BD PhaSeal Optima Closed System Transfer Device

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November 30, 2018 Becton, Dickinson and Company Amy Honey Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K181221 Trade/Device Name: BD PhaSeal Ontima Closed System Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: October 22, 2018 Received: October 24, 2018 Dear Amy Honey: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Alan M. Stevens -S Tina Kiang, Ph.D. for 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) K181221 Device Name BD PhaSeal Optima Closed System Transfer Device #### Indications for Use (Describe) The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours. Type of Use (Select one or both, as applicable) | <span style="font-size:10px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------| | <span style="font-size:10px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | ### 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. 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The letters "BD" are in a bold, rounded font. ## K181221 # 510(k) Summary (21 CFR §807.92) # BD PhaSeal™ Optima Closed System Transfer Device | Submitter<br>Information | Submitter Name: | Becton, Dickinson and Company | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | | Submitter Address: | 1 Becton Drive<br>Franklin Lakes, NJ 07417 | | | Contact Person: | Amy Honey | | | Email Address: | Staff Regulatory Affairs Specialist<br>amy.honey@bd.com | | | Phone Number: | Phone: (801) 304-3908 | | | Fax Number: | Fax: (801) 304-3963 | | | Date of Preparation: | November 30, 2018 | | Subject Device | Trade Name: | BD PhaSeal™ Optima Closed System Transfer Device | | | Common Name: | Closed Antineoplastic and Hazardous Drug<br>Reconstitution and Transfer System | | | Regulation Number: | 21 CFR §880.5440 | | | Regulation Name: | Intravascular Administration Set | | | Regulatory Class: | II | | | Product Code: | ONB | | | Classification Panel: | General Hospital | | Predicate Device | Trade Name: | BD PhaSeal™ Closed System Transfer Device | | | 510(k) Reference: | K123213 | | | Common Name: | Closed Antineoplastic and Hazardous Drug<br>Reconstitution and Transfer System | | | Regulation Number: | 21 CFR §880.5440 | | | Regulation Name: | Intravascular Administration Set | | | Regulatory Class: | II | | | Product Code: | ONB | | | Classification Panel: | General Hospital | | Device<br>Description | The BD PhaSeal™ Optima Closed System Transfer Device (CSTD) is a sterile single-<br>use closed system drug transfer device intended for the reconstitution and transfer of<br>antineoplastic or other hazardous drugs in the healthcare setting. The system is<br>comprised of four devices-Protector, Injector, Connector, and Infusion Adapter.<br>The closed transfer of liquid drugs takes place through a double membrane utilizing<br>self-sealing elastomeric membranes that are tightly fitted together through the collet-<br>style fitting on each of the BD PhaSeal™ Optima system devices. During use, the<br>single lumen cannula of the Injector perforates the double membranes for the transfer<br>of liquids. When the cannula is retracted the membranes seal off the transfer of<br>environmental contaminants into the system and/or escape of drug or vapor<br>concentrations outside the system, thereby minimizing the individual and<br>environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™<br>Optima system prevents microbial ingress for up to 168 hours. Performance of the<br>self-sealing membrane has been substantiated up to 10 penetrations. | | | Indications for<br>Use | The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug<br>transfer device (CSTD) that mechanically prohibits the transfer of environmental<br>contaminants into the system and the escape of drug vapor concentrations outside<br>the system, thereby minimizing individual and environmental exposure to drug vapor,<br>aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial<br>ingress for up to 168 hours. | | | Technological<br>Characteristics | Technological characteristics of the subject BD PhaSeal™ Optima Closed System<br>Transfer Device (CSTD) are substantially equivalent to that of the predicate BD<br>PhaSeal™ Closed System Transfer Device (CSTD) with respect to basic design and<br>function. The subject BD PhaSeal™ Optima Closed System Transfer Device (CSTD)<br>achieves its intended use based on the same technology and principles of operation<br>as the predicate BD PhaSeal™ Closed System Transfer Device (CSTD).<br>The key differences between the subject and predicate device are as follows: | | | | • The action to connect mating devices within the subject BD PhaSeal™ Optima<br>CSTD system is a push on-pull off motion rather than the push-turn-push<br>motion of the predicate BD PhaSeal™ CSTD device. | | | | • The connection between the subject BD PhaSeal™ Optima CSTD system<br>devices (Injector to Protector, Connector, or Infusion Adapter) is a collet-style<br>fitting with elastomeric double membranes rather than the bayonet fitting with<br>elastomeric double membranes of the predicate BD PhaSeal™ CSTD device. | | | | • The Injector needle mechanism of the subject BD PhaSeal™ Optima CSTD<br>device is a collet-style fitting rather than the Safety Sleeve ErgoMotion™ of<br>the predicate BD PhaSeal™ CSTD device. | | {4}------------------------------------------------ A comparison of the subject and predicate device technological