VIAL2BAG

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS Ltd. The logo features the letters "MOP" in a bold, sans-serif font, with a globe-like image placed behind the letters. Below the letters, the word "MEDIMOP" is written in a similar font, and below that, the full name of the company, "MEDICAL PROJECTS Ltd.", is written in a smaller font. K072759 17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com DEC 1 3 2007 1 # 510(k) summary for the VIAL2BAG (as required by section 807.92) 510(k) Notification submitted by: Medimop Medical Projects Ltd. 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel Phone: + 972 (9) 7757122 Fax: +972 (9) 7485916 Nachum Naveh Manager, Quality Assurance and Regulatory Affairs August 24, 2007 Vial2Bag General Hospital Class II, 80LHI Per 21 CFR 880.5440 Intravascular administration set Same as Trade name ROBERTSITE VIAL ADAPTER 510(k) No. K040634 Halkey-Roberts PHASEAL INFUSION ADAPTER 510(k) No. K980381 Carmel Pharma TEVADAPTOR, DRUG RECONSTITUTION AND TRANSFER SYSTEM 510(k) No. K051669 Teva Medimop Medical Projects Ltd. 17 Hatidhar St. P.O. Box 2499 Ra'anana 43665 Israel Contact person: Date Summary Prepared Trade Name: Classification name: Common device name: Predicate devices: Manufacturer: {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows a logo for MEDIMOP MEDICAL PROJECTS LTD. The logo features the letters "MOP" in large, bold font, with a globe image in the center. Below the letters, the word "MEDIMOP" is written in a smaller, sans-serif font, and below that, the words "MEDICAL PROJECTS LTD." are written in an even smaller font. K072759 17 Hatidhar St., P.O.B 2499 Ra`anana 43665 Israel Tel. + 972 (9) 7757122 Fax. +972 (9) 7485916 E-mail: info@medimop.com www.medimop.com ### Material: The Vial2Bag is composed of materials that were tested in accordance with the ISO 10993-1 standard and/or USP VI requirements and were determined suitable for the Indications for Use of this product. #### Device Description: The Vial2Bag is designed to serve as a connecting part between the IV bag and an external IV Line while allowing safe and easy transfer of drugs/diluents from and into an IV bag. The product allows quick transfer of the contents of a syringe or vial into an IV bag. The Vial2Bag is an assembly of three components a spike, a Swabable valve and a twist-off. #### Indications for Use: The Vial2Bag is indicated to serve as a connecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve. #### Technological comparison to Predicate Device: The Vial2Bag has Indications for Use identical to the PhaSeal Infusion Adapter and similar to the TEVADAPTOR-all are intended for admixing drugs and diluents and add it to the contents of an IV bag. All products have multiple access valves and piercing spikes, which enable the users to create a direct passage from vials to IV bags (and vice-versa), in a sterile manner. The Vial2Bag allows any standard accessory with a luer connection to be connected to the IV bag. Once mixing of the diluent and the drug is complete the drug solution can be transferred into the IV bag. This can be repeated several times. The Vial2Bag assembly is a single use device and should be disposed of with the IV bag. All devices are packaged sterile and designed ergonomically. Any differences between the Vial2Bag and the equivalent devices have no significant influence on safety or effectiveness. #### Safety and Effectiveness: All finished products are tested and must meet all required release specifications prior to distribution. The array of testing required for release include but are not limited to; Physical testing and visual examination (in-process and finished product). #### Conclusion: It is our conclusion that the Vial2Bag and its predicates are substantially equivalent in their Indications for Use, design, material, sterility and packaging. The Vial2Bag is to be used in a similar manner to the predicate devices and introduces no new issues of safety and effectiveness. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the caduceus symbol. DEC 1 3 2007 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medimop Medical Projects, Limited C/O Mr. Ari Y. Sobel Director, Regulatory Affairs West Pharmaceutical Services 101 Gordon Drive Lionville, Pensylvania 19341 Re: K072759 Trade/Device Name: Vial2Bag Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 17, 2007 Received: September 28, 2007 Dear Mr. Sobel: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Sobel 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): Device Name: Vial2Bag Indications for Use: The Vial2Bag is indicated to serve as a cornecting part between the IV bag and an external IV Line. The Vial2Bag has a built in connector which makes it possible to admix drugs into the infusion solution using a Swabable Valve. K072759 Caitlin (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: k072759 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PI.EASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page _ of CONFIDENTIAL Medimop Medical Projects Ltd. VIAL2BAG: 510(k) Submission September 17, 2007 App. 9 - Page 2 of 2