Imed Technology Intravascular Administration Set, Imed Technology Extension Set

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 28, 2015 Imed Technology, Inc. Mr. Kyle Adams President 2544 Tarpley Rd., Suite 112 Carrollton, Texas 75006 Re: K150513 > Trade/Device Name: Imed Technology Intravascular Administration Sets and Imed Technology Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: January 28, 2015 Received: February 27, 2015 Dear Mr. Adams: 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. {1}------------------------------------------------ Page 2 - Mr. Kyle Adams 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 Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known):__K150513 Device Name: I Med Technology Intravascular Administration Set and Imed Technology Extension sets Indications For Use: IMed Technology Intravascular administration set and Imed Technology Extension sets intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. IMed Technology infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient. Prescription Use ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) {3}------------------------------------------------ # IMed Technology, LLC | Date Submitted: | May 1, 2015 | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------| | Submitted By: | iMed Technology, Inc<br>2515 Tarpley Road, Suite 104<br>Carrollton, TX 75006<br>Tel: 972-732-7333<br>Contact email: kyle.adams@imedtechnology.com | | Subject Device Name: | Imed Technology Intravascular Administration sets<br>and Imed Technology Extension sets | | Common Name of Device: | Intravascular Administration Set | | Predicate Device: | Acta Medical Intravascular Administration Set (K121803) | | Panel: | General Hospital and Personal Use | | Product Code: | FPA | | Device Classification: | 21 CFR880.5440, Class II | {4}------------------------------------------------ ### Name & Model Numbers of Devices. - 1. IMEDINF01, Intravascular administration set - 2. IMEDINF02, Intravascular administration set with 0.2 micron filter - 3. IMEDINF03, Intravascular administration set with flow regulator - 4. IMEDINF04, Intravascular administration set with flow regulator, 0.2 micron filter - 5. IMEDEXT01, Minibore extension set Other Model Numbers and configurations may be assembled per customer request ### Device Classification - Set, Administration, Intravascular a. - b. FPA - 21CFR880.5440 C. - d. Device Classification II ### Indications For Use IMed Technology Intravascular administration sets and Imed Technology Extension sets intended use is to deliver sterile, infusion fluid from a container to the patient with or without flow control features. IMed Technology infusion tubing may act as an extension of other infusion tubing in delivering intravenous fluids from a container to patient. ### Device Description IMed Technology, Intravascular administration/extension set is sterile, non-pyrogenic, non-DEHP PVC tubing with the following combination of components. - Universal Spike. Universal spike is constructed from ABS material and has a a. hydrophobic vent for transfer of fluids from closed containers such as infusion bottles. The spike dimensions are variable to deliver fluid at 10, 15, 20 and 60 drops per ml. Alternatively, the spike may have a luer lock at one end which connects to non-DEHP tubing for the purposes of transporting intravenous fluids from a vial to the patient. - Drip chamber with 15 micron filter. The drip chamber is constructed from nonb. DEHP PVC or EVA, is flexible and has inbuilt 15 micron particulate disc filter which filters solution passing through it. - Non-DEHP PVC tubing. Variable length non-DEHP PVC tubing with differing C. ID/OD combinations to ensure tubing performance. Extension tubing shall have ID/OD combinations of 0.03"/0.05" (minibore), 0.01"/0.03" (microbore), various lengths; 7" to 60". Infusion tubing shall have ID of 0.1" and OD of 0.125". Various combinations of the above tubing shall be designed to deliver desired performance. {5}------------------------------------------------ - d. Flow Regulator. A commercially available dial type flow regulator may be incorporated in-line to control the flow rate of infusion fluids. The flow regulator will provide standard graduations of 5ml/hr to a maximum of 250ml/hr. The flow regulator shall be constructed from medical grade ABS and medical grade silicone disc. Optionally, a rate restricted tubing may be also incorporated in the infusion set whereby the ID and length of the tubing has been calibrated to provide a specific flow rate at gravity pressure