TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of four abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of health, well-being, and human connection. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 2 2005 Ms. Yossi Shachar QA/RA Manager Migada Plant P.O. Box 888 Kiryat Shmona 10258 ISRAEL Re: K051669 Trade/Device Name: TEVADAPTOR™, Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 14, 2005 Received: June 22, 2005 .Dear Ms. Shachar: This letter corrects our substantially equivalent letter of September 1, 2005. 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 (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 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. {1}------------------------------------------------ Page 2 - Ms. Shachar 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 continue 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/dsma/dsmamain.html Sincerely yours, Sylite y. Michie Davis. 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 {2}------------------------------------------------ K051669 page 1 of 3 Image /page/2/Picture/2 description: The image contains three lines of text. The first line contains the word "TEVA" in a stylized, blocky font, followed by the word "Medical" in a cursive font, and the abbreviation "ltd.". The second line contains the word "nigada" in a stylized, cursive font. Below the word "nigada" is a small, circular graphic. Image /page/2/Picture/3 description: The image shows a logo with the text "CERTIFIED QMS ISO 13485: 2003". The logo is stamped with the date "SEP - 1 2005" at the top. The text "THE STANDARDS INSTITUTION OF ISRAEL" is at the bottom of the image. The logo appears to be a certification mark related to quality management systems. מדיקל דע שיות איוד # 510(k) Summary: TEVADAPTOR", Drug Reconstitution and Transfer System Company Name: Migada Plant Contact Person: Yosi Shahar QA/RA manager Telephone: +972-4-690-8826 +972-9-892-1665 Fax: E-mail: yosi.shahar(@teva.co.il #### US Agent: George Svokos MIGADA, INC. 482 Hudson Terrace Englewood Cliffs, NJ 07632 Phone: 201-561-1010 Fax: 201-567-7994 Date prepared: May 10, 2005 Trade Name: TEVADAPTOR"M. Drug Reconstitution and Transfer System Classification name: Set. IV Fluid Transfer 9-2 a MEMBER OF I GROUP מְקֻבֶּצֶת אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקס: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISBAEL TEL: (972)-4-6908800 FAX: (972)-9-8921665 {3}------------------------------------------------ K051669 page 2 of 3 Image /page/3/Picture/1 description: The image shows the logo for Teva Medical Ltd. The word "Teva" is in a bold, blocky font, and the words "Medical Ltd." are in a cursive font. Below that is the word "nigada" in a thin, stylized font with a small circle below the "g". Image /page/3/Picture/2 description: The image shows a logo with the text "CERTIFIED QMS" in a circular arrangement above "ISO 13485: 2003". The logo is from "THE STANDARDS INSTITUTION OF ISRAEL". The logo is black and white and has a triangular shape. עצים מודייקל מיגדה תעשיות ציוד רפואי Common/usual name: Drug reconstitution system Product Code: LHI Regulation No.: 880.5440 Class: II Panel identification: General Hospital Panel #### Predicate Device: PhaSeal® closed system for the preparation and administration of parenteral drugs, Carmel Pharma AB. S-402 28 Gottingen, Sweden, cleared under 510(k) no. K980381. ### Description of the device: The device comprises of the following components: - Vial Adaptor System with 13 mm Vial converter - - Syringe Adaptor System - - Infusion Bag Adaptor - - -I Connector The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic. sterile, pressure equalization within the vial, preventing drug particle escape into the environment. An elastomeric, non-latex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. 9-3 A MEMBER OF = / I GROUP ‫מִקְבּוּצַת אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקם: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISRAEL TEL: (972)-4-6908800 FAX: (972)-9-8921665 {4}------------------------------------------------ K051669 page 30. Image /page/4/Picture/1 description: The image shows the logos for Teva Medical Ltd. and nigada. The Teva Medical Ltd. logo is on the top and consists of the word "TEVA" in a blocky font and the words "Medical Ltd." in a cursive font. The nigada logo is on the bottom and consists of the word "nigada" in a stylized font with a small circle below the "g". Image /page/4/Picture/2 description: The image shows a logo for the Standards Institution of Israel. The logo is a triangle shape with the words "CERTIFIED QMS" in a circular pattern at the top. Inside the circle is the text "ISO 13485: 2003". Below the triangle is the text "THE STANDARDS INSTITUTION OF ISRAEL". ת"ש מדוייקל מיגדה תעשיות ציוד רפואי The Syringe Adaptor System is intended for connection to a standard luer lock svringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components. The Infusion Bag Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. A capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward. An injection accessory enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection. #### Indications for Use: The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. ## Substantial Equivalence: The TEVADAPTORTM, Drug Reconstitution and Transfer System has the same intended use as the PhaSeal® closed system for the preparation and administration of parenteral drugs, cleared under 510(k) no. K980381 and has equivalent performance characteristics. It is therefore substantially equivalent to that device. #### Conclusion - The evaluation of the TEVADAPTORTM, Drug Reconstitution and Transfer System does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices. {5}------------------------------------------------ K051669 # Indications for Use 510(k) Number (if known): K051669 Device Name: TEVADAPTOR™, Drug Reconstitution and Transfer System Indications for Use: The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection. Prescription Use X (Part 21 CFR 801 Subpart D) ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . AND/OR 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) Antone Vime (Division Sign-Off) (Division Sign of Anesthesiology, General Hospital, Infection Control, Denta! Devices Page 1 of 1 510(k) Number: K931669