TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K051669 · Migada Plant · LHI · Sep 1, 2005 · General Hospital

Device Facts

• Record ID: K051669
• Device Name: TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Applicant: Migada Plant
• Product Code: LHI · General Hospital
• Decision Date: Sep 1, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

Device Story

TEVADAPTOR is a closed system for drug reconstitution and transfer; used by pharmacists/healthcare professionals in clinical settings. Components include Vial Adaptor (with 13mm/20mm cap compatibility), Syringe Adaptor, Infusion Bag Adaptor, and L-Connector. Vial Adaptor features automatic sterile pressure equalization to prevent drug particle escape. Syringe Adaptor connects to standard luer lock syringes with non-latex elastomer needle protection. Infusion Bag Adaptor connects to infusion bag spike ports. System enables safe withdrawal of diluents and introduction of drugs. Benefits include containment of hazardous substances, such as cytotoxic drugs, during preparation and transfer, protecting the user and environment from exposure.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Components: Vial Adaptor, Syringe Adaptor, Infusion Bag Adaptor, L-Connector. Materials: Non-latex elastomers. Principle: Closed system with automatic sterile pressure equalization. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for use by pharmacists or healthcare professionals to prepare drugs, including cytotoxic agents, for intravenous infusion or injection.

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® closed system for the preparation and administration of parenteral drugs (K980381)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of four abstract human profiles facing to the right, with flowing lines suggesting movement or progress. The overall design is simple and conveys a sense of health, well-being, and human connection.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2005

Ms. Yossi Shachar QA/RA Manager Migada Plant P.O. Box 888 Kiryat Shmona 10258 ISRAEL

Re: K051669

Trade/Device Name: TEVADAPTOR™, Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 14, 2005 Received: June 22, 2005

.Dear Ms. Shachar:

This letter corrects our substantially equivalent letter of September 1, 2005.

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 (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 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 - Ms. Shachar

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 (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.

This letter will allow you to continue 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/dsma/dsmamain.html

Sincerely yours,

Sylite y. Michie Davis.

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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K051669

page 1 of 3

Image /page/2/Picture/2 description: The image contains three lines of text. The first line contains the word "TEVA" in a stylized, blocky font, followed by the word "Medical" in a cursive font, and the abbreviation "ltd.". The second line contains the word "nigada" in a stylized, cursive font. Below the word "nigada" is a small, circular graphic.

Image /page/2/Picture/3 description: The image shows a logo with the text "CERTIFIED QMS ISO 13485: 2003". The logo is stamped with the date "SEP - 1 2005" at the top. The text "THE STANDARDS INSTITUTION OF ISRAEL" is at the bottom of the image. The logo appears to be a certification mark related to quality management systems.

מדיקל

דע שיות איוד

# 510(k) Summary: TEVADAPTOR", Drug Reconstitution and Transfer System

Company Name: Migada Plant

Contact Person:

Yosi Shahar QA/RA manager

Telephone: [phone] [phone] Fax: E-mail: yosi.shahar(@teva.co.il

#### US Agent:

George Svokos MIGADA, INC. 482 Hudson Terrace Englewood Cliffs, NJ 07632

Phone: [phone] Fax: [phone]

Date prepared: May 10, 2005

Trade Name: TEVADAPTOR"M. Drug Reconstitution and Transfer System

Classification name: Set. IV Fluid Transfer

9-2

a MEMBER OF I GROUP

מְקֻבֶּצֶת

אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקס: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISBAEL TEL: [phone] FAX: [phone]

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K051669 page 2 of 3

Image /page/3/Picture/1 description: The image shows the logo for Teva Medical Ltd. The word "Teva" is in a bold, blocky font, and the words "Medical Ltd." are in a cursive font. Below that is the word "nigada" in a thin, stylized font with a small circle below the "g".

Image /page/3/Picture/2 description: The image shows a logo with the text "CERTIFIED QMS" in a circular arrangement above "ISO 13485: 2003". The logo is from "THE STANDARDS INSTITUTION OF ISRAEL". The logo is black and white and has a triangular shape.

עצים מודייקל

מיגדה תעשיות ציוד רפואי

Common/usual name: Drug reconstitution system

Product Code: LHI

Regulation No.: 880.5440

Class: II

Panel identification: General Hospital Panel

#### Predicate Device:

PhaSeal® closed system for the preparation and administration of parenteral drugs, Carmel Pharma AB. S-402 28 Gottingen, Sweden, cleared under 510(k) no. K980381.

### Description of the device:

The device comprises of the following components:

- Vial Adaptor System with 13 mm Vial converter -
- Syringe Adaptor System -
- Infusion Bag Adaptor -
- -I Connector

The Vial Adaptor System is intended to fit over vials with 20mm caps. A converter accessory enables the use of the Vial Adaptor System with a 13 mm cap vial. A special venting mechanism ensures automatic. sterile, pressure equalization within the vial, preventing drug particle escape into the environment. An elastomeric, non-latex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid.

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A MEMBER OF = / I GROUP

‫מִקְבּוּצַת

אזור התעשיה הצפוני ת.ד 888 קרית שמונה 10258 טלפון: 04-6908800 פקם: 09-8921665 NORTH IND. ZONE P.O.BOX 888 KIRYAT SHMONA 10258 ISRAEL TEL: [phone] FAX: [phone]

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K051669 page 30.

Image /page/4/Picture/1 description: The image shows the logos for Teva Medical Ltd. and nigada. The Teva Medical Ltd. logo is on the top and consists of the word "TEVA" in a blocky font and the words "Medical Ltd." in a cursive font. The nigada logo is on the bottom and consists of the word "nigada" in a stylized font with a small circle below the "g".

Image /page/4/Picture/2 description: The image shows a logo for the Standards Institution of Israel. The logo is a triangle shape with the words "CERTIFIED QMS" in a circular pattern at the top. Inside the circle is the text "ISO 13485: 2003". Below the triangle is the text "THE STANDARDS INSTITUTION OF ISRAEL".

ת"ש מדוייקל

מיגדה תעשיות ציוד רפואי

The Syringe Adaptor System is intended for connection to a standard luer lock svringe. A special non-latex elastomer protector covers the liquid dispensing needle tip. A clamp mechanism reversibly connects the Syringe Adaptor System to the other components.

The Infusion Bag Adaptor is intended for connection to the spike port of an infusion bag. A non- latex septum enables connection to the Syringe Adaptor System for withdrawal of diluents or introduction of drug. A capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.

An injection accessory enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

#### Indications for Use:

The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

## Substantial Equivalence:

The TEVADAPTORTM, Drug Reconstitution and Transfer System has the same intended use as the PhaSeal® closed system for the preparation and administration of parenteral drugs, cleared under 510(k) no. K980381 and has equivalent performance characteristics. It is therefore substantially equivalent to that device.

#### Conclusion -

The evaluation of the TEVADAPTORTM, Drug Reconstitution and Transfer System does not raise any additional concerns regarding safety and effectivity and may therefore be considered substantially equivalent to the predicate devices.

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K051669

# Indications for Use

510(k) Number (if known): K051669

Device Name: TEVADAPTOR™, Drug Reconstitution and Transfer System

Indications for Use:

The TEVADAPTOR™, Drug Reconstitution and Transfer System is a contained system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.

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)

Antone Vime

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

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510(k) Number: K931669