(472 days)
No
The device description and performance studies focus on mechanical and physical properties, with no mention of AI or ML.
No
The device is a vial adaptor used to prevent exposure to drugs and contaminants, and to facilitate drug transfer, not to treat a disease or medical condition.
No
The device is described as a "ToxiSeal™ Vial Adaptor with External Balloon" used for preventing contamination and exposure to drugs or vapors during the preparation and administration of medication. Its function is mechanical (prohibiting entry/escape, equalizing pressure) and for sterility, not for diagnosing medical conditions.
No
The device description clearly outlines a physical, single-use, sterile, nonpyrogenic CSTD drug vial adaptor with an external balloon/expansion chamber. It is a hardware component designed to be fitted to drug vials.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device for mechanically preventing contamination and exposure to drugs during preparation and administration. It focuses on the physical handling of drugs and maintaining sterility of the drug path. This is not related to testing samples from the human body to diagnose or monitor a condition.
- Device Description: The description details a vial adaptor used for transferring fluids to and from drug vials. It's a component of a Closed System Drug Transfer Device (CSTD) system, designed to protect healthcare workers and the environment from hazardous drugs. This is a drug delivery/handling device, not a diagnostic device.
- Performance Studies: The performance studies focus on functional aspects like leak integrity, pressure equalization, microbial ingress, and biocompatibility. These are relevant to the safe and effective handling of drugs, not to the analytical performance of a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
In summary, the ToxiSeal™ Vial Adaptor with External Balloon is a medical device used in the preparation and administration of drugs, specifically designed to enhance safety and sterility in that process. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
ONB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Functional Performance:
- Conformance with ISO 22413: 2010, ISO 8871-5: 2016, ISO 8536-2:2010, ISO 8536-4: 2019.
- 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.
Biocompatibility:
- Classification: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d) in accordance with ISO 10993-1: 2018.
- Testing done: Cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Subacute/subchronic systemic toxicity, Hemocompatibility study, Chemical characterization, Toxicological risk management.
- Particulate matter testing conducted in accordance with USP Particulate Matter in Injections.
Sterility, Shipping, and Shelf-Life:
- Complies with ISO 11135:2014 for sterilization.
- Package Integrity Test: Seal strength ASTM F88.
- Shelf-life validation: 3 years using ASTM 1980-16.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
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.(b)
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.
0
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"
1
(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
2
OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
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 |
| and Transfer Device | |
| Classification Name | Intravascular administration set |
| Regulation Medical | |
| 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 |
5
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.
6
| Parameter/
characteristic
compared | Predicate Device
BD PhaSeal® Closed System
Drug Transfer Device –
PhaSeal I® Protector
(K123213) | Subject Device
Epic Medical ToxiSeal™
Vial Adaptor with External
Balloon
(K222929) | Discussion |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------|
| System
component | Vial Adaptor
(Vial Access Device) | Vial Adaptor
(Vial Access Device) | Same |
| Closed System
Technology | Physical barrier to prevent
all drug mass
from crossing the system
boundary | Physical barrier to prevent
all drug mass
from crossing the system
boundary | Same |
| Drug vial
air pressure
equalization | Integrated
pressure equalization
chamber | Integrated
pressure equalization
chamber | Same |
| Interface
between system
components | Elastomeric
resealing double-membrane | Elastomeric
resealing double-membrane | Same |
| Membrane
material | Thermoplastic elastomer
(TPE) | Isoprene rubber (IR) | Different
See comment # 1 |
| Vial adaptor spike | Plastic (Model P28, plastic
(polypropylene (PP)) | Plastic (all models,
Copolyester) | Different
See comment #1 |
| Sterilization
method | EO, SAL 10-6 | EO, SAL 10-6 | Same |
| System
components | o PhaSeal® Protector
o PhaSeal® Injector
o PhaSeal® Connector | o ToxiSeal™ Vial Adaptor
with External Balloon
o ProSeal™ Injector
o ProSeal™ Connector | Same |
| Hydrophobic filter
(non-fluid path) | Polytetrafluoroethylene
(PTFE) | Polytetrafluoroethylene
(PTFE) | Same |
| Expansion films | Polypropylene (PP),
Polyamide aka Nylon (PA) | Polyethylene terephthalate -
Polyethylene (PET/PE)
laminate
and Polyethylene (PE) | Different
See comment #2 |
| Filter cover | Polypropylene (PP) | Acrylonitrile
Butadiene Styrene (ABS) | Different
See comment #2 |
| Housing | Polypropylene (PP) | Polycarbonate (PC) and
Copolyester | Different |
| Parameter/
characteristic
compared | Predicate Device
BD PhaSeal® Closed System
Drug Transfer Device –
PhaSeal 1® Protector
(K123213) | Subject Device
Epic Medical ToxiSeal™
Vial Adaptor with External
Balloon
(K222929) | Discussion |
| | | | See comment #2 |
| Protective lid | Polyethylene
aka polythene (PE) | Polyvinylchloride (PVC) | Different
See comment #2 |
| Non-fluid
path materials in
general that are
not listed above | Polypropylene (PP),
Polyamide aka Nylon (PA) | Polypropylene (PP),
Acrylonitrile
Butadiene Styrene (ABS),
Polyvinylchloride (PVC) | Different
See comment #2 |
| Discussion of differences in technological characteristics | | | |
Technological characteristics comparison
7
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).
8
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 Particulate Matter in Injections and found to have met the USP acceptance criteria.
9
-
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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