MED-RX PATIENT DELIVERY SET

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for Benlan MED-RX Patient Delivery Sets. The logo features a stylized drop shape to the left of the word "Benlan" in bold, followed by "MED-RX Patient Delivery Sets" in a smaller font size. The text is black against a white background. ## SECTION 5 - 510(K) SUMMARY Date of Summary: February 3, 2012 JUN 2 8 2012 akville. ON LGH ! Tel (905) 829-5004 Fax (905) 829-5006 | Official Contact: | Cheryl Brown - QA / RA Manager | |-----------------------------------|---------------------------------------------------------------------------------| | Proprietary Name:<br>Common Name: | MED-RX® Patient Delivery Set<br>Intravascular Administration Set | | Classification Name: | Intravascular Administration Set, 880.5440 Intravascular Administration<br>Set. | | Class: | Class II | | Product Code: | FPA | | Predicate Device: | Liebel-Flarsheim Optistar MR Injector System→ Y-Tubing Set (K984088) | #### Device Description The MED-RX® Patient Delivery Sets each consist of a male luer lock, two female luer locks, 3 tubing pieces, and either a dual check valve, a single check valve, or a Y-connector. The tube is made of polyvinyl chloride (PVC). The total length of the sets varies from 18″ to 86″ and is also available in a coiled configuration. The MED-RX® Patient Delivery Sets are provided sterile and are not to be resterilized. #### Indications for Use The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images. #### Substantial Equivalence The information provided in the premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed MED-RX® Patient Delivery Sets are substantially equivalent to the Liebel-Flarsheim Optistar Y-Tubing Set (K984088). Both devices have the same intended use for injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images. The product configurations are identical between the proposed device and the predicate. NOTE: The predicate device upon which to determine substantial equivalence is the Ytubing set included as a sterile disposable in K984088. A comparison of features and principles of operation between the proposed device and predicate device is provided in Table 1 below. {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Benlan MED-RX Patient Delivery Sets. The logo features a stylized droplet shape on the left, followed by the word "Benlan" in bold, sans-serif font. Below "Benlan" is the text "MED-RX Patient Delivery Sets", with "MED-RX" in a slightly larger font size than "Patient Delivery Sets". Table 1: Comparison between MED-RX® Patient Delivery Set and Liebel-Flarsheim Optistar Y-Tubing Set (K984088 | ATTRIBUTE | PROPOSED DEVICE - MED-RX®<br>Patient Delivery Set | PREDICATE DEVICE - Liebel- Flarsheim Optistar Y-Tubing Set (K984088) | |-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------| | General Indications | | | | Indications for Use | The MED-RX® Patient Delivery Set<br>is to be used in the injection of<br>contrast agents and flushing<br>solutions for the purpose of<br>enhancing diagnostic images. | The Optistar MR is designed to<br>inject MR contrast agents and<br>flushing solutions for the purpose<br>of enhancing diagnostic images of<br>humans. | | Disposable | Yes . | Yes | | Prescription | Yes | Yes | | Non-Pyrogenic | Yes | Yes | | Intended Environment of Use | Hospital | Same | | Material Composition | | | | Tubing | Polyvinyl Chloride - DEHP free | Medical grade tubing | | Components | Medical grade plastics (PVC, LDPE,<br>HDPE, Polycarbonate) | Medical grade plastics | | Packaging and Sterilization | | | | Sterile | Yes | Yes | | Sterilization Method | Ethylene Oxide (EO). | Same | | Packaging Configuration | Medical grade paper/film pouch | Same | | Physical Specifications | | | | Tubing outer diameter (OD) | 0.156" | 0.130" | | Tubing inner diameter (ID) | 0.060" | 0.060" | | Total set length | 18" - 86" | 66" | | Design Features | | | | Distal Configuration | Male Luer Lock | Same | | Proximal Configuration | Two Female Luer Locks | Same | | Y-Site | Dual Check Valve OR Single Check<br>Valve OR Y-Connector | Dual Check Valve OR Single Check<br>Valve OR Y-Connector | | Y-Leg Tube Configuration | Straight | Straight | | Long Arm Tube Configuration | Straight OR Coiled | Coiled | | Maximum Pressure Rating | 400 PSI | Same | | Caps | Luer caps | Same | #### Summary of Differences There are no significant differences between the proposed MED-RX® Patient Delivery Sets and the predicate device, Liebel-Flarsheim Optistar Y-Tubing Set (K984088). Similarities between the proposed device and the predicate device include indications for use and design configuration. The MED-RX® Patient Delivery Sets and the Liebel-Flarsheim Optistar Y-Tubing Set are sterile, disposable devices, packaged in paper/film pouches and sterilized using ethylene oxide. Both the proposed MED-RX® Patient Delivery Sets and the predicate device feature two female luer locks on the proximal end of the set, followed by two short Y-leg tubes that meet at either a {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the logo for Benlan MED-RX Patient Delivery Sets. The logo features a stylized drop-like shape to the left of the word "Benlan" in a bold, sans-serif font. Above the "lan" portion of the name is a small "TM" symbol, indicating a trademark. Below the name is the text "MED-RX Patient Delivery Sets" in a smaller, sans-serif font. dual check valve, a single check valve, or a Y-connector. The Y-site is followed by one long arm tube