FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

K130507 · Footprint Medical, Inc. · LJS · Jun 3, 2013 · General Hospital

Device Facts

• Record ID: K130507
• Device Name: FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER
• Applicant: Footprint Medical, Inc.
• Product Code: LJS · General Hospital
• Decision Date: Jun 3, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.

Device Story

Footprint Medical Polyurethane PICC Catheter is a percutaneous, implanted, long-term intravascular catheter. Device provides venous access for delivery of medications, TPN nutritional solutions, and fluids to neonatal and small pediatric patients. Operated by clinicians in hospital settings. Device functions as a conduit for fluid therapy; no electronic or software components involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Polyurethane PICC catheter; percutaneous, implanted, long-term intravascular design. Class II device (21 CFR 880.5970).

Indications for Use

Indicated for neonatal and small pediatric patients requiring administration of medications, TPN nutritional solutions, and intravenous fluids.

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2013

Mr. Clyde N. Baker Regulatory Manager Footprint Medical, Incorporated 12727 Cimarron Path SAN ANTONIO Texas 78249

Re: K130507

Trade/Device Name: Footprint Medical Polyurethane PICC Catheter Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-Term intravascular catheter Regulatory Class: II Product Code: LJS Dated: May 1, 2013 Received: May, 15, 2013

Dear Mr. Baker:

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 10. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Baker

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

v.signed by Mary S. Runner -S 00300 100 1 1=130008 2013.06.03 15:00:14 -04'00 Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): K-130507

DEVICE NAME: FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER

## INDICATIONS FOR USE:

This product is intended for use in the neonatal and small pediatric patient. PICC Catheters are indicated when: Medications, TPN nutritional solutions, and Intravenous infusion of fluids are needed.

PRESCRIPTION USE XX (per 21 CFR 801 Subpart D)

OR

Over The Counter Use (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

Image /page/2/Picture/15 description: The image shows the FDA logo. The logo is made up of the letters "FDA" in a stylized font. The letters are outlined with multiple lines, giving the logo a three-dimensional appearance. The logo is simple and recognizable.

Richard C. Chapman 2013.06.03 14:26:30 -04'00'

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

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510(k) Number. Ki30507