Equashield Closed System drug Transfer Device (CSTD)

K170706 · Equashield Medical , Ltd. · ONB · Jul 3, 2017 · General Hospital

Device Facts

• Record ID: K170706
• Device Name: Equashield Closed System drug Transfer Device (CSTD)
• Applicant: Equashield Medical , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Jul 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Closed System drug Transfer Device (CSTD) for preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and also prevents microbial ingress up to 7 days.

Device Story

Equashield is a sterile, single-use Closed System Transfer Device (CSTD) used in hospitals and clinics by pharmacists and healthcare professionals. It facilitates the preparation, reconstitution, compounding, and administration of hazardous drugs. The system comprises a piston syringe unit, vial adaptors, spike adaptors, and luer lock connectors. It utilizes a variable sterile air chamber integrated into the syringe for self-contained pressure equalization. Connections are made via a double-membrane method, which is pierced upon engagement to create a leak-proof, drug-residual-free seal. This mechanism prevents the escape of drug vapors/aerosols and blocks environmental contaminants/microbial ingress for up to 7 days. By maintaining a closed system, it minimizes occupational exposure to hazardous substances for healthcare workers and protects the drug from contamination, potentially improving patient safety during drug delivery.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-1, 4, 5, 10, 11), sterility (ISO 11135, 11137-1), package integrity (ASTM F1140, F129, F88), bench performance (ISO 594-1/2, 7886-1, 8536-4, 22413), sharps protection (ISO 23908), drug/DMA compatibility, extractables/leachables screening, hazardous vapor containment (GC-FID), microbial ingress protection (validated for 7 days), and particulate testing (USP 788).

Technological Characteristics

Multi-component system including piston syringe, vial/spike/luer adaptors. Materials: Polypropylene. Principle: Double-membrane septum with integrated closed pressure equalization via sterile air chamber. Connectivity: Mechanical luer/spike connections. Sterilization: EO and Gamma radiation (SAL 10^-6). Standards: ISO 10993, ISO 11135, ISO 11137, ISO 594, ISO 7886, ISO 8536, ISO 22413, ISO 23908, USP 788.

Indications for Use

Indicated for preparation, reconstitution, compounding, and administration of drugs, including antineoplastic and hazardous drugs, in patients requiring such therapies. No specific age or gender restrictions.

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 Closed System drug Transfer Device (CSTD) (K132899)
• Equashield Closed System drug Transfer Device (CSTD) (K150219)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 3, 2017

Equashield Medical Ltd. % Mr. Raymond Kelly Consultant Licensale Inc. 68 Southwoods Terrace Southbury, Connecticut 06488

Re: K170706

Trade/Device Name: Equashield Closed System drug Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: ONB Dated: May 28, 2017 Received: May 31, 2017

Dear Mr. Kelly:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Lori A. Wiggins -S6

Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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)

K170706

Device Name

Equashield Closed System drug Transfer Device (CSTD)

#### Indications for Use (Describe)

Closed System drug Transfer Device (CSTD) for preparation, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and also prevents microbial ingress up to 7 days.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Date Prepared: July 3, 2017

510k Number: K170706

Applicant Equashield Medical Ltd. POB 12, Tefen Industrial Park Migdal Tefen 24959, Israel Attn: Dorit Valal Phone: [phone] (ex. 114)

Contact Person Raymond Kelly 68 Southwoods Terrace Southbury, CT 06488 USA Phone: [phone]

## Device Information

| Trade Name: | Equashield Closed System drug Transfer Device (CSTD) |
|------------------|--------------------------------------------------------------------------------|
| Model Numbers: | Generation 2: (VA-x, SU-x, SA-x, LL-x, MC-x, FC-x, PP-x) |
| Regulation Name: | Intravascular administration set |
| Review Panel: | General Hospital |
| Product Code: | ONB |
| Common Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer<br>System |
| Device Class: | Class II |
| Regulation: | 21 C.F.R. §880.5440 |

Predicate Device Information

K132899 Equashield Closed System drug Transfer Device (CSTD) K150219 Equashield Closed System drug Transfer Device (CSTD)

## Indications for Use

Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress up to 7 days.

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## Device Description

Equashield is a sterile, single use, Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs. The Equashield closed system consists of a piston syringe (Syringe Unit), an adaptor to the medication vial (Vial Adaptor), an adaptor for the IV bag for injection (Spike Adaptor), an adaptor for the IV bag for withdrawal (Spike Adaptor-W), adaptors for injection into IV lines, syringes, or catheters (Luer Lock Adaptors). Nursing Pair connectors for standard IV tubing set ports (Female Luer Lock Connector and Male Luer Lock Connector), a Protective Plug, an adaptor for injection into an IV line with a Y-Site Tubing Set, or Secondary Tubing Accessory, and a Reconstitution Tubing Set for reconstituting powder drugs. The variable sterile air chamber integrated into the encapsulated syringe provides self-contained pressure equalization. The connector unit is welded to the syringe and uses the double-membrane method as high efficiency microbial barrier and for leak-proof and drug residual-free connections to the adaptors of the system. The double membrane seals off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, spills and also prevents microbial ingress up to 7 days.

