(386 days)
The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container has been penetrated, whichever occurs first.
Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.
The Liebel-Flarsheim™ IBP Transfer Set is a sterile tubing set connection between Optiray® (Ioversol) contrast media imaging bulk packages (hereinafter Optiray IBPs) and empty sterile singleuse syringes on syringe-based automatic contrast injection systems. The Liebel- Flarsheim™ IBP Transfer Set consists of a small bore (1/8" ID) clear polyvinyl chloride (PVC) tube with standard medical component end terminations. Bonded to the proximal end of the PVC tube is a vented IV spike that is used to pierce a rubber stopper belonging to an imaging bulk contrast media container. Distally, a self-sealing Luer type connector (Smiths Medical Nu- Site®) is bonded to the opposite end of the PVC tube. The Liebel-Flarsheim™ IBP Transfer Set, shown in the image below, has an overall length of 19-inches, a protective cap on the IV Spike, and both untethered and tethered protective caps on the Luer end to protect the Nu-Site® Luer Activated fitting between syringe fills. The transfer sets are individually packaged in blister packs with a perimeter heat sealed Tyvek lid. Sealed blister packs are packaged in an outer box containing 50 units (50 units/box) which are terminally sterilized with ethylene oxide.
The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.
Here's a breakdown of the acceptance criteria and study information for the Liebel-Flarsheim™ IBP Transfer Set, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device (a transfer set) and does not describe an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies (like test set size for AI, number of experts for ground truth, MRMC studies, training set size for AI, etc.) are not applicable to this device. The study described is a traditional medical device verification and validation (V&V) study, comparing a new device to a predicate device.
Acceptance Criteria and Device Performance (Verification and Validation)
The document describes various tests performed to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. The acceptance criteria are generally "compliance with the standards" or "performs as intended."
| Acceptance Criteria Category | Acceptance Criteria (Implied) | Reported Device Performance/Verification |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶; EtO residuals comply with ISO 10993-7:2008 limits. | Validated to SAL of 10⁻⁶ in accordance with ISO 11135:2014 and ISO 10993-7:2008. Validation results indicate compliance. |
| Shelf Life | Maintains integrity of primary package and functional user requirements for 3 years. | Verification and validation testing in accordance with ISO 11607 (framework described, not full conformity) demonstrated maintenance of primary package integrity. Functional user requirements were also verified over the proposed three-year shelf life. |
| Biocompatibility | Verified in accordance with ISO 10993-1:2018 for cytotoxicity, hemocompatibility, irritation, sensitization, acute systemic toxicity, material mediated pyrogenicity; complies with ISO 10993-18:2005 (chemical characterization), USP (particulate matter), and USP (bacterial endotoxin). | Verification results indicate that the materials comply with the standards listed: ISO 10993-1:2018 (cytotoxicity, hemocompatibility, irritation, sensitization, acute systemic toxicity, material mediated pyrogenicity), ISO 10993-18:2005, USP , and USP . |
| Bench Performance (General/Functional) | Performance and functional user requirements verified according to product specifications and relevant ISO standards. | Tested for performance and verified in accordance with ISO 8536-4 (infusion sets), ISO 594-2 (Luer taper fittings), and ISO 22413:2010 (transfer sets). Additional testing included Microbial Ingress Testing, Chemical Compatibility (with Optiray®), Extractables and simulation testing for leachable compounds and particulates, and Verification of functional performance according to product specifications. The device "performs as intended." |
| Microbial Ingress | No microbial ingress (implied good performance). | Performed, implied successful. |
| Chemical Compatibility | Compatible with Optiray® (Ioversol) Imaging Bulk Package contrast media. | Approved Release Specifications for Optiray® (Ioversol) Imaging Bulk Package. |
| Extractables/Leachables | Acceptable levels of extractable and leachable compounds and particulates (implied). | Extractables and simulation testing for leachable compounds and particulates was performed. |
Study Details (Traditional Medical Device V&V)
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Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an AI/ML model where data provenance like country of origin or retrospective/prospective is relevant.
- Instead, for traditional device testing, sample sizes would be determined by statistical methods for each specific test (e.g., sterilization validation, biocompatibility, functional performance). These specific sample sizes are not explicitly stated in this summary for each test, but standard good manufacturing practices and regulatory requirements would apply.
- The data provenance is implicitly from manufacturing and laboratory testing conducted by Liebel-Flarsheim Company LLC (part of Guerbet LLC).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not an AI/ML device, so there is no "ground truth" in the sense of expert annotation for an algorithm. The "ground truth" for this type of device is established through adherence to recognized international standards (ISO, USP) and verified performance against predefined specifications, often evaluated by qualified laboratory personnel and engineers.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are specific to expert consensus in AI/ML model evaluation. For this device, compliance is assessed against objective technical specifications and performance limits defined by the relevant standards and internal company requirements.
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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:
- N/A. This is not an AI/ML device. MRMC studies are for evaluating clinical performance of diagnostic algorithms with human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (in the AI/ML context). For this device, "ground truth" is based on:
- Objective physical measurements and chemical analyses: e.g., sterility levels, EtO residuals, particulate matter, leachable compounds.
- Functional performance tests: verifying fluid transfer, connection integrity (Luer taper), and absence of microbial ingress.
- Biocompatibility evaluations: ensuring the materials are safe for patient contact according to established biological testing standards.
- Adherence to recognized industry standards: ISