(371 days)
The ProSeal™ Closed System drug Transfer Device (CSTD) 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 ProSeal system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
The ProSeal™ CSTD is a sterile, single-use, closed system drug transfer device for preparation, reconstitution, compounding and administration of antineoplastic and hazardous drugs intended for use in clinical settings by trained healthcare providers and/or pharmacists. The ProSeal™ CSTD consists of three system components and one accessory: ProSeal Vial Adaptor, ProSeal Injector, ProSeal Connector, and ProSeal Assembly Fixture. The closed transfer of liquid takes place through a double membrane septum utilizing self-sealing elastomeric membranes and a cannula.
This document is a 510(k) Pre-Market Notification from the FDA for the ProSeal™ Closed System Drug Transfer Device (CSTD). However, it does not contain a detailed study report with specific acceptance criteria and reported device performance values in a table or the breakdown of sample sizes, ground truth establishment, or expert involvement as requested.
The document primarily focuses on establishing substantial equivalence to a predicate device (BD PhaSeal® CSTD, K123213) by comparing technological characteristics and listing the types of performance tests conducted.
Here is a breakdown of the information that can be extracted or inferred from the provided text, and what is missing:
Information Provided/Inferred:
- Device Name: ProSeal™ Closed System drug Transfer Device (CSTD)
- Predicate Device: BD PhaSeal® Closed System Drug Transfer Device (K123213)
- Indications for Use: The ProSeal™ CSTD 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. It also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
- Types of Performance Tests Conducted (listed without specific results or acceptance criteria):
- Biocompatibility studies (Cytotoxicity, Sensitization, Intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Material mediated pyrogenicity, Chemical characterization/Toxicological Risk Assessment)
- Sterilization validation (ISO 11137-1:2006, ISO 11137-2:2013, ISO 11135:2014, AAMI TIR28:2016)
- Bacterial Endotoxin test (USP )
- Accelerated aging (ASTM F1980-16)
- Infusion equipment closures (ISO 8536-2:2010)
- Sterile hypodermic needles requirements (ISO 7864:2016)
- Particulate Matter in Injections (USP )
- Sharps injury protection (ISO 23908:2011)
- Small-bore connectors (ISO 80369-7:2016)
- Internal specifications testing: volume of pressure equalization, leak integrity, vapor containment testing with titanium tetrachloride (visual indicator), Fluorescein testing - dry connections, microbial ingress testing, Assembly fixture validation.
- Ground Truth for performance tests (Inferred): For many of these tests (e.g., sterilization, bacterial endotoxin, particulate matter), the "ground truth" is defined by compliance with the specified ISO, ASTM, or USP standards and their pass/fail criteria. For internal tests like "microbial ingress testing" and "vapor containment testing," the ground truth would be the absence of microbial contamination or vapor escape, respectively.
- Sample Size for Training Set: Not applicable as this is a physical medical device, not an AI/ML algorithm.
- How Ground Truth for Training Set was Established: Not applicable.
Information NOT Provided (Required by the prompt):
- A table of acceptance criteria and the reported device performance: The document lists the types of tests, but does not provide the specific acceptance criteria for each test or the quantitative or qualitative results that demonstrate the device met those criteria. For example, it mentions "microbial ingress testing" but doesn't state the acceptance criterion (e.g., "no microbial growth after X days") or the result (e.g., "no microbial growth observed").
- Sample sizes used for the test set and the data provenance: No sample sizes are provided for any of the performance tests. Data provenance (country of origin, retrospective/prospective) is not mentioned.
- Number of experts used to establish the ground truth for the test set and their qualifications: No information about expert involvement in establishing ground truth for the performance tests is provided. For tests based on international standards, the "ground truth" is typically defined by the standard itself rather than expert consensus on individual test results.
- Adjudication method for the test set: Not applicable, as detailed test results and any need for adjudication are not described.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable, as this is a physical medical device, not an AI system being evaluated with human readers.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion based on the provided text:
The document describes the regulatory submission for a physical medical device (ProSeal™ CSTD) and lists various non-clinical performance tests conducted to support its substantial equivalence to a predicate device. While it indicates that performance testing was done to address technological differences and support safety and effectiveness, it does not provide the level of detail requested regarding specific acceptance criteria, reported performance values, sample sizes, or the methodology of establishing ground truth for individual test results within the context of a study report. The information provided is typical for a 510(k) summary, which generally summarizes the types of testing rather than presenting full study reports.
§ 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.