PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS

K060866 · Carmel Pharma Ab. · LHI · Apr 28, 2006 · General Hospital

Device Facts

• Record ID: K060866
• Device Name: PHASEAL - CLOSED SYSTEM FOR THE PREPARATION AND ADMINISTRATION OF PARENTERAL DRUGS
• Applicant: Carmel Pharma Ab.
• Product Code: LHI · General Hospital
• Decision Date: Apr 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.

Device Story

PhaSeal Y-site Line is a single-use intravascular administration set component; serves as an IV port for patients lacking Luer Lock fittings. Device incorporates a built-in connector enabling drug administration via the PhaSeal closed system. Principle of operation relies on a double membrane technique; elastomeric membranes on component devices join to form a sealed path for liquid transfer via a specially cut injection cannula. Upon separation, membranes act as tight seals to prevent leakage. Used in clinical settings by healthcare providers to minimize exposure to hazardous drug aerosols and spills during parenteral drug administration. Benefits include enhanced safety for clinicians and patients by containing cytotoxic medications throughout the administration process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use intravascular administration set. Features a built-in connector and double membrane interface. Materials include elastomeric membranes for sealing. Operates as a closed system to prevent leakage of parenteral/cytotoxic drugs. Non-powered, mechanical device.

Indications for Use

Indicated for use as an intravascular administration set port for the administration of parenteral drugs, including cytotoxic drugs, in patients requiring IV therapy where a Luer Lock fitting is unavailable.

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

• PhaSeal (K980381)

Submission Summary (Full Text)

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# K060866

#### Exhibit 8

APD 18 2006

Special 510(k) Summary

Carmel Pharma AB Company name:

PhaSeal® - closed system for the preparation and administration of Product Name: parenteral drugs

Device name:

Y-site Line

PhaSeal is a closed system for handling of parenteral drugs where the component devices are dedicated to each other to create the system. These single use devices are designed to promote safe handling of medications, particularly cytotoxic drugs. Leakage of drug into the environment is effectively avoided during all three phases of drug handling when the PhaSeal system is used: the preparation of the drug, the administration of the drug to the patient, and waste handling.

All drug transferring utilizes a double membrane technique. Each component device is sealed off with an elastomeric membranes are joined together and transfer is made via a specially cut injection cannula. When the component devices of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

#### PhaSeal, Y-site Line

The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible administer drugs into the IV line of the patient using the PhaSeal Injector. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that occur during the administration and disposal processes.

## Comparison of Predicate Devices/Equivalence

The device is substantially equivalent to previously cleared PhaSeal devices included in 510(k) Number K980381.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 28 2006

Mr. Kjell Andreasson Vice President Quality Assurance and Regulatory Affairs Carmel Pharma AB Aminogatan 30, Molndal, Box 5352 Goteborg, Sweden SE 402 28

Re: K060866

Trade/Device Name: PhaSeal Y-Site Line-Intravascular Administration Set Regulation Number: 880,5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: March 27, 2006 Received: March 30, 2006

Dear Mr. Andreasson:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Andreasson

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Exhibit 3

### Indications for Use

510(k) Number (if known): K060866

PhaSeal Y-site Line - Intravascular Administration Set Device name:

Indications for use:

The Y-site Line serves as the port for IV administration with PhaSeal if there is no Luer Lock fitting, for Connector Luer Lock in the patients IV line. The Y-site Line has a built in Connector which makes it possible to administer drugs into the patient using the sealed double membrane technique.

Prescription Use: Yes (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use: No (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device evaluation (ODE)

Anthong D. hme

· Joneral Huspitul,

K46.0866