ToxiSeal™ Vial Adaptor with External Flip Balloon

K241476 · Epic Medical Pte. , Ltd. · ONB · Jun 21, 2024 · General Hospital

Device Facts

• Record ID: K241476
• Device Name: ToxiSeal™ Vial Adaptor with External Flip Balloon
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Jun 21, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ToxiSeal™ Vial Adaptor with External Flip Balloon 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

Device Story

Single-use, sterile, non-pyrogenic CSTD vial adaptor; interfaces between drug vials and ProSeal™ Injector/Injector Plus. Functions as closed system to prevent drug/vapor escape and microbial ingress. Features integrated pressure equalization chamber with external flip balloon to manage pressure differentials during fluid/air transfer. Used by healthcare professionals/pharmacists in clinical settings. Device mechanically prohibits environmental contaminants; maintains neutral pressure via expansion film. Enhances ProSeal™ CSTD portfolio. Benefits include reduced occupational exposure to hazardous drugs and maintained sterility of drug path for up to 7 days.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via fragmentation study (ISO 22413/8871-5), vial adaptor penetration force (ISO 22413), leakage testing (ISO 8536-4), and particulate matter testing (USP <788>). Biocompatibility established via reference to predicate testing (ISO 10993 series). Sterility and shelf-life validated per ISO 11135 and ASTM F1980.

Technological Characteristics

Materials: Polypropylene (spike), Isoprene rubber (membrane), PTFE (filter), PET/PE laminate/PE (expansion film). Principle: Closed system pressure equalization via external balloon. Connectivity: Standalone component of ProSeal™ CSTD. Sterilization: Ethylene Oxide (SAL 10^-6). Shelf-life: 3 years.

Indications for Use

Indicated for use by adequately trained healthcare professionals or pharmacists in clinical settings for the reconstitution and transfer of parenteral drugs. Used as a closed system transfer device (CSTD) component to maintain a sterile fluid path and prevent drug/vapor exposure.

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

• ToxiSeal™ Vial Adaptor with External Balloon (K222929)

Reference Devices

• ProSeal™ CSTD system (K240433)
• ProSeal™ Injector (K192075)
• ProSeal™ Connector (K192075)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

June 21, 2024

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

Re: K241476

Trade/Device Name: ToxiSeal™ Vial Adaptor with External Flip Balloon Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: May 24, 2024 Received: May 24, 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 QS 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.

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).

Sincerely,

Persache 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

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### Indications for Use

510(k) Number (if known) K241476

#### Device Name

ToxiSeal™ Vial Adaptor with External Flip Balloon

#### Indications for Use (Describe)

The ToxiSeal™ Vial Adaptor with External Flip Balloon 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

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

| <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# o il

#### K241476 – 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: June 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special

#### II. Subject Device

| 510(k) Number: | K241476 |
|------------------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ToxiSeal™ Vial Adaptor with External Flip Balloon |
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>Transfer Device |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Classification Product Code: | ONB |

#### III. Predicate

| 510(k) Number: | K222929 |
|------------------------------|--------------------------------------------------------------------------------|
| Trade/ Device Name: | ToxiSeal™ Vial Adaptor with External Balloon |
| Common/Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and<br>Transfer Device |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Classification Product Code: | ONB |

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### IV. Device Description

The purpose of this Special 510(k) Submission is to seek FDA clearance prior to the introduction in the US, of a modified design of a ToxiSeal™ Vial Adaptor - the Subject ToxiSeal™ Vial Adaptor with External Flip Balloon. This device is an addition to the ProSeal™ CSTD system of devices (cleared K240433). The nominated Predicate device is the existing ToxiSeal™ Vial Adaptor with External Balloon (cleared K222929).

The ToxiSeal™ Vial Adaptor with External Flip Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and are sealed against the closures of the vials. They are used as sterile interfaces between the drug vials and the ProSeal™ Injector or the ProSeal™ Injector Plus (both are syringe adaptors) for the injection of diluents into the drug vials and/or withdrawal of liquids from the vials.

In addition, the ToxiSeal™ Vial Adaptor with External Flip Balloon devices equalize the pressure difference which occurs when fluid or air is added to or removed from the drug vial. This neutral pressure is maintained utilizing an external balloon/ expansion chamber.

The ToxiSeal™ Vial Adaptor with External Flip Balloon devices, designed to be used with the cleared ProSeal™ Injector or Injector Plus within the ProSeal™ CSTD system (K240433), are variants of CSTD vial adaptor component device offerings to the ProSeal™ CSTD system. The additions enhance the completeness of the portfolio of ProSeal™ CSTD devices system.

Changes proposed in this Special 510(k) Submission are as follow:

- · Change of material of vial spike to polypropylene from Tritan copolyester
- · Non-fluid path changes in retention method to external flip balloon, removal of carbon filter and the positioning of its one-way valve

### V. Indications for Use Statement (unchanged)

The ToxiSeal™ Vial Adaptor with External Flip Balloon 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 device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.

