NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS

{0}------------------------------------------------ K132734 Special 510(k) Premarket Notification Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with the One-Link Needle-free IV connector Section 5. 510(k) Summary Page 1 of 4 ## 5. 510(K) SUMMARY September 24, 2013 ### OWNER: Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015 ## CONTACT PERSON: Gary Chumbimune Manager, Global Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-3312 Fax: (224) 270-4900 #### DEVICE NAME: #### Trade name: Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with One-Link Needle-free IV connector ост о 8 2013 {1}------------------------------------------------ # Table 5-1. Proposed Set Configurations | Code<br>number | Name | |----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2N1333 | Non-DEHP Standard Bore Catheter Extension Set, Power Injectable (325 psi,<br>2241 kPa) | | 7N8390 | One-Link Non-DEHP Microbore Catheter Extension Set. Bonded Needle-free<br>IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi,<br>2241 kPa) | | 7N8391 | One-Link Non-DEHP Standard Bore Catheter Extension Set, Bonded Needle-<br>free IV Connector with Neutral Fluid Displacement, Power Injectable (325 psi,<br>2241 kPa) | | 7N8301 | One-Link Non-DEHP Standard Bore Catheter Extension Set, Needle-free IV<br>Connector with Neutral Fluid Displacement, Power Injectable (325 psi, 2241<br>kPa) | | 7N8310 | One-Link Non-DEHP Microbore Catheter Extension Set, Needle-free IV<br>Connector with Neutral Fluid Displacement, Power Injectable (325 psi, 2241<br>kPa) | #### Common name: IV Administration Set Classification name: IV Administration Set: 21 CFR 880.5440, Product Code FPA #### PREDICATE DEVICE: Table 5-2. Predicate 510(k) | Device | Company | Previous<br>\$10(k) | Clearance<br>date | |-------------------------------------------------------------------------------------------|-------------------|---------------------|-------------------| | Neutral Luer Activated Device and<br>Extension Sets with Neutral Lucr Activated<br>Device | Baxter Healthcare | K120443 | May 22, 2012 | ### DESCRIPTION OF THE DEVICE: The proposed devices, which are the subject of this Special 510(k) Premarket Notification. consist of a power injectable extension set without the One-Link Needle-free IV connector, extension set codes with the One-Link Needle-free IV connector bonded to the rest of the set, standard bore power injectable extension sets, and a power injectable extension set with a one piece male Luer. They are single use disposable devices intended for use with a vascular access {2}------------------------------------------------ device for the withdrawal of fluids and/or the continuous or intermittent administration of fluids, The proposed devices will provide additional set configurations to clinicians that: - 1. Require/prefer the larger bore tubing to infuse fluid via gravity at high rates that cannot be achieved with microbore tubing, - 2. Request the use of extension sets with a permanently affixed One-Link Needle-free IV connector. - 3. Prefer an extension set without the One-Link Needle-free IV connector. They may be used with low pressure power injectors having a maximum pressure of 325 psi (2241 kPa) and a maximum flow rate of 10 mL/s. These proposed devices are equivalent to the current marketed devices, previously cleared under 510(k) premarket notification K120443 (cleared on May 22, 2012). The basis for this premarket notification is the addition of five extension sets to the product line to provide additional options to the clinician. The addition of these five set configurations (3 with standard bore tubing and 2 with microbore tubing) to the product line does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update. # STATEMENT OF INTENDED USE: The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors. ## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE: The proposed devices are equivalent to Baxter's currently legally marketed devices cleared on May 22, 2012 (K120443). The addition of five set configurations to the product line does not impact the intended use or the fundamental scientific technology of the device. No new materials of construction are being introduced into this device as part of this update. The intended use, the basic design, function and the materials for the proposed devices are equivalent to the predicate device. {3}------------------------------------------------ # DISCUSSION OF NONCLINICAL TESTS: Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results meet their acceptance criteria, and support that the proposed devices are appropriately designed for their intended use. Performance Data: The following tests were conducted to evaluate the addition of five set configurations to the product line: - ISO Luer tests on male Luer lock connectors - . Tubing bond strength test on solvent bonds - . Solvent bond pressure test - . Clamp shut-off test - � Power injector compatibility test - . Connector disengagement test - � Post sterilization lipid stress test - . Pressure failure mode simulation - . Burst pressure test All tests met the acceptance criteria. Biocompatibility: No new materials of construction are being introduced into these devices as part of this Special 510(k) premarket submission. Biocompatibility assessment has been conducted based on ISO-10993, Biological Evaluation of Medical Devices for prolonged duration, external communicating, indirect blood path and Blue Book Memorandum G95-1 "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," as recommended in the I.V. Administration sets guidance. ## CONCLUSION: The data from the non-clinical tests demonstrate that the proposed devices are as safe and effective, and perform as well as or better to the predicate devices. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the United States. The logo consists of two main elements: the department's name arranged in a circular fashion around the perimeter and a stylized symbol in the center. The symbol is a stylized representation of a human figure embracing a bird, which is meant to symbolize the department's mission of protecting and promoting the health and well-being of Americans. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002 October 8, 2013 Baxter Health Corporation Mr. Gary Chumbimune Manager, Global Regulatory Affairs 32650 North Wilson Road ROUND LAKE IL 60073 Re: K132734 Trade/Device Name: Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connector Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Il Product Code: FPA Dated: August 30, 2013 Received: September 3, 2013 Dear Mr. Chumbimune: 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 for ase stated in the More 28, 1976, the enactment date of the Medical Device Amendments. or 10 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 I he general variable 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 If your device is blussined (beourols. Existing major regulations affecting your device can be may be subject to additions. Title 21. Parts 800 to 898. In addition. FDA may round in ther announcements concerning your device in the Eederal Register. {5}------------------------------------------------ Page 2 - Mr. Chumbimune 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/ResourcesforYou/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.B.Dyner -S Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ #### 4. INDICATIONS FOR USE 510(k) Number (if known): K (32734 Device Name: Neutral Luer Activated Device (One-Link Needle-free IV connector) and Extension Sets with the One-Link Needle-free IV connector Indications for Use: The Baxter Neutral Luer Activated Device is intended for single patient use with a vascular access device for the administration of drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids. This device may be used with low pressure power injectors. | Prescription Use | X | |----------------------|---| | AND/OR | | | Over-The-Counter Use | | (Part 2) CFR 801 Subparı D) (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) FDA 21 CFR Part 11 Richard C. Chapman 2013.10.03 12:12:15 04'00 (Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices 510(k) Number: K132734