ZeroClear™ Bag Access (423100)

K243976 · Epic Medical Pte. , Ltd. · ONB · Jan 22, 2025 · General Hospital

Device Facts

• Record ID: K243976
• Device Name: ZeroClear™ Bag Access (423100)
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Jan 22, 2025
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ 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

ZeroClear™ Bag Access is a component of the ProSeal™ Closed System Transfer Device (CSTD). It facilitates the transfer of parenteral drugs from standard IV bags to patients. The device features a bi-directional Luer lock connector (ISO 80369-7:2021) and an IV bag spike (ISO 8536-4:2019). It connects to IV bags and matching component devices to create an airtight, leak-proof fluid path. Used by healthcare professionals in clinical settings, it minimizes exposure to hazardous drug vapors, aerosols, and spills, and prevents microbial ingress for up to 7 days. The device is single-use and sterile. Healthcare providers use the system to safely reconstitute and transfer hazardous medications, reducing occupational exposure risks and maintaining drug sterility.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via microbial ingress (ANSI AAMI CN27:2021), leak integrity (ISO 8536-4:2019), vapor containment (NIOSH 2016), tensile strength, and spike penetration. Biocompatibility testing performed per ISO 10993 series (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemolysis, pyrogenicity).

Technological Characteristics

Materials: Spike (ABS), Medication port (ABS, polycarbonate, silicone). Connectivity: Luer lock (ISO 80369-7:2021), IV bag spike (ISO 8536-4:2019). Sterilization: Ethylene Oxide (SAL 10^-6). Shelf-life: 3 years. Packaging: Medical grade paper/plastic film. Single-use, sterile, gravity feed compatible.

Indications for Use

Indicated for use by healthcare professionals, including pharmacists, in clinical settings for handling hazardous drugs and infusing IV fluids/drug solutions from standard IV bags to patients.

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

• ProSeal™ Closed System Bag Access (K241988)

Reference Devices

• eZSURE™ Empty Fluid Container (K223674)
• eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (K241442)
• ProSeal™ Injector or Injector Plus (K240433)

Submission Summary (Full Text)

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January 22, 2025

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.

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

Re: K243976

Trade/Device Name: ZeroClear™ Bag Access (423100) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: December 20, 2024 Received: December 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"

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(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).

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 Rue"). 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-devices/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,

Daniel Walloschek

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) K243976

Device Name ZeroClear™ Bag Access (423100)

### Indications for Use (Describe)

The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ 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.

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

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# 으킨 미

# K243976- 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: December 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special

#### II. Subject Device

| 510(k) Number: | K243976 |
|---------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ZeroClearTM 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 |

#### Predicate III.

| 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 |

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#### IV. Device Description

The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).

This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.

The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).

#### V. Indications for Use Statement

The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ 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.

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

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

## Intended Use comparison

- 1) Indications for use statements (similar)
- 4) Intended drug type

5) Single use or reusable, single patient use

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

## Technological characteristics comparison Equivalencies - Technology & Design

The ZeroClear™ Bag Access and the Predicate device share the following 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:

- 1) Principles of operation
- 2) Number of access points
- 4) Sterilization process
- 5) Shelf-life

- 3) Sterile barrier packaging

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# GDIC

An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided hereunder.

