V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a circular seal for the Department of Health and Human Services (HHS) in the USA. The seal features the department's emblem, which consists of a stylized caduceus-like symbol with three abstract human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 TZ Medical, Inc. c/o Ms. Madalyn Duncan Supervisory Consumer Safety Officer TZ Medical, Inc. 7272 S.W. Durham Rd., #800 Portland, OR 97224 DEC 1 5 2006 Re: K062577 Trade/Device Name: VI Multiport Connector Regulation Number: 21 CFR 870.2900 Regulation Name: Transducer and Electrode Patient Cable Regulatory Class: II Product Code: DSA Dated: Undated Received: December 4, 2006 Dear Ms. Duncan: 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, EDA may publish further announcements concerning your device in the Federal Register. 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 {1}------------------------------------------------ ## Page 2 - Ms. Duncan 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 (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. 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) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Bfzimmerman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Indications for Use: The V1 Multi-port Connector is intended to be used primarily in electrophysiology (EP) laboratories as a multi-port connector with switching capabilities for connection to defibrillator, EP study equipment and electrosurgical devices. It provides a stable, focal location for multiple wires, cables and connections. The device allows the defibrillator to be used as a back-up for stimulating and pacing when those pieces of equipment are unavailable. Prescription Use × (21 CFR Subpart D) And/Or Over-The-Counter Use (21 CFR Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office OF Device Evaluation (ODE) B. Hummer F. Sirm, OR (Division Sign-Off) (Division of Cardiovascular Devices 510(k) Number_