The purpose of this submission is to add new components to the system including a thin size for components, introduce different material to the components and make labeling changes.

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# Summary of Technological Characteristics Including Modifications to the Device:

Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects. The proposed modified device is SE to the predicate device and does not raise different questions of safety or effectiveness.

| | Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same | Same | Same |
| Indications for Use | Closed System drug Transfer Device<br>(CSTD) for safe preparation,<br>reconstitution, compounding and<br>administration of drugs, including<br>antineoplastic and hazardous drugs.<br>This closed system mechanically<br>prohibits the transfer of environmental<br>contaminants into the system and the<br>escape of drug or vapor concentrations<br>outside the system, thereby<br>minimizing individual and<br>environmental exposure to drug vapor,<br>aerosols, and spills and also prevents<br>microbial ingress up to 7 days. | Closed System drug Transfer Device<br>(CSTD) for safe preparation,<br>reconstitution, compounding and<br>administration of drugs, including<br>antineoplastic and hazardous drugs.<br>This closed system mechanically<br>prohibits the transfer of environmental<br>contaminants into the system and the<br>escape of drug or vapor concentrations<br>outside the system, thereby<br>minimizing individual and<br>environmental exposure to drug vapor,<br>aerosols, and spills and also prevents<br>microbial ingress. | Closed System drug Transfer<br>Device (CSTD) for safe<br>preparation, reconstitution,<br>compounding and<br>administration of drugs,<br>including antineoplastic and<br>hazardous drugs.<br>This closed system<br>mechanically prohibits the<br>transfer of environmental<br>contaminants into the system<br>and the escape of drug or vapor<br>concentrations outside the<br>system, thereby minimizing<br>individual and environmental<br>exposure to drug vapor,<br>aerosols, and spills and also<br>prevents microbial ingress up<br>to 7 days. |
| Classification | Class II | Class II | Class II |
| Regulation<br>Number | 888.5440 | 888.5440 | 888.5440 |
| Product Code | ONB | ONB | ONB |
| | Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) |
| System<br>components | Vial Adaptor (VA) | Vial Adaptor | Vial Adaptor |
| | Syringe Unit (SU) | Syringe Unit | Syringe Unit |
| | Spike Adaptor for injection (SA-<br>Regular and Thin Size) | Spike Adaptor for injection | Spike Adaptor for injection |
| | Spike Adaptor W- for withdrawal (SA-W) | Spike Adaptor W- for withdrawal | Spike Adaptor W- for withdrawal |
| | Luer Lock Adaptor (LL-1) | Luer Lock Adaptor | Luer Lock Adaptor |
| | Male Luer Lock Connector (MC-1) | Male Luer Lock Connector | Male Luer Lock Connector |
| | Female Luer Lock Connector (FC-1) | Female Luer Lock Connector | Female Luer Lock Connector |
| | Protective Plug (PP-1) | Protective Plug | Protective Plug |
| | Y-Site Tubing (Accessory) (LL-1Y) | Y-Site Tubing (Accessory) | Y-Site Tubing (Accessory) |
| | Secondary Tubing (Accessory) (SA-<br>1S) (Regular and Thin Size) | Secondary Tubing (Accessory) | Secondary Tubing (Accessory) |
| | Reconstitution Tubing(Accessory)<br>(LL-1R) | NA | Reconstitution Tubing(Accessory) |
| | Catheter Luer Lock Adaptor (LL-1C) | NA | NA |
| | Syringe-Syringe Luer Lock Adaptor<br>(LL-1DC) | NA | NA |
| Characteristics | Closed System used for antineoplastic<br>and hazardous drug reconstitution,<br>transfer and administration, in order to<br>prevent contamination of the<br>surrounding environment and of the<br>drug | Closed System used for antineoplastic<br>and hazardous drug reconstitution,<br>transfer and administration, in order to<br>prevent contamination of the<br>surrounding environment and of the<br>drug | Closed System used for antineoplastic<br>and hazardous drug reconstitution,<br>transfer and administration, in order to<br>prevent contamination of the<br>surrounding environment and of the<br>drug |
| Principles of<br>Operation | Multi-component system. Components<br>are intended to be used as a system. | Multi-component system.<br>Components are intended to be used as<br>a system | Multi-component system.<br>Components are intended to be used as<br>a system |
| | Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) |
