TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K071741 · Migada Plant · LHI · Sep 24, 2007 · General Hospital

Device Facts

• Record ID: K071741
• Device Name: TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Applicant: Migada Plant
• Product Code: LHI · General Hospital
• Decision Date: Sep 24, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The TEVADAPTOR™, Closed Drug Reconstitution and Transfer System is a closed 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 drug reconstitution and transfer system used by pharmacists and healthcare professionals in hospital settings. It facilitates the safe preparation and administration of parenteral drugs, including cytotoxic agents. The system comprises a vial adaptor (with 13mm/20mm converters), syringe adaptor, connecting set, spike port adaptor, and luer lock adaptor. It utilizes a venting mechanism with a charcoal layer for sterile pressure equalization and containment of drug vapors/aerosols, preventing environmental contamination. The syringe adaptor features a non-latex elastomer protector and passive-needle protection to prevent needle-stick injuries. The system allows for the withdrawal of diluents and the introduction of drugs into infusion bags or directly into IV lines. By maintaining a closed environment, the device protects healthcare workers from exposure to toxic substances and ensures the sterility of the drug during the reconstitution and transfer process.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System components include vial adaptors, syringe adaptors, connecting sets, spike port adaptors, and luer lock adaptors. Materials include non-latex elastomers. Features sterile venting with charcoal filtration for pressure equalization and vapor containment. Passive-needle protection mechanism included. Connectivity is manual/mechanical. Sterilization method not specified.

Indications for Use

Indicated for use by pharmacists or healthcare professionals to prepare and transfer 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/2 description: The image shows a logo with the text "CERTIFIED QMS" in a circular arrangement around an oval shape. Inside the oval shape, the text "ISO 13485: 2003" is visible. Below the logo, the text "THE STANDARDS INSTITUTION OF ISRAEL" is printed. The logo appears to be a certification mark issued by The Standards Institution of Israel, indicating compliance with the ISO 13485:2003 standard for quality management systems.

SEP 2 4 2007

ת"מ
מודרקל
שמואל

מיגדה תעשיות ציוד רפואי

# 510(k) Summary:

# TEVADAPTOR™, Closed Drug Reconstitution and Transfer System

Company Name: Migada Plant

## Contact Person:

Yossi Shachar QA/RA Manager Telephone: [phone] [phone] Fax: E-mail: [e-mail]

#### US Agent:

Mr. John Riggi Donawa Consulting 152 Schimwood Court Getzville, NY 14608 Phone: [phone]

Date prepared: June 10, 2007

# Trade Name:

TEVADAPTOR™, Closed Drug Reconstitution and Transfer System

Common/usual name: Closed Drug reconstitution system

Classification name: Set, IV Fluid Transfer

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#### A MEMBER OF T = I GROUP

שקבוצת

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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K071741

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Image /page/1/Picture/1 description: The image shows the logos for "TEVA Medical ltd" and "nigada". The "TEVA" logo is in a bold, blocky font, while "Medical ltd" is in a cursive font. The "nigada" logo is in a stylized font that resembles a continuous line.

Image /page/1/Picture/2 description: The image is a black and white logo for The Standards Institution of Israel. The logo features a stylized triangle shape at the top, with the words "CERTIFIED QMS" arranged in an arc inside the triangle. Below this, there is a circle containing the text "ISO 13485: 2003". The words "THE STANDARDS INSTITUTION OF ISRAEL" are printed at the bottom of the logo.

Image /page/1/Picture/3 description: The image contains Hebrew text. The text appears to be a title or heading, possibly related to a document or book. The text is written in a traditional Hebrew font, and the letters are clearly visible. The text is "תשובות מודיקל"

מיגדה תעשיות ציוד רפואי

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
- ﻌ Syringe Adaptor System
- Connecting Set -
- Spike Port Adaptor -
- -Luer Lock Adaptor

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 and aerosol escape into the environment. The Vial Adaptor is also effective when used with Radionuclide drugs. A special charcoal layer within the venting system prevents also drug vapor from escaping, ensuring the system is closed to all toxic species. The air entering the vial is sterile due to this combination of filters. An elastomeric, nonlatex septum is designed for connection of the Syringe Adaptor System for introduction or withdrawal of liquid. The interface for connecting with the Syringe Adaptor is designed so that it can be easily cleaned and disinfected when required.

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A MEMBER OF T = I GROUP

מקבוצת |

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 ISRAEL TEL: [phone] FAX: [phone]

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Image /page/2/Picture/1 description: The image shows the logos for Teva Medical and Nigada. The Teva Medical logo is on the top row, with the word "TEVA" in a boxy font and the words "Medical ltd." to the right of it in a cursive font. The Nigada logo is on the bottom row, with the word "nigada" in a stylized font.

Image /page/2/Picture/2 description: The image is a logo for the Standards Institution of Israel. The logo features a stylized triangle shape with the text "CERTIFIED QMS" and "ISO 13485: 2003" inside a circle. The text "THE STANDARDS INSTITUTION OF ISRAEL" is located at the bottom of the logo.

תע"מ מודיקל

מיגדה תעשיות ציוד רפואי

The Syringe Adaptor System is intended for connection to a standard luer lock syringe. 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 design incorporates a Passive-Needle protection that eliminates chances of needle-stick injuries.

The Spike Port 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. Capped short tubing enables connection of the drug containing bag to a delivery set in the hospital ward.

The Connecting set is similar to the Spike Port Adaptor, except for a female luer lock connection at the distal end.

The Luer Lock Adaptor enables the connection of the Syringe Adaptor System to an intravenous infusion line for direct drug injection.

## Intended Use:

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

#### Substantial Equivalence:

The TEVADAPTOR The, Closed 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 TEVADAPTOR™, Closed Drug Reconstitution and Transfer System does not raise any additional concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate devices.

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A MEMBER OF T = // GROUP

**ישי** מקצוע

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 ISRAEL TEL: [phone] FAX: [phone]

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

SEP 2 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Yossi Shachar Quality Assurance/Regulatory Affairs Manager Migada Plant North Industrial Zone P.O. Box 888 Kiryat Shmona, 10258 ISRAEL

Re: K071741

Trade/Device Name: TEVADAPTOR™, Closed Drug Reconstitution and Transfer System Regulation Number: 21 CFR 880.5540 Regulation Name: Set, IV Fluid Transfer Regulatory Class: II Product Code: LHI Dated: June 25, 2007 Received: June 27, 2007

Dear Mr. Shachar:

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. 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 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 vours.

Clus

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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#### INDICATIONS FOR USE

510(k) Number (if known):

K071741

Device Name:

TEVADAPTOR™, Closed Drug Reconstitution and Transfer System

Indications for Use:

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

Prescription Use X OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

181

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

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

Antin V.

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

510(k) Number: _______________________________________________________________________________________________________________________________________________________________ 15471941

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