VALVED TEARWAY INTRODUCER

K090394 · Medcomp · DYB · Sep 1, 2009 · Cardiovascular

Device Facts

• Record ID: K090394
• Device Name: VALVED TEARWAY INTRODUCER
• Applicant: Medcomp
• Product Code: DYB · Cardiovascular
• Decision Date: Sep 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Device Story

The Medcomp Valved Tearaway Introducer is a single-use, two-part vascular access device. It consists of a peelable introducer sheath with a duckbill valve and a dilator with a locking hub. The device is used by a physician to obtain percutaneous vascular access; the dilator and sheath are inserted over a guidewire. The duckbill valve minimizes air embolism and blood loss during dilator removal. Once the dilator is removed, a catheter is inserted through the sheath into the central venous system. The sheath hub is then broken, and the sheath is peeled away from the catheter for removal. The device facilitates safe catheter placement by maintaining vascular access and minimizing blood loss.

Clinical Evidence

No clinical data provided. Safety and effectiveness were demonstrated through bench testing and biocompatibility assessment.

Technological Characteristics

Device components include a PTFE sheath and a high-density polyethylene dilator containing barium sulfate for radiopacity. The device features a duckbill valve for hemostasis and a peelable hub design. Biocompatibility meets ISO 10993 requirements for external communicating devices with limited duration blood path contact.

Indications for Use

Indicated for patients requiring central venous access to facilitate the insertion of catheters into the central venous system.

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

• MedAmicus FlowGuard™ Peelable Introducer (K040150)
• Medcomp Vascu-Sheath® II Introducer Set (K053092)

Submission Summary (Full Text)

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K090394

# 510(K) SUMMARY

#### Submitter Information: A.

Submitter:

Contact:

Date Prepared:

B. Trade Name: .

> Common Name: Classification: C.F.R. Section:

். Predicate Device: SEP - 1 2009

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MEDCOMP® 1499 Delp Drive Harleysville, PA 19438 [phone] Telephone [phone] Fax Jean Callow Requiatory Specialist February 16, 2009

Valved Tearaway Introducer

Introducer, Catheter DYB 870.1340

K040150 MedAmicus FlowGuard™ Peelable Introducer K053092 Medcomp Vascu-Sheath® II Introducer Set

#### D. Device Description:

The Medcomp Valved Tearaway Introducer is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Valved Tearaway Introducer consists of a peel-able introducer sheath which contains a "duckbill" seal to substantially minimize air/blood from entering or escaping when the dilator is removed. The dilator is comprised of a cylindrical tube with a locking hub; the sheath is also a cylindrical tube with a hub and valve. When the dilator is fully seated it snaps into the hub of the introducer sheath to prevent independent movement of either piece when in use. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The sheath and dilator when used in conjunction with an introducer needle and guidewire provide a means to obtain a percutaneous opening to the vascular system to facilitate the insertion of a catheter. After removing the dilator a catheter can then be placed through the sheath. Breaking the sheath's hub and peeling the sheath away from the catheter then allows the sheath to be removed. The dilator is composed of a High Density Polyethylene with Barium Sulfate for visibility under fluoroscopy by the attending physician during insertion. The sheath is composed of PTFE to provide a smooth, consistent peel.

#### E. Intended Use:

The Valved Tearaway Introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Medcomp Valved Tearaway Introducer Summary

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#### F. Comparison to Predicate Device:

The technological characteristics of the Valved Tearaway Introducers are substantially equivalent to the predicate devices in terms of intended use, design, material type, performance, and method of sterilization.

#### ું. Performance Data:

In Vitro performance data for the Medcomp Valved Tearaway Introducer, including peel force, demonstrates that this device is substantially equivalent to the legally marketed devices.

Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device.

#### માં. : Biocompatibility:

Biocompatibility testing demonstrates that the materials used meets the requirements of ISO 10993 for an external communicating device with limited duration blood path contact.

### Conclusion:

.

The Valved Tearaway Introducers have equivalent indications for use as the predicate devices. The bench testing and biocompatibility testing contained in our submission demonstrates that there are no differences in technological characteristics which would raise any new issues of safety or effectiveness. Thus, the Valved Tearaway Introducers are substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

MEDCOMP® % Ms. Jean Callow Regulatory Specialist 1499 Delp Drive Harleysville, PA 19438

Re: K090394

Trade/Device Name: Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Introducer Catheter Regulatory Class: Class II Product Code: DYB Dated: August 20, 2009 Received: August 21, 2009

Dear Ms. Callow:

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. Ilsting 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.

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

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Page 2 - Ms. Jean Callow

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duma R. Lochner

Image /page/3/Picture/8 description: The image shows the name "Bram Zuckerman, M.D." in a clear, sans-serif font. Below the name, the title "Director" is printed, also in a similar font style. The text is neatly aligned, suggesting a professional or formal document.

Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known):

K090394

Device Name: __ Valved Tearaway Introducer

Indications for Use:

THE VALVED TEARAWAY INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENOUS ACCESS TO FACILITATE CATHETER INSERTION INTO THE CENTRAL VENOUS SYSTEM.

Prescription Use X (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma D. Lachner

(الان-القات ، اللوات ، التالكات Division of Cardiovascular Devices

-10/k) Number

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