PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS

K972527 · Quality System Consulting · FPA · Sep 18, 1997 · General Hospital

Device Facts

• Record ID: K972527
• Device Name: PHASEAL, SYSTEM FOR SEALED HANDLING OF CHEMOTHERAPEUTIC AGENTS
• Applicant: Quality System Consulting
• Product Code: FPA · General Hospital
• Decision Date: Sep 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

PhaSeal® closed system for the preparation and administration of parenteral drugs

Device Story

PhaSeal is a closed system for handling parenteral, particularly cytotoxic, drugs. System comprises four components: Protector 20 (vial adapter), Injector Luer (syringe-to-component transfer), Connector Luer-Lock (syringe-to-IV line connection), and Infusion Set (IV administration). Principle of operation: patented double-membrane technique using elastomeric seals to prevent leakage during connection/disconnection; built-in pressure equalization chamber in Protector 20 prevents aerosol leakage by managing pressure/vacuum during fluid transfer. Used in clinical settings by healthcare professionals for drug preparation, administration, and waste handling. System ensures sealed transfer of diluent, drug, or air between vials, syringes, and IV lines, reducing provider exposure to hazardous substances.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components utilize elastomeric membranes for sealed connections. Pressure equalization is achieved via an integrated expansion chamber. Components include Luer fittings for compatibility with standard syringes and IV lines. Non-vented infusion set design. Single-use, sterile components.

Indications for Use

Indicated for the preparation and administration of parenteral drugs, particularly cytotoxic drugs, in a closed system to minimize exposure to hazardous drug aerosols and spills during reconstitution, administration, and disposal.

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

• CytoGuard Drug Reconstitution Device (K883614)
• Becton Dickinson SafetyGlide Shielding IM Injection Needle (K951254)
• Sherwood Davis & Geck Monoject Luer Adapter (K940961)
• Codan Medlon IV Administration Set Catalog #443

Submission Summary (Full Text)

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APP VI
K972527
DATA Sept. 18, 1997

## SUMMARY OF SAFETY AND EFFECTIVENESS DATA

## Carmel Pharma AB PhaSeal® closed system for the preparation and administration of parenteral drugs

### Carmel Pharma Contact Person

Britt Novén Manager, Regulatory Affairs Carmel Pharma AB Box 5352 S-402 28 Göteborg, Sweden Phone: [phone] [phone] Fax:

### Device Name

PhaSeal® closed system for the preparation and administration of parenteral drugs.

- Protector 20 Injector Luer Connector Luer Lock Infusion Set
### Predicate Devices

- Bristol-Myres Squibb/Mead Johnson Oncology Products (Survival Technology), CytoGuard® . Drug Reconstitution Device, K883614
- Becton Dickinson, SafetyGlide™ Shielding IM Injection Needle, K951254 ●
- Sherwod Davis & Geck, Monoject® Luer Adapter, K940961 .
- Codan Medlon. IV Administration Set Catalog #443, preammendment device ●

### Product Description, Function, Safety and Efficacy

The PhaSeal™ closed system for preparation and administration of parenteral drugs has four component devices that 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 patented double membrane technique. Each element is sealed off with an elastomeric membrane cover. The membranes are joined together and transfer is made via a specially cut injection cannula. When the elements of the system are separated after transfer, the membranes act as tight seals that prevent leakage.

PhaSeal utilizes a built-in, patented pressure equalization technique. Air passes from the vial into a special expansion chamber. Neither excess pressure nor vacuum can occur during drug preparation. This effectively prevents aerosol leakage.

- PhaSeal Protector 20 Drug Vial Transfer Adapter ●
The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 equilibrates the pressure

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difference which occurs when fluid or air is added or removed from the drug vial. Liquid transfer takes place through tightly fitting elastomeric membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes.

### PhaSeal Injector Luer - Drug Transfer Needle Device ●

The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases.

### PhaSeal Connector Luer-Lock - Luer Lock Device .

The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient's IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage.

#### PhaSeal Infusion Set - Intravascular Administration Set .

The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.

### Comparison of Predicate Devices/Equivalence

#### PhaSeal Protector 20 .

Is substantially equivalent to the CytoGuard Drug Reconstitution Device in that they both serve as a docking station for drug vials and act to minimize or eliminate the aerolization of drug being transferred from the drug vial into a single-use syringe.

#### ● PhaSeal Injector Luer

Is substantially equivalent to the Becton Dickinson SafetyGlide Shielding IM Injection Needle in that they both transfer fluid and drug between drug vials and infusate. In addition they both have protected needles which provide protection from accidental needle sticks.

#### . PhaScal Connector Luer Lock

Is substantially equivalent to the Sherwod Davis & Geck, Monoject® Luer Adapter in that they both provide a means of connecting various components of a drug delivery system via a luer fitting.

#### . PhaSeal Infusion Set

Is substantially equivalent to the Codan Medlon, IV Administration Set - Catalog #443 in that they both use similar components and provide a pathway to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. (Neither device provides the needle or catheter.)

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Image /page/2/Picture/2 description: The image shows a black and white logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol of three stylized human profiles facing right. The profiles are stacked on top of each other, creating a sense of depth and unity. The overall design is simple and professional, conveying a sense of authority and trustworthiness.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Fred Schlador Consultant Quality System Consulting C/O Carmel Pharma AB 1425 Cressa Court 92009 Carlsbad, California

SEP 1 8 1997

Re : K972527 PhaSeal™ System For Sealed Handling Of Trade Name: Chemotherapeutic AG Regulatory Class: II Product Code: LHI Dated: June 30, 1997 Received: July 7, 1997

Dear Mr. Schlador:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note:

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Page 2 - Mr. Schlador

this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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 Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosure

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27. Indications for Use Statement:

510(k) Number (if known): K472507

# Device Name: PhaSear® closed system for the preparation and administration of parenteral drugs

Indications for Use:

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## PhaSeal Protector 20 - Drug Vial Transfer Adapter

The Protector 20 is fitted to the drug vial and is used as a docking station between the drug vial for the parenteral drug and Injector Luer. In addition the Protector 20 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 membranes to minimize exposure to potentially hazardous drug aerosols and spills that can occur during the reconstitution, administration and disposal processes.

### PhaSeal Iniector Luer - Drug Transfer Needle Device

The Injector Luer has an encapsulated cannula that is permanently locked onto a syringe using a Luer fitting. Sealed transfer of diluent, drug or air, between the single-use syringe and the various components in the system can be made via the Injector Luer in both the preparation and administration phases.

## PhaSeal Connector Luer-Lock - Luer Lock Device

The Connector Luer Lock ensures a sealed connection between the single-use syringe and Injector Luer and the patient's IV line. With the help of the Connector Luer Lock, injections can be made without drug spillage.

## PhaSeal Infusion Set - Intravascular Administration Set

The Infusion Set is a non-vented infusion device that has a built-in connector to be used as a way of making additions of parenteral drugs to infusion fluids in a closed system. The Infusion Set may be used to administer the infusion fluid.

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Concurrence of CDRH, Office of Device Evaluation

Patricia Casceneti

Prescription Use (Per 21 CFR 801.109)

Over the Counter Use √