that terminates with a male luer lock. Protective luer caps are provided for all luer locks. All proximal and distal components are compatible with standard luer devices, similar to the predicate device. The predicate Liebel-Flarsheim Optistar Y-Tubing Set is available in identical configurations to the predicate device. Any minor differences between the proposed device and the predicate have been evaluated to have no impact on safety or effectiveness of the MED-RX® Patient Delivery Sets. Therefore the proposed device can be considered substantially equivalent to legally market devices and raises no new issues of safety and effectiveness. ### Non-Clinical Test Summary The MED-RX® Patient Delivery Sets were subject to numerous performance tests including tensile strength, resistance to leakage, particulate contamination, and for chemical requirements. The MED-RX® Patient Delivery Sets have successfully completed all required performance testing following the applicable guidelines of ISO 8536-4: 2010. The MED-RX® Patient Delivery Sets were also tested for natural rubber latex content. Please refer to Table 2. | Test | Standard | Results | |------------------------------|----------------------------------------|-------------------------------------------------| | Tensile Strength | ISO 8536-4:2010 | Withstand 15 N for 15 Seconds, Pass | | Resistance to Leakage | As per Benlan internal<br>requirements | Pass | | Particulate Contamination | ISO 8536-4:2010 | Samples met contamination index<br>limit | | Chemical Requirements | ISO 8536-4:2007 PER<br>Clause 5 & 7 | Pass | | Natural Rubber Latex Content | Modified Lowry Method | Device does not contain natural<br>rubber latex | Table 2: Non-Clinical Test Summary #### Summary of Sterilization Each MED-RX® Patient Delivery Set is individually packaged using a medical grade breathable coated paper heat sealed to a polypropylene medical grade film and sterilized using ethylene oxide. Please see Table 3 for a summary. 2760 Brighton Rd. Oakville ON L6H 5T4 www.benlan.com {3}------------------------------------------------ Sets Table 3: Sterilization Summary | Test Description | Standard | Results | |----------------------------|-----------------------------------|---------------------------------------------------------| | Method of Validation | ANSI/AAMI/ISO 11135-1: 2007 | Validated to a Sterility<br>Assurance Level of 1 x 10-6 | | EO Sterilization Residuals | ISO 10993-7: 2008 | Pass | | Bacterial Endotoxins | Current edition of ANSI/AAMI ST72 | Pass | # Summary of Biocompatibility Tests Biocompatibility testing was successfully completed on sterile finished devices. The MED-RX® Patient Delivery Sets are classified as external communicating devices with limited to prolonged use, indirect blood path contact. A summary of the testing completed and the relevant standards are listed in Table 4. Table 4: Biocompatibility Test Summary | Standard | Test Description | Results | |-------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | ASTM F-756-00 | Hemolysis Assay - Extract Method | Product code 10-1254T is<br>considered non-hemolytic and<br>passes the test. | | ISO 10993-11 | Acute Systemic Injection Test | The findings indicate that the<br>requirements of the ISO Acute<br>Systemic Injection Test have been<br>met. | | USP 32:2009 <151> | Materials Mediated Rabbit Pyrogen Test | Product code 10-1254T was<br>considered non-pyrogenic. | | ISO 10993-10:2002 | Intracutaneous Reactivity Test | The requirements of the ISO<br>Intracutaneous Reactivity Test have<br>been met. | | ISO 10993-10:2002 | Guinea Pig Maximization Sensitization<br>Test | Product code 10-1254T did not elicit<br>a sensitization response. | | ISO 10993-5: 2009 | ISO MEM Elution with L-929 Mouse<br>Fibroblast Cells (Cytotoxicity) | Product code 10-1254T is<br>considered non-cytotoxic. | # Benla r 905 829 5004 2760 Brighton Rd. Ookville OR L6H 5T4 www.benlan.com {4}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Cheryl Brown Quality Assurance/Regulatory Affairs Manager Benlan, Incorporated 2760 Brighton Road Oakville, Canada L6H 5T4 JUN 2 8 2012 Re: K120375 Trade/Device Name: MED-RX® Patient Delivery Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 15, 2012 Received: June 20, 2012 Dear Ms. Brown: 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- Ms. Brown 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 vours. Fd Shef SyrohitnD 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Benlan MED-RX Patient Delivery Sets. The logo features a stylized letter "O" to the left of the word "Benlan" in a bold, sans-serif font. Below "Benlan" is the text "MED-RX Patient Delivery Sets," with "MED-RX" in a slightly larger font size and a trademark symbol next to it. # SECTION 4 - INDICATIONS FOR USE 510(K) Number (If Known): ヒ (2003 フ S Device Name: MED-RX® Patient Delivery Set Indications For Use: The MED-RX® Patient Delivery Set is to be used in the injection of contrast agents and flushing solutions for the purpose of enhancing diagnostic images. | Prescription Use: | <span style="text-align: center;"> ✔ </span> | |-----------------------------|------------------------------------------------------------| | (Part 21 CFR 801 Subpart D) | | | AND/OR | | | Over-the-Counter Use | | | (21 CFR 801 Subpart C) | | | N/A | | (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED. Concurrence of CDRH, Office of Device Evaluation (ODE) Mli C. 6/28/12 Page 1 of 1 (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K120373 4-1