FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER

K120304 · Footprint Medical, Inc. · FOS · Mar 1, 2012 · General Hospital

Device Facts

• Record ID: K120304
• Device Name: FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER
• Applicant: Footprint Medical, Inc.
• Product Code: FOS · General Hospital
• Decision Date: Mar 1, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

Device Story

Footprint Medical Polyurethane Umbilical Catheter is an intravascular device designed for neonatal care. It provides access for blood sampling, hemodynamic monitoring (blood pressure), and intravenous fluid administration. The catheter is inserted into the umbilical artery or vein by clinical staff in a hospital setting. It functions as a conduit for fluid/blood transport between the patient's circulatory system and external monitoring or infusion equipment. The device facilitates essential neonatal life support and diagnostic monitoring.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Polyurethane intravascular catheter; designed for neonatal umbilical access. Functions as a passive conduit for fluids and pressure monitoring. Class II device under 21 CFR 880.5200.

Indications for Use

Indicated for neonatal patients requiring intravenous fluid administration, blood pressure monitoring, or blood sampling.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Mr. Clyde Baker Regulatory Manager Footprint Medical Inc. 1203 Camden Street San Antonio, Texas 78215

MAR - 1 2012

Re: K120304

Trade/Device Name: FOOTPRINT MEDICAL POL YURETHANE UMBILICAL CATHETER

Regulation Number: 21 CFR 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOS Dated: January 26, 2012 Received: February 1, 2012

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 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. 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 Eederal 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

്ലം Anthony D. Watson, B.S., M.S., M.B.A. 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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# INDICATIONS FOR USE STATEMENT

510(K) NUMBER (if known): K /20 3044

### FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER DEVICE NAME:

## INDICATIONS FOR USE:

This product is intended for use in neonatal patients to sample blood, monitor blood pressure, or administer fluids intravenously.

# CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION

PRESCRIPTION USE XX (per 21 CFR 801.109)

OR

Over, The Counter Use

(Division Sign Off) 2/28/12

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

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510(k) Number: _ K/20504