ProSeal™ Closed System Bag Access

K241988 · Epic Medical Pte. , Ltd. · ONB · Oct 23, 2024 · General Hospital

Device Facts

• Record ID: K241988
• Device Name: ProSeal™ Closed System Bag Access
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Oct 23, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

Device Story

ProSeal™ Closed System Bag Access is a sterile, single-use adaptor connecting standard I.V. bags to ProSeal™ CSTD components (e.g., Injector, Injector Plus). It facilitates closed-system fluid transfer for antineoplastic and hazardous drugs. Operation involves a double-membrane septum design; when engaged with a ProSeal™ Injector, a cannula perforates the membranes to create a fluid path. Upon retraction, membranes self-seal to prevent drug vapor/aerosol escape and microbial ingress. Used in clinical settings by trained professionals. The device maintains a closed system for up to 7 days, minimizing environmental and individual exposure to hazardous drugs. It supports gravity infusion via connection to an I.V. set.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench performance testing, including leak integrity, tensile strength, penetration force, and protective cap testing per ISO 8536-4 and ISO 22413. Biocompatibility, sterility, and shelf-life (3 years) were validated via testing on cleared reference devices (K222929).

Technological Characteristics

Materials: Polypropylene (spike), polyisoprene (septum). Principle: Elastomeric double-membrane resealing technology. Energy: Gravity-fed. Connectivity: Mechanical interface for I.V. bags and ProSeal™ components. Sterilization: Ethylene Oxide (SAL 10^-6). Form factor: Single-use bag access adaptor.

Indications for Use

Indicated for use by trained healthcare professionals and pharmacists in clinical settings for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs. Compatible with standard I.V. bags and ProSeal™ CSTD components.

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

• Closed System Transfer Device (K201460)

Reference Devices

• ProSeal™ Injector or ProSeal™ Injector Plus (K240171)
• ProSeal™ Closed System Administration Set (K230343)
• ToxiSeal™ Vial Adaptor with External Balloon (K222929)

Submission Summary (Full Text)

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October 23, 2024

Epic Medical Pte. Ltd. Freddie Lee CEO/md 105 Cecil Street #20-04, The Octagon Singapore, 069534 Singapore

Re: K241988

Trade/Device Name: ProSeal™ Closed System Bag Access Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: September 23, 2024 Received: September 23, 2024

Dear Freddie Lee:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

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Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K241988

Device Name ProSeal™ Closed System Bag Access

### Indications for Use (Describe)

The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# CDIL

# K241988 – 510(k) Summary

#### I. Submitter

Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534. Phone: [phone] Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director Date Prepared: October 23, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Traditional

#### II. Subject Device

| 510(k) Number: | K241988 |
|---------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ProSeal™ Closed System Bag Access |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>Transfer System |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |

#### III. Predicate

| 510(k) Number: | K201460 |
|---------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | Closed System Transfer Device |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>Transfer System |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |

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#### IV. Device Description

The ProSeal™ CSTD is a sterile, single-use, pyrogen-free CSTD for the preparation, reconstitution, compounding, and administration of antineoplastic and hazardous drugs, intended for use in clinical settings by trained health care professionals and/or pharmacists.

The ProSeal™ Closed System Bag Access is a component of the ProSeal™ CSTD system which is intended for connection to a standard I.V. bag and appropriate ProSeal™ CSTD component devices for the injection and infusion of I.V. infusion fluids. It is an adaptor between IV bags and ProSeal™ CSTD components for closed system fluid transfer into and out of the I.V. bag. The Subject bag access is compatible with the ProSeal™ Injector or the ProSeal™ Injector Plus (cleared K240171) and other ProSeal™ component devices, e.g. ProSeal™ Closed System Administration Set (for infusion from the I.V. bag). The ProSeal™ Closed System Bag Access and all its corresponding interface membranes exhibit a dry connection with the communicating surfaces in a fluid transfer. The use of this component device and its appropriate ProSeal CSTD connecting component device reduces the risk of microbial ingress for up to 168 hours or 7 days, when used as intended.

The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system as follows:

- A double membrane septum design utilizing self-sealing elastomeric membranes tightly fits . together when the system components engage. A cannula within the ProSeal™ Injector Plus housing perforates the double membranes for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environmental contaminants into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination, when used as intended.
#### V. Indications for Use Statement

The ProSeal™ Closed System drug Transfer Device (CSTD) mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.

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### Comparison of Intended Use & Technological Characteristics VI.

