ToxiSeal Vial Adapter with External Balloon
Device Facts
| Record ID | K222929 |
|---|---|
| Device Name | ToxiSeal Vial Adapter with External Balloon |
| Applicant | Epic Medical Pte. , Ltd. |
| Product Code | ONB · General Hospital |
| Decision Date | Jan 11, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
The ToxiSeal™ Vial Adaptor with External 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
ToxiSeal™ Vial Adaptor with External Balloon is a single-use, sterile CSTD component. It attaches to drug vials to provide a closed docking interface for ProSeal™ Injectors. Input: drug vials and diluents. Operation: utilizes an integrated external balloon/expansion chamber to equalize pressure during fluid/air transfer, preventing drug/vapor escape and environmental contamination. Output: closed fluid path for drug reconstitution and aspiration. Used in clinical settings by healthcare professionals. Benefits: minimizes clinician/environmental exposure to hazardous drugs and maintains drug sterility for up to 168 hours.
Clinical Evidence
Bench testing only. No clinical data. Performance validated against ISO 22413, ISO 8871-5, ISO 8536-2, and ISO 8536-4. Testing included fragmentation, penetration force, leak integrity, pressure equalization volume, NIOSH CSTD protocol, and microbial ingress. Biocompatibility testing per ISO 10993-1 (cytotoxicity, sensitization, reactivity, systemic toxicity, pyrogenicity, hemocompatibility). Particulate matter testing per USP <788>. Sterility validated per ISO 11135; shelf-life validated per ASTM 1980-16.
Technological Characteristics
Single-use, sterile, nonpyrogenic vial adaptor. Materials: Isoprene rubber membrane, Copolyester spike, PC/Copolyester housing, PET/PE laminate expansion film, ABS filter cover, PVC lid. Sensing/Actuation: Integrated pressure equalization chamber (balloon). Connectivity: None. Sterilization: Ethylene Oxide (SAL 10^-6). Standards: ISO 22413, ISO 8871-5, ISO 8536-2/4, ISO 10993-1, USP <788>, ISO 11135, ASTM F88, ASTM 1980-16.
Indications for Use
Indicated for use as a closed system drug transfer device (CSTD) to minimize exposure to hazardous drugs, vapors, and aerosols during reconstitution and transfer, and to maintain sterility of the drug/fluid path for up to 7 days.
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)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 11, 2024
Epic Medical Pte Ltd Freddie Lee CEO, MD 105 Cecil, 20-01 The Octagon Singapore, Singapore 069534 Singapore
Re: K222929
Trade/Device Name: ToxiSeal™ Vial Adapter with External Balloon Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: ONB Dated: January 8, 2024 Received: January 8, 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.
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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
David Walloschek
David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors
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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) K222929
### Device Name
ToxiSeal™ Vial Adaptor with External Balloon
### Indications for Use (Describe)
The ToxiSeal™ Vial Adaptor with External 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.
| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="font-family: Arial, sans-serif;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
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# K222929 - 510(K) Summary
# Date Prepared: January 11, 2023
#### Submitter I.
Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie LEE, CEO/MD E-mail: freddie.lee@epic-med.com
#### II. Subject Devices
| Trade /Device Name | ToxiSeal™ Vial Adaptor with External Balloon |
|---------------------------------------------------|--------------------------------------------------------------------------------|
| Common /Usual Name | Closed Antineoplastic and Hazardous Drug Reconstitution<br>and Transfer Device |
| Classification Name | Intravascular administration set |
| Regulation Medical<br>Specialty, and Review Panel | General Hospital |
| Regulation Number | 21 CFR 880.5440 |
| Regulatory Classification | Class II |
| Product Code | ONB |
#### III. Predicate
| 510(K) Number | K123213 |
|---------------------------|------------------------------------------------|
| Trade /Device Name | BD PhaSeal® Closed System Drug Transfer Device |
| Regulation Number | 21 CFR 880.5440 |
| Regulatory Classification | Class II |
| Product Code | ONB |
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#### IV. Indications for Use Statement
The ToxiSeal™ Vial Adaptor with External 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.
#### V. Device Description
The ToxiSeal™ Vial Adaptor with External Balloon devices are single-use, sterile, nonpyrogenic CSTD drug vial adaptors that are fitted to the drug vials and seal against the closures of the vials. They are used as sterile docking interfaces between the drug vials and the ProSeal™ Injectors for injection of diluents into the drug vials and/or aspiration of liquid drug from the vials.
In addition, the ToxiSeal™ Vial Adaptor with External 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 Balloon devices, designed to be used with the cleared ProSeal™ Injector within the ProSeal™ CSTD system (K192075), are additions 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.
#### VI. Comparison of Technological Characteristics
The ToxiSeal™ Vial Adaptor with External Balloon devices and the Predicate devices share the following characteristics:
- use of CSTD vial adaptor barrier technology .
- use of an integrated pressure equalization chamber .
- same interfaces between system components ●
- same materials of construction for vial adaptor spike
The ToxiSeal™ Vial Adaptor with External Balloon devices and the Predicate devices PhaSeal® Protector vial adaptor devices are different with respect to the membrane material and the spike material.
The table that follows compares key technological features between the Subject and Predicate devices.