from liquid height of 36-40" - e. Roller clamp. A roller clamp may be inserted in combination with the above components to control flow rate or to turn fluid flow on and off. Roller clamp shall be constructed from medical grade ABS plastic - f. Slide clamp. A slide clamp may be inserted in combination with the above components to turn the fluid flow on and off. Slide clamp shall be constructed from medical grade ABS material. - g. Luer locks. Female luer locks and male luer locks may be a part of the infusion set as required and shall be constructed from medical grade ABS or non-DEHP hard PVC or medical grade PP. - h. Filters. In-line air eliminating filters may be incorporated into the infusion tubing. These filters will have pore size of 0.2 micron or 1.2 micron and shall be constructed from medical grade PVC or medical grade ABS and cellulose acetate membrane. - i. "Y" site (not made with natural rubber latex) or pre-approved needleless "Y" site for secondary infusions or medication administration. The "Y" site shall be integrated in combination with the above components and shall be constructed from hard PVC or PP or ABS (all components are medical grade). In case of an "injection port" (not made with natural rubber latex), the material shall be medical grade silicone. # Specification & Dimensions IMed Technology, Intravascular Administration Set will have the following dimensional specifications: - a. Infusion tubing OD = 4.1mm, ID = 3.0mm (approximately) - b. Extension tubing regular bore OD = 2.7mm, ID = 1.6mm (approximately) - c. Extension tubing minibore OD = 2.0mm, ID = 1.0mm (approximately) - d. Extension tubing microbore OD = 1.6mm. ID = 0.6mm (approximately) - e. Additional custom dimensions may be manufactured for customers - f. Length may vary from 5" for extension set to 105" for primary infusion set ### Materials Acrylonitrile Butadiene Styrene Non-DEHP Poly Vinyl Chloride Polypropylene (non fluid pathway material, utilized in protective caps only) Silicone {6}------------------------------------------------ ### COMPARISON TABLE ### IMed Technology Intravascular Administration Set Comparison To Acta Medical Intravascular Administration Set (K121803) | Feature | Details | Predicate Device<br>K121803 | Conclusion | |-------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Intended Use | IMed<br>Technology,<br>Intravascular<br>Administration<br>set intended use<br>is to deliver<br>sterile, infusion<br>fluid from a<br>container to the<br>patient with or<br>without flow<br>control features. | Acta Medical<br>Intravascular<br>Administration set<br>intended use is to<br>deliver sterile,<br>infusion fluid from a<br>container to the<br>patient with or<br>without flow control<br>features. | Substantially<br>Equivalent | | Design and Materials<br>of Construction | The materials of<br>construction for the<br>proposed device are<br>exactly the same as the<br>materials for the<br>predicate product | The design and<br>materials of<br>construction remain<br>the same as the<br>predicate product. | Substantially<br>Equivalent | | Labeling | Compliant with<br>21CFR807.87 | Compliant with<br>21CFR807.87 | Substantially<br>Equivalent | | Biocompatibility | Meets requirements for<br>ISO 10993-1, External<br>Communicating Device,<br>Blood Path Indirect,<br>Contact Duration A | Meets requirements<br>for ISO 10993-1,<br>External<br>Communicating<br>Device, Blood Path<br>Indirect, Contact<br>Duration A | Substantially<br>Equivalent | | Bench Testing | USP Physicochemical<br>tests for plastics and<br>performance testing<br>compliant with ISO<br>Standards | USP<br>Physicochemical<br>tests for plastics and<br>performance testing<br>compliant with ISO<br>Standards | Substantially<br>Equivalent | | Sterilization | Sterility assurance level<br>of 10-6 | Sterility assurance<br>level of 10-6 | Substantially<br>Equivalent | | Labeling | As per Guidance Document | As per Guidance Document | Substantially Equivalent | | ISO 8536-4:2010 tests<br>for Intravascular<br>Administration sets | Meets the acceptance<br>criteria as specified in<br>ISO 8536-4: 2010 | Meets the<br>acceptance criteria<br>as specified in ISO<br>8536-4: 2010 | Substantially<br>Equivalent | {7}------------------------------------------------ ## Substantial Equivalence: IMed Technology, Intravascular Administration Set is substantially equivalent to the predicate device, Acta Medical Intravascular Administration Set (K121803). The component materials, indication for use, SAL are substantially equivalent and present no additional concerns as compared to the predicate device.