The Subject device and the Predicate device share the following similar characteristics:

# Intended Use comparison

- 1) Indications for use statements
- 2) Primary product code and regulation number
- 3) Intended user population/ intended use environment

### Technological characteristics comparison Equivalencies - Technology & Design

The ProSeal" Closed System Bag Access and the Predicate device share the following similar design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a different question of safety or effectiveness:

- 1) Principles of operation
- 2) Number of access points
- 3) Intended connector type to be used with the bag spike adapter
- 4) Safety feature to prevent microbial contamination
- An overview table summarizing the comparison between the Subject and the Subject and the Predicate device is provided hereunder.

| Characteristic<br>compared | Predicate Device (K201460)<br>CSTD - Spike Adapter | Subject Device (K241988)<br>ProSeal™ Closed System Bag Access | Comment/<br>Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Intended use<br>and<br>Indications for Use<br>statement | "The Closed System Transfer Device (CSTD) for<br>preparation, reconstitution, compounding and<br>administration of drugs, including<br>antineoplastic and hazardous drugs. This closed<br>system mechanically prohibits the transfer of<br>environmental contaminants into the system<br>and the escape of drug or vapor concentrations<br>outside the system, thereby minimizing<br>individual and environmental exposure to drug<br>vapor, aerosols, and spills and also prevents<br>microbial ingress." | "The ProSeal™ Closed System drug Transfer<br>Device (CSTD) mechanically prohibits<br>environmental contaminants from entering the<br>system and the escape of drug or vapor<br>concentrations from the system, thereby<br>minimizing individual and environmental<br>exposure to drug vapor, aerosols, and spills.<br>The ProSeal™ system also prevents the<br>introduction of microbial contaminations into<br>the drug or fluid path for up to 7 days when<br>used as intended." | Similar |
| Characteristic<br>compared | Predicate Device (K201460)<br>CSTD - Spike Adapter | Subject Device (K241988)<br>ProSeal™ Closed System Bag Access | Comment/<br>Discussion |
| Primary product code<br>and regulation number | ONB<br>21 CFR 880.5440 | ONB<br>21 CFR 880.5440 | Same |
| Intended user<br>population/ intended<br>use environment | Adequately trained<br>health care professionals including pharmacists/<br>clinical setting | Adequately trained<br>health care professionals including pharmacists/<br>clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| Single use or reusable | Single use only | Single use only | Same |
| Principles<br>of operation | Infusion bag is connected with spike adapter,<br>then in order to realize the connection<br>between infusion bag and spike adaptor, they<br>are connected with the matching end of the<br>dispensing connector.<br>All system components are sealed with<br>resealing membranes, and elastomeric double<br>membrane technology is used to ensure that<br>there is no drug leakage at the connecting<br>parts during the dispensing process. As closed<br>Infusion Set, the working principle of the<br>infusion set is gravity infusion, which is<br>connected with the indwelling needle or other<br>connector(s). Under the action of gravity, the<br>medicine is infused into human blood vessels<br>through the infusion tube. | The infusion bag is connected with the bag<br>access and, in order to create a fluid path<br>connection between the infusion bag and the<br>bag access, they are connected with the<br>matching end of the ProSeal Injector or<br>Injector Plus (K240171).<br>All system components are sealed with self-<br>resealing membranes incorporating<br>elastomeric double membrane technology that<br>features airtight and leakage-proof<br>connections during the fluid transfer process.<br>Transfer is performed through the connection<br>of an I.V. set with indwelling needle of the<br>ProSeal Injector (or Injector Plus) connector,<br>e.g. the ProSeal Closed System Administration<br>Set (cleared K230343), into the human veins. | Same |
| Components | • Vial Adapter<br>• Spike Adapter<br>• Dispensing Connector<br>• Closed Infusion Set | • Spike Adapter | Different,<br>See Comment #1 |
| Characteristic<br>compared | Predicate Device (K201460)<br><i>CSTD - Spike Adapter</i> | Subject Device (K241988)<br><i>ProSeal™ Closed System Bag Access</i> | Comment/<br>Discussion |
| Number<br>of access points | Device has 2 access points:<br>1. Closed system port<br>2. Spiking/ administration port, IV spike bag<br>access | Device has 2 access points:<br>1. Closed system port<br>2. Spiking/ administration port, IV spike bag<br>access | Same |
| Composition<br>of fluid path materials | ABS (spike), synthetic rubber<br>(sealing element/ membrane/ septum) | Polypropylene (PP) (spike), polyisoprene<br>(IR) (sealing element/ membrane/ septum) | Different,<br>See Comment #2 |
| Intended<br>connector type to be<br>used with the bag<br>spike adapter | Image: Shiva Ande Healthcare Apparatus manufacturer's dedicated Dispensing Connector (K201460) male Luer lock tip, connected to an external standard MLL syringe | Image: Epic Medical Pte Ltd manufacturer's cleared ProSeal™ Injector or Injector Plus (K240433) male Luer lock tip, connected to an external standard MLL syringe | Same |
| Safety feature to<br>prevent microbial<br>contamination | Leak proof connector with membranes<br>(septums) seal – elastomeric resealing<br>double membrane | Airtight and leakage-proof adaptor with<br>membranes (septums) seal – elastomeric<br>resealing double membrane – closed system<br>technology | Same |
| Sterile barrier<br>packaging | Medical grade paper and<br>medical plastic film, heat sealed | Medical grade paper and<br>medical plastic film, heat sealed | Same |
| Sterilization process | Ethylene Oxide (EO), SAL 10-6 | Ethylene Oxide (EO), SAL 10-6 | Same |
| Shelf-life validation | 3 years (36 months) | 3 years (36 months) | Same |