### VI. Comparison of Technological Characteristics

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

- . Principles of operation
- Expansion film of External Balloon .
- Sterile barrier packaging .
- . Sterilization process
- Shelf-life

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

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| Characteristic<br>compared | Predicate Device<br>ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929) | Subject Device<br>ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) | Comment/<br>Discussion |
|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use<br>statement | "The ToxiSeal™ Vial Adaptor with External<br>Balloon mechanically prohibits environmental<br>contaminants from entering the system and the<br>escape of drug or vapor concentrations from<br>the system, thereby minimizing individual and<br>environmental exposure to drug vapor,<br>aerosols, and spills. The device also prevents<br>the introduction of microbial contaminations<br>into the drug or fluid path for up to 168 hours<br>(or 7 days) when used as intended." | "The ToxiSeal™ Vial Adaptor with External<br>Flip Balloon 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 device also prevents the introduction of<br>microbial contaminations into the drug or fluid<br>path for up to 168 hours (or 7 days) when used<br>as intended." | Same |
| Primary product code<br>and regulation<br>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<br>or pharmacists/ clinical setting | Adequately trained<br>health care professionals<br>or pharmacists/ clinical setting | Same |
| Intended<br>drug type | Parenteral drugs | Parenteral drugs | Same |
| R/<br>Prescription use | R only | R only | Same |
| Characteristic<br>compared | Predicate Device<br>ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929) | Subject Device<br>ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) | Comment/<br>Discussion |
| System component<br>devices | 1. ProSeal™ Injector (model 421010)<br>(K240433)<br>2. ProSeal™ Injector Plus (model 421050)<br>(K240433)<br>3. ProSeal™ Connector (model 422010)<br>(K240433)<br>4. ProSeal™ Injection Site Extended Male Luer<br>Lock (K240433)<br>5. ProSeal™ Vial Adaptor (3 models 4200X0,<br>for options of vial neck sizes and pressure<br>equalizations) (K240433)<br>6. ToxiSeal™ Vial Adaptor with External<br>Balloon (K222929)<br>7. ProSeal™ Assembly Fixture (Fixture for<br>ProSeal™ Vial Adaptor assembly, model<br>424010) (K240433) | 1. ProSeal™ Injector (model 421010) (K240433)<br>2. ProSeal™ Injector Plus (model 421050)<br>(K240433)<br>3. ProSeal™ Connector (422010) (K240433)<br>4. ProSeal™ Injection Site Extended Male Luer<br>Lock (K240433)<br>5. ProSeal™ Vial Adaptor (3 models 4200X0, for<br>options of vial neck sizes and pressure<br>equalizations) (K240433)<br>6. ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929)<br>7. ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) <b>the Subject device</b> )<br>8. ProSeal™ Assembly Fixture (Fixture for<br>ProSeal™ Vial Adaptor assembly, model<br>424010) (K240433) | Different,<br>the Subject system<br>component device<br>(#7 in the column<br> |
| Closed System<br>Technology | Physical barrier to prevent<br>all drug masses<br>from crossing the system boundary | Physical barrier to prevent<br>all drug masses<br>from crossing the system boundary | Same |
| Drug vial<br>air pressure<br>equalization | Integrated<br>pressure equalization chamber | Integrated<br>pressure equalization chamber | Same |
| Characteristic<br>compared | Predicate Device<br>ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929) | Subject Device<br>ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) | Comment/<br>Discussion |
| Interface<br>between system<br>components | Elastomeric<br>resealing double-membrane | Elastomeric<br>resealing double-membrane | Same |
| Membrane material | Isoprene rubber (IR) | Isoprene rubber (IR) | Same |
| Intended Injector for<br>use with the Subject<br>device | ProSeal™ Injector (model 421010)<br>(cleared K192075, K222929, K240171)<br>Male Luer Lock tip | ProSeal™ Injector (model 421010) or<br>ProSeal™ Injector Plus (model 421050)<br>(cleared K241071 & K240433)<br>both Male Luer Lock tip | Same<br>both the ProSeal™<br>Injector Plus and<br>ProSeal™ Injector are<br>cleared devices that<br>may be used with the<br>Subject device |
| Vial adaptor spike | Plastic (all 12 models, copolyester) | Plastic (all 6 models, polypropylene) | Different<br>See Comment #1 |
| Characteristic<br>compared | Predicate Device<br>ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929) | Subject Device<br>ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) | Comment/<br>Discussion |
| Design configuration<br>of External Balloon<br>(non-fluid path) | Retention method of external balloon with 2<br>options of clip-on or sticker features<br>(resulting in 12 REFs/ models) | Non-fluid path changes: retention method to<br>external flip balloon, removal of carbon filter and<br>the positioning of its one-way valve (resulting in<br>6 REFs/ models) | Different<br>See Comment #2 |
| | Image: clip-on balloon retainer and sticker on balloon retainer | Image: external flip balloon retainer | |
| | 12 models:<br>clip-on balloon retainer (left picture)<br>and sticker on balloon retainer (right picture) | 6 models:<br>external flip balloon retainer | |
| Hydrophobic filter<br>(non-fluid path) | Polytetrafluoroethylene (PTFE) | Polytetrafluoroethylene (PTFE) | Same |
| Expansion films<br>(non-fluid path) | Polyethylene terephthalate - Polyethylene<br>(PET/PE) laminate<br>and Polyethylene (PE) | Polyethylene terephthalate - Polyethylene<br>(PET/PE) laminate<br>and Polyethylene (PE) | Same |
| Primary<br>package top web | Medical grade paper and<br>medical plastic film, heat sealed | Medical grade paper and<br>medical plastic film, heat sealed | Same |
| Sterilization method | Ethylene Oxide, EO, SAL 10-6 | Ethylene Oxide, EO, SAL 10-6 | Same |
| Characteristic<br>compared | Predicate Device<br>ToxiSeal™ Vial Adaptor with External Balloon<br>(K222929) | Subject Device<br>ToxiSeal™ Vial Adaptor with External Flip<br>Balloon (K241476) | Comment/<br>Discussion |
| Validated<br>Shelf life | 3 years (36 months) | 3 years (36 months) | Same |
| Reuse<br>or single-use | Single-use only | Single-use only | Same |
| Labeling<br>specifications | Meets the requirements<br>specified in 21 CFR 801 | Meets the requirements<br>specified in 21 CFR 801 | Same |

