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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EQUASHIELD™ Luer Lock Connector Pair, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the manner one might find for an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as typically applied for AI/ML device studies, is not present in the provided text.

The document states:

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

However, it does not provide the specific acceptance criteria themselves, the reported performance against those criteria in a table, or any of the detailed study parameters (sample size, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment methods) that you've requested. The document primarily focuses on regulatory approval based on demonstrating substantial equivalence through non-clinical performance data and bench tests, rather than clinical efficacy studies.

Summary

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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: +972 4 9873737 Fax: +972 4 9873001

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: (972)4-987-3737
	Fax: (972)4-987-3001
Contact Person:	Elissa Burg
	Tefen Industrial Park
	P.O.B 26, ISRAEL , 24959
	Tel: +972-4-987-3737; Fax: +972-4-987-3001
	Email: qa@plastmed.com
Trade Name:	EQUASHIELD™ Luer Lock Connector Pair
Common name:	Closed drug transfer system
Classification:	Name: Intravascular administration setProduct Code: LHIRegulation No: 880.5440Class: IIClassification Panel: General hospital
Predicate Devices:	Modified EQUASHIELD™ Luer Lock Connector Pair is substantiallyequivalent to the original EQUASHIELD™ system for the preparationand administration of parenteral drugs, cleared under Plastmed's 510(k)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: +972 4 9873737
Fax: +972 4 9873001

Device Description:

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:

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: +972 4 9873737
Fax: +972 4 9873001

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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Image /page/3/Picture/0 description: The image shows a circular seal with an eagle in the center. The eagle is facing left and has its wings spread. The seal is surrounded by text, but the text is too blurry to read. The seal appears to be from a government agency.

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 (800) 638-2041 or (240) 276-3150 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: +972 4 9873737
Fax: +972 4 9873001

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:

Prescription Use __ C (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

Anthony V. Nouri

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

510(k) Number: 大�g1389

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.