INFUSET FLOW CONTROL EXTENSION SET

{0}------------------------------------------------ # MAY 1 5 2014 #### Section 5. 510(k) Summary K Number Submission Date: January 16, 2014 General Information Classification Trade Name Class II Infuset™ Flow Control Extension Set Common Name: I.V. Flow Controller Classification Name and Reference: Intravascular Administration Set 21 CFR §880.5440 Submitter Peter Kollings EMED Technologies Corporation 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, Ca 95762 Tel: 916.932.0071 x114 Fax: 916.932.0074 #### Intended Use Infuset™ Flow Control Extension Sets are intended for use with the RMS Freedom 60 Syringe Infusion Pump System to provide flow rate control to administer fluids from a container to a patient's vascular system. #### Predicate Device(s) Freedom 60 Syringe Infusion Pump System (K933652) #### Device Description EMED Infuset™ Flow Control Extension Sets are disposable devices allowing users to obtain a controlled and precise rate of fluid flow when used with the RMS Freedom 60 Syringe Infusion Pump System. Each Infuset™ Flow Control Extension Sets consist of a given length of medium-density PVC tubing and rigid PVC standard luer lock connectors. Robust componentry and bonding techniques allow the Infuset™ Flow Control Extension Sets to withstand fluid pressures up to 25 psi. These sets can be physically connected to fluid sources {1}------------------------------------------------ compatible with the Freedom60 Syringe Infusion System and patient administrations sets using the standard luer lock connectors. The Infuset™ Flow Control Extension Sets are provided sterile for single use. The Infuset™ Flow Control Extension Sets rely upon the properties inherent to the static fluid path dimensions dictated by the Infuset™ Flow Control Extension Set length and tubing inner diameter to provide a precise, controlled flow rate. This follows the Poiseuille equation in that pressure, length of fluid path, diameter of fluid path, and viscosity of a fluid in a system directly influence resultant flow rates of that fluid. Available configurations with differing lengths and tubing diameters offer users several target flow rates to choose from. This basic construction and principle of action are essentially identical to that of the predicate flow control accessory that has had market clearance and been actively marketed for decades. ## Materials and Characteristics Infuset™ Flow Control Extension Sets are equivalent in performance, physical properties, using similar materials, and having the same indications for use as the predicate. Therefore no new issues of safety or effectiveness are introduced by the minimal differences in design. Table 5-1 below provides a comparison of technological and other characteristics of the EMED Infuset™ Flow Control Extension Sets and the predicate. | | Infuset™ Flow Control<br>Extension Sets | RMS Precision Flow Rate<br>Tubing Sets (K933652) | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>for Use | Intended for use with the RMS<br>Freedom 60 Syringe Infusion<br>Pump System to provide flow<br>rate control to administer fluids<br>from a container to a patient's<br>vascular system. | Intended for use with the RMS<br>Freedom 60 Syringe Infusion<br>Pump System to provide flow<br>rate control to administer fluids<br>from a container to a patient's<br>vascular system. | | Material | PVC | PVC | | Design –<br>Lengths | 7.5 cm - 97 cm | 34.3 cm - 100 cm | | Design –<br>components | Male Luer Lock<br>Tubing<br>Female Luer Lock<br>Slide Clamp | Male Luer Lock<br>Tubing<br>Female Luer Lock<br>Slide Clamp | ### Table 5-1 {2}------------------------------------------------ | | Infuset™ Flow Control<br>Extension Sets | RMS Precision Flow Rate<br>Tubing Sets (K933652) | |-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Design -<br>Approximate<br>Residual<br>Volume | 0.10 – 0.20 ml | 0.01 – 0.09 ml | | Principle of<br>Flow Rate<br>Control | The internal fluid path<br>dimensions of each Infuset<br>configuration is fixed, thereby<br>providing a single flow rate for<br>each configuration. | The internal fluid path<br>dimensions of each RMS flow<br>rate tubing set