000177)
• Excelsior® SL-10 Pre-Shaped Microcatheter (K042568)

Submission Summary (Full Text)

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APR 2 0 2012

Stryker Neurovascular Traditional 510(k) Submission Excelsior® XT-27™ Microcatheter

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K113778

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

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| Trade Name: | Excelsior® XT-27™ Microcatheter |
|-------------------|------------------------------------------------------------------------------------------------|
| Generic Name: | Percutaneous Catheter, Microcatheter |
| Classification: | CLASS II, 21 CFR 870.1250 |
| Submitted By: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515 |
| Contact: | Yoko Y Enrile |
| Predicate Device: | K000177, Renegade™ Hi-Flo™ Microcatheter<br>K042568, Excelsior® SL-10 Pre-Shaped Microcatheter |

Indications for Use: The Excelsior XT-27 Microcatheter is intended to assist in the delivery of
diagnostic agents (such as contrast media), therapeutic agents, and non-
liquid interventional devices (such as stents) that are indicated for use in
the neurovasculature and with a catheter of 0.027 inches in inner diameter.

Device Description: The Excelsior® XT-27™ Microcatheter is a sterile, single lumen 0.027 in
ID device with one tip marker designed to aid the physician in accessing
distal vasculature when used with a guide catheter and steerable
guidewire. Graded shaft stiffness ranging from a highly flexible tip to a
semi-rigid proximal section aids the physician in tracking over selectively
placed guidewires. A luer fitting located on the microcatheter hub is used
for the attachment of accessories. One radiopaque tip marker is positioned
at the distal tip of the device to facilitate fluoroscopic visualization. The
Excelsior XT-27 Microcatheter is coated on the outer surface with
Hydrolene™ coating which reduces friction during manipulation in the
vessel.

The Excelsior XT-27 Microcatheters are available in effective lengths of
both 135cm (53.1 inch) and 150 cm (59.1 inch), with two distal shaft
configurations achieved through distal shaft lengths of 6 cm (XT-27
model) and 18 cm (XT-27 Flex model). Both straight tip and Pre-Shaped
versions are available.

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Accessories: Each Excelsior XT-27 Microcatheter is provided with accessories (a shaping mandrel, and peel away introducer) within a separate inner Tyvek™ pouch (Accessory pouch). The Excelsior XT-27 Microcatheter is available in a single pack (one unit per package) only. The device pouch and Directions for Use (DFU) are both provided inside a shelf carton.

Summary Differences in Technological Characteristics: The Excelsior XT-27 Microcatheters introduce several enhanced design features:

- a) The OD profile of the Excelsior XT-27 Microcatheter is smaller than the Renegade Hi-Flo Microcatheter.
- b) The Excelsior XT-27 Microcatheter has up to five zones of polymer stiffness which vary from the distal to proximal shaft and help to enhance the trackability and pushability of the catheter.
- c) The Excelsior XT-27 Microcatheter has a more supportive double helix winding reinforcement compared to the Renegade Hi-Flo Microcatheter.

### Bench Test Summary:

| Test | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------|
| Visual Inspection:<br>Durable Hydrophilic Coating<br>Surface Defects<br>Surface-Extraneous matter | Met same criteria as<br>predicate |
| Dimensional Measurement:<br>Kink Radius of Curvature / Proximal<br>Shaft Kink<br>Distal OD Reduction<br>Tip Configuration<br>Catheter Hub | Met same criteria as<br>predicate |
| Corrosion Resistance | Met same criteria as<br>predicate |

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| Simulated use: | Met same criteria as predicate |
|---------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| * Introduction | |
| * Tracking | |
| * Reposition / Deployment | |
| * Detachment | |
| * Overall Performance | |
| Advancement / Retraction Force | Met same criteria as predicate |
| In-vitro Cytotoxicity, MEM Elution | Non-cytotoxic |
| Intracutaneous reactivity | Non-irritating |
| Acute systemic toxicity, Injection | Non-toxic |
| Sensitization, Guinea Pig<br>Maximization | Non- sensitizing |
| Hemocompatibility, Direct Contact;<br>Complement Activation C3a and<br>SC5b-9; PTT; blood cell counts and<br>hemoglobin / hematocrit levels | Non-hemolytic |
| Materials Mediated Pyrogen levels,<br>Rabbit test | Non-pyrogenic |
| USP impurities, <661> | None |
| Latex test, ELISA Inhibition | None |

