NEOSHIELD

K172499 · JMS North America Corporation · ONB · Jun 1, 2018 · General Hospital

Device Facts

• Record ID: K172499
• Device Name: NEOSHIELD
• Applicant: JMS North America Corporation
• Product Code: ONB · General Hospital
• Decision Date: Jun 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that 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. The NEOSHIELD system also prevents microbial ingress for 3 days.

Device Story

NEOSHIELD is a needle-free closed system drug transfer device (CSTD) designed to facilitate the safe reconstitution and transfer of hazardous drugs between vials, syringes, and IV bags. The system utilizes an elastomeric double-membrane mechanism and push-to-connect interfaces to maintain a closed environment, preventing the escape of drug vapors/aerosols and the ingress of environmental contaminants. Components include a transfer device with a stopcock, bag adaptor, infusion set, plug, lever lock, and vial cover. Used in clinical settings by healthcare professionals, the device ensures airtight and leak-proof connections. By maintaining a closed system, it protects clinicians from hazardous drug exposure and maintains the sterility of the drug solution for up to 3 days. The device is single-use and sterilized via ethylene oxide (EO).

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by non-clinical bench testing, including leak-proof and airtight connection testing, microbial ingress testing (demonstrating no ingress for 3 days), biocompatibility, and drug compatibility crack testing.

Technological Characteristics

Materials include plastics, elastomeric double membrane, and PTFE filter. Sensing/actuation is mechanical (push-to-connect, stopcock flow control). Dimensions/form factor: modular components (transfer, bag adaptor, infusion set, plug, lever lock, vial cover). Connectivity: N/A (mechanical). Sterilization: EO (ISO 11135). Standards: ISO 8536-4:2010 for bag adaptor and infusion set components.

Indications for Use

Indicated for use as a closed system drug transfer device (CSTD) to minimize exposure to hazardous drugs, vapors, and aerosols during drug reconstitution and transfer, and to prevent microbial ingress for up to 3 days. Contraindicated for use with anticancer drugs or solutions containing the plasticizer N, N-dimethylacetamide.

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

• BD PhaSeal Closed System Drug Transfer Device (K123213)

Reference Devices

• Vented IV Set (K965027)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 1, 2018

JMS North America Corporation % Yolanda Smith Smith Associates 1468 Harwell Ave Crofton, Maryland 21114

Re: K172499

Trade/Device Name: NEOSHIELD Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: April 30, 2018 Received: May 2, 2018

Dear Yolanda Smith:

We have reviewed vour 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.

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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 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.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tina Kiang
-s

Tina Kiang, Ph.D. 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) K172499

Device Name

NEOSHIELD

Indications for Use (Describe)

The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that 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.

The NEOSHIELD system also prevents microbial ingress for 3 days.

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is in blue and features the letters JMS in a stylized font. Below the letters is the text "North America Corporation".

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone] Fax [phone]

#### K172499 Section 05: 510(k) Summary [807.92(c)]

## Owner [807.92(a)1]:

| Company Name: | JMS North America Corp. |
|------------------|---------------------------------|
| Company Address: | 22320 Foothill Blvd., Suite 350 |
| | Hayward, CA 94541 |
| Telephone: | 510-888-9090 |
| Fax: | 510-888-9099 |

Contact Person: Sho Hosoki Summary Preparation Date: 06/01/2018

## Device of Submission [807.92(a)(2)]

| Classification Name: | Intravascular Administration Set |
|------------------------------|--------------------------------------------------------------------------------|
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug<br>Reconstitution and Transfer System |
| Proprietary Name: | NEOSHIELD |
| Classification: | Class II |
| Product Code: | ONB |
| Code of Federal Regulations: | 21 CFR 880.5440 |

## Predicate Device [807.92(a)(3)]

| K Number | Product | Company |
|-----------------------------------|--------------------------------------------------------------------------------------|------------------------|
| K123213<br>(Primary<br>Predicate) | BD PhaSeal Closed System Drug Transfer Device<br>Protector, injector, Luer connector | Becton Dickinson & Co. |

## Reference Device

| K965027 | Vented IV Set | JMS Co., Ltd |
|---------|---------------|--------------|
|---------|---------------|--------------|

## Device Description [807.92(a)(4)]

NeoShield is a needle free closed system drug transfer device (CSTD). Neoshield prevents transfer of environmental contaminants into the system and also prevents the escape of drug or vapor from the system.