configuration is<br>fixed, thereby providing a single<br>flow rate for each configuration. | | Method of<br>Sterilization | Ethylene Oxide (ETO) | Radiation | ## Performance Table 5-2 below summarizes testing results performed to establish conformance of the Infuset™ Flow Control Extension Sets to internal product specifications and requirements, as well as equivalence to the predicate device. ## Table 5-2 | | Infuset™ Flow Control<br>Extension Sets. | RMS Precision Flow<br>Rate Tubing Sets<br>(K933652) | |----------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | Flow Rate Control<br>(0.9% saline at 20-<br>23°C, with<br>Freedom60) | Range:<br>202-2244 ml/hr<br><br>Precision<br>Less than 5% RSD<br><br>Accuracy:<br>+/- 10% | Range:<br>47 - 1743 ml/hr<br><br>Precision<br>Less than 5% RSD<br><br>Accuracy:<br>-27% to + 38% | | Pressure | Not Less than 25 psi | Not Less than 15 psi | The outcomes of these tests further indicate that the Infuset™ Flow Control Extension Set is substantially equivalent to the predicate accessory in performance, effectiveness, and safety. {3}------------------------------------------------ # Biocompatibility In accordance with ISO 10993-1:2009 and based on the intended use of the Infuset™ Flow Control Extension Sets, studies were performed including the following: cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, and hemocompatibility. Table 5-3 presents a summary of testing and results indicating compliance with biocompatibility standards. ## Table 5-3 | Standard | Test Name | Test<br>Result | Other Name | |--------------|----------------------------|----------------|---------------------------------------------------------| | ISO 10993-5 | Cytotoxicity | Pass | Neutral Red Uptake | | ISO 10993-10 | Sensitization | Pass | Kligman Maximization | | ISO 10993-10 | Irritation | Pass | Intracutaneous Injection | | ISO 10993-11 | Acute systemic<br>toxicity | Pass | Systemic Injection | | ISO 10993-11 | Pyrogenicity | Pass | Rabbit Pyrogen | | ISO 10993-4 | Hemocompatibility | Pass | Unactivated Partial Throbmoplastin<br>Time | | ASTM 756 | Hemocompatibility | Pass | Hemolysis (complete) | | USP <85> | LAL Endotoxin<br>Test | Pass | LAL Endotoxin Quantitation Test<br>(Kinetic-QCL Method) | ## Sterility, Shelf-life, and Packaging The Infuset™ Flow Control Extension Sets will be sterilized to a sterility assurance level (SAL) of 10t and with a shelf life of 5 years. ## Summary of Substantial Equivalence EMED Technologies Corporation Infuset™ Flow Control Extension Sets are substantially equivalent to the commercially available predicate device accessory in terms of function, safety, performance, intended use, technology/principles and mechanical properties. Differences between the EMED Infuset™ Flow Control Extension Sets and the predicate do not raise any new issues of safety or effectiveness. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol. ood and Drug Administration 903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002 May 15, 2014 EMED Technologies Corporation Peter Kollings Director Regulatory Affairs and Quality Assurance 1264 Hawks Flight Ct., Ste. 200 El Dorado Hills, CA 95762 Re: K140133 Trade/Device Name: Infuset Flow Control Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: April 11, 2014 Received: April 15, 2014 Dear Mr. Kollings: 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. {5}------------------------------------------------ ### Page 2 - Mr. Kollings 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/Resourcesfor You/Industry/default.htm. Sincerely yours, Mary S. Runner -S Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K140133 #### Device Name Infuset™ Flow Control Extension Set #### Indications for Use (Describe) The Infuset™ Flow Control Extension Set is intended for use with the RMS Freedom 60 Syringe Infusion Pump System to provide flow rate control to administer fluids from a contained to a patient's vascular system. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) Digitally signed by Richard C. Chapman Date: 2014.05.15 11:50:03 -04'00' This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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