ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT

K060887 · AngioDynamics, Inc. · LJS · Apr 28, 2006 · General Hospital

Device Facts

• Record ID: K060887
• Device Name: ANGIODYNAMIC, INC. MORPHEUS CT PICC AND PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. For blood sampling, infusion, or therapy use a 4 French or larger catheter.

Device Story

Morpheus™ CT PICC is a percutaneous, long-term intravascular catheter; provides peripheral access to central venous system. Used for intravenous therapy and power injection of contrast media. Procedure kit includes necessary components for insertion. Operated by clinicians in clinical settings. Enables delivery of fluids, medications, and contrast agents; facilitates blood sampling. Benefits include reliable venous access for diagnostic imaging and therapeutic administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous, long-term intravascular catheter. Designed for central venous access. Supports power injection of contrast media. Materials and dimensions consistent with standard PICC specifications. No software or electronic components.

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. Blood sampling, infusion, or therapy requires a 4 French or larger catheter.

Regulatory Classification

Identification

A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 2006

Ms. Teri Juckett Regulatory Affairs Manager ANGIODYNAMICS, Incorporated 603 Queensbury Avenue Queensbury, New York 12804

Re: K060887

Trade/Device Name: AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit Regulation Number: 880.5970 Regulation Name: Percutaneous, Inplanted, Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 29, 2006 Received: April 11, 2006

Dear Ms. Juckett:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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 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. Juckett

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 yours,

Clues

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 660887

## INDICATIONS FOR USE

510(k) Application: Special 510K Application

AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit Device Name:

Indications for Use:

The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and power injections of contrast media. For blood sampling, infusion, or therapy use a 4 French or larger catheter.

Prescription Use (Per 21 CFR 801.109)

OR

Over-the-Counter Use

Please do not write below this line - continue on another page if needed

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony V. nora

Divison Sig Carision of Anesthaniology, General Hospital, Infection Control. Dental Devices

510(k) Number: *K140613*