FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815

K100799 · Contract Medical Intl. GmbH · DYB · Feb 25, 2011 · Cardiovascular

Device Facts

• Record ID: K100799
• Device Name: FORTRESS INTRODUCER SHEATH SYSTEM MODEL 358813, 358814, 358815
• Applicant: Contract Medical Intl. GmbH
• Product Code: DYB · Cardiovascular
• Decision Date: Feb 25, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures. The device is designed to facilitate easier access to the femoral, popliteal and infrapopliteal arteries by means of the crossover approach, which would otherwise be difficult or impossible to access by conventional means, as exemplified in patients with damaged, occluded or blocked vessels. The Fortress Introducer Sheath System is intended to be used by physicians trained in performing arterial catheterizations, primarily in hospital environment.

Device Story

Fortress Introducer Sheath System facilitates percutaneous vascular access; consists of introducer sheath with hemostasis valve, side port with 3-way stopcock, and dilator with tapered tip. Used by physicians in hospital settings for diagnostic/interventional procedures; enables crossover approach for difficult-to-access femoral, popliteal, or infrapopliteal arteries. Hemostasis valve seals around guide wires/catheters to minimize blood loss; radiopaque marker identifies distal tip position. System provides conduit for guide wires and catheters; aids navigation through occluded or damaged vessels; improves procedural success in complex arterial anatomy.

Clinical Evidence

No clinical data; substantial equivalence based on design, material, and technological comparison to predicate devices.

Technological Characteristics

System includes introducer sheath with hemostasis valve, side port, and dilator. Features radiopaque marker for visualization. Materials and design are equivalent to predicate devices. Non-powered, mechanical device.

Indications for Use

Indicated for patients requiring percutaneous access to femoral, popliteal, and infrapopliteal arteries for diagnostic or interventional procedures, including those with damaged, occluded, or blocked vessels requiring crossover approach.

Regulatory Classification

Identification

A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.

Predicate Devices

• Prelude and Prelude Pro Sheath Introducers (K073035)
• Pinnacle Destination Peripheral Guiding Sheaths (K091329)

Submission Summary (Full Text)

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K100799

## SECTION 1. 510(K) SUMMARY

| Submission Owner / Correspondent: | Jan Kloboucnik<br>Director, RA/QA<br>Contract Medical, GmbH<br>Zur Wetterwarte 50<br>01109 Dresden, Germany | FEB 25 2011 | | | | | | | | |
|--------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|-------------|---------------|-----------------------------|--------------------------------------------|---------|----------------------------|-------------------------------------------------|---------|
| | Phone: [phone] .<br>Fax: [phone]<br>Email: [e-mail]<br>Contact: Jan Kloboucnik | | | | | | | | | |
| Device Manufacturer | Contract Medical Intl. GmbH<br>Zur Wetterwarte 50<br>House 302<br>Dresden, GERMANY 01109<br>Registration Number: 3003637635 | | | | | | | | | |
| Date summary prepared: | December 22, 2010 (supersedes original summary from March 18, 2010) | | | | | | | | | |
| Device trade name: | Fortress Introducer Sheath System | | | | | | | | | |
| Device common name: | Introducer Sheath | | | | | | | | | |
| Device classification name: | Catheter Introducer<br>DYB, Class II per 21 CFR 870.1340, and<br>Dilator, Vessel, For Percutaneous Catheterization<br>DRE, class II at 21 CFR Part 870.1310 | | | | | | | | | |
| Legally marketed device to which the device is substantially equivalent: | <table><tr><th>Manufacturer</th><th>Device Name</th><th>510(k) Number</th></tr><tr><td>Merit Medical Systems, Inc.</td><td>Prelude and Prelude Pro Sheath Introducers</td><td>K073035</td></tr><tr><td>Terumo Medical Corporation</td><td>Pinnacle Destination Peripheral Guiding Sheaths</td><td>K091329</td></tr></table> | Manufacturer | Device Name | 510(k) Number | Merit Medical Systems, Inc. | Prelude and Prelude Pro Sheath Introducers | K073035 | Terumo Medical Corporation | Pinnacle Destination Peripheral Guiding Sheaths | K091329 |
| Manufacturer | Device Name | 510(k) Number | | | | | | | | |
| Merit Medical Systems, Inc. | Prelude and Prelude Pro Sheath Introducers | K073035 | | | | | | | | |
| Terumo Medical Corporation | Pinnacle Destination Peripheral Guiding Sheaths | K091329 | | | | | | | | |
| Description of the device: | The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and Luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The Fortress Introducer Sheath System consists of the following components:<br>- One: introducer sheath<br>- Two: dilators | | | | | | | | | |

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Intended use of the device: The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures. The device is designed to facilitate easier access to the femoral, popliteal and infrapopliteal arteries by means of the crossover approach, which would otherwise be difficult or impossible to access by conventional means, as exemplified in patients with damaged, occluded or blocked vessels. The Fortress Introducer Sheath System is intended to be used by physicians trained in performing arterial catheterizations, primarily in hospital environment. Technological The proposed device has the same technological characteristics characteristics: as the predicate devices. Conclusions: The results of the comparison of design, materials, intended use and technological characteristics demonstrate that the device is as substantially equivalent to the legally marketed predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

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

Contract Medical GmbH c/o Ms. Jan Kloboucnik Director, RA/OA Zur Wetterwarte 50 01109 Dresden, Germany

FEB 2 5 231

Re: K100799

Trade/Device Name: Fortress Introducer Sheath System Model 358813, 358814 and 358815 Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II (two) Product Code: DYB Dated: December 22, 2010 Received: December 29, 2010

Dear Ms. Kloboucnik:

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.

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.

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Page 2 - Ms. Jan Kloboucnik

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 yours,

Tom Brake M.P.

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION 4. INDICATIONS FOR USE STATEMENT

| 510(k) Number: | K100799 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Fortress Introducer Sheath System |
| Indications for Use: | The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while while maintaining hemostasis during diagnostic and interventional procedures |

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.S.

scular Devices

510(k) number K10074