(246 days)
The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (Iopamidol Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringe-based contrast injection systems included automatic administration on the venous side, of contrast agents for CT procedures. The Transfer Set is to be discarded after the contrast media container has been deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.
The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast delivery systems (injectors). The BINJ Transfer Set is approximately 20 inches long, and its components are made with medical grade materials. The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6, and is individually packaged. At the time of this submission, accelerated aging tests confirm a one (1) year shelf life. The BINJ Transfer Set is disposable, and is to be discarded after the contrast media container has been depleted, or 10 hours has elapsed since the container was spiked.
This document is a 510(k) Summary for the Bracco Injeneering Transfer Set, indicating substantial equivalence to a predicate device. It primarily details the device's intended use, technological characteristics, and performance testing related to safety and manufacturing standards, rather than providing a study comparing device performance against specific clinical acceptance criteria in terms of diagnostic accuracy or reader improvement.
Based on the provided text, here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily related to safety, sterility, shelf-life, and material compatibility, demonstrating that the device meets established medical device standards. No specific performance metrics like sensitivity, specificity, or accuracy (as one might find for an AI diagnostic device) are provided, as this is a medical device for fluid transfer, not a diagnostic tool.
| Acceptance Criteria Category | Specific Standard/Test | Reported Device Performance |
|---|---|---|
| Sterilization | ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Validation for a Sterility Assurance Level (SAL) of 10-6. | Verification results indicate that the BINJ Transfer Set complies with the standard and was validated to a SAL of 10-6. |
| Shelf-Life & Packaging | ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems. | |
| ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Accelerated aging tests confirm a one (1) year shelf life. | Verification results indicate that the BINJ Transfer Set complies with the standards. Accelerated aging tests confirmed a one-year shelf life. | |
| Biocompatibility | ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. | Verification results indicated that the materials comply with the standard. |
| Performance (Bench Testing) | - IEC 62366: 2007, Medical devices Application of usability engineering to medical devices |
- ISO 594-2: 1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings
- ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
- Microbial ingress testing
- Chemical compatibility, leachable compounds, and particulates testing. | Test and verification results indicate that the BINJ Transfer Set complies with its predetermined specifications and the standards. |
| Substantial Equivalence (Overall) | Demonstrated equivalence to predicate device (E-Z-EM, Inc. Empower Transfer Set, K041178) in intended use, indications for use, and technological characteristics. | The BINJ Transfer Set is considered substantially equivalent to the predicate device, being safe and effective when used in accordance with its intended use and labeling. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of diagnostic accuracy, as this is a device for fluid transfer. The testing described (sterilization, shelf-life, biocompatibility, and bench performance) involves specific samples of the device and its components, but the sample sizes for these engineering tests are not explicitly stated. The data provenance is internal testing conducted by Bracco Injeneering S.A.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a transfer set, and the "ground truth" for its performance is assessed through compliance with engineering and safety standards, not through expert consensus on diagnostic interpretations.
4. Adjudication method for the test set
This information is not applicable for the reasons stated above.
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
No such study was conducted or is relevant for this type of medical device (a fluid transfer set). This is not an AI diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical component, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is adherence to established international and national standards for medical devices, including:
- Sterility: Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1.
- Packet integrity and Shelf-life: Compliance with ISO 11607-1 and ISO 11607-2, and confirmed 1-year shelf life via accelerated aging.
- Biocompatibility: Compliance with ISO 10993-1.
- Functional Performance: Compliance with IEC 62366, ISO 594-2, ISO 8536-4, and specific testing for microbial ingress, chemical compatibility, leachable compounds, and particulates.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of device development for a fluid transfer set.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above.
§ 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.