characteristics is provided in the table below. | Subject and Predicate Device Comparison Table | | | |----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Attribute | SUBJECT BD PhaSeal™ Optima Closed System Transfer Device | PREDICATE BD PhaSeal™ Closed System Transfer Device (K123213) | | Indications for Use | The BD PhaSeal™ Optima system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours. | The PhaSeal™ system is an airtight and leakproof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal™ system also prevents microbial ingress. | | Devices of the CSTD System | Protector, Injector, Connector, Infusion Adapter | Protector, Injector, Connector, Infusion Adapter | | Subject and Predicate Device Comparison Table (cont.) | | | | Attribute | SUBJECT<br>BD PhaSeal™ Optima Closed System<br>Transfer Device | PREDICATE<br>BD PhaSeal™ Closed System Transfer<br>Device (K123213) | | Primary Device<br>Materials | Membrane (all devices)<br>Polyisoprene<br>Cannula (Injector)<br>Stainless Steel<br>Injector Lube<br>Silicone<br>Needle Hub (Injector)<br>Polypropylene<br>Spike (Protector)<br>Polypropylene<br>Spike Sleeve (Protector)<br>Thermoplastic Elastomer (TPE)<br>Connector Body<br>Polypropylene<br>Infusion Spike (Infusion Adapter)<br>Polypropylene<br>Infusion Port (Infusion Adapter)<br>Thermoplastic Elastomer (TPE) | Membrane (all devices)<br>Thermoplastic Elastomer (TPE)<br>Cannula (Injector)<br>Stainless Steel<br>Injector Lube<br>N/A<br>Needle Hub (Injector)<br>Polypropylene<br>Spike or Cannula (Protector)<br>Polypropylene or Stainless Steel<br>Spike Sleeve (Protector)<br>N/A<br>Connector Body<br>Polypropylene<br>Infusion Spike (Infusion Adapter)<br>Polypropylene<br>Infusion Port (Infusion Adapter)<br>Thermoplastic Elastomer (TPE) | | Mating Method<br>(Action of Device<br>Connections) | Push on-Pull off | Push-Turn-Push | | Connection<br>between Devices<br>within the System | Collet-style fitting with elastomeric double<br>membranes | Bayonet fitting with elastomeric double<br>membranes | | Transfer<br>Mechanism<br>(responsible for<br>airtight &<br>leak-proof<br>connections): | Elastomeric double membrane | Elastomeric double membrane | | Injector Needle<br>Mechanism | Collet-style fitting | Safety Sleeve, ErgoMotion™ | | Injector<br>Connection to<br>Syringe | Luer Lock | Luer Lock | | Connector<br>Connection to<br>Patient IV Line | Luer Lock connection or Spike Port | Luer Lock connection or Spike Port | {5}------------------------------------------------ {6}------------------------------------------------ ## Performance Tests Performance testing was conducted to support a determination of substantial equivalence as compared to BD's own predicate device. Results of these tests demonstrate that the subject device is substantially equivalent to the predicate device. Any testing performed to a recognized standard is noted in the table below. | Performance Test | Results | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Microbial ingress testing per FDA guidance document,<br>Intravascular Administration Sets Premarket Notification<br>Submissions [510(k)] | PASS | | Airtight connections utilizing TiCl4 vapor test | PASS | | Leakproof connections testing utilizing Fluorescein test | PASS | | Protector assembly force and removal force testing | PASS | | Protector expansion chamber burst testing | PASS | | Packaging integrity and shelf life testing per the following:<br>ASTM D4169-16 Standard Practice for Performance<br>Testing of Shipping Containers and Systems<br>ASTM F88/F88M-15 Standard Test Method for Seal<br>Strength of Flexible Barrier Materials<br>ASTM F2096-11 Standard Test Method for Detecting<br>Gross Leaks in Packaging by Internal Pressurization<br>(bubble test) | PASS | | Hazardous vapor containment using alcohol residuals<br>level criterion | PASS | | EO residuals testing per ISO 10993-7 | PASS | | EO sterilization validation (SAL of 10-6) per ISO 11135 | PASS | | Pyrogenicity - bacterial endotoxin test (LAL) | PASS | In addition, a biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted: | Biocompatibility Test | Results | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | Cytotoxicity per ISO 10993-5 Sensitization per ASTM F2148 and ISO 10993-10 Intracutaneous Reactivity per ISO 10993-10 and USP 39-NF 34 <88> Acute Systemic Toxicity per ISO 10993-11 Pyrogenicity (material-mediated rabbit pyrogen) per USP <151> and ISO 10993-11 Hemolysis per ISO 10993-4 | All materials are biocompatible. | Per the design control requirements specified in 21 CFR 820.30, the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device. {7}------------------------------------------------ ### Summary of Substantial Equivalence Both the subject BD PhaSeal™ Optima Closed System Transfer Device and predicate BD PhaSeal™ Closed System Transfer Device rely on similar technology to achieve the intended use. Both devices utilize elastomeric double membranes to create the sealed environment. The main difference between the subject device and predicate device is the connection method used to attach and detach system components; however, the fundamental scientific technology used to assure an airtight and leak-proof connection remains unchanged. The results of performance and biological testing of the subject BD PhaSeal™ Optima Closed System Transfer Device met all predetermined acceptance criteria and demonstrate that the subject device is substantially equivalent to the predicate device.