(150 days)
The Halo system is an airtight and leak proof closed system drug transfer device (CSTD) that mechanically prohibits the transfer of environmental contaminants into the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and spills. The Halo system also prevents microbial ingress for up to 168 hours.
The Halo™ is a Closed System Transfer Device (CSTD) for the handling of hazardous drugs, especially for the compounding and administering of hazardous drugs according to the National Institute for Occupational Safety and Health (NIOSH) definition of an airtight and leak proof closed system transfer device. It is a sterile single-use device. There are four components of the Halo TM system, Closed Vial Adaptor (CVA), Closed Syringe Adaptor (CSA), Closed Bag Adaptor (CBA) and Closed Line Adaptor (CLA). These components integrate with industry standard luer-lock syringes, IV bags, infusion sets, and other patient connections to form a complete closed system. This system prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. In addition, the components are designed to prevent microbial ingress into the system, including maintaining sterility of drugs in the vial for up to 168 hours. The ability to prevent microbial ingress for 168 hours should not be interpreted as modifying, extending, or superseding a drug manufacturers labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations for shelf life and sterilityinformation.
The system uses industry compatible luer locks, bag spikes and spike ports, dual lumen spikes, single lumen needles, and dry to dry compression fit seals when connecting Halo™ components together. A single lumen needle perforates the dry-to-dry compression fit seals for the transfer of drugs between Halo™ components. Upon separation the needle is retracted and the seal membrane prevents transfer of environmental contaminants into the system and/or escape of drug or vapor.
The provided document for the Halo™ Closed System Drug Transfer Device (CSTD) does not contain a study of a device that meets acceptance criteria in the typical sense of an AI/ML medical device submission.
Instead, this is a 510(k) premarket notification for a traditional medical device, primarily demonstrating substantial equivalence to a predicate device (BD PhaSeal CSTD). The "acceptance criteria" here refer to performance tests demonstrating the device's functional and safety characteristics, rather than diagnostic accuracy metrics.
Therefore, many of the requested fields regarding AI/ML device studies, such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance, are not applicable to the information provided in this document.
However, I can extract information related to the performance testing described.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various performance tests conducted on the Halo™ system. It states that the "Results from tests completed on the Halo TM components demonstrates that the system prevents microbial ingress and/or escape of drug or vapor through multiple reconnections of components up to 14 times and are substantially equivalent with respect to operational performance."
| Acceptance Criteria/Test Type | Reported Device Performance |
|---|---|
| Prevent Microbial Ingress | Prevents microbial ingress for up to 168 hours |
| Prevent Escape of Drug or Vapor Concentrations / Airtight & Leak-proof | Prevents escape of drug or vapor concentrations outside the system. |
| Mechanically prohibits transfer of environmental contaminants into the system and escape of drug/vapor. | |
| Durability/Multiple Reconnections | Prevents microbial ingress and/or escape of drug or vapor through multiple reconnections of components up to 14 times. |
| Biocompatibility (ISO 10993-1) | Passed tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, hemocompatibility and pyrogenicity. |
| Operational Performance (Overall) | Substantially equivalent to predicate device (BD PhaSeal CSTD). |
| Pressure Test (System, CLA) | (Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...") |
| Vapor Test | (Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...") |
| Leakage (CBA) | (Passed, implied by "substantially equivalent" and "demonstrates that the system prevents...") |
| Insertion and Retention Force (CVA, CBA, CBA Spike Port) | (Passed, implied by "substantially equivalent") |
| Connection Force (CSA) | (Passed, implied by "substantially equivalent") |
| Residual Volume (CLA, CBA) | (Passed, implied by "substantially equivalent") |
| Human Factors / Comparative Testing | (Passed, confirmed no new questions regarding safety/efficacy) |
| ISO594 Luer Fitting Compliance Test | (Passed, implied by "substantially equivalent") |
| Particulate Contamination | (Passed, implied by "substantially equivalent") |
| Extended Beyond-use-date drug vial sterility testing | (Passed, implied by "substantially equivalent" and microbial ingress claim) |
| Chemical Tests (Extractables/Leachables) | (Passed, implied by "substantially equivalent") |
| Packaging Testing | (Passed, implied by "substantially equivalent") |
2. Sample size used for the test set and the data provenance
- Not Applicable in the AI/ML sense. The document describes performance testing for a physical device. Details on specific sample sizes for tests like fluorescein tests, pressure tests, or microbial ingress tests are not provided in this summary. The data provenance would be laboratory testing of the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not an AI/ML device where expert ground truth is established for diagnostic accuracy. Performance tests typically rely on established protocols, measurement devices, and technical standards.
4. Adjudication method for the test set
- Not Applicable. This is not an AI/ML device with diagnostic outputs requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI/ML device. "Human Factors / Comparative testing" is mentioned, likely comparing user interaction with Halo™ vs. the predicate, but not in the context of an MRMC study with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for this device's performance is based on established engineering principles, physical measurements, chemical analysis, and microbiological testing according to recognized standards (e.g., ISO 10993-1, ISO594). For instance, microbial ingress testing results (sterility) would be confirmed via microbiology assays.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device.
Summary of the Study:
The studies described are a series of laboratory and bench tests designed to demonstrate the functional performance and safety of the Halo™ CSTD. These tests collectively aimed to prove that the device is "as safe, as effective, and performs as well as the predicate devices" (BD PhaSeal CSTD), thereby demonstrating "substantial equivalence." The tests covered aspects such as:
- Containment: Preventing the escape of hazardous drugs/vapors and the entry of environmental contaminants (e.g., Fluorescein Test, System Pressure Test, Vapor Test, Leakage tests).
- Microbial Integrity: Preventing microbial ingress, specifically up to 168 hours for drug vial sterility (Microbial Ingress Testing, Extended Beyond-use-date drug vial sterility testing).
- Mechanical Integrity and Durability: Ensuring components connect securely, withstand forces, and maintain function over multiple reconnections (Insertion and Retention Force, Connection Force, ISO594 Luer Fitting Compliance Test).
- Biocompatibility: Ensuring materials are safe for human contact (ISO 10993-1 tests).
- Residual Volume: Minimizing drug waste.
- Chemical Properties: (Extractables/Leachables Testing).
- User Interface: (Human Factors / Comparative testing)
The document explicitly states that "Comparative testing against the predicate device confirmed there were no new questions raised regarding safety or efficacy of the Halo™device." The results from these tests demonstrated that the device performs as intended and is "substantially equivalent" to already marketed devices.
§ 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.