MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S

K090114 · Oscor, Inc. · DYB · Jun 4, 2009 · Cardiovascular

Device Facts

• Record ID: K090114
• Device Name: MODIFICATION TO:INTRODUCER SETS, MODEL ADELANTE AND ADELANTE-S
• Applicant: Oscor, Inc.
• Product Code: DYB · Cardiovascular
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1340
• Device Class: Class 2

Intended Use

The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.

Device Story

Introducer sets (Adelante Sigma, Adelante Sigma AT, Adelante Targa) facilitate percutaneous insertion of pacing leads and catheters into the vascular system. Used by clinicians in clinical settings. Device consists of introducer sheath and dilator components. Operates via standard percutaneous entry techniques to provide access path for diagnostic or therapeutic devices. Benefits include reliable vascular access for cardiac procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Introducer sheath and dilator set. Materials and design consistent with standard catheter introducer devices (21 CFR 870.1340).

Indications for Use

Indicated for the introduction of pacing leads and catheters into the body.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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## Public Health Service

ood and Drug Administration 200 Corporate Boulevard Rockville MD 20850

## JUN - 4 2009

Oscor, Inc. c/o Ms. Mila Doskocil Director of Regulatory Affairs/Compliance 3816 De Soto Boulevard Palm Harbor, FL 34683

Re: K090114

Trade/Device Name: Introducer Set, Models Adelante Sigma, Adelante Sigma AT, and Adelante Targa Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 1, 2009

Received: May 5, 2009

Dear Ms. Doskocil:

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. Mila Doskocil

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 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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours,

R. Valenes

Image /page/1/Picture/6 description: The image contains a handwritten symbol or signature on the left side. To the right of the symbol, there are three lines of text, but the text is illegible due to the image quality. The symbol appears to be a stylized letter or a unique design.

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): K090114

Device Name: Introducer Sets, models Adelante Sigma, Adelante Sigma AT, and Adelante Targa

Indications For Use: The Introducer sets, models Adelante Sigma, Adelante Sigma AT and Adelante Targa are indicated for the introduction of pacing leads and catheters into the body.

Over-The-Counter Use AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dana R. Holmes

்vision Sign-Off) Orvision of Cardiovascular Devices

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