COMCASET SAFETY IV CATHETER

{0}------------------------------------------------ Kp62148 (P.10^3) ### Pitango Medical Ltd. #### 510(k) Summary: AUG - 8 2006 ComCaSet Safety IV Catheter #### Company Name: Pitango Medical Ltd. Ltd. Contact Person: Ben Levin Managing Director Telephone: +972-3-613-0480 +972-3-613-0481 Fax: E-mail: belevin@pitangomedical.com #### Authorized US Agent: George J. Hattub, RAC & CQE Senior Staff Consultant MedicSense Inc. 291 Hillside Avenue Somerset, Massachusetts 02726 Phone: (508) 479-6116 (508) 677-1418 Fax: E-Mail: george@medicsense.com Date prepared: May 25, 2006 Trade Name: ComCaSet Safety IV Catheter Classification name: Intravascular catheter Class: II Panel identification: General Hospital Devices Product code: FOZ Regulation number: 880.5200 Predicate Devices: Insyte™ Autoguard™ Shielded IV Catheter form Becton-Dickinson Infusion Therapy Systems Inc in Sandy, Utah, cleared under 510(k) no. K984059 {1}------------------------------------------------ K462198 (p.2aA3) ## Pitango Medical Ltd. #### Device description: The ComCaSet Safety IV Catheter consists of several parts common to most IV catheters: stainless steel needle. Teflon catheter tube with hub and the catheter body. In addition, the ComCaSet Safety IV Catheter has a safety locking mechanism which, when activated, enables the needle and the flash chamber to retract into a safety barrel The activation element holds the needle assembly in the forward position until the user activates the device. Pulling the activator releases the latexfree elastic rubber band and allows the needle and flash chamber to retract quickly into the safety barrel. In this way user maintains control of the process by determining when to activate the safety mechanism. The product is available in seven gauges identified also by specific colors as follows: | Size | Color | Catheter | | Catheter<br>Length(mm) | Water<br>Flow Rate<br>(ml./min.) | |------|--------|------------|------------|------------------------|----------------------------------| | | | I.D.<br>mm | O.D.<br>mm | | | | 14G | Orange | 1.7 | 2.1 | 45 | 270 | | 16G | Grey | 1.3 | 1.7 | 45 | 180 | | 17G | White | 1.1 | 1.5 | 45 | 125 | | 18G | Green | 0.9 | 1.3 | 45 | 80 | | 20G | Pink | 0.8 | 1.1 | 32 | 54 | | 22G | Blue | 0.6 | 0.9 | 25 | 33 | | 24G | Yellow | 0.5 | 0.7 | 19 | 20 | #### Indications for Use: The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube. {2}------------------------------------------------ # K462148 (P.3 of 3) Pitango Medical Ltd. #### Substantial Equivalence: The ComCaSet Safety IV Catheter has the same intended use and the same principle of operation as the Insyte " Autoguard " Shielded IV Catheter form Becton-Dickinson Infusion Therapy Systems Inc in Sandy, Utah, cleared under 510(k) no. K984059. The main technological difference between ComCaSet Safety IV Catheter and the predicate devices is the release element of the needle retraction element, which at the ComCaSet Safety IV Catheter consists of a latex-free elastic rubber band and at the predicate device consists of a spring. #### Conclusion: The evaluation of the ComCaSet Safety IV Catheter does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (USA). The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG - 8 2006 Pitango Medical Limited C/O Ms. Patricia L. Murphy Responsible Third Party Official Kema Quality B.V. 4377 County Line Road Chalfont, Pennsylvania 18914 Re: K062108 Trade/Device Name: ComCaSet Safety IV Catheter Regulation Number: 880.5200 Regulation Name: Intravascular Catheter Regulatory Class: II Product Code: FOZ Dated: July 18, 2006 Received: July 24, 2006 Dear Ms. Murphy: 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. {4}------------------------------------------------ #### Page 2 - Ms. Murphy 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 (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) 276-0115. 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, State of Michigan Oms 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 {5}------------------------------------------------ ### Indications for Use K 462138 510(k) Number (if known): _ Device Name: ComCaSet Safety IV Catheter Indications for Use: The ComCaSet Safety IV Catheter is indicated to sample blood, monitor blood pressure, or administer fluids intravenously. The ComCaSet Safety IV Catheter may be used for any patient population with consideration given to adequacy of the vascular anatomy appropriateness for the solution being administered and duration of the therapy. The ComCaSet Safety IV Catheter provides a shielding mechanism intended to reduce the incidence of accidental needle sticks. When the catheter hub and needle assembly components are withdrawn, the user activates the shielding mechanism and the needle retracts into the shielding tube. 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) Cutter is n on of Anesthesiology, General Hospital, Jon Control. Dental Devices ) Number: 5962198 4-2 Page 1 of 1