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{0}------------------------------------------------ TEND Medical Lat igada # 510(k) Summary: Company Name: Migada Plant Contact Person: Ido Kanyon Manager, Quality Assurance and Regulatory affairs Phone: +972-4-690-8826 Fax: +972-3-9267865 E-mail: ido.kanyon@teva.co.il 121269 x ## US Agent: Mr. Stephen H. Lieberman Donowa Consulting LLC 4545 N. Ocean Blvd., Unit 11A Boca Raton, Florida 33431 Phone: (561) 302 0777 E-mail: Lieberman@donawa.com Date prepared: April 15, 2012 (revised on December, 2012) Trade Name: I.V. Administration Set Common/usual name: I.V. administration set Classification name: Set, Administration, Intravascular ## 5-2 JAN 2 2 2013 {1}------------------------------------------------ TEND Medical use ## Product Code: FPA Regulation No.: 880.5440 Class: II ### Panel identification: General Hospital Panel ### Description of the device: The I.V. Administration Set is single use, sterile, non-pyrogenic device used to administer intravenous solutions and/or drugs solutions from a container to a patient's vascular system. This device is not made with natural rubber latex. The I.V Administration set is comprised of various generic components which are broadly used through the industry such as: Spike, drip chamber, Y-site, tubing, flow regulator, clamp, needless injection site and luer connection. The set may include two unique components: - 1. Spike: The Spike is intended for connection to the spike port of an infusion bag. In cases when a drug needs to be introduced, a septum enables connection to the Tevadaptor™ Syringe Adaptor for withdrawal of diluents or introduction of drug. - 2. ULTRASITE In Injection site (cleared under 510(k) No. K031923). The Ultrasite Valve is a needle-free, cap less positive displacement valve to be use in place of needles for the administration of fluids. The ULTRASITE™ Valve may be accessed with standard male luer connectors and requires no special accessories devices. The Ultrasite device eliminates the use of needles to access the set during IV administration and aids in the prevention of needle stick injuries. Teva Medical Migada Plant offers both standard and custom sets with tubing of various lengths to meet customer requirements and specifications. #### Intended Use: The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system. ## Conclusion - The evaluation of the I.V. Administration Set does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices. 5-3 Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tel: +972-4-6908800 {2}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 ### January 22, 2013 Mr. Ido Kanyon Manager, Quality Assurance and Regulatory Affairs Migada Plant North Industrial Zone Kiryat Shmona, Israel 10258 Re: K121269 Trade/Device Name: I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 6, 2012 Received: December 13, 2012 Dear Mr. Kanyon: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enorosale) to regary the Medical Device Ameral Food and Food Food Food Drys commerce prov to May 20, 1978, the encordance with the provisions of the Federal Food, Drug, uevices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The 1 ou may, therefore, market the do requirements for annual registration, listing of general controls provisions of uabeling, and prohibitions against misbranding and devices, good manufacturing pravates, not evaluate information related to contract liability autheration. I lease note: ODAT doos not over in the 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 your device is classified (see above) . Existing major regulations affecting your device can be It may be subject to additional controllar shilling millions and to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA is issualled of a backed on a suith other requirements of the Act that I DA has made a decommandinan administered by other Federal agencies. You must or any Federal statures and regulations daminding, but not limited to: registration and listing (21 comply with all the Act 3 requirements, morations, morting (reporting (reporting of medical CFK Fall 607), labeling (21 OFR 803); good manufacturing practice requirements as set device-related adverse events) (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, 1950 iorul in the quality systems (Q5) regalicns (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 If you desire specific advice for your devices of our accessor offices/ucm 115809.htm for go to mip://www.ida.gov/About Drives.html s (CDRH's) Office of Compliance. Also, please the Center for Devices and Radiological Health's (CDRH's) Office of COLORE Box the Center 10 Devices and Radionegroung by reference to premarket notification" (21 CFR Part note the regulation entitled, "Misorananing of reference to presents 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 You may obtain other general miorinations on Joan Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 036-2041 of (2017) 720 Devices/ResourcesforYou/Industry/default.htm. Sincerely yours, Anthong to min Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, ·Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ **TEVA** Medical Ltd igada INDICATIONS FOR USE | 510(k) Number (if | K121269 | |-------------------|------------------------------------------| | known): | Carolina Collegal Concession of Children | Device Name: I.V. Administration Set Indications for Use: The I.V. Administration Set is a single use, sterile I.V. set for administration of drugs and/ or fluids from a container to a patient vascular system. OR Prescription Use X (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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE): Digitally signed by Richard C. Chapman Date: 2013.01.22 14:09:12 -05'00' (Division Sign-Off) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Devices Division of Antsulocio.org Infection Control, Dental Devices 17.1269 510(k) Number:_ 4-2 Teva Medical Ltd. Migada Plant - Industrial Zone Kiryat Shmona, ISRAEL, Tei: +972-4-6908800