INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022

{0}------------------------------------------------ K083851 1 of 3 510(k) Summary (As required by 21 CFR 807.92(a)) - Submitter Information ilə MAY 15 2009 Inviro Medical 1755 North Brown Road Suite 150 Lawrenceville, GA 30043 Phone Number: Fax Number: Contact: 678-405-4031 678-405-4044 Jim Barley Director RA/QA Trade Name: InviroBlunt/InviroBlunt w/EZ Wings Cannula - B. Device Information Trade/Proprietary Name: InviroBlunt and /InviroBlunt w/EZ Wings Cannula Set, I.V. Fluid Transfer Common name of device: Syringe Cannula Classification Name: Product Code: Regulatory Class: Classification Number: 880.5440 Reason for 510(k): New Device 80 LHI II {1}------------------------------------------------ K083851/ 2 of 3 C. Predicate Device: Inviro Medical InviroLink and InviroLink w/EZ Wings Cannula Predicate 510(k) #: K071307 Predicate product code: LHI - Device Description D. The InviroBlunt/InviroBlunt Cannula were designed to replace hypodermic needles currently for withdrawal of medication from rubber-stoppered vials or injection into I.V. Systems and pre-slit septums covering injection sites. The family of InviroBlunt Plastic Cannulas are 18 gauge stainless steel blunt cannulas for penetrating medicine vials and dispensing medications or for injection into I.V. Systems and for use in pre-slit septums covering injection sites. Following is a list of the InviroBlunt Cannulas: - InviroBlunt, Model # 120022 1. - InviroBlunt with EZ wings, Model # 120522 2. The InviroBlunt Cannulas are used in conjunction with a svringe to penetrate rubber-stopered medicine vials and pre-slit septums covering injection sites. The cannula is pre-lubricated to reduce septum insertion forces. The devices are individually packaged and are provided sterile and are labeled as single use. Statement of Indications for Use E. > The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites. {2}------------------------------------------------ K08 3857 3 of 3 - Comparison of Required Technological Characteristics: F. Information was submitted to demonstrate that there are no significant differences in technological characteristics between the InviroBlunt and InviroBlunt w/EZ Wings Cannulas and the cited predicate device. Summary and Conclusion of Nonclinical and Clinical Tests: G. The InviroBlunt/InviroBlunt w/EZ Wings Cannulas met the following product/performance requirements: A visual inspection of the device showed that the surface of the device was smooth and without oil contamination or extraneous matter or other defects. The lubricant on the cannula was invisible and the device was free of flash and burrs. The color of each hub and cap met the product requirement. Dimensional - All components of the InviroBlunt and InviroBlunt w/EZ Wings met the dimensional, visual and functional requirements listed on the part/assembly drawing. Functional - The InviroBlunt and InviroBlunt w/EZ Wings met the requirements for Cap Pull off Force, InviroBlunt/Syringe interface, penetration, bending and tip breaking Forces and flow rate. Interface - The interfaces between the InviroBlunt and the medicine vial stopper and the InviroBlunt and the syringe luer lock fitting were secure and able to withstand 330 kPa of pressure for 30 seconds without leakage. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Public Health Service . MAY 15 2009 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. James Barley Director of Regulation Affairs/Quality Assurance Inviro Medical Devices, Incorporated 1755 North Brown Road, Suite 150 Lawrenceville, Georgia 30043 Re: K083851 Trade/Device Name: InviroBlunt and /InviroBlunt w/EZ Wings Cannula Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 31, 2009 Received: April 22, 2009 Dear Mr. Barley: 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, thereforc, 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. {4}------------------------------------------------ ## Page 2- Mr. Barley 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/. 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, Susan Bunner Susan Runner, D.D.S., MA Acting 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 510(k) Number (if known): " | Device Name: Indications For Use: The InviroBlunt and InviroBlunt w/EZ Wings Cannulas are used in conjunction with a syringe as an additive device for aspiration from multi-dose medicine vials or injection into I.V. Systems and pre-slit septums covering injection sites. Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) R.J. Musick for LCAR. Colburn 05/15/09 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: k083851 Page 1 of