EQUASHIELD SYSTEM

K083152 · Plastmed, Ltd. · LHI · Feb 2, 2009 · General Hospital

Device Facts

• Record ID: K083152
• Device Name: EQUASHIELD SYSTEM
• Applicant: Plastmed, Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Feb 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The EQUASHIELD™ 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

EQUASHIELD is a closed system for drug reconstitution and transfer; prevents escape of hazardous drugs and vapors via air-tight enclosure. Components include vial adaptor, proprietary piston syringe, infusion bag spike adaptors (injection/withdrawal), and Luer lock adaptor. Used by pharmacists or healthcare professionals in clinical settings to prepare parenteral drugs. System maintains containment during transfer; protects operators from exposure to hazardous substances. Benefits include enhanced safety for healthcare personnel handling cytotoxic agents.

Clinical Evidence

Bench testing and simulated clinical testing were performed to validate the device's performance as a closed drug transfer system. Results demonstrated satisfactory performance and confirmed the device functions as intended for the preparation of drugs, including cytotoxic agents.

Technological Characteristics

Closed system for drug transfer; consists of vial adaptor, piston syringe, spike adaptors, and Luer lock adaptor. Materials are biocompatible per ISO 10993-1. Mechanical containment principle; no electronic or software components.

Indications for Use

Indicated for pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, 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 (K972527)
• TEVADAPTOR (K051669)
• Texium™ Syringe (K071108)

Submission Summary (Full Text)

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K083152

Image /page/0/Picture/1 description: The image shows the logo for "Plastmed, A Medical Device Company". The logo is in black and white and features a stylized eye in the "d" of "Plastmed". The text is in a bold, sans-serif font.

0.8 26 efen Industrial Pari 1959. Israe [phone] x: [phone]

FEB - 2 2009

# 510(K) SUMMARY

# 510(k) Number K_

Applicant's Name: Plastmed Ltd.

Tefen Industrial Park

P.O.B 26, ISRAEL

Tel: [phone]

Fax: [phone]

Contact Person:

Tefen Industrial Park

Elissa Burg

P.O.B 26, ISRAEL , 24959

Tel [phone]; Fax [phone]

[e-mail]

EQUASHIELDTM system

Closed drug transfer system

Trade Name:

Common name:

Classification:

Name: Intravascular administration set Product Code: LHI Regulation No: 880.5440 Class: II Classification Panel: General hospital

Predicate Devices:

Substantial equivalence to the following predicate device is claimed:

1. PhaSeal closed system for the preparation and administration of parenteral drugs; Carmel Pharma AB K972527

2. TEVADAPTOR; Migada Plant K051669

3. Texium™ Syringe; Cardinal Health, Aleris® Products K071108

Plastmed Ltd. | EQUASHIELD TM 510k Notification

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Plastmed Ltd.
Building No. 7
P.O.B 26
Tefen Industrial Park
24959, Israel
Tel: [phone]
Fax: [phone]

#### Device Description:

EQUASHIELD™ is a closed system for drug transfer and reconstitution. The EQUASHIELD™ system consists of an adaptor to the medication vial (Vial Adaptor), a proprietary piston syringe (Syringe Unit), an adaptor for connection to the infusion bag for injection (Spike Adaptor 1), an adaptor for connection to the infusion bag for withdrawal (Spike Adaptor W) and an adaptor to the Luer Lock (Luer Lock Adaptor).

The EQUASHIELD™ system is a closed system - it prohibits the escape of hazardous drugs and vapors to the surrounding environment, by air-tight enclosing of air and all contaminants within the system.

#### Indication for Use Statement:

The EQUASHIELD™ 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

## Performance Validation: Performance Testing - bench tests

A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance.

#### Performance Testing - Simulated clinical test

A simulated clinical test was performed in order to evaluate the Plastmed EQUASHIELD™ System and to ensure it performs its intended use as a closed drug transfer system. The simulated test has

Plastmed Ltd. | EQUASHIELD TM 510k Notification

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Image /page/2/Picture/0 description: The image shows the logo for "Plastmed, a medical device company". The logo is in black and white and features a stylized font. The word "Plastmed" is in a larger font than the words "A Medical Device Company".

x; [phone]

demonstrated that the EQUASHIELD™ system performs its intended

use.

Tests conclusion:

Both bench tests and simulated clinical test have shown that the device performs its intended use.

## Materials:

Materials of the EQUASHIELD™ device are biocompatible in accordance with ISO 10993-1.

## Substantial Equivalence:

We have demonstrated that the EQUASHIELD ™ meets its labeled performance claims, and that it is substantially equivalent to the predicate devices.

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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 consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" are arranged in a circle around the eagle. The logo is black and white.

FEB -2 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elissa Burg Quality Assurance and Regulatory Assurance Manager Plastmed Limited Building No. 7 P.O.B 26 Tefen Industrial Park ISRAEL 24959

Re: K083152

Trade/Device Name: EQUASHIELD™ System Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: December 25, 2008 Received: December 29, 2008

Dear Ms. Burg:

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 - Ms. Burg

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

Anthony D. Anzalone, for

Ginette Y. Michaud, M.D. Acting 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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Image /page/5/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The logo is in black and white, with the word "Plastmed" in large, bold letters. Below the company name is the phrase "A Medical Device Company" in smaller letters. The logo is simple and professional, and it conveys the company's focus on medical devices.

Plastmen I to Tefen Industrial Park [phone] 9873001

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: EQUASHIELD TM System

Indications for Use:

The EQUASHIELD™ 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-off) Division of Division of General, Restorative and Neurological Devices

510(k) Number

Hall Sar

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

510(k) Number: Korg152

Plastmed Ltd. | EQUASHIELD TM 510k Notification