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

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.

AI/ML Overview

The provided text includes a 510(k) summary for the EQUASHIELD™ System, a closed drug transfer system. However, it does not contain detailed information regarding specific acceptance criteria, a comprehensive study design with reported performance metrics, sample sizes for test or training sets, ground truth establishment methods, or expert qualifications as requested.

The document only states that:

"A series of bench tests were performed to ensure that the device performs as intended. All testing results demonstrated satisfactory performance."
"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 demonstrated that the EQUASHIELD™ system performs its intended use."
"Both bench tests and simulated clinical test have shown that the device performs its intended use."

Without further details, it is impossible to populate the requested table and information points accurately.

Here's a breakdown of what cannot be extracted from the provided text:

Table of Acceptance Criteria and Reported Device Performance: No specific quantitative or qualitative acceptance criteria are listed, nor are any performance metrics and their results reported. The document only offers general statements of "satisfactory performance" and "performs its intended use."
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The testing involves bench and simulated clinical tests, but it's unclear if "experts" were involved in establishing ground truth (e.g., for contamination assessment).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a closed drug transfer system, not an AI-assisted diagnostic or imaging device for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Again, this is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For bench and simulated clinical tests, ground truth would typically refer to established standards or verifiable measurements of containment or drug transfer accuracy.
The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document only offers a high-level overview of performance validation, stating that tests were performed and results were satisfactory. It lacks the granular detail required to complete the requested information.

Summary

{0}------------------------------------------------

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 +972 4 9873737 x: +972 4 9873001

FEB - 2 2009

510(K) SUMMARY

510(k) Number K_

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:

Tefen Industrial Park

Elissa Burg

P.O.B 26, ISRAEL , 24959

Tel (972)4-987-3737; Fax (972)4-987-3001

qa@plastmed.com

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:

PhaSeal closed system for the preparation and administration of parenteral drugs; Carmel Pharma AB K972527
TEVADAPTOR; Migada Plant K051669
Texium™ Syringe; Cardinal Health, Aleris® Products K071108

Plastmed Ltd. | EQUASHIELD TM 510k Notification

{1}------------------------------------------------

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 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:

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

{2}------------------------------------------------

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; +972 4 9873001

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.

{3}------------------------------------------------

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.

{4}------------------------------------------------

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

{5}------------------------------------------------

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 +972 4 9873 4 1972 4 9873001

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: EQUASHIELD TM System

Indications for Use:

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

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.