EQUALSHIELD LUER LOCK CONNECTOR PAIR

K091389 · Plastmed, Ltd. · LHI · Oct 22, 2009 · General Hospital

Device Facts

• Record ID: K091389
• Device Name: EQUALSHIELD LUER LOCK CONNECTOR PAIR
• Applicant: Plastmed, Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Oct 22, 2009
• Decision: SESE
• Submission Type: Special
• 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™ Luer Lock Connector Pair is a closed system drug transfer device (CSTD) designed to prevent the escape of hazardous drugs and vapors during preparation and administration. The system consists of a female Luer lock connector for infusion sets and a male Luer lock connector for IV catheters. It functions by creating an air-tight, closed fluid path during connection and disconnection. Used in clinical settings by pharmacists and healthcare professionals, the device protects users from exposure to hazardous substances. By enclosing air and contaminants within the system, it ensures safe handling of cytotoxic drugs, reducing environmental contamination risks and enhancing provider safety during intravenous drug reconstitution and transfer.

Clinical Evidence

Bench testing only. Performance data demonstrated that the modified device meets all established specifications and acceptance criteria, supporting substantial equivalence to the predicate.

Technological Characteristics

Closed system drug transfer device consisting of female and male Luer lock connectors. Utilizes biocompatible materials consistent with the predicate device. Operates as a mechanical, air-tight fluid path enclosure. No electronic components or software.

Indications for Use

Indicated for 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

• EQUASHIELD™ system (K083152)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The word "Plastmed" is written in a bold, sans-serif font, with a stylized image of a medical device to the right of the word. Below the company name, the text "A MEDICAL DEVICE COMPANY" is written in a smaller, sans-serif font.

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

K091389

# Section 14 – SPECIAL 510(K) SUMMARY

# SPECIAL 510(K) SUMMARY

EQUASHIELD™ Luer Lock Connector Pair

## 510(k) Number K091389

| Applicant's Name: | Plastmed Ltd. |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Tefen Industrial Park |
| | P.O.B 26, ISRAEL |
| | Tel: [phone] |
| | Fax: [phone] |
| Contact Person: | Elissa Burg |
| | Tefen Industrial Park |
| | P.O.B 26, ISRAEL , 24959 |
| | Tel: [phone]; Fax: [phone] |
| | Email: [e-mail] |
| Trade Name: | EQUASHIELD™ Luer Lock Connector Pair |
| Common name: | Closed drug transfer system |
| Classification: | Name: Intravascular administration set<br>Product Code: LHI<br>Regulation No: 880.5440<br>Class: II<br>Classification Panel: General hospital |
| Predicate Devices: | Modified EQUASHIELD™ Luer Lock Connector Pair is substantially<br>equivalent to the original EQUASHIELD™ system for the preparation<br>and administration of parenteral drugs, cleared under Plastmed's 510(k)<br>number K083152 |

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Image /page/1/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The word "Plastmed" is in large, bold, black letters. Below the company name, in smaller letters, is the phrase "A MEDICAL DEVICE COMPANY."

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

### Device Description:

The EQUASHIELD™ Luer Lock Connector Pair is a closed system for drug transfer. It utilizes some of the predicate device components to create a closed system during drug transfer. The EQUASHIELD™ Luer Lock Connector Pair consists of a connector to an infusion set (Female Luer Lock Connector) and a connector to an IV catheter (Male Luer Lock Connector).

The connector pair provides closed system protection during connection and disconnection of a fluid path, thereby prohibiting the escape of the hazardous drug and its harmful vapors into the 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.

#### Technological characteristics and Substantial Equivalence:

The modified EQUASHIELD™ Luer Lock Connector Pair is substantially equivalent to the original EQUASHIELD™ System that was previously cleared under 510(k) number K083152.

Both new and predicate devices have the same indication for use, same functions, same components design, similar and biocompatible materials and same characteristics. Certain changes that differs the modified device from the original (predicate) device were fully addressed.

The modifications performed do not affect the device's intended use and do not alter the device's fundamental scientific technology.

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Image /page/2/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The word "Plastmed" is written in a bold, sans-serif font, with the "d" stylized to include a teardrop shape. Below the company name, the words "A MEDICAL DEVICE COMPANY" are written in a smaller, sans-serif font.

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

Modified device verification and validation tests showed that it is as safe and as effective as the predicate device.

### Non clinical performance data:

Test results support all labeling claims and substantial equivalency. The modified device was tested in accordance to Plastmed's legally marketed device specification. All testing results demonstrated satisfactory performances and met all acceptance criteria.

### Conclusions:

The evaluation of Plastmed's modified Device's bench tests demonstrated that the device performs as intended and that it is as safe and as effective as the predicate device.

Therefore, we believe it is substantially equivalent to Plastmed's legally marketed device.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

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

OCT 22 2009

Re: K091389

Trade/Device Name: EQUASHIELD™ Luer Lock Connector Pair Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: October 7, 2009 Received: October 13, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Susan Suarez

Susan Runner, D.D.S., M.A. Acting 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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Image /page/5/Picture/0 description: The image shows the logo for Plastmed, a medical device company. The word "Plastmed" is written in large, bold letters. Below the company name, the words "A MEDICAL DEVICE COMPANY" are written in smaller letters.

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

# Section 4 - Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): 409 (389

Device Name: EQUASHIELD TM Luer Lock Connector Pair

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 __ C (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number

Anthony V. Nouri

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

510(k) Number: 大�g1389