PHASEAL

K023747 · Carmel Pharma Ab. · LHI · Nov 15, 2002 · General Hospital

Device Facts

• Record ID: K023747
• Device Name: PHASEAL
• Applicant: Carmel Pharma Ab.
• Product Code: LHI · General Hospital
• Decision Date: Nov 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

Device Story

PhaSeal Infusion Adapter acts as a connector between IV bags and external IV lines. It incorporates a double membrane technique to enable closed-system drug admixture. When connected, elastomeric membranes join to allow fluid transfer via an injection cannula; upon disconnection, membranes seal to prevent drug leakage. Used in clinical settings for parenteral drug administration, particularly for cytotoxic agents. Protects healthcare workers from exposure by maintaining a closed system during preparation, administration, and waste handling.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use device; utilizes elastomeric membranes and injection cannula for double-membrane sealing mechanism. Designed for integration with existing PhaSeal system components. Mechanical connection interface.

Indications for Use

Indicated for use as a component of the PhaSeal closed system for the handling of parenteral drugs, specifically to facilitate the safe transfer and admixture of medications, including cytotoxic drugs, into infusion solutions while preventing environmental leakage.

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)
• PhaSeal (K001368)

Submission Summary (Full Text)

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KO23947

NOV 1 5 2002

Exhibit 8

Special 510(k) Summary

Carmel Pharma AB Company name:

Product Name: PhaSeal® - a system for closed handling of parenteral drugs.

Infusion Adapter Device name:

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 patient, and waste handling.

All drug transferring utilizes a patented 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, Infusion Adapter

The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

#### Comparison of Predicate Devices/Equivalence

The device is substantially equivalent to previously accepted PhaSeal devices included in 510(k) Number K980381 and K001368.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# NOV 1 5 2002

Mr. Kjell Andreasson Vice President, OA/RA Carmel Pharma AB Box 5352 SE-402 28 Göteborg, SWEDEN

Re: K023747

Trade/Device Name: PhaSeal® Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: November 1, 2002 Received: November 8, 2002

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 vour 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours!

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

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# KC23-747

## Exhibit 3 - Indications for Use Statement

Device Name: PhaSeal® - a System for Closed handling of Parenteral Drugs

#### Infusion Adapter

The Infusion Adapter serves as a the connecting part between the IV bag and an external IV line (e.g. IV regulators). The Infusion Adapter has a built in Connector which makes it possible to admix drugs into the infusion solution using the sealed PhaSeal double membrane technique.

Patricia Crescent

(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Denta

510(k) Number: K023747