# 4) Intended drug type

- 5) Single use or reusable, single patient use
-

- 5) Sterile barrier packaging
- 6) Sterilization process
- 7) Shelf-life

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Image /page/9/Picture/0 description: The image shows the word "EPIC" in a stylized, bold, sans-serif font. The "E" has a circular dot in the upper left corner, and a horizontal line underlines the entire word. The letters are closely spaced, giving the word a compact appearance.

### Discussion of difference in technological characteristics

### Comment #1

Submission K241988 is to include an authorization of the ProSeal™ Closed System Vial Access, a single component device, to the existing ProSeal™ CSTD system of 11 component devices (K241823). Compared to Predicate K201460, the application was for 4 component devices. The different questions of safety and effectiveness as the Subject device of the Predicate device component devices. Bench top, biocompatibility, and sterility data demonstrate the difference does not raise different questions in safety and effectiveness as described in section VII.

### Comment #2

Though the Subject device's bag spike and membrane material differ with the Predicate, both the PP and IR materials are the same in type, make, grade and manufacturer source as those used in the cleared ToxiSeal™ Vial Adaptor with External Balloon (K222929) that have been tested to demonstrate biocompatibility. In addition, performance testing demonstrates the difference in material does not raise different questions of safety and effectiveness.

#### VII. Performance Data Supporting Substantial Equivalence

A. Functional Performance

The Subject device in this Summary was evaluated to be in conformance with the following ISO and FDA recognized standards and FDA guidance document:

- ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated ● into medical devices for intravascular applications
- . ISO 8536-4: 019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
- . Intravascular-Administration-Sets-Premarket-Notifications-J510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred-to and performed:

- Leak integrity test (functional) per ISO 8536-4:2019, paragraph 7.2 and Annex A.3, performed ● on Subject devices
- Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject devices
- . Penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject devices
- . Protective caps test (functional) - per ISO 8536-4:2019, Section 7.13, performed on Subject devices
- Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data ● on devices cleared under K222929
- Microbial ingress test per FDA guidance and ANSI AAMI CN27:2021 (functional) from testing ● data on devices cleared under K222929

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# e Dio

- B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on referred-to cleared devices:

- Cytotoxicity to ISO 10993-5 under K222929 ●
- Sensitization to ISO 10993-10 under K222929 ●
- Intracutaneous Reactivity to ISO 10993-10 under K222929 ●
- Acute Systemic Toxicity to ISO 10993-11 under K222929 .
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K222929 .
- In-vitro Hemolysis Assessment to ISO 10993-4 under K222929 ●
- . Material Mediated Pyrogenicity to ISO 10993-11 under K222929

Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP <788> Particulate Matter in Injections.

## C. Sterility, Shipping, and Shelf-Life

The Subject device complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/ evaluations conducted devices cleared under K222929;

- Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing . of Shipping Containers and Systems
- Package Integrity Tests per ASTM F1980-21, Standard guide for accelerated aging of sterile . barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials: Dye Penetration - ASTM F1929-23. Standard test method for detecting seal leaks in porous medical device packaging by dye penetration; EN 868-5:2009, Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction – Requirements and test methods
- Pyrogen Tests per ANSI/AAMI ST72/2019, Bacterial endotoxins Test methods, routing . monitoring, and alternatives to batch testing, USP 40 <151>, Pyrogen test (USP rabbit test), USP-NF <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF <85>, Bacterial Endotoxins Test and testing will be conducted on every lot
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.

## VIII. Clinical Tests

Not applicable.

#### IX. Conclusion

The difference between the Predicate and the Subject device does not raise any new or different questions of safety or effectiveness. The Subject device - ProSeal™ Closed System Bag Access is substantially equivalent to the Predicate device, CSTD-Spike Adapter (manufactured by Shinva Ande Healthcare Apparatus Co., Ltd.), (K201460) - with respect to its indications for use, principles of operation and technological characteristics.