EXELINT ALUMINUM HUB BLUNT NEEDLES

{0}------------------------------------------------ ## 510(K) SUMMARY Date Revised: July 22, 2010 1.1 SUMMARY OF SAFETY AND EFFECTIVENESS Submitted By: Armand Hamid . Director EXELINT International, Co. 5840 West Centinela Avenue, Los Angeles, CA 90045 Telephone: (310)-649-0707 Fax: (310) 649-1168 OCT 2 0 2010 - 1.1 Trade/Proprietary Name - 1.2 Common/Usual Name - 1.3 Classification Name 1.4 Classification EXELINT Aluminum Hub Blunt Needles Blunt Fluid Transfer Needle Needle, hypodermic, single lumen - Class: Il Panel: 80 Product Code: FMI Cite: 21 CFR 880.5470 - 1.5 Description The EXELINT Aluminum Hub Blunt Needles are sterile, non-pyrogenic, single use fluid transfer needles consisting of blunt Type 304 stainless steel cannulas staked into aluminum luer lock hubs. The gauge and length of the cannula determines the final gauge and length of the product. The hubs are identical for all of the needles. Each needle is packaged into a Polypropylene tube and sealed with a polypropylene cap. The needles are final packaged into a multineedle box and ETO sterilized. #### 1.6 Indication for Use The product is intended to be used in a variety of medical, pharmaceutical and laboratory procedures to extract fluid or medication from vials or ampoule for transfer or for irrigation. - 1.7 Substantial Equivalence The devices are substantially equivalent to the MONOJECT® Rigid Pack Blunt Cannula, cleared as the Monoject Sterile M200 Aluminum Hub Blunt Cannula Device under 510(k) file number K854547. #### 1.8 Technological Characteristics The EXELINT Aluminum Hub Blunt Needles are constructed of the same materials (aluminum and Stainless steel), have the same dimension (lengths, gauges), are sterilized with EtO in packaging of the same materials, design and colors, and comply with the same standards as the currently marketed predicate products. #### 1.9 Performance Data The devices were tested and found in compliance with the ISO standards for Needles (ISO 7864) and Stainless Steel Tubing (ISO 9626). The packaging was tested for seal strength. These tests demonstrated that the EXELINT Aluminum Hub Blunt Needles are safe and effective and that their performance meets the requirements of their pre-defined acceptance criteria and intended use. - 1.10 Conclusion EXELINT International concludes based on the information presented that the new products lines are substantially equivalent to products currently legally marketed in the USA. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Armand Hamid Director Exelint International Company 5840 W. Centinela Avenue Los Angeles, California 90045 UCI 2 0 200 Re: K101309 Trade/Device Name: EXELINT Aluminum Hub Blunt Needles : Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: September 27, 2010 Received: September 30, 2010 Dear Mr. Hamid: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however .that device 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 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. : · {2}------------------------------------------------ ## Page 2- Mr. Hamid 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. Wh for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use OCT 2 0 2010 | 510(k) Number: | K101309 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name: | EXELINT Aluminum Hub Blunt Needles | | Indications for Use: | The EXELINT Aluminum Hub Blunt Needles are intended to<br>be used in a variety of medical, pharmaceutical and<br>laboratory procedures to extract fluid or medication from<br>vials or ampoule for transfer or for irrigation. | Prescription Use (Per 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Ri C. A 10/20/10 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: _______________________________________________________________________________________________________________________________________________________________