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| Parameter/<br>characteristic<br>compared | Predicate Device<br>BD PhaSeal® Closed System<br>Drug Transfer Device –<br>PhaSeal I® Protector<br>(K123213) | Subject Device<br>Epic Medical ToxiSeal™<br>Vial Adaptor with External<br>Balloon<br>(K222929) | Discussion |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------|
| System<br>component | Vial Adaptor<br>(Vial Access Device) | Vial Adaptor<br>(Vial Access Device) | Same |
| Closed System<br>Technology | Physical barrier to prevent<br>all drug mass<br>from crossing the system<br>boundary | Physical barrier to prevent<br>all drug mass<br>from crossing the system<br>boundary | Same |
| Drug vial<br>air pressure<br>equalization | Integrated<br>pressure equalization<br>chamber | Integrated<br>pressure equalization<br>chamber | Same |
| Interface<br>between system<br>components | Elastomeric<br>resealing double-membrane | Elastomeric<br>resealing double-membrane | Same |
| Membrane<br>material | Thermoplastic elastomer<br>(TPE) | Isoprene rubber (IR) | Different<br>See comment # 1 |
| Vial adaptor spike | Plastic (Model P28, plastic<br>(polypropylene (PP)) | Plastic (all models,<br>Copolyester) | Different<br>See comment #1 |
| Sterilization<br>method | EO, SAL 10-6 | EO, SAL 10-6 | Same |
| System<br>components | o PhaSeal® Protector<br>o PhaSeal® Injector<br>o PhaSeal® Connector | o ToxiSeal™ Vial Adaptor<br>with External Balloon<br>o ProSeal™ Injector<br>o ProSeal™ Connector | Same |
| Hydrophobic filter<br>(non-fluid path) | Polytetrafluoroethylene<br>(PTFE) | Polytetrafluoroethylene<br>(PTFE) | Same |
| Expansion films | Polypropylene (PP),<br>Polyamide aka Nylon (PA) | Polyethylene terephthalate -<br>Polyethylene (PET/PE)<br>laminate<br>and Polyethylene (PE) | Different<br>See comment #2 |
| Filter cover | Polypropylene (PP) | Acrylonitrile<br>Butadiene Styrene (ABS) | Different<br>See comment #2 |
| Housing | Polypropylene (PP) | Polycarbonate (PC) and<br>Copolyester | Different |
| Parameter/<br>characteristic<br>compared | Predicate Device<br>BD PhaSeal® Closed System<br>Drug Transfer Device –<br>PhaSeal 1® Protector<br>(K123213) | Subject Device<br>Epic Medical ToxiSeal™<br>Vial Adaptor with External<br>Balloon<br>(K222929) | Discussion |
| | | | See comment #2 |
| Protective lid | Polyethylene<br>aka polythene (PE) | Polyvinylchloride (PVC) | Different<br>See comment #2 |
| Non-fluid<br>path materials in<br>general that are<br>not listed above | Polypropylene (PP),<br>Polyamide aka Nylon (PA) | Polypropylene (PP),<br>Acrylonitrile<br>Butadiene Styrene (ABS),<br>Polyvinylchloride (PVC) | Different<br>See comment #2 |
| Discussion of differences in technological characteristics | | | |
# Technological characteristics comparison
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### Technological characteristics comparison
### Comment #1
Isoprene Rubber (IR) and Copolyester of medical grade/ formulated for medical devices are widely used in medical devices as fluid path materials. IR is used in the Subject device in place of thermoplastic elastomer (TPE) in the Predicate. Both TPE and IR are nonallergenic, unlike natural rubber latex; and both TPE and IR offer easy sterilization and have great abrasion resistance, flexibility, and stability. Both Copolyester (Subject device) and polypropylene (Predicate device) are chemically resistant and are materials of choice in devices that contact drugs containing chemical solvents, surfactants, and/or fat emulsions.
In addition, biocompatibility studies and chemical analyses for added safety assurance are conducted for the materials and validated to be safe for the intended use (see section VII-B).
The Subject device underwent analytical and functional performance tests to assure safety and performance standards are met. The evaluations of the membrane and spike material differences confirmed these do not raise any new or different safety or performance effectiveness issues/ concerns (see section VII-A and VII-C).
### Comment #2
These specific material differences do not raise any new or different safety or performance issues/ concerns as they are not within the fluid-path. Moreover, their functional performances are tested and found to have met their respective safety and effectiveness acceptance criteria (see section VII-A and VII-C).
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### Performance Data Supporting Substantial Equivalence VII.
- A. Functional Performance
The sterile, single-use, vial adaptor with external balloon described in this Summary were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards:
- ISO 22413: 2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
- ISO 8871-5: 2016, Elastomeric parts for parenterals and for devices for pharmaceutical . use Part 5: Functional requirements and testing
- 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, gravity feed
Testing done:
- . Fragmentation study
- . Vial Adaptor penetration force testing
- Device leak integrity testing .
- Volume of pressure equalization study
- Testing to (draft) NIOSH CSTD Test Protocol
- Microbial ingress/ microbiological integrity testing
- B. Biocompatibility
In accordance with ISO 10993-1: 2018, the Vial Adaptor with External Balloon is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were conducted, and found to have met their respective acceptance criteria:
- Cytotoxicity ●
- Skin sensitization ●
- Intracutaneous reactivity ●
- Acute systemic toxicity ●
- Pyrogenicity ●
- Subacute/subchronic systemic toxicity
- Hemocompatibility study
- Chemical characterization
- Toxicological risk management ●
Particulate matter testing was conducted in accordance with USP <788> Particulate Matter in Injections and found to have met the USP acceptance criteria.
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- 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.
- . Package Integrity Test
- Sterile Barrier Packaging Testing performed on the proposed device: .
- Seal strength ASTM F88 -
- Shelf-life of 3 years is validated using the FDA recognized standard, ASTM 1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
# VIII. Conclusions
The differences between the Predicate and the Subject device do not raise any new or different questions of safety or effectiveness. The ToxiSeal™ Vial Adaptor with External Balloon is substantially equivalent to the BD PhaSeal® Closed System Drug Transfer Device with respect to the indications for use, target populations, treatment method, and technological characteristics.
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