(110 days)
Not Found
No
The description focuses on mechanical and physical properties of the device for closed system drug transfer and does not mention any AI or ML components.
No
The device is a closed system drug transfer device (CSTD) that minimizes exposure to hazardous drugs and prevents microbial ingress. It does not exert any therapeutic effect on a patient.
No
The device is described as a closed system drug transfer device (CSTD) for minimizing exposure to hazardous drugs and preventing microbial ingress, with no mention of diagnosing conditions or diseases.
No
The device description clearly outlines physical components (Protector, Injector, Connector, Infusion Adapter) and their mechanical function (double membrane, cannula, collet-style fitting) for transferring liquids. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the BD PhaSeal™ Optima system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "minimize individual and environmental exposure to drug vapor, aerosols and spills" and "prevent microbial ingress" during the reconstitution and transfer of hazardous drugs. This is a drug delivery and safety function, not a diagnostic function.
- Device Description: The description focuses on the mechanical aspects of creating a closed system for drug transfer. It describes how the device works to prevent contamination and exposure, not how it analyzes biological samples or provides diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing any information related to a patient's health status or disease.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BD PhaSeal™ Optima system does not perform any of these functions.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONB
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Tests:
- Attachment/detachment force: PASS
- Fragmentation: PASS
- System flow rate: PASS
Testing results demonstrate that the subject device is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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. |