ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

K041420 · AngioDynamics, Inc. · LJS · Jul 26, 2004 · General Hospital

Device Facts

• Record ID: K041420
• Device Name: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jul 26, 2004
• Decision: SESE
• Submission Type: Traditional
• 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. The device is indicated for central venous system access for the administration of fluids, medications, and blood products, and for blood sampling. Power injection of contrast media is indicated for use with a 4 French or larger catheter.

Device Story

Morpheus™ CT PICC is a percutaneous, long-term, central venous catheter. Device provides peripheral access to central venous system for infusion of fluids, medications, blood products, and blood sampling. Features power injection capability for contrast media in 4 French or larger sizes. Used in clinical settings by healthcare professionals for patients requiring vascular access. Device facilitates therapy delivery and diagnostic imaging procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Percutaneous, long-term, central venous catheter. Materials include radiopaque polyurethane. Designed for power injection of contrast media (4F+ sizes). Sterilized via ethylene oxide. Standalone device; 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, including fluid/medication administration, blood sampling, and power injection of contrast media (for 4F or larger catheters).

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.”

Predicate Devices

• AngioDynamics PICC (K033666)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 2 6 2004

Mr. Teri Juckett Regulatory Affairs Manager AngioDynamics, Incorporated 603 Queensbury Avenue Queensbury, New York 12804

Re: K041420

Trade/Device Name: AngioDynamics, Incorporated Morpheus™ CT PICC and Procedure Kit Regulation Number: 880.5970 Regulation Name: Percutaneous Implanted Long-Term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: May 26, 2004 Received: May 28, 2004

Dear Mr. 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 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 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 - Mr. 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/dsma/dsmamain.html

Sincerely yours,

Susan Runne

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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## Indications for Use

510(k) Number (if known): K041420

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

Indications For Use:

The AngioDynamics, Inc. Morpheus™ CT PICC and Procedure Kit is indicated for short or long 111e AngloDynamillo, mo. Morpheas
term peripheral access to the central venous system for intravenous therapy and power injections term penpherar aboob to the ocharing, infusion, or therapy use a 4 French or larger catheter.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruase

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

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510(k) Number: K041420