Paclitaxel Sets

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 19, 2016 Baxter Healthcare Corporation Ms. Tiffany Lin Manager, Regulatory Affairs 32650 North Wilson Road Round Lake, Illinois 60073 Re: K160007 Trade/Device Name: Paclitaxel Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: November 15, 2016 Received: November 16, 2016 #### Dear Ms. Lin: 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 - Ms. Tiffany Lin 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang-S". The signature is complex and illegible. The name is written in a simple, sans-serif font and is positioned to the right of the signature. The background of the image has a light blue watermark of the letters "FDA". Tina Kiang, Ph.D. Acting 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) K160007 Device Name Paclitaxel Sets Indications for Use (Describe) To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to admining the chemotherapeutic drug paclitaxel, but can also be used for general solution administration. Type of Use (Select one or both, as applicable) | <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |-------------------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is the primary focus of the image and is set against a white background. ### Section 5 – 510(k) Summary December 16, 2016 #### OWNER: Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015 ## CONTACT PERSON: Tiffany Lin Manager, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 270-4343 Fax: (224) 270-4119 ### IDENTIFICATION OF THE DEVICE: Common Name: Intravascular Administration Sets Trade Name: Paclitaxel Sets Classification Panel: 80 General Hospital Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA | Code Number | Name | |-------------|----------------------------------------| | 2C7557 | Interlink System Vented Paclitaxel Set | | 2C7558 | Interlink System Paclitaxel Set | | 2C8857 | Clearlink System Vented Paclitaxel Set | | 2C8858 | Clearlink System Paclitaxel Set | ### Table 1. Code Number for Paclitaxel Sets {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and the letters are closely spaced together. ### PREDICATE DEVICE: #### Table 2. Predicate 510(k) | Device | Company | Predicate 510(k) | Clearance Date | |-----------------------------|-------------------|------------------|-----------------| | Solution Administration Set | Baxter Healthcare | K981792 | August 17, 1998 | #### REFERENCE DEVICES: #### Table 3. Reference 510(k)s | Device | Company | Reference 510(k) | Clearance Date | |--------------------------------------------------------|-------------------|------------------|-------------------| | Nitroglycerin Sets with DUO-<br>VENT Spike | Baxter Healthcare | K150860 | April 16, 2015 | | Solution Administration Sets<br>with 0.2 Micron Filter | Baxter Healthcare | K153158 | December 28, 2015 | ## DESCRIPTION OF THE DEVICE: The Paclitaxel Sets product line consists of single use disposable devices intended for the administration of fluids from a container into the patient's vascular system through a vascular device, primarily for solutions containing the chemotherapeutic drug paclitaxel. These devices are the same as the current marketed devices, which were previously cleared under 510(k) premarket notification K981792 (cleared August 17, 1998). The sets are each comprised of a non-DEHP drip chamber with a spike, 0.2 micron filter, non-DEHP polyvinyl chloride tubing pump segment, polyethylene (PE)-lined trilayer tubing, and a luer lock. On all sets there is a fixtured slide clamp and an on-off roller clamp. Configurations of these sets differ in overall length, type of injection site (Interlink or Clearlink), and type of spike (vented or non-vented). The basis for this premarket notification is a change to the PE-lined trilayer tubing and the 0.2 micron filter currently used in this product line. The inner layer material of the trilayer tubing is changing from Low Density Polyethylene to Linear Low Density Polyethylene. The solution membrane material of the 0.2 micron filter is changing from a hydrophilic polyethersulfone (PES) to another equivalent hydrophilic PES. All changes have been previously cleared under 510(k) premarket notifications for other Baxter Intravascular (IV) Administration Sets. These changes do not impact the intended use or the fundamental scientific technology of the device. No other materials of construction are being introduced into this device as {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the logo for the healthcare company Baxter International. part of this update. The product labels are also being updated to revise statements regarding latex and pump device references, add the indications for use statement of the device, and implement other changes to comply with Baxter's labeling standards. # INDICATIONS FOR USE: To administer fluids with Baxter infusion pumps to a patient's vascular system from a container though a needle or catheter inserted into a vein, primarily used to administer solutions containing the chemotherapeutic drug paclitaxel, but can also be used for general solution administration. ## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE: The proposed devices are equivalent to Baxter's currently legally marketed devices cleared under 510(k) premarket notification K981792 (cleared August 17, 1998). The modifications consist of a changes to the PE-lined trilayer tubing and 0.2 micron filter, which have been previously cleared under 510(k) premarket notifications K150860 (cleared April 16, 2015) and K153158 (cleared December 28, 2015), respectively. The intended use, basic design, and function for the proposed device are equivalent to the predicate device. Table 4 is a device comparison table outlining the differences between the current (predicate) device and the proposed device. | Features | Current Device<br>(Cleared under K981792) | Proposed Device | |---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | For the administration of fluids from a<br>container into the patient's vascular<br>system through a vascular device. | Same | | Indications for use | To administer fluids to a patient's<br>vascular system from a container through<br>a needle or catheter inserted into a vein.