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### Discussion of differences in technological characteristics

### Comment #1

The formulation (type, make, grade) manufacturer source of polypropylene, manufacturing, processing, sterilization, and addivives are the same as the polypropylene material included in the cleared ProSeal™ Injection Site (K240433) and the cleared ProSeal"" Comector (K192075). Therefore, biocompatibility was leveraged from K240433 and K192075. In additional bench top performance vertification testing over the shelf life was conducted to ISO 8536-4:2019, ISO 22413:2021, and ISO 8871-5:2016 to demonstrate that the difference in technological characteristic (i.e., material) does not raise different questions of safety and effectiveness.

## Comment #2

The differences arising out of the proposed chave been functionally verified to the standards listed in Comment #1, and to the standards listed in section VII.B hereunder, on test samples in their finished form aged to the intention i the Subject device validation lots and these differences were found not to raise any new or safety or effectiveness. Further details are provided in sections VII.A and VII.B hereunder.

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#### Performance Data Supporting Substantial Equivalence VII.

#### A. Functional Performance

The sterile, single-use, non-pyrogenic flexible IV container devices/ bags described in this Summary were evaluated to be in conformance with the following ISO and FDA recognized standards:

- ISO 8536-2:2010. Infusion equipment for medical use Part 2: Closures for infusion bottles .
- ISO 8536-4:2019, Infusion equipment for medical use Part 4: Infusion sets for single use, ● gravitv feed
- ISO 8871-5:2016, Elastomeric parts for parenterals and for devices for pharmaceutical use ● Part 5: Functional requirements and testing
- . ISO 22413:2021, Transfer sets for pharmaceutical preparations – Requirements and test methods

Bench performance verifications and validations are referred to or were performed on the Subject device as detailed hereunder:

- Fragmentation study to ISO 22413 & ISO 8871-5, performed on the Subject device ●
- Vial Adaptor penetration force testing to ISO 22413, performed on the Subject device
- Tests for leakages to ISO 8536-4:2019, Annex A.3, performed on the Subject device ●
- Volume of pressure equalization study under K222929
- Testing to (draft) NIOSH CSTD Test Protocol on existing devices under K222929 ●
- . Microbial ingress/ microbiological integrity testing on existing devices under K222929

#### B. Biocompatibility

In accordance with ISO 10993-1: 2018, the Subject device, just like the existing device, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to, from testing on the existing devices cleared as listed hereunder:

- Cytotoxicity to ISO 10993-5 under K192075 ●
- Sensitization to ISO 10993-10 under K192075 .
- Intracutaneous Reactivity to ISO 10993-10 under K192075 .
- Acute Systemic Toxicity to ISO 10993-11 under K192075
- . 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K192075
- . In-vitro Hemolysis Assessment to ISO 10993-4 under K192075 and K192075/S001
- Material Mediated Pyrogenicity to ISO 10993-11 under K192075 .
- . Chemical Characterization and Toxicological Risk Management to ISO 10993-18 and ISO 10993-17 under K192075/S001

Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections, and found to have met the acceptance criteria therein.

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## ani t

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

The Subject device, like the existing device cleared under K222929, 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:

- Package Integrity Tests per ASTM F1980-16, 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, ASTM F1929-15, 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
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-16, ● Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

#### VIII. Clinical Tests

Not applicable.

#### IX. Conclusion

The differences between the Predicate and the Subject device do not raise any new or different questions of safety or effectiveness. The Subject ToxiSeal™ Vial Adaptor with External Flip Balloon is substantially equivalent to the Predicate, the ToxiSeal™ Vial Adaptor with External Balloon, with respect to the indications for use, principles of operation and technological characteristics.