ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT

K030415 · AngioDynamics, Inc. · LJS · Apr 30, 2003 · General Hospital

Device Facts

• Record ID: K030415
• Device Name: ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT
• Applicant: AngioDynamics, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Apr 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

Device Story

Morpheus™ PICC and Procedure Kit provides peripheral access to central venous system. Used for intravenous therapy and blood sampling. Device consists of peripherally inserted central catheter (PICC) and associated procedure kit components. Intended for clinical use by healthcare professionals. Facilitates delivery of fluids, medications, and blood withdrawal. Benefits include established venous access for patients requiring therapy.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Percutaneous, implanted, long-term intravascular catheter. Class II device (21 CFR 880.5970).

Indications for Use

Indicated for patients requiring short or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

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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Public Health Service

APR 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K030415

Trade/Device Name: AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: March 24, 2003 Received: March 26, 2003

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 vours.

Susan Runroe

Susan Runner, DDS, MA Interim 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) Application: New Application

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

## Indications for Use:

The AngioDynamics, Inc. Morpheus™ PICC and Procedure Kit is indicated for short or long term peripheral access to the central venous system for intravenous therapy and blood sampling.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

**Prescription Use** ✓

Over-the-Counter Use

(Per 21 CFR 801.109)

Patricia Crescenti

n of Anesthesiology, General Hospital, Infection Control, Dental D

510(k) Number: K030715