(110 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.
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."
The provided text describes the regulatory clearance for the BD PhaSeal™ Optima Closed System Drug Transfer Device-Injector (N40-O). It does not describe an AI/ML powered medical device. Therefore, many of the requested fields are not applicable.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Test) | Reported Device Performance |
|---|---|
| Attachment/detachment force | PASS |
| Fragmentation | PASS |
| System flow rate | PASS |
The text states: "all predetermined acceptance criteria were met."
2. Sample sized used for the test set and the data provenance
The sample sizes for the performance tests are not specified in the provided document.
The data provenance is not specified beyond the tests being conducted by the manufacturer, Becton, Dickinson and Company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system requiring expert ground truth for interpretation.
4. Adjudication method for the test set
This is not applicable as the device is a mechanical Closed System Drug Transfer Device, not an AI/ML system or a diagnostic device requiring adjudication of interpretations. The performance tests appear to be quantitative measurements against defined criteria.
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
This is not applicable. The device is a mechanical Closed System Drug Transfer Device and not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical Closed System Drug Transfer Device and does not have an algorithm component.
7. The type of ground truth used
For the performance tests (Attachment/detachment force, Fragmentation, System flow rate), the ground truth would be established by objective physical measurements against predefined engineering or regulatory specifications.
8. The sample size for the training set
This is not applicable as there is no training set for a mechanical device.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for a mechanical device.
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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
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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
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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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 DriveFranklin Lakes, NJ 07417 |
| Contact Person: | Amy HoneySr. 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 forSubmission | The reason for this submission is to introduce a new product offering-the subject BDPhaSeal™ Optima Injector (N40-O)-to the BD PhaSeal™ Optima family of devices. | |
| DeviceDescription | BD PhaSeal™ Optima Closed System Drug Transfer Devices (CSTD) are sterile,single use closed system drug transfer devices intended for the reconstitution andtransfer 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 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. | ||
| Device labeling includes the following statement: "The ability to prevent microbialingress for up to 7 days should not be interpreted as modifying, extending, orsuperseding a manufacturer's labeling recommendations for the storage andexpiration dating of the drug vial. Refer to drug manufacturer's recommendations andUSP compounding guidelines for shelf life and sterility information." | ||
| 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 device are substantially equivalent to thepredicate device. The subject BD PhaSeal™ Optima Injector N40-O achieves itsintended use based on the same technology and principles of operation as thepredicate device. | |
| The changes to the device include modifications to the needle hub and gripcomponents to incorporate a ratchet mechanism that locks when rotated duringclockwise rotation, and a new needle hub cover component has been added torestrict access to the needle hub. These differences were assessed in theperformance tests that were carried out and there were no new questions of safetyand effectiveness. | ||
| In addition, there were changes to the colorants and silicone formulation used in thesubject device. The colorant used in the subject device is used in differentcomponents of the predicate device; therefore, there were no new risks introduced.The silicone lube material is unchanged; therefore, there are no new biocompatibilityrisks introduced to the device. | ||
| A comparison of the subject and predicate device technological characteristics isprovided in the table below. |
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| Attribute | SUBJECTBD PhaSeal™™ Optima Closed SystemTransfer Device – Injector (N40-O) | PREDICATE (K181221)BD PhaSeal™™ Optima Closed SystemTransfer Device (Injector [N35-O] device) |
|---|---|---|
| Indications forUse | The BD PhaSeal™™ Optima system is anairtight and leakproof closed system drugtransfer device (CSTD) that mechanicallyprohibits the transfer of environmentalcontaminants into the system and theescape of drug vapor concentrations outsidethe system, thereby minimizing individual | The BD PhaSeal™™ Optima system is anairtight and leakproof closed system drugtransfer device (CSTD) that mechanicallyprohibits the transfer of environmentalcontaminants into the system and the escapeof drug vapor concentrations outside thesystem, thereby minimizing individual and |
| SUBJECT | PREDICATE (K181221) | |
| Attribute | BD PhaSeal™ Optima Closed SystemTransfer Device - Injector (N40-O) | BD PhaSeal™ Optima Closed SystemTransfer Device (Injector [N35-O] device) |
| and environmental exposure to drug vapor,aerosols and spills. The BD PhaSeal™Optima system also prevents microbialingress for up to 168 hours | environmental exposure to drug vapor,aerosols and spills. The BD PhaSeal™ Optimasystem also prevents microbial ingress for upto 168 hours | |
| Devices of theCSTD System | Protector, Injector, Connector, InfusionAdapter | Protector, Injector, Connector, InfusionAdapter |
| Injector Membrane LubeSilicone | Injector Membrane LubeSilicone | |
| MembranePolyisoprene | MembranePolyisoprene | |
| Injector Grip 1Polypropylene + white colorant | Injector Grip 1Polypropylene + white colorant | |
| Injector Grip 2Polypropylene + white colorant | Injector Grip 2Polypropylene + white colorant | |
| Needle HubPolypropylene + white colorant | Needle HubPolypropylene + blue colorant | |
| DeviceComponents/Materials | Needle Hub CoverPolypropylene + white colorant | N/A - does not incorporate a Needle HubCover |
| CannulaStainless Steel | CannulaStainless Steel | |
| Cannula LubeSilicone | Cannula LubeSilicone | |
| CapPolypropylene | CapPolypropylene | |
| ColletPolyoxymethylene (POM) | ColletPolyoxymethylene (POM) | |
| SpringStainless Steel | SpringStainless Steel | |
| Mating Method(action of deviceconnections) | Push on-Pull off | Push on-Pull off |
| Connectionbetween Deviceswithin theSystem | Collet style fitting with elastomeric doublemembranes | Collet style fitting with elastomeric doublemembranes |
| TransferMechanism(responsible forairtight & leak-proofconnections) | Elastomeric double membrane | Elastomeric double membrane |
| Injector NeedleSafetyMechanism | Collet style fitting | Collet style fitting |
| Attribute | SUBJECTBD PhaSealTM Optima Closed SystemTransfer Device – Injector (N40-O) | PREDICATE (K181221)BD PhaSealTM Optima Closed SystemTransfer Device (Injector [N35-O] device) |
| InjectorConnection toExternal Device(e.g. syringe) | Luer Lock | Luer Lock |
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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. |
§ 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.