VALVED TEARAWAY INTRODUCER GENERATION II

K132498 · Medcomp (Medical Components, Inc.) · DYB · Nov 25, 2013 · Cardiovascular

Device Facts

• Record ID: K132498
• Device Name: VALVED TEARAWAY INTRODUCER GENERATION II
• Applicant: Medcomp (Medical Components, Inc.)
• Product Code: DYB · Cardiovascular
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Special
• 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 Generation II Valved Tearaway Introducer is a medical device used to facilitate the insertion of catheters into the central venous system. It functions as an access sheath that allows for the introduction of catheters while minimizing blood loss or air embolism through an integrated valve mechanism. The device is intended for use by trained clinicians in a clinical setting. By providing a secure and controlled access point, it assists in the placement of central venous catheters, thereby supporting patient treatment requiring long-term or intensive venous access.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device is a valved tearaway introducer designed for central venous access. It consists of a sheath and a dilator, with an integrated valve to prevent blood loss and air ingress during catheter placement. The tearaway feature allows for the removal of the sheath after the catheter is positioned. Materials are medical grade; sterilization is performed via standard methods.

Indications for Use

Indicated for patients requiring central venous access for catheter insertion 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.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 25, 2013

Medcomp, Inc. C/O Timothy Holwick Regulatory Associate 1499 Delp Dr. Harleysville, PA 19438 US

Re: K132498

> Trade/Device Name: Generation II Valved Tearaway Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: October 31, 2013 Received: November 01, 2013

Dear Mr. Holwick:

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.

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Page 2 - Mr. Timothy Holwick

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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 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.

M. Zeller

for 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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1499 Delp Drive

Hurleysville, PA 19438

Tel: [phone]

Fax: [phone]

www.medcompnet.com

## Indications for Use

K132498 510(k) Number (if known):

Device Name: Valved Tearaway Introducer Generation II

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 (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

M. Freeman

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