Who is the manufacturer of BD PhaSeal Optima Closed System Drug Transfer Device?

Becton, Dickinson and Company filed the 510(k) submission for BD PhaSeal Optima Closed System Drug Transfer Device (K201099).

What is the FDA product code for BD PhaSeal Optima Closed System Drug Transfer Device?

ONB. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for BD PhaSeal Optima Closed System Drug Transfer Device?

510(k) clearance (submission type: Special).

What are the predicate devices for BD PhaSeal Optima Closed System Drug Transfer Device?

BD PhaSeal™ Optima Closed System Transfer Device (K181221).

Who can help prepare an FDA 510(k) submission like BD PhaSeal Optima Closed System Drug Transfer Device?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

BD PhaSeal Optima Closed System Drug Transfer Device

K201099 · Becton, Dickinson and Company · ONB · Aug 12, 2020 · General Hospital

Device Facts

Record ID	K201099
Device Name	BD PhaSeal Optima Closed System Drug Transfer Device
Applicant	Becton, Dickinson and Company
Product Code	ONB · General Hospital
Decision Date	Aug 12, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 880.5440
Device Class	Class 2

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.

Device Story

BD PhaSeal Optima Injector (N40-O) is a sterile, single-use closed system drug transfer device (CSTD) component. It facilitates the reconstitution and transfer of hazardous drugs (e.g., antineoplastics) in healthcare settings. The device utilizes a single-lumen cannula and a collet-style fitting with self-sealing elastomeric double membranes to create an airtight, leakproof connection. When the cannula is inserted, it perforates the membranes; upon retraction, the membranes reseal, preventing drug vapor escape and environmental contaminant ingress. The N40-O model incorporates a new ratchet mechanism in the needle hub/grip for secure connection and a needle hub cover to restrict access. It connects to external devices via Luer Lock. The device is operated by healthcare professionals. It benefits patients and staff by minimizing exposure to hazardous drug aerosols and spills and maintaining drug sterility for up to 168 hours.

Clinical Evidence

Bench testing only. Performance testing included attachment/detachment force, fragmentation, and system flow rate. All tests met predetermined acceptance criteria.

Technological Characteristics

Materials: Polypropylene (needle hub, grip, cap), Polyoxymethylene (collet), Stainless Steel (cannula, spring), Polyisoprene (membrane), Silicone (lube). Principle: Collet-style fitting with self-sealing elastomeric double membranes. Connection: Luer Lock. Sterilization: Sterile, single-use. Features: Ratchet mechanism for clockwise rotation locking, needle hub cover.

Indications for Use

Indicated for use as a closed system drug transfer device (CSTD) for the reconstitution and transfer of antineoplastic or other hazardous drugs in healthcare settings to minimize exposure to drug vapors, aerosols, and spills, and to prevent microbial ingress.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

BD PhaSeal™ Optima Closed System Transfer Device (K181221)