| Technological<br>Characteristics | A leak-proof connector with a single<br>use syringe permanently attached to it<br>as part of the system. | A leak-proof connector with a single<br>use syringe permanently attached to it<br>as part of the system. | A leak-proof connector with a single<br>use syringe permanently attached to<br>it as part of the system. |
| | All system components are sealed with<br>resealing membranes (Septum). When<br>components are joined together the<br>two membranes are pressed together<br>and then pierced by needles.<br>System has integrated closed pressure<br>equalization. | All system components are sealed with<br>resealing membranes (Septum). When<br>components are joined together the<br>two membranes are pressed together<br>and then pierced by needles.<br>System has integrated closed pressure<br>equalization. | All system components are sealed<br>with resealing membranes (Septum)<br>When components are joined<br>together the two membranes are<br>pressed together and then pierced by<br>needles.<br>System has integrated closed<br>pressure equalization. |
| | The system syringe is closed from all<br>sides. The syringe barrel is sealed<br>airtight also at its rear end, thereby<br>isolating the plunger rod and the<br>interior of the barrel. | The system syringe is closed from all<br>sides. The syringe barrel is sealed<br>airtight also at its rear end, thereby<br>isolating the plunger rod and the<br>interior of the barrel. | The system syringe is closed from all<br>sides. The syringe barrel is sealed<br>airtight also at its rear end, thereby<br>isolating the plunger rod and the<br>interior of the barrel. |
| | Proposed Device | Predicate Device (K132899) | Predicate Device (K150219) |
| Secondary Tubing<br>Sets | Spike Adaptor with drip chamber and<br>secondary tubing attached, Y Tubing<br>set with Y-Connector attached. | Spike Adaptor with drip chamber<br>and secondary tubing attached, Y<br>Tubing set with Y-Connector | Spike Adaptor with drip chamber and<br>secondary tubing attached, Y Tubing<br>set with Y-Connector attached. |
| | A fully encapsulated Syringe Unit is | A fully encapsulated Syringe Unit is | A fully encapsulated Syringe Unit is |
| | the active transfer device of this closed<br>system. | the active transfer device of this<br>closed system. | the active transfer device of this closed<br>system. |
| System | The syringe barrel is sealed airtight | The syringe barrel is sealed airtight | The syringe barrel is sealed airtight also |
| | also at its rear end, thereby isolating | also at its rear end, thereby isolating | at its rear end, thereby isolating the |
| | the plunger rod and the interior of the | the plunger rod and the interior of | plunger rod and the interior of the |
| | barrel. | barrel. | barrel. |
| | A leak-proof connector is permanently | A leak-proof connector is | A leak-proof connector is permanently |
| | welded to the syringe. | permanently welded to the syringe. | welded to the syringe. |
| | The closed pressure equalization<br>system with a chamber containing<br>sterile air is built-in the Syringe Unit<br>and makes the system airtight<br>consequently containing all aerosols,<br>particles and vapors. | The closed pressure equalization<br>system with a chamber containing<br>sterile air is built-in the Syringe Unit<br>and makes the system airtight<br>consequently containing all aerosols,<br>particles and vapors. | The closed pressure equalization<br>system with a chamber containing<br>sterile air is built-in the Syringe Unit<br>and makes the system airtight<br>consequently containing all aerosols,<br>particles and vapors. |
| | For transfer of fluids the Syringe Unit<br>connects to the passive Vial Adaptors,<br>infusion bag and infusion tubing<br>adaptors of the system, using the<br>double membrane method to create a<br>leak-proof and drug residual-free<br>connection. | For transfer of fluids the Syringe<br>Unit connects to the passive Vial<br>Adaptors, infusion bag and infusion<br>tubing adaptors of the system, using<br>the double membrane method to<br>create a leak-proof and drug<br>residual- free connection. | For transfer of fluids the Syringe Unit<br>connects to the passive Vial Adaptors,<br>infusion bag and infusion tubing<br>adaptors of the system, using the<br>double membrane method to create a<br>leak-proof and drug residual-free<br>connection. |
| Device Type | Rx/Single Use | Rx/Single Use | Rx/Single Use |
| Target Users | Licensed Pharmacists/Health Care | Licensed Pharmacists/Health Care | Licensed Pharmacists/Health Care |
| | Professionals | Professionals | Professionals |
| Environment | Hospitals and clinics | Hospitals and clinics | Hospitals and clinics |
| Sterilization | EO and Gamma SAL 10-6 | EO and Gamma SAL 10-6…