The ability to prevent microbial ingress for up to 3 days should not be interpreted as modifying, extending, or superseding a manufacturer labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding guidelines for shelf life and sterility information.

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Image /page/4/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters JMS in a stylized font. Below the letters is the text "North America Corporation" in a smaller font, also in blue. The logo is simple and professional.

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone] Fax [phone]

#### Device components:

| Name of Component | General Description |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| NEOSHIELD Transfer | NEOSHIELD Transfer is used to transfer a solution from a vial container to another container such as an IV bag. It has a female connector, bag adaptor connector, and vial connector. It also has a stopcock to change the direction of flow<br><br>Depending on the stopcock's position it can open the flow from female connector to/from NEOSHIELD Bag Adaptor or from female connector to/from vial. During usage, the NEOSHIELD Transfer keeps aerosol and liquid from being exposed to the outer environment to keep a closed system. |
| NEOSHIELD Bag Adaptor | NEOSHIELD Bag Adaptor is connected to a liquid container such as IV bags for injection or extraction of liquid. The spike is used for the connection to liquid container and the injection port is used for injection or extraction of liquid in/out of container without leakage maintaining closed system. |
| NEOSHIELD Infusion Set | The NEOSHIELD Infusion Set is used for infusion of drug solution<br>into a patient. |
| NEOSHIELD plug | The NEOSHIELD Plug is an optional accessory that can be connected with a female connector (such as one from NEOSHIELD Infusion Set) to inject/ extract solution without using needle in a closed system environment. The slit septum of the NEOSHIELD Plug opens upon connection with NEOSHIELD Lever Lock and the flow path opens. The slit septum of NEOSHIELD plug and the flow path closes once male portion of the NEOSHIELD Lever Lock is removed to keep a closed system. |
| NEOSHIELD Lever Lock | The NEOSHIELD Lever Lock is used for injecting/extracting solution in a closed system by connecting a device such as syringe to the female connector. |
| NEOSHIELD Vial Cover | NEOSHIELD Vial Cover is attached to drug vials in order to prevent leakage during extraction. The NEOSHIELD Vial Cover keeps the system closed to outer environment |

## Intended Use [807.92(a)(5)]

The NEOSHIELD System is an airtight and leak proof closed system drug transfer device (CSTD) that 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.

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Image /page/5/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters "JMS" stacked on top of each other. There are three horizontal lines going through the letters. Below the letters is the text "North America Corporation".

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone] Fax [phone]

The NEOSHIELD system also prevents microbial ingress for 3 days.

## Predicate Comparison [807.92(a)(6)]

| Device | Modified Device | Currently Legally Marketed Predicate Device<br>(Primary Predicate) |
|---------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NeoShield | BD PhaSeal Closed System Transfer Device |
| Manufacture | JMS Co., Ltd / JMS Singapore Pte Ltd | Becton Dickinson & Co. |
| 510(K) # | ---- | K123213 |
| Classification | Class II | Class II |
| Product Code | ONB | ONB |
| Intended Use | The Neoshield System is an airtight and<br>leak proof closed system drug transfer<br>device (CSTD) that mechanically prohibits<br>the transfer of environmental<br>contaminants into the system and the<br>escape of drug or vapor concentrations<br>outside the system, thereby minimizing<br>individual and environmental exposure to<br>drug vapor, aerosols and spills.<br>The NEOSHIELD system also prevents<br>microbial ingress for 3 days. | The PhaSeal System is an airtight and leak proof<br>closed system drug transfer device (CSTD) that<br>mechanically prohibits the transfer of<br>environmental contaminants into the system and<br>the escape of drug or vapor concentrations<br>outside the system, thereby minimizing individual<br>and environmental exposure to drug vapor,<br>aerosols and spills.<br>The PhaSeal system also prevents microbial<br>ingress. |
| Equalizes Vial<br>Pressure<br>when<br>Accessed | Yes | Yes |
| Prevents<br>Escape of<br>Drug or Vapor<br>Concentration | Yes | Yes |
| Closed Drug<br>Transfer<br>Mechanism | Elastomeric double membrane(non-ISO) | Elastomeric double membrane(non-ISO) |
| Activation<br>Mechanism | Push-to connect<br>(Non-ISO) | Push-to connect<br>with bayonet lock (Non-ISO) |
| Needle Free | Needle free | 18G needle with safety sleeve and /or steal spike |
| Connection to<br>External<br>Equipment | Standard ISO Luer Connections and Vial Spikes | Standard ISO Luer Connections and Vial Spikes |

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Image /page/6/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is in blue and features the letters "JMS" stacked on top of the words "North America Corporation". The letters "JMS" are stylized and bolded. The words "North America Corporation" are in a smaller font size.

