(207 days)
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 BD PhaSeal™ Optima Closed System Transfer Device (CSTD) is a sterile single-use closed system drug transfer device intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The system is comprised of four devices-Protector, Injector, Connector, and Infusion Adapter. The closed transfer of liquid drugs takes place through a double membrane utilizing self-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, the single lumen cannula of the Injector perforates the double membranes for the transfer of liquids. When the cannula is retracted the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™ Optima system prevents microbial ingress for up to 168 hours. Performance of the self-sealing membrane has been substantiated up to 10 penetrations.
The BD PhaSeal™ Optima Closed System Transfer Device is an airtight and leakproof closed system drug transfer device (CSTD) designed to prevent environmental contaminants from entering the system and to prevent drug vapor concentrations from escaping, thus minimizing exposure to drug vapor, aerosols, and spills. It also prevents microbial ingress for up to 168 hours.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Test | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Microbial ingress testing | Per FDA guidance document, "Intravascular Administration Sets Premarket Notification Submissions [510(k)]" (presumably demonstrating no microbial ingress for up to 168 hours). | PASS |
| Airtight connections | Utilizing TiCl4 vapor test (specific acceptance criteria for vapor leakage not detailed, but likely related to no detectable vapor escape). | PASS |
| Leakproof connections | Utilizing Fluorescein test (specific acceptance criteria for liquid leakage not detailed, but likely related to no detectable liquid escape). | PASS |
| Protector assembly force and removal force testing | Not explicitly stated, but implies forces within acceptable ranges for proper device function and user interaction. | PASS |
| Protector expansion chamber burst testing | Not explicitly stated, but implies the chamber can withstand internal pressure without bursting. | PASS |
| Packaging integrity and shelf life testing | Per ASTM D4169-16 (Performance Testing of Shipping Containers), ASTM F88/F88M-15 (Seal Strength), ASTM F2096-11 (Gross Leak Detection). Acceptance criteria would involve maintaining package integrity and sterility over the shelf life. | PASS |
| Hazardous vapor containment | Using alcohol residuals level criterion (specific residual level not detailed, but implies levels below a hazardous threshold). | PASS |
| Ethylene Oxide (EO) residuals testing | Per ISO 10993-7 (Biological evaluation of medical devices – Part 7: Ethylene oxide sterilization residuals). Acceptance criteria would be below specified limits. | PASS |
| EO sterilization validation | Per ISO 11135 (Sterilization of health care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process). Acceptance criterion: Sterility Assurance Level (SAL) of 10-6. | PASS |
| Pyrogenicity - bacterial endotoxin test (LAL) | Acceptance criteria not explicitly stated, but implies endotoxin levels below a specified threshold. | PASS |
| Biocompatibility: Cytotoxicity | Per ISO 10993-5. Acceptance criteria: non-cytotoxic. | All materials are biocompatible. |
| Biocompatibility: Sensitization | Per ASTM F2148 and ISO 10993-10. Acceptance criteria: non-sensitizing. | All materials are biocompatible. |
| Biocompatibility: Intracutaneous Reactivity | Per ISO 10993-10 and USP 39-NF 34 <88>. Acceptance criteria: no significant irritation or reactivity. | All materials are biocompatible. |
| Biocompatibility: Acute Systemic Toxicity | Per ISO 10993-11. Acceptance criteria: no systemic toxicity. | All materials are biocompatible. |
| Biocompatibility: Pyrogenicity (material-mediated rabbit pyrogen) | Per USP <151> and ISO 10993-11. Acceptance criteria: no pyrogenic response. | All materials are biocompatible. |
| Biocompatibility: Hemolysis | Per ISO 10993-4. Acceptance criteria: non-hemolytic. | All materials are biocompatible. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the specific sample sizes used for each performance test. It only indicates that "Performance testing was conducted" and that the "Results of these tests demonstrate that the subject device is substantially equivalent to the predicate device." The data provenance is not specified beyond being generated by the device manufacturer, Becton, Dickinson and Company. The studies appear to be retrospective in nature, performed by the manufacturer to demonstrate product performance for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
Not applicable. This device is a medical device (Closed System Transfer Device), not an AI-powered diagnostic or assistive tool that would require expert-established ground truth for its performance assessment. The tests conducted are laboratory-based and measure physical, chemical, and biological properties according to established standards.
4. Adjudication Method for the Test Set:
Not applicable. See point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This is not an AI-powered device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is not an AI-powered device. The "standalone" performance here refers to the device's inherent mechanical and material performance.
