CELSITE/ CELSITE CONCEPT, ACCESS PORTS

K061424 · Aesculap, Inc. · LJT · Jul 31, 2006 · General Hospital

Device Facts

• Record ID: K061424
• Device Name: CELSITE/ CELSITE CONCEPT, ACCESS PORTS
• Applicant: Aesculap, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Jul 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

Device Story

Implantable port and catheter system providing repeated access to patient bloodstream. Used for administration of medications, fluids, parenteral nutrition, and blood sampling/transfusions. System consists of port chamber and catheter. Operated by clinicians in clinical settings. Provides safe, long-term vascular access; facilitates delivery of therapies and diagnostic blood draws.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Implantable subcutaneous port and catheter system. Materials and design are consistent with legally marketed predicate systems. No specific materials or standards provided.

Indications for Use

Indicated for patients requiring intravenous access for chemotherapy, antibiotics, anti-viral drugs, parenteral nutrition, blood sampling, or transfusions.

Regulatory Classification

Identification

A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

• Aesculap® Access Port Systems (K902401, K952548, K954297, K962230, K993024)
• Deitec Inc., PORT-A-CATH® II (K032557, K992697, K932840)

Submission Summary (Full Text)

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Kolo1424

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#### 510(k) SUMMARY (as required by 21 CFR 807.92) в.

### Celsite®/Celsite® Concept™ Access Ports May 3, 2006

JUL 3 1 2006

| COMPANY: | Aesculap®, Inc. |
|------------------------------------|-------------------------|
| | 3773 Corporate Parkway |
| | Center Valley, PA 18034 |
| Establishment Registration Number: | 2916714 |

- Lisa M. Boyle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
Celsite®/Celsite® Concept™ Access Ports TRADE NAME:

Port & Catheter, Implanted, Subcutaneous, Intravascular COMMON NAME:

### CLASSIFICATION NAME: Port & Catheter, Implanted, Subcutaneous, Intravascular 880.5965 REGULATION NUMBER: LJT PRODUCT CODE:

## SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the Celsite®/ Celsite® Concept™ Access Ports are substantially equivalent to Aesculap's currently marketed Celsite® Access Port Systems (K902401, K952548, K954297, K962230, K993024) and Deitec Inc., PORT-A-CATH® II (K032557, K992697, K932840).

# DEVICE DESCRIPTION

The Celsite®/ Celsite® Concept™ Access Ports are an implantable port and catheter system which allows safe, repeated access to the patient's bloodstream. The port chamber and catheter design can be used for the administration of medications and fluids.

### INDICATIONS FOR USE

The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

# TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s)}

The Aesculap Celsite®/ Celsite® Concept™ Access Ports is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing results of the subject device showed to be similar in performance to the previously cleared Aesculap® Access Ports with similar indications.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 1 2006

Ms. Lisa Boyle Regulatory Affairs Specialist Aesculap®, Incorporated 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K061424

Trade/Device Name: Celsite®/Cclsite® Concept™ Access Ports Regulation Number: 880.5965 Regulation Name: Subcutaneous. Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: Mav 22, 2006 Received: May23, 2006

Dear Ms. Boyle:

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 Hi (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. Boyle

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.

Chi-Lin, Ph.D.

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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#### A. INDICATIONS FOR USE STATEMENT

510(k) Number:_j/061424

Device Name:

Indications for Use:

The Aesculap Celsite®/Celsite® Concept™ Access Ports are indicated for intra-venous administration of drugs for chemotherapy, antibiotics and anti-viral drugs, and for parenteral nutrition, blood sampling or transfusions.

| Prescription Use | X | and/or Over-the-Counter Use | |
|-----------------------------|---|-----------------------------|--|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ad. D. Peranio 7/31/2006

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