<br>The proposed solution set will be<br>primarily used to administer solutions<br>containing the chemotherapeutic drug<br>paclitaxel, but can also be used for<br>general solution administration with<br>Baxter Flo-Gard® (6200 and 6300 series)<br>and Colleague™ volumetric infusion<br>pumps. | To administer fluids with Baxter<br>infusion pumps to a patient's<br>vascular system from a container<br>though a needle or catheter<br>inserted into a vein, primarily<br>used to administer solutions<br>containing the chemotherapeutic<br>drug paclitaxel, but can also be<br>used for general solution<br>administration.a | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is the only element in the image and is set against a white background. | Features | Current Device<br>(Cleared under K981792) | Proposed Device | |-----------------------------|---------------------------------------------------------------------------|------------------------------------------------------------------------------| | Sterile | Yes | Same | | Non-Pyrogenic | Yes | Same | | Single Use | Yes | Same | | Materials | | | | Spike | Acrylonitrile Butadiene Styrene | Same | | Drip Chamber | Polyvinyl Chloride | Same | | Interlink Y-Site | Copolyester and Synthetic Polyisoprene | Same | | Clearlink Y-Site | Polycarbonate and Silicone | Same | | Minidrip Adapter | Synthetic Polyisoprene and Stainless<br>Steel | Same | | Trilayer Tubing | Polyvinyl Chloride, Polyolefin and Low<br>Density Polyethylene | Polyvinyl Chloride, Polyolefin and<br>Linear Low Density Polyethyleneb | | Tubing | Polyvinyl Chloride | Same | | 0.2 Micron Filter | Copolyester, Polyethersulfone (Millipore)<br>and Polyvinylidiene Fluoride | Copolyester, Polyethersulfone<br>(Membrana) and Polyvinylidiene<br>Fluoridec | | Male Luer Lock<br>Connector | Acrylonitrile Butadiene Styrene | Same | ## Table 4. Device Comparison a The indications for use are being clarified to remove brand names of infusion pumps to align with current market terminology. This does not alter the intended use of the device. b Materials previously cleared under 510(k) premarket notification K150860 on April 16, 2015. 6 Materials previously cleared under 510(k) premarket notification K153158 on December 28, 2015. # 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 bench tests were conducted to evaluate the effect of the modifications on the functional performance of the Paclitaxel Sets. | Test | Acceptance Criteria | |--------------------|-------------------------| | Clear Passage Test | Per Baxter test method. | #### Table 5. Performance Testing Summary {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif and slightly italicized. The word is centered and takes up most of the frame. The background is plain white. | Test | Acceptance Criteria | |----------------------------------------------------------------------------------------|----------------------------------| | Roller Clamp Force Test | Per Baxter test method. | | Roller Clamp Shut-Off Test | Per Baxter test method. | | Roller Clamp Tubing Leak Test | Per Baxter test method. | | Solvent Bond Tensile Strength Test | Per Baxter test method. | | Solvent Bond Air Pressure Test | Per Baxter test method. | | Air Diffusion Test | Per Baxter test method. | | Bubble Point Test | Per Baxter test method. | | Gravity Flow Rate Test | Per Baxter test method. | | Flow Rate Test Post Sterile Water Conditioning | Per Baxter test method. | | Flow Rate Test Post Parenteral Nutrition Conditioning | Per Baxter test method. | | Bacterial Retention Test | Per Baxter test method. | | Upstream/Downstream Occlusion Test<br>(with Baxter pumps: FLO-GARD and SIGMA Spectrum) | Per Baxter test method. | | Drug Compatibility Test (Paclitaxel Concentration) | Equivalence to predicate device. | | Drug Compatibility Test (pH) | Equivalence to predicate device. | | Drug Compatibility Test (Color) | Equivalence to predicate device. | | Drug Compatibility Test (Visual Inspection) | Equivalence to predicate device. | Table 5. Performance Testing Summary #### Biocompatibility: Biocompatibility assessments were conducted in accordance with ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," to the category of prolonged duration, external communicating device, indirect blood path as recognized by FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993 and as recommended by the FDA Guidance Document issued July 11, 2008 "Guidance for Industry and FDA Staff - Intravascular Administration Sets Premarket Notification Submissions [510(k)]." The battery of testing included the following tests: - Cytotoxicity (per ISO 10993-5) - Systemic Toxicity (Acute and Sub-chronic) (per ISO 10993-11) ● - Irritation/Intracutaneous Reactivity (per ISO 10993-10) ● - Sensitization (per ISO 10993-10) - Hemocompatibility (In Vitro Hemolysis) (per ISO 10993-4) {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the word "Baxter" in a bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif and has a modern look. - Material Mediated Pyrogen (per ISO 10993-11) ● - USP Physiochemical (per USP <661>) #### Sterility: The Paclitaxel Sets are sterilized with gamma radiation. The Minimum Sterilizing Dose (MSD) required to provide a 10 € Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facilities to be within 14.2 – 25.0 kGy. Radiation sterilization validation and routine control at Baxter Healthcare Corporation is in compliance with ANSI/AAMI/ISO 11137-2. These products are labeled "Sterile, nonpyrogenic." Package verification testing is based on Visual Inspection, ASTM F88 Seal Strength, and ASTM F2096 Bubble Leak. #### Shelf-Life: Baxter has provided aging tests to support a shelf-life claim of eighteen (18) months. ## CONCLUSION: The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device that is currently marketed for the same intended use.