(28 days)
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.
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.
This is a 510(k) summary for a medical device called "ToxiSeal™ Vial Adaptor with External Flip Balloon". This submission seeks to demonstrate that the new device, which has some material and design changes compared to a previously cleared predicate device, is substantially equivalent and does not require a new premarket approval application.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a comparative format for each specific criterion. Instead, it lists the standards and types of tests performed, implying that the device met the requirements of these standards. The "Reported Device Performance" in this context refers to the affirmation that testing was conducted and demonstrated conformance with the cited standards and previously cleared devices' performance.
| Acceptance Criterion (Standard or Test Type) | Reported Device Performance |
|---|---|
| Fragmentation study to ISO 22413 & ISO 8871-5 | Performed on the Subject device; met criteria (implied) |
| Vial Adaptor penetration force testing to ISO 22413 | Performed on the Subject device; met criteria (implied) |
| Tests for leakages to ISO 8536-4:2019, Annex A.3 | Performed on the Subject device; met criteria (implied) |
| Volume of pressure equalization study | Leveraged from K222929; met criteria (implied) |
| Testing to (draft) NIOSH CSTD Test Protocol | Leveraged from K222929; met criteria (implied) |
| Microbial ingress/ microbiological integrity testing | Leveraged from K222929; met criteria (implied) |
| Biocompatibility (Cytotoxicity to ISO 10993-5) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (Sensitization to ISO 10993-10) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (Intracutaneous Reactivity to ISO 10993-10) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (Acute Systemic Toxicity to ISO 10993-11) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (In-vitro Hemolysis Assessment to ISO 10993-4) | Leveraged from K192075 and K192075/S001; met criteria (implied) |
| Biocompatibility (Material Mediated Pyrogenicity to ISO 10993-11) | Leveraged from K192075; met criteria (implied) |
| Biocompatibility (Chemical Characterization and Toxicological Risk Management to ISO 10993-18 and ISO 10993-17) | Leveraged from K192075/S001; met criteria (implied) |
| Particulate matter testing (USP ) | Met the acceptance criteria therein |
| Sterilization (ISO 11135: 2014) | Complies with requirements (implied) |
| Package Integrity Tests (ASTM F1980-16, ASTM F88/F88M-21, ASTM F1929-15, EN 868-5: 2009) | Performed on the proposed device; met criteria (implied) |
| Pyrogen Tests (ANSI/AAMI ST72/ 2019, USP 40 , USP-NF , USP-NF ) | Performed; met criteria (implied) |
| Shelf-life validation (ASTM 1980-16) | 3 years (36 months) validated |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes: The document does not explicitly state the specific number of units or samples used for each individual test. It mentions that testing was performed "on the Subject device" or "on test samples in their finished form aged to the intention i the Subject device validation lots."
- Data Provenance: The document does not specify the country of origin of the data. The studies are described as "bench performance verifications and validations" and refer to past clearances (K222929, K240433, K192075) for much of the leveraged data, implying these were laboratory-based tests. The submission originates from Singapore.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to this type of device submission. The device is a physical medical device (vial adaptor), not an AI/ML-based diagnostic or prognostic tool that would require expert-established ground truth for a test set. The validation relies on technical performance standards and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable. This is not an AI/ML-based diagnostic device where reader studies would be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by conformance to recognized industry standards (ISO, ASTM, USP, ANSI/AAMI) for mechanical, chemical, biological, and sterility properties. For example:
- Mechanical Integrity: Conformance to ISO 22413, ISO 8536-4.
- Biocompatibility: Conformance to ISO 10993 series.
- Sterility: Conformance to ISO 11135.
- Particulate Matter: Conformance to USP .
- Shelf-life: Conformance to ASTM 1980-16.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML system that utilizes a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
§ 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.