2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC

K120981 · Medical Components, Inc. · LJS · May 2, 2012 · General Hospital

Device Facts

• Record ID: K120981
• Device Name: 2.6F X 20CM VASCU-PICC 2.6F X 50CM VASCU-PICC
• Applicant: Medical Components, Inc.
• Product Code: LJS · General Hospital
• Decision Date: May 2, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5970
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The 2.6F Vascu-PICC® catheters are indicated for short or long term access to the central venous system in neonates, infants, and children for the administration of fluids, medication, and nutritional therapy.

Device Story

2.6F Vascu-PICC is a percutaneous, implanted long-term intravascular access catheter. Used for central venous access in pediatric populations (neonates, infants, children). Facilitates administration of fluids, medications, and nutritional therapy. Operated by clinicians in clinical settings. Device provides venous access; does not involve complex signal processing or software-based analysis.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Percutaneous, implanted long-term intravascular access catheter. 2.6F diameter. Class II device (Product Code: LJS). Mechanical device; no energy source, software, or algorithm.

Indications for Use

Indicated for short or long-term central venous access in neonates, infants, and children for fluid, medication, and nutritional therapy administration.

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

Ms. Jean Callow Regulatory Specialist Medcomp 1499 Delp Drive Harleysville, Pennsylvania 19438

MAY - 2 2012

Re: K120981

Trade/Device Name: 2.6F Vascu-PICC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, implanted long-term intravascular access catheter Regulatory Class: Class II Product Code: LJS Dated: March 30, 2012 Received: April 2, 2012

Dear Ms. Callow

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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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/ucm115809.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,

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

Enclosure

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## Indications for Use

12098 510(k) Number (if known): _

Device Name: 2.6F Vascu-PICC®

Indications for Use:

The 2.6F Vascu-PICC® catheters are indicated for short or long term access to The 2.6F Vascu-PICO& Cathetoro and interest in in neonates, infants, and nutriti the central venous system wa pemphonen inforcent in the medication, and nutitional therapy.

Katuca L. Arnold for RZC

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

510(k) Number: K12

Over-The-Counter Use Prescription Use X_ Prescription Use X_
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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