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone]
Fax [phone]

| Single Use | yes | yes |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Sterilization<br>Method | EO | EO |
| Open or<br>Closed<br>System | closed system<br>Following tests were conducted:<br>Leaking Pressure of Pre-Slit Septum<br>Pressure Resistant Test (Liquid Tightness)<br>Pressure Resistant Test (Air tightness)<br>Pressure Resistant Test (Connecting Part of<br>Closed System)<br>Airtight Connection<br>Leakproof Connections<br>Microbial Ingress Testing | closed system |
| Filter | PTFE (NeoShield Transfer) | PTFE (Protector) |
| Material | Contains plastics, elastomeric double<br>membrane, PTFE filter | Plastics, elastomeric double membrane, PTFE<br>filter, stainless steel |
| Performance<br>testing | Leak proof connections<br>Airtight connections<br>Microbial Ingress | Leak proof connections<br>Airtight connections<br>Microbial Ingress |

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Image /page/7/Picture/0 description: The image contains the logo for JMS North America Corporation. The logo is blue and features the letters "JMS" in a stylized font with horizontal lines above the letters. Below the letters is the text "North America Corporation" in a smaller font.

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone] Fax [phone]

## Non-Clinical Performance Data [807.92(b)(1)]

The following non-clinical tests were conducted:

#### Performance test (bench testing)

| Name of device | Result |
|------------------------------------------------------------------------|--------|
| NeoShield Transfer | Pass |
| NeoShield Bag Adaptor (Also includes tests<br>from ISO 8536-4 : 2010) | Pass |
| NeoShield Infusion Set (Also includes tests<br>from ISO 8536-4 : 2010) | Pass |
| NeoShield Plug | Pass |
| NeoShield Lever Lock | Pass |
| NeoShield Vial Cover | Pass |

| Name of Test | Result |
|------------------------------------------------------------|-----------------------|
| Leaking Pressure of Pre-Slit Septum | No leak |
| Pressure Resistant Test (Liquid Tightness) | No leak |
| Pressure Resistant Test (Air tightness) | No leak |
| Pressure Resistant Test (Connecting Part of Closed System) | No leak |
| Airtight Connection | No leak |
| Leakproof Connections | No leak |
| Microbial Ingress Testing | No ingress for 3 days |

#### Other tests

| Name of Test | Result |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Pyrogen test | Non-pyrogenic |
| Crack Test for drug compatibility with:<br>N, N-dimethylacetamide Polyethylene Glycol benzyl alcohol polysorbate 80 polyoxyethylene castor oil NaOH CH3COOH | No cracks except for<br>N, N-dimethylacetamide |

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Image /page/8/Picture/0 description: The image shows the logo for JMS North America Corporation. The logo is blue and features the letters JMS stacked on top of each other. There are also horizontal lines above the letters. The words "North America Corporation" are written below the letters.

MAIN OFFICE 22320 Foothill Blvd. Suite 350 Hayward, CA 94541 Tel. [phone] Fax [phone]

SALES OFFICE 480 Sawgrass Corp. Pkwy. Suite 120 Sunrise, FL 33325 Tel. [phone] Fax [phone]

| Sterility Testing (EO)<br>ISO 11135 | Sterile |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|
| Shelf Life Testing | Sterility kept for 3 years |
| Biocompatibility Testing:<br>Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Systematic Toxicity (Acute) Haemocompatibility Pyrogen Particulate Matter | All materials are biocompatible |
| Package Testing: Seal Strength/dye<br>penetration testing | Pass/Pass |

Note: Based on the crack test for drug compatibility results, DO NOT use NEOSHIELD system with anticancer drug or any solution that contains the plasticizer N, N-dimethylacetamide.

#### Clinical Performance Data [807.92(b)(2)]

Not applicable as no clinical tests were referenced in this submission

## Conclusion [807.92(b)(3)]

The device is equivalent to the predicate device K123213.

Through non-clinical performance testing the subject devices have demonstrated that they are substantially equivalent to the predicate device.