OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05

K031282 · LeMaitre Vascular, Inc. · LJT · Aug 5, 2003 · General Hospital

Device Facts

• Record ID: K031282
• Device Name: OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05
• Applicant: LeMaitre Vascular, Inc.
• Product Code: LJT · General Hospital
• Decision Date: Aug 5, 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 filtids, medications, antiblotics, nutritionals, and the withdrawl of blood samples.

Device Story

OptiLock Implantable Port provides long-term vascular access; used for intravascular injection, continuous infusion, or blood withdrawal. Device consists of an implantable port and catheter system. Operated by clinicians in clinical settings. Provides access point for delivery of medications, nutritionals, or antibiotics; facilitates blood sampling. Benefits patient by reducing need for repeated venipuncture.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Subcutaneous implanted, intravascular infusion port and catheter. 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 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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 5 2003

Mr. Brian Keogh Quality Assurance Supervisor LeMaitre Vascular, Incorporated 26 Ray Avenue Burlington, Massachusetts 01803

Re: K031282

Trade/Device Name: OptiLock Implantable Port Regulation Number: 880.5965 Regulation Name: Subcutaneous Implanted, Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: LJT Dated: April 18, 2003 Received: April 22, 2003

Dear Mr. Keogh

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. Keogh

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 (OS) 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 broceed 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.htm

Sincerely your.

Susan Runroe

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center of Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for LeMaitre Vascular. The logo consists of a stylized, abstract shape on the left, resembling a curved ribbon or wave within a square. To the right of the shape is the text "LeMaitre" in a bold, sans-serif font, with a trademark symbol next to it. Below "LeMaitre" is the word "VASCULAR" in a smaller, bolder font.

Indication Statement:

Page 1 of 1

K031282 510(k) Number (if known):

OptiLock Implantable Port 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 filtids, medications, antiblotics, nutritionals, and the withdrawl of blood samples.

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

510(k) Number . ______________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

Patricio Caccenote

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

510(k) Number. K031282