6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for medCOMP. The logo consists of a geometric shape above the word "medCOMP." The geometric shape is made up of black and white lines and a circle. The word "medCOMP" is written in a serif font. Se A B. (j 1499 Delp Drive Harleysville, PA 19438 Tel. 215-256-4201 Fax: 215-256-1787 www.medcompnet.com | Section 5 | 510(k) SUMMARY | Traditional 510K | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------| | Submitter Information: | | | | Submitter: | MEDCOMP®<br>1499 Delp Drive<br>Harleysville, PA 19438<br>Tel: (215) 256-4201, x2271<br>Fax: (215) 256-9191 | | | Contact: | Jessica Leo | | | | Regulatory Associate | | | Date Prepared: | June 7, 2013 | | | Trade Name: | Medcomp® Pro-Line ^CT Power Injectable CVC | | | Common Name: | power injectable central venous catheter | | | Classification Name: | Long Term Intravascular Catheter (80 LJS) | | | Regulation Name: | Percutaneous, implanted, long-term intravascular catheter | | | C.F.R. Section: | 880.5970 | | | Class: | II | | | Predicate Devices: | K092347, Medcomp® Pro-PICC ^CT<br>K121094, Medcomp® Vascu-PICC and Midline Catheters<br>K093309, Medcomp® Pro-Line™ CT Power Injectable CVC<br>K123617, Medcomp® Pro-PICC ^CT | | | | | | | AUG 16 2013 | | | KI31687 #### D. Device Description: The Pro-Line of Power Injectable CVC triple lumen is an open-ended triple lumen catheter designed for power injection through one designated lumen. The power injectable central venous catheter is comprised of a soft radiopaque polyurethane material. The lumen has a reverse taper design and is connected to the extensions via a soft pliable hub with suture wing for secure placement. Clamps are provided on the extension tubes to prevent air/fluid communication. Female luer connectors provide the connection for intravenous administration. The designated 17ga. power injectable extension line and clamp material are purple in color to differentiate it from the clear 19ga. non-power injectable extensions. The purple lumen identifies it as a power injectable catheter. The center extension is also printed with the words power injectable. The I.D. Ring within the clamp on the power extension contains information regarding checking for blood return and flushing along with rate of infusion for power injection. The catheter has a usable length of 60 cm with numerical markings every 5 cm and depth markings in 1 cm increments. Stylet and adaptor sideport are provided to assist in catheter insertion. Medcomp Pro-Line OCT Power Injectable CVC Triple Lumen Summary Page 1 of 3 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo with the text "medCOMP." below it. The logo is a stylized design featuring geometric shapes in black and white. The shapes include a circle and angled lines, creating an abstract and modern look. 1499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax: 215-256-1787 www.medcompnet.com The catheter is packaged sterile with the necessary accessories to facilitate catheter insertion. # Indications for Use: ដើ The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering L.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal. allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is Scc/sec. F. Comparison to Predicate Devices: > The Pro-Line on Power Injectable CVC is substantially equivalent to the predicate devices in terms of intended use, anatomical location, basic design, materials, performance, labeling, manufacturing process and method of sterilization. ## () Bench / Performance Data: Performance data for the Pro-Line CT Power Injectable CVC demonstrates that this device is substantially equivalent to the legally marketed device. Performance testing of the proposed device was conducted in accordance with applicable international standards and along with internal engineering protocols. The results of these tests in conjunction with the substantial equivalence claims effectively demonstrate the proposed devices are equivalent to the predicate devices. # ਜ਼. Biocompatibility: Testing for all materials used for the Pro-Line of Power Injectable CVC has been submitted in previously cleared Medcomp devices. All biocompatibility testing demonstrates the materials used meet the requirements of ISO 10993. ### Technological Characteristics: I. Technological similarities between the proposed device and predicate devices remain the same. ### ... Summary of Substantial Equivalence: The proposed device meets the performance criteria of design verification as specified by ISO standards. guidance documents and internal test protocols. The proposed device has the same intended use, operation and function as the predicates. There are no differences that raise new issues of safety and effectiveness. The proposed device is substantially equivalent to the legally marketed predicate device. Medcomp Pro-Line T Power Injectable CVC Triple Lumen Summary Page 2 of 3 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows a logo with a geometric design above the word "medCOMP." The geometric design consists of a combination of curved and straight lines, creating an abstract shape. The word "medCOMP" is written in a stylized font, with the letters appearing to be italicized. The logo has a professional and modern look. 1 499 Delp Drive Harleysville, PA 19438 Tel: 215-256-4201 Fax: 215-256-1787 www.medcompnet.com Clinical studies were not deemed necessary since in-vitro testing was sufficient to demonstrate safety and effectiveness by way of comparison to the legally marketed predicate device. Medcomp Pro-Line Power Injectable CVC Triple Lumen Summary Page 3 of 3 {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002 Agust 16, 2013 Medical Components, Incorporated Ms. Jessica Leo Regulatory Associate 1499 Delp Drive HARLEYSVILLE PA 19438 Re: K131687 Trade/Device Name: Pro-Line™CT Power Injectable CVC Regulation Number: 21 CFR 880.5970 Regulation Name: Percutaneous, Implanted, Long-term Intravascular Catheter Regulatory Class: II Product Code: LJS Dated: June 7, 2013 Received: June 11, 2013 Dear Ms. Leo: 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 for association to May 28, 1976. the enactment date of the Medical Device Amendments, or to eonimers 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. {4}------------------------------------------------ Page 2 - Ms. Leo 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours, Mary S. Runner -S 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 {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): _ K131687 Pro-Line @CT Power Injectable CVC_____________________________________________________________________________________________________________________________________________ Device Name: Indications for Use: The Medcomp@ 6F Triple Pro-Line® CT Power Injectable CVC is indicated for short or long term access to the central venous system. It is designed for administering I.V. fluids, blood products, drugs, and parenteral nutrition solutions. as well as blood withdrawal, allows for central venous pressure monitoring and power injection of contrast media. The maximum recommended infusion rate is 5cc/sec. X Prescription Use AND/OR (Part 21 CFR 801 Subpart D) Over - The-Counter Use (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) | Richard C. Chapman | |---------------------| | 2013.08.15 13:26:29 | | -04'00' | Page _1_of_1_ (Division Sign-Off) Division of Anesthesiology, General Hospital Respiratory, Infection Control and Dental Devices 510 (k) Number: ___K131687____________________________________________________________________________________________________________________________________________________