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. August 12, 2020 Becton, Dickinson and Company Amy Honev Sr. Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417 Re: K201099 Trade/Device Name: BD PhaSeal Optima Closed System Drug Transfer Device-Injector (N40-0) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: July 9, 2020 Received: July 13, 2020 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 {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201099 Device Name BD PhaSeal™ Optima Closed System Drug Transfer Device - Injector (N40-O) 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) | |-------------------------------------------------| |-------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |---------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## 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 BD logo. The logo consists of an orange circle with a stylized sunburst design on the left and the letters "BD" in blue on the right. The sunburst design has a central circle with rays emanating outwards, and the letters "BD" are in a bold, sans-serif font. ## K201099 510(k) Summary (21 CFR §807.92) BD PhaSeal™ Optima Closed System Drug Transfer Device – Injector (N40-O) | Submitter | Submitter Name: | Becton, Dickinson and Company | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Information | Submitter Address: | 1 Becton Drive Franklin Lakes, NJ 07417 | | | Contact Person: | Amy Honey Sr. Staff Regulatory Affairs Specialist | | | Email Address: | amy.honey@bd.com | | | Phone Number: | (801) 304-3908 | | | Date of Preparation: | August 11, 2020 | | Subject Device | Trade Name: | BD PhaSeal™ Optima Closed System Drug Transfer Device - Injector (N40-O) | | | Common Name: | Closed System Drug Transfer Device (CSTD) | | | Regulation Number: | 21 CFR §880.5440 | | | Regulation Name: | Intravascular Administration Set | | | Regulatory Class: | Class II | | | Product Code: | ONB | | | Classification Panel: | General Hospital | | Predicate | Trade Name: | BD PhaSeal™ Optima Closed System Transfer Device | | Device | 510(k) Reference: | K181221 | | | Common Name: | Closed System Drug Transfer Device (CSTD) | | | Regulation Number: | 21 CFR §880.5440 | | | Regulation Name: | Intravascular Administration Set | | | Regulatory Class: | Class II | | | Product Code: | ONB | | | Classification Panel: | General Hospital | | Reason for Submission | The reason for this submission is to introduce a new product offering-the subject BD PhaSeal™ Optima Injector (N40-O)-to the BD PhaSeal™ Optima family of devices. | | | Device Description | BD PhaSeal™ Optima Closed System Drug Transfer Devices (CSTD) are sterile, single use closed system drug transfer devices intended for the reconstitution and transfer of antineoplastic or other hazardous drugs in the healthcare setting. The BD | | | | PhaSeal™ Optima 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. | | | | Device labeling includes the following statement: "The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding a manufacturer's labeling recommendations for the storage and expiration dating of the drug vial. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information." | | | 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. | | | Technological Characteristics | Technological characteristics of the subject device are substantially equivalent to the predicate device. The subject BD PhaSeal™ Optima Injector N40-O achieves its intended use based on the same technology and principles of operation as the predicate device. | | | | The changes to the device include modifications to the needle hub and grip components to incorporate a ratchet mechanism that locks when rotated during clockwise rotation, and a new needle hub cover component has been added to restrict access to the needle hub. These differences were assessed in the performance tests that were carried out and there were no new questions of safety and effectiveness. | | | | In addition, there were changes to the colorants and silicone formulation used in the subject device. The colorant used in the subject device is used in different components of the predicate device; therefore, there were no new risks introduced. The silicone lube material is unchanged; therefore, there are no new biocompatibility risks introduced to the device. | | | | A comparison of the subject and predicate device technological characteristics is provided in the table below. | | {4}------------------------------------------------ | Attribute | SUBJECT BD PhaSeal™™ Optima Closed System Transfer Device – Injector (N40-O) | PREDICATE (K181221) BD PhaSeal™™ Optima Closed System Transfer Device (Injector [N35-O] device) | |----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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 | 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 | | | SUBJECT | PREDICATE (K181221) | | Attribute | BD PhaSeal™ Optima Closed System Transfer Device - Injector (N40-O) | BD PhaSeal™ Optima Closed System Transfer Device (Injector [N35-O] device) | | | and environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours | environmental exposure to drug vapor, aerosols and spills. The BD PhaSeal™ Optima system also prevents microbial ingress for up to 168 hours | | Devices of the CSTD System | Protector, Injector, Connector, Infusion Adapter | Protector, Injector, Connector, Infusion Adapter | | | Injector Membrane Lube Silicone | Injector Membrane Lube Silicone | | | Membrane Polyisoprene | Membrane Polyisoprene | | | Injector Grip 1 Polypropylene + white colorant | Injector Grip 1 Polypropylene + white colorant | | | Injector Grip 2 Polypropylene + white colorant | Injector Grip 2 Polypropylene + white colorant | | | Needle Hub Polypropylene + white colorant | Needle Hub Polypropylene + blue colorant | | Device Components/ Materials | Needle Hub Cover Polypropylene + white colorant | N/A - does not incorporate a Needle Hub Cover | | | Cannula Stainless Steel | Cannula Stainless Steel | | | Cannula Lube Silicone | Cannula Lube Silicone | | | Cap Polypropylene | Cap Polypropylene | | | Collet Polyoxymethylene (POM) | Collet Polyoxymethylene (POM) | | | Spring Stainless Steel | Spring Stainless Steel | | Mating Method (action of device connections) | Push on-Pull off | Push on-Pull off | | Connection between Devices within the System | Collet style fitting with elastomeric double membranes | Collet style fitting with elastomeric double membranes | | Transfer Mechanism (responsible for airtight & leak- proof connections) | Elastomeric double membrane | Elastomeric double membrane | | Injector Needle Safety Mechanism | Collet style fitting | Collet style fitting | | Attribute | SUBJECT BD PhaSealTM Optima Closed System Transfer Device – Injector (N40-O) | PREDICATE (K181221) BD PhaSealTM Optima Closed System Transfer Device (Injector [N35-O] device) | | Injector Connection to External Device (e.g. syringe) | Luer Lock | Luer Lock | {5}------------------------------------------------ {6}------------------------------------------------ A risk analysis was performed for the modifications to the subject device in accordance with ISO 14971, Medical devices – Applications of risk management to medical devices, and possible risks were identified. Based on risk identification, verification and validation activities were carried out to ensure the risk acceptability criteria have been met and the risks have been mitigated. | Performance Tests | Per the design control requirements specified in 21 CFR 820.30, and the risks identified, the following performance tests were conducted, and all predetermined acceptance criteria were met. | | |------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | | Performance Test | Results | | | Attachment/detachment force | PASS | | | Fragmentation | PASS | | | System flow rate | PASS | | | Testing results demonstrate that the subject device is substantially equivalent to the predicate device. | | | Summary of Substantial Equivalence | The subject device uses the same technology as the predicate device to meet its intended use of minimizing individual and environmental exposure to drug vapors, aerosols, leaks, and spills during fluid transfer when mated to other devices within the system. The indications for use, technological characteristics, and performance testing results demonstrate that the subject BD PhaSeal™ Optima Injector (N40-O) is substantially equivalent to the predicate device. | |

BD PhaSeal Optima Closed System Drug Transfer Device

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

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