MEDCOMP VASCU-SHEATH II

K053092 · Medcomp · DYB · Aug 1, 2006 · Cardiovascular

Device Facts

• Record ID: K053092
• Device Name: MEDCOMP VASCU-SHEATH II
• Applicant: Medcomp
• Product Code: DYB · Cardiovascular
• Decision Date: Aug 1, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

Vascu-Sheath® II introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

Device Story

Vascu-Sheath® II is a two-part, single-use vascular access device consisting of a peelable introducer sheath and a vessel dilator. Used by clinicians to obtain percutaneous access to the central venous system. The dilator, composed of high-density polyethylene with barium sulfate for fluoroscopic visibility, extends beyond the sheath to ensure zero-tolerance clearance during insertion. The sheath is composed of PTFE to facilitate smooth, consistent peeling. In practice, the device is used in conjunction with an introducer needle and guidewire to create an opening; once the dilator is removed, a catheter is inserted through the sheath. The sheath hub is then broken, and the sheath is peeled away from the catheter for removal. The device facilitates efficient catheter placement, benefiting patients by providing a reliable pathway for central venous access.

Clinical Evidence

Bench testing only. In vitro performance data, including peel force testing, was provided to demonstrate substantial equivalence. No clinical studies were deemed necessary to establish safety and effectiveness.

Technological Characteristics

Two-part introducer system consisting of a peelable sheath and vessel dilator. Materials: High-density polyethylene (dilator) with barium sulfate for radiopacity; PTFE (sheath). Dimensions: Dilator lengths of 5cm, 10cm, and 13.5cm; French sizes 5F-7F (5/10cm lengths) and 5F-18F (10cm length). Single-use. Non-electronic, mechanical device.

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

• TFX Medical Introducer Assembly (K993191)
• Medcomp Vascu-Sheath® (K022513)

Submission Summary (Full Text)

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## 510(k) SUMMARY

# < 053092

Introducer Set

### Submitter Information: A.

MEDCOMP® Submitter: AUG () 1 2006 1499 Delp Drive Harlevsville, PA 19438 [phone] Telephone [phone] Fax Contact: Jean Callow Regulatory Specialist Date Prepared: October 25, 2005 B. Trade Name: Vascu-Sheath® II Common Name: Introducer, Catheter Classification: DYB 870.1340 C.F.R. Section: C. Predicate Device: K993191 TFX Medical Introducer Assembly K022513 Medcomp Vascu-Sheath®

### Device Description: D.

The Medcomp Vascu-Sheath® II is a two-part single use device used to obtain vascular access and facilitate intravascular catheter insertion. The Medcomp Vascu-Sheath® II consists of a peel-able introducer sheath and vessel dilator. The dilator is comprised of a cylindrical tube with a hub; the sheath is also a cvlindrical tube with a hub. The dilator extends beyond the sheath to provide a zero tolerance clearance between sheath and dilator. The device is available in three dilator lengths, 5cm, 10cm and 13.5cm and a range of French sizes from 5F thru 7F for the 5 and 10cm lengths and 5F thru 18F for the 10cm length. 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 sheaths 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 in the dilator 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:

Vascu-Sheath® II introducers are intended to obtain central venous access to facilitate catheter insertion into the central venous system.

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### г. Comparison to Predicate Device:

The technological characteristics of the Vascu-Sheath® II are substantially equivalent to the predicate devices in terms of intended use, design, material type, performance, and method of sterilization.

### G. Performance Data:

In Vitro performance data for the Medcomp Vascu-Sheath® II, including peel force, demonstrates that this device is substantially equivalent to the legally marketed device.

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.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 1 2006

Medcomp c/o Ms. Jean Callow Regulatory Specialist 1499 Dale Drive Harleysville, PA 19438

Re: K053092 Vascu-Sheath® II Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: II Product Code: DYB Dated: June 29, 2006 Received: June 30, 2006

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. Iisting 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 such 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. Jean Callow

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely vours.

tin R. Richner

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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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### Indications for Use

510(k) Number (if known): ___053092___________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

VASCU-SHEATH II® II INTRODUCERS ARE INTENDED TO OBTAIN CENTRAL VENTRAL VENOUS CHIPEL 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)

Diving P b. Junes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_i 5 2 2 10(k) 10(510

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