BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE

K123213 · Becton, Dickinson & CO · ONB · Jan 9, 2013 · General Hospital

Device Facts

• Record ID: K123213
• Device Name: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE
• Applicant: Becton, Dickinson & CO
• Product Code: ONB · General Hospital
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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 or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

Device Story

PhaSeal is a sterile, single-use closed system drug transfer device (CSTD) designed to facilitate the safe reconstitution and transfer of hazardous drugs. The system utilizes a double-membrane mechanism with self-sealing elastomeric membranes and a bayonet fitting to create an airtight, leakproof connection. A single-lumen cannula perforates the membranes during transfer; retraction of the cannula seals the system, preventing the escape of drug vapors, aerosols, or spills and blocking the ingress of environmental contaminants. Components include a protector, injector, and connector. The device is used in clinical settings by healthcare professionals to handle antineoplastic agents. By maintaining a closed environment, the system protects clinicians from hazardous drug exposure and maintains the sterility of the drug product.

Clinical Evidence

No clinical data. Performance substantiated via bench testing, including leakproof connections (fluorescein test), airtight connections (TiCl4 test), and microbial ingress testing.

Technological Characteristics

Components: Protector, Injector, Connector. Materials: Stainless steel or plastic. Transfer mechanism: Elastomeric double membrane with bayonet fitting. Connectivity: Luer/Luer lock connection to syringes; spike port/Luer lock to IV lines. Safety: Integrated safety sleeve on injector. Sterilization: Ethylene oxide (EO).

Indications for Use

Indicated for use as a closed system drug transfer device (CSTD) to minimize healthcare worker exposure to hazardous drugs and prevent microbial ingress during the reconstitution and transfer of antineoplastic and hazardous drugs.

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® Connector, Injector, Protector (K120384)

Submission Summary (Full Text)

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# 510(K) Summary of Safety and Effectiveness

JAN 0 9 2013

Date Prepared: 12 October 2012

- Submitted By: 1.
John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 Tel: [phone]; Fax: [phone]

#### 2. Device Name:

BD PhaSeal® Closed System Drug Transfer Device Trade Name: Common Name: Closed antineoplastic & hazardous drug reconstitution & transfer system Classification Name: Intravascular administration set Classification: Class II, 21 CFR 880.5440

#### 3. Predicate Device:

BD PhaSeal® Connector, Injector, Protector - K120384

#### 4. Device Description:

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liquid takes place through a double membrane utilizing self-sealing elastomeric membranes, tightly fitted together through a bayonet fitting on all PhaSeal components. A single lumen cannula perforates the double membranes fro the transfer of liquid. 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 and spills and also minimizing the risk of microbial contamination.

#### 5. Indications for Use:

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 or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

#### 6. Technological Characteristics:

· The technological characteristics of the subject device are identical to those of the predicate devices.

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K123213. page 2 of 3

| Characteristic | Subject Device: BD PhaSeal | Predicate Device: BD PhasSeal K120384 | Equivalence |
|-------------------------------------------------|--------------------------------------------------|--------------------------------------------------|------------------------|
| Transfer Mechanism | Elastomeric Double Membrane | Elastomeric Double Membrane | Identical to Predicate |
| Connection between PhaSeal Components | Bayonet Fitting with Elastomeric Double Membrane | Bayonet Fitting with Elastomeric Double Membrane | Identical to Predicate |
| Components | Protector, Injector, Connector | Protector, Injector, Connector | Identical to Predicate |
| Protector Spike | Stainless Steel or Plastic | Stainless Steel or Plastic | Identical to Predicate |
| Injector Cannula | Stainless Steel | Stainless Steel | Identical to Predicate |
| Fitting Connection to external standard syringe | Injector: Luer / Luer Lock Connection | Injector: Luer / Luer Lock Connection | Identical to Predicate |
| Fitting Connection to external standard IV line | Luer Lock or Spike Port | Luer Lock or Spike Port | Identical to Predicate |
| Fitting Connection to external standard IV bag | Spike | Spike | Identical to Predicate |
| Needle Safety Feature (Injector Only) | Safety sleeve | Safety sleeve | Identical to Predicate |
| Sterilization Method | EO | EO | Identical to Predicate |

#### 7. Performance:

The additional tests referenced in the table have been provided in order to substantiate the use of product code ONB - Closed antineoplastic and hazardous drug reconstitution and transfer system - for the BD PhaSeal® Closed System Drug Transfer Device. BD has included the additional airtight and leakproof requirement as both of these requirements are cited by the National Institute for Occupational Safety and Health (NIOSH) and the International Society of Oncology Pharmacy Practitioners (ISOPP) as essential requirements necessary to reduce health care workers from exposure to hazardous drugs. In addition, NIOSH also cites the need to prevent contaminates from entering the closed system during transfer. As such. BD proposes to extend the microbial ingress claim to the entire system; not just the PhaSeal Protector. As there is no change to the subject device in comparison to the predicate devices, the performance data provided represent the performance of both the predicate and subject device of this 510(k).

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| Item# | Performance Specification: | Status of BD PhaSeal® System |
|-------|----------------------------|------------------------------------------|
| 1 | Leakproof Connections | No Leaks (Fluorescein Test)1,2 |
| 2 | Airtight Connections | No Visable Smoke (TiCl4 Test)3 |
| 3 | Microbial Ingress | No Ingress at the Protector or Connector |

73213

#### 8. Conclusion:

Based on comparison to the predicate device and the nonclinical tests provided, the modified BD PhaSeal® Closed System Drug Transfer Device is as safe, as effective, and performs as well as the legally marketed predicate device. ·

Spivey S, Connor T. Determining sources of workplace contamination with antineoplastic drugs and comparing

conventional IV drug preparation with a closed system. Hosp Pharm. 2003; 38(2): 13-139.
3 Jorgenson J, Spivey S, Au C et al. Contamination comparison of transfer devices inte Hosp Pharm. 2008; 43(9): 723-727 ·
³ Ibid.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a horizontal line below the text. To the left of the text is a symbol that appears to be three curved lines.

### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## January 9, 2013

Mr. John Roberts Regulatory Affairs Specialist Becton Dickinson & Company l Becton Drive MC237 FRANKLIN LAKES NJ 07417

Re: K123213

Trade/Device Name: PhaSeal® - Closed System Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB Dated: October 12, 2012 Received: October 15, 2012

Dear Mr. Roberts:

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. 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.

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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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthony De mint

Anthony D. Watson, B.S., M.S., M.B.A. 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 Statement

510(k) Number (if known): K123113

Device Name:

PhaSeal® - A Closed System Transfer Device

Indications for Use:

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 or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The PhaSeal system also prevents microbial ingress.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

| Over-The-Counter Use | ____________________ |
|------------------------|----------------------|
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER
PAGE OF NEEDED)Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of Sajjad H. Syed

ate: 2013.01.09 15:12:01 -05'00

| (Division Sign-Off) |
|----------------------------------------------|
| Division of Anesthesiology, General Hospital |
| Infection Control, Dental Devices |

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VIII

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