| Characteristic<br>compared | Predicate Device (K241988)<br>ProSeal™ Closed System Bag Access | Subject Device (K243976)<br>ZeroClear™ Bag Access | Comment/<br>Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Intended use<br>and<br>Indications for Use<br>statement | "The ProSeal™ Closed System drug Transfer Device<br>(CSTD) mechanically prohibits environmental<br>contaminants from entering the system and the<br>escape of drug or vapor concentrations from the<br>system, thereby minimizing individual and<br>environmental exposure to drug vapor, aerosols,<br>and spills. The ProSeal™ system also prevents the<br>introduction of microbial contaminations into the<br>drug or fluid path for up to 7 days when used as<br>intended." | "The ZeroClear™ Bag Access is a component of the<br>ProSeal™ Closed System drug Transfer Device<br>(CSTD) system. The ProSeal™ CSTD mechanically<br>prohibits environmental contaminants from entering<br>the system and the escape of drug or vapor<br>concentrations from the system, thereby minimizing<br>individual and environmental exposure to drug vapor,<br>aerosols, and spills. The ProSeal™ system also<br>prevents the introduction of microbial contaminations<br>into the drug or fluid path for up to 7 days when used<br>as intended." | Similar,<br>Subject component<br>device's brand name<br>ZeroClear™ is<br>included in the IFU<br>statement |
| 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 use<br>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 patient use | Single use only, single patient use | Same |
| Principles<br>of operation | 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 a<br>matching component device incorporated with<br>a compatible connector.<br>All system components when connected, are<br>sealed airtight and leakage-proof during the<br>fluid transfer process. Transfer is performed<br>through the connection of a matching<br>component device incorporated with a<br>compatible connector, for dispensing into the<br>human veins. | The infusion bag is connected with the bag access<br>and, in order to create a fluid path connection<br>between the infusion bag and the bag access, they<br>are connected with a matching component device<br>incorporated with a compatible connector.<br>All system components when connected, are sealed<br>airtight and leakage-proof during the fluid<br>transfer process. Transfer is performed through<br>the connection of a matching component device<br>incorporated with a compatible connector, for<br>dispensing into the human veins. | Same |
| Characteristic<br>compared | Predicate Device (K241988)<br>ProSeal™ Closed System Bag Access | Subject Device (K243976)<br>ZeroClear™ Bag Access | Comment/<br>Discussion |
| Number<br>of access points | Device has 2 access points:<br>1. Spiking/ administration port, IV spike bag<br>access<br>2. Injection port/administration port, medication<br>access | Device has 2 access points:<br>1. Spiking/ administration port, IV spike bag<br>access<br>2. Injection port/administration port, medication<br>access | Same |
| Composition<br>of fluid path materials | Spike material: Polypropylene (PP)<br>Medication port material: polyisoprene (IR)<br>and polypropylene (PP) | Spike material: Acrylonitrile Butadiene Styrene<br>( (ABS) )<br>Medication port material: acrylonitrile<br>butadiene styrene, polycarbonate, and silicone | Different,<br>See Comment #1 |
| Intended<br>connector type to be<br>used with the bag spike<br>adapter | Its ProSeal™ Injection Site port is intended<br>to be connected to Epic Medical Pte Ltd<br>manufacturer's cleared ProSeal™ Injector<br>or Injector Plus (K240433) male Luer lock<br>tip, connected to an external standard<br>MLL syringe | The needle-free Luer activated valve port is<br>directly connected to a component device<br>incorporated with a standard male Luer<br>connector e.g. syringe without needle that<br>complies with ISO 80389-7:2021 | Different,<br>See Comment #1 |
| Sterile barrier 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 |

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## Discussion of difference in technological characteristics

## Comment #1

Though the Subject device's bag spice and materials differ from the Predicat, the spile is of the same material the same subcomponents of the same materials) as the incorporated LAV in the cleared eZSURE " Empty Fluid Container (K223674). The materials of the spike and the LAV subasemby's subcomponents are with their corresponding cleared devices in formulation, processing, sterlization, and geometry. Pocessing is performed at the same modely processes at our US HDA registered establishment - Epo international (Thailand) Co. Ltd. - and no other chemicals are being additives, cleaning agents, mold release agents,

Functional tests, viz. the microbial ingress test per the ANSI AAM CN27:2021 and the ISO 80369-7:2021 had been conducted on the cleared device (K223674/800); and the leak megnty test per 130 8536-4:2019 had also been performed on the Subject device. Vapor contament test to NOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy and Administration of Hazardous Drugs had also been conducted for the Subject device 's the difference was considered and addressed in the vertication testing of the Subject device over its shelf life, to the aforementioned standards, and found it did not raise any new or different questions, its safety and effectiveness are assured.

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#### VIL. 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 15747: 2018, Plastic containers for intravenous injections ●
- ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
- ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -● Part 7, Connectors for intravascular or hypodermic application
- . NIOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
- . Intravascular-Administration-Sets-Premarket-Notifications-[510(k)]---Guidancefor-Industry-and-FDA-Staff

Bench performance verifications and validations referred-to and performed:

- Airtightness & water leak integrity tests (functional) per ISO 8536-4:2019, paragraph 7.2 and ● Annex 3, performed on Subject device
- Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject device
- . Spike penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject device
- Spike protective cap tests (functional) per ISO 8536-4:2019, Section 7.13, performed on ● Subject device
- Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data . on the Subject device's NFV (LAV) connector
- . Microbial ingress test per FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 (functional) from testing data on device cleared under K223674/S001
- 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 devices cleared under K151650,K223674/S001:

- Cytotoxicity to ISO 10993-5 ●
- Sensitization to ISO 10993-10 ●
- . Intracutaneous Reactivity to ISO 10993-10
- Acute Systemic Toxicity to ISO 10993-11 ●
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 ●
- In-vitro Hemolysis Assessment to ISO 10993-4
- Material Mediated Pyrogenicity to ISO 10993-11
- . Chemical Requirements to ISO 15747, Annex B on device under K223674
- Chemical Characterization and Toxicological Risk Assessment under K151650 .

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# 다. 이 대

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 on 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 - ZeroClear™ Bag Access - is substantially equivalent to the Predicate device, ProSeal™ Closed System Bag Access (K241988) - with respect to its indications for use, principles of operation and technological characteristics.