MACLIN POWER INTRAVASCULAR ADMINISTRATION SET

{0}------------------------------------------------ # KI2151 Maclin Power Inc. 510(K) NOTIFICATION Maclin Power IV Administration Set ### Section 05 510(k) Summary ### MAR 0 7 2013 ## 510 (k) Summary of safety and effectiveness #### APPLICANT Company Name: Company Address: Company Phone: Company Fax: Company e-mail Maclin Power, Inc. 1465 Northwest, 97th Avenue Miami, FL 32172 (305) 591-0181 (305) 591-0707 maclinpower@yahoo.com Contract Manufacturer: Multimedical s.r.l. Via Guido Rossa, 71 46019 Viadana (MN) Italy #### CONTACT PERSON: Contact Phone: Contact Fax Contact E-mail Studio ingegneria Enrico Bisson +39 0498630080 +39 0498630080 enrico.bisson@isoplan.org Date Summary Prepared: March 26, 2012 Enrico Bisson #### DEVICE IDENTIFICATION B. - Maclin Power IV administration set A. Trade name: - Generic/ Common Name: Intravascular Administration Set - Intravascular Administration Set, 21 CFR 880.5440, Class II ். Classification name: - D. Product Code: FPA ### LEGALLY MARKETED DEVICES (PREDICATE DEVICES) CLAVE Connector, ICU Medical Inc., K970855 VITALCARE I.V. ADMINISTRATION SET, VITALCARE GROUP, INC, K050906 BURETTE-IN LINE, TUTA HEALTHCARE PTY, K023595 INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET, LIFEMED OF CALIFORNIA, K001329 {1}------------------------------------------------ Maclin Power Inc. 510(K) NOTIFICATION #### INTENDED USE The Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. #### DEVICE DESCRIPTION The Maclin Power Intravascular Administration Sets are devices used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include one or more of the following: tubing, flow regulators, drip chamber, filters, backflow valves, fluid delivery tubing, clamps, connectors between parts of the set, needleless connectors, needleless Y sites, burettes, extension sets, Y tubing connector, protection caps and a hollow spike to connect the tubing to an IV bag or other infusion fluid container. Maclin Power will offer both standard sets and custom sets to meet customer specifications. #### DISCUSSION OF NON CLINICAL TESTS Bench test and biocompatibility tests were performed on the device and are included in this submission. The results of these tests supported the safety and effectiveness of the Maclin Power IV administration sets. #### SUBSTANTIAL EQUIVALENCE The indications for use of the Maclin Power IV administration set are substantially equivalent to the indications for use of the predicate devices. Materials used are similar and technological characteristics do not show any significant difference. In further support of a substantial equivalence determination, this submission provides a comparison chart of the submitted device and the predicate devices. Based on the available information, we conclude that the Maclin Power IV administration set is substantially equivalent to the existing legally marketed devices under Federal Food, Drug and Cosmetic Act. Therefore, the applicant device is determined as safe and effective. Section 5 rev 0 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 いた #### March 7, 2013 Maclin Power, Incorporated C/O Mr. Enrico Bisson President Studio DI Ingegneria Enrico Bisson Via Marzia, 9 Abano Terme, PD Italy 35031 Re: K121511 Trade/Device Name: Maclin Power Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 25, 2013 Received: March 1, 2013 Dear Mr. Bisson: 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 Federal Register. {3}------------------------------------------------ Page 2 - Mr. Bisson 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Image /page/3/Picture/6 description: The image contains a complex, hand-drawn design with a combination of geometric and cursive elements. The word "for" is visible in the upper left corner. There are also some other words that are difficult to read. The design includes a series of parallel lines, curved shapes, and triangular patterns, creating a dense and intricate composition. Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Maclin Power IV Administration Set ### Section 04 Indications for Use Statement ### INDICATIONS FOR USE 510(k) Number (if known): K121511 Device Name: Maclin Power Administration Set Indications for Use: The Maclin Power intravascular administration is a single use, sterile device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) Page 4 - 1 (Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/4/Figure/20 description: The image shows the FDA logo. The logo is a stylized version of the letters FDA. The letters are outlined in black and white. The logo is simple and recognizable. 510 Richard C. Chapman 2013.03.07 10:43:06 05.00 esiology, General Hospital Section4 rev 0