7. The Type of Ground Truth Used:
The "ground truth" for this device's performance is established by the pre-defined acceptance criteria set by recognized international (ISO, ASTM) and national (FDA, USP) standards and guidance documents. For example, for microbial ingress, the ground truth is the absence of microbial contamination as defined by the FDA guidance. For airtight connections, the "ground truth" is the non-detection of vapor using the TiCl4 test. For biocompatibility, the ground truth is that the materials do not elicit adverse biological responses as defined by ISO 10993 standards.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
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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
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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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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K181221
510(k) Summary (21 CFR §807.92)
BD PhaSeal™ Optima Closed System Transfer Device
| SubmitterInformation | Submitter Name: | Becton, Dickinson and Company |
|---|---|---|
| Submitter Address: | 1 Becton DriveFranklin Lakes, NJ 07417 | |
| Contact Person: | Amy Honey | |
| Email Address: | Staff Regulatory Affairs Specialistamy.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 DrugReconstitution 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 DrugReconstitution and Transfer System | |
| Regulation Number: | 21 CFR §880.5440 | |
| Regulation Name: | Intravascular Administration Set | |
| Regulatory Class: | II | |
| Product Code: | ONB | |
| Classification Panel: | General Hospital | |
| DeviceDescription | The BD PhaSeal™ Optima Closed System Transfer Device (CSTD) is a sterile single-use closed system drug transfer device intended for the reconstitution and transfer ofantineoplastic or other hazardous drugs in the healthcare setting. The system iscomprised of four devices-Protector, Injector, Connector, and Infusion Adapter.The closed transfer of liquid drugs takes place through a double membrane utilizingself-sealing elastomeric membranes that are tightly fitted together through the collet-style fitting on each of the BD PhaSeal™ Optima system devices. During use, thesingle lumen cannula of the Injector perforates the double membranes for the transferof liquids. When the cannula is retracted the membranes seal off the transfer ofenvironmental contaminants into the system and/or escape of drug or vaporconcentrations outside the system, thereby minimizing the individual andenvironmental exposure to drug vapor, aerosols, leaks and spills. The BD PhaSeal™Optima system prevents microbial ingress for up to 168 hours. Performance of theself-sealing membrane has been substantiated up to 10 penetrations. | |
| Indications forUse | The BD PhaSeal™ Optima system is an airtight and leakproof closed system drugtransfer device (CSTD) that mechanically prohibits the transfer of environmentalcontaminants into the system and the escape of drug vapor concentrations outsidethe system, thereby minimizing individual and environmental exposure to drug vapor,aerosols and spills. The BD PhaSeal™ Optima system also prevents microbialingress for up to 168 hours. | |
| TechnologicalCharacteristics | Technological characteristics of the subject BD PhaSeal™ Optima Closed SystemTransfer Device (CSTD) are substantially equivalent to that of the predicate BDPhaSeal™ Closed System Transfer Device (CSTD) with respect to basic design andfunction. The subject BD PhaSeal™ Optima Closed System Transfer Device (CSTD)achieves its intended use based on the same technology and principles of operationas the predicate BD PhaSeal™ Closed System Transfer Device (CSTD).The key differences between the subject and predicate device are as follows: | |
| • The action to connect mating devices within the subject BD PhaSeal™ OptimaCSTD system is a push on-pull off motion rather than the push-turn-pushmotion of the predicate BD PhaSeal™ CSTD device. | ||
| • The connection between the subject BD PhaSeal™ Optima CSTD systemdevices (Injector to Protector, Connector, or Infusion Adapter) is a collet-stylefitting with elastomeric double membranes rather than the bayonet fitting withelastomeric double membranes of the predicate BD PhaSeal™ CSTD device. | ||
| • The Injector needle mechanism of the subject BD PhaSeal™ Optima CSTDdevice is a collet-style fitting rather than the Safety Sleeve ErgoMotion™ ofthe predicate BD PhaSeal™ CSTD device. |
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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 | SUBJECTBD PhaSeal™ Optima Closed SystemTransfer Device | PREDICATEBD PhaSeal™ Closed System TransferDevice (K123213) |
| Primary DeviceMaterials | Membrane (all devices)PolyisopreneCannula (Injector)Stainless SteelInjector LubeSiliconeNeedle Hub (Injector)PolypropyleneSpike (Protector)PolypropyleneSpike Sleeve (Protector)Thermoplastic Elastomer (TPE)Connector BodyPolypropyleneInfusion Spike (Infusion Adapter)PolypropyleneInfusion Port (Infusion Adapter)Thermoplastic Elastomer (TPE) | Membrane (all devices)Thermoplastic Elastomer (TPE)Cannula (Injector)Stainless SteelInjector LubeN/ANeedle Hub (Injector)PolypropyleneSpike or Cannula (Protector)Polypropylene or Stainless SteelSpike Sleeve (Protector)N/AConnector BodyPolypropyleneInfusion Spike (Infusion Adapter)PolypropyleneInfusion Port (Infusion Adapter)Thermoplastic Elastomer (TPE) |
| Mating Method(Action of DeviceConnections) | Push on-Pull off | Push-Turn-Push |
| Connectionbetween Deviceswithin the System | Collet-style fitting with elastomeric doublemembranes | Bayonet fitting with elastomeric doublemembranes |
| TransferMechanism(responsible forairtight &leak-proofconnections): | Elastomeric double membrane | Elastomeric double membrane |
| Injector NeedleMechanism | Collet-style fitting | Safety Sleeve, ErgoMotion™ |
| InjectorConnection toSyringe | Luer Lock | Luer Lock |
| ConnectorConnection toPatient IV Line | Luer Lock connection or Spike Port | Luer Lock connection or Spike Port |
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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,Intravascular Administration Sets Premarket NotificationSubmissions [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:ASTM D4169-16 Standard Practice for PerformanceTesting of Shipping Containers and SystemsASTM F88/F88M-15 Standard Test Method for SealStrength of Flexible Barrier MaterialsASTM F2096-11 Standard Test Method for DetectingGross Leaks in Packaging by Internal Pressurization(bubble test) | PASS |
| Hazardous vapor containment using alcohol residualslevel 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.
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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.
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.