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| Predicate / Subject | Product Feature Comparison for Excelsior® SL-10 Pre-Shaped |
|---------------------|--------------------------------------------------------------------------|
| Device | Microcatheter (K042568) and Renegade™ Hi-Flo™ Microcatheter<br>(K000177) |
| Comparison: | (K000177) |

| Feature | K042568<br>Excelsior® SL-10<br>Pre-Shaped<br>Microcatheter | K000177<br>Renegade™ Hi-Flo™<br>Microcatheter | Subject Device |
|----------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Materials | PTFE, Pebax,<br>Stainless Steel<br>wire, Nylon,<br>Santoprene | PTFE, Pebax,<br>Vectran Fiber and<br>Pt/Ir wire, Nylon,<br>Santoprene | PTFE, Pebax,<br>Stainless Steel<br>wire, Nylon,<br>Santoprene |
| Tip shape | Preshaped | Straight | Offers both shapes<br>(Straight and<br>Preshaped) |
| | Option of steam<br>shaping by<br>physician for<br>proper adjustment<br>to the anatomy<br>prior to use | Option of steam<br>shaping by<br>physician for<br>proper adjustment<br>to the anatomy<br>prior to use | Option of steam<br>shaping by<br>physician for<br>proper adjustment<br>to the anatomy<br>prior to use |
| Effective<br>Lengths | 150 cm | 135 cm, 150 cm | 135 cm, 150 cm |
| Proximal<br>/Distal OD | Proximal OD 2.4F<br>Distal OD 1.7F | Proximal OD 3F<br>Distal OD 2.8F | Proximal OD: 2.9F<br>Distal OD: 2.7F |
| ID | 0.0165 inch | 0.027inch | 0.027inch |
| Hydrophilic<br>Coating<br>Length | 100 cm | 60 cm | 80 cm |
| Tip Length | 6cm | 10cm and 20cm | 6cm and 18cm |
| Tip Markers | 90%Pt-10%Ir | 90%Pt-10%Ir | 90%Pt-10%Ir |
| Coating | Polyvinylpyrrolidone Polyacrylamide | Hydropass<br>Hydrophilic<br>Coating | Polyvinylpyrrolidone Polyacrylamide |
| Method of<br>supply | Sterile, single-use,<br>non-pyrogenic | Sterile, single-use,<br>non-pyrogenic | Sterile, single-use,<br>non-pyrogenic |

Summary of Substantial Equivalence: The Excelsior XT-27 Microcatheter subject of this submission is substantially equivalent to the predicate devices with regard to design, materials, sterilization, principle of operation, performance, and indications for use.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's commitment to promoting health, well-being, and human services. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

#### Public Health Service

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

Stryker Neurovascular c/o Ms. Tina Lochner DEKRA Certification. Inc. 4377 County Line Road Chalfont, PA 18914

APR 2 0 2012

Re: K113778

Trade/Device Name: Excelsior XT-27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY, KRA Dated: March 16, 2012 Received: March 22, 2012

Dear Ms. Lochner:

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 r ou may, thereforey issues 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 fray be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Tina Lochner

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Ea. Hemm

Malvina B. Eydelman, MD Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K113778

Device Name: . . . . . _ _ _ Excelsior® XT-27™ Microcatheter

Indications For Use:

The Excelsior XT-27 Microcatheter is intended to assist in the delivery of diagnostic agents (such as contrast media), therapeutic agents, and non-liquid interventional devices (such as stents) that are indicated for use in the neurovasculature and with a catheter of 0.027 inches in inner diameter.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Quyuh Hoang
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number_

K113778

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