BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55

K130197 · Becton, Dickinson and Company · ONB · Feb 27, 2013 · General Hospital

Device Facts

• Record ID: K130197
• Device Name: BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - P55
• Applicant: Becton, Dickinson and Company
• Product Code: ONB · General Hospital
• Decision Date: Feb 27, 2013
• Decision: SESE
• Submission Type: Special
• 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 contractions 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 P55 is a sterile, single-use closed system drug transfer device (CSTD). It utilizes a double-membrane design with self-sealing elastomeric membranes and a bayonet fitting. A single-lumen cannula perforates these membranes for liquid transfer. When the cannula is retracted, the membranes seal to prevent environmental contaminant ingress and drug vapor/aerosol escape. The system includes a Protector component that acts as a drug vial adapter and pressure-equalization docking station. Used in clinical settings by healthcare professionals during hazardous drug reconstitution, administration, and disposal. The device protects clinicians and the environment from hazardous drug exposure and maintains drug sterility.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Sterile, single-use CSTD. Materials include self-sealing elastomeric membranes. Mechanical principle: double-membrane, single-lumen cannula, bayonet fitting, and pressure-equalization docking. No software or electronic components.

Indications for Use

Indicated for use as a closed system drug transfer device (CSTD) to minimize exposure to hazardous drugs and prevent microbial ingress during reconstitution, administration, and disposal processes.

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 (K123213)

Submission Summary (Full Text)

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K-130197

# 510(K) Summary of Safety and Effectiveness

Date Prepared: 25 January 2013

FEB 2 7 2013

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 Transfer Device - P55 Trade Name: Closed antineoplastic & hazardous drug reconstitution & transfer system Common Name: Classification Name: Intravascular administration set Classification: Class II, 21 C.F.R. § 880.5440

#### 3. Predicate Device

BD PhaSeal® Connector, Injector, Protector - K123213

### .4. Device Description:

The PhaSeal® System is a sterile single-used closed system drug transfer device. The closed transfer of liguid 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 for 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.

The PhaSeal Protector is one component of the PhaSeal system. It is a drug vial adapter that is fitted to the drug vial and is used as a docking station between the drug vial and the BD PhaSeal Injector. In addition the Protector equilibrates the pressure difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric double membranes to minimize exposure to potentially hazardous drug aerosols and spills occurring during reconstitution, administration and disposal processes.

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

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and the comments of the comments of the country of

# SMDA INFORMATION XII.

### A. 510(k) Summary

A 510(k) summary is provided in Attachment XII.1. This 510(k) Summary meets the requirements identified in 21 CFR §807.92.

. . . .

## Pre-Market Notification Truthful and Accurate Statement B.

As required per 807.87(k), an Accurate and Truthful Statement is provided in Attachment XII.2. .

.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 27, 2013

Mr. John Roberts Regulatory Affairs Specialist Becton, Dickinson and Company 1 Becton Drive MC237 FRANKLIN LAKES, NJ 07417

Re: K130197

Trade/Device Name: PhaSeal® - A Closed System Transfer Device - P55 Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: ONB Dated: January 25, 2013 Received: January 28, 2013

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 (QS) 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/ucm115809.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,

for

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

K130197 510(k) Number (if known):

PhaSeal® - A Closed System Transfer Device - P55 Device Name:

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 contractions 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

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# Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Number: K130197

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