OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05

K021580 · LeMaitre Vascular, Inc. · LJT · Feb 12, 2003 · General Hospital

Device Facts

• Record ID: K021580
• Device Name: OPTILOCK IMPLANTABLE ACCESS PORT, MODELS #1700-01, 1700-02, 1700-03, 1700-04 AND 1700-05
• Applicant: LeMaitre Vascular, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5965
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OptiLock Implantable Port is designed for patients who require repeated long term access to the vascular system for intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples. The OptiLock Introducer Kit is designed to assist in obtaining access to the vascular system for OptiLock Port catheter placement. The OptiLock Anti-coring needle is designed to gain intracutaneous access to the OptiLock Port septurn for injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

Device Story

OptiLock system comprises implantable port, introducer kit, and anti-coring needles. Port provides long-term vascular access for infusion/aspiration; introducer kit facilitates catheter placement; anti-coring needles provide access to port septum. Used in clinical settings by healthcare professionals for patients needing chronic therapy (e.g., chemotherapy, nutrition). Device enables repeated access without repeated venipuncture, reducing patient trauma and infection risk.

Clinical Evidence

bench testing only

Technological Characteristics

Subcutaneous, implanted, intravascular infusion port and catheter system. Includes port, introducer kit, and anti-coring needles. Class II device (Product Code LJT).

Indications for Use

Indicated for patients requiring repeated long-term vascular access for infusion of fluids, medications, antibiotics, nutritionals, or venous blood sampling.

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## FEB 1 2 2003

Mr. James Ashby Quality Assurance Specialist LeMaitre Vascular, Incorporated 26 Ray Avenue Burlington, Massachusetts 01803

Re: K021580

Trade/Device Name: The LeMaitre Vascular OptiLock Implantable Port Kit, The LeMaitre Vascular OptiLock Introducer Kit, The LeMaitre Vascular OptiLock Port Compatible Anti-coring Needles Regulation Number: 880.5965 Regulation Name: Subcutaneous, Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: December 26, 2002 Received: January 6, 2003

Dear Mr. Ashby:

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. Ashby

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.

usen Josen Joseph 1982 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1992 to 1999 to 1999 to 1999

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

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K021580 510(k) Number (if known):

OptiLock Implantable Kit Device Name:

Indications For Use:

The OptiLock Implantable Port is designed for patients who require repeated long term access to the vascular system for intravascular injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

The OptiLock Introducer Kit is designed to assist in obtaining access to the vascular system for OptiLock Port catheter placement

The OptiLock Anti-coring needle is designed to gain intracutaneous access to the OptiLock Port septurn for injection or continuous infusion of fluids, medications, antibiotics, nutritionals and the withdrawal of venous blood samples.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ruben Cuente

Division Signion of Anesthesionav. C ontrol. Dental

510(k) Number: K021588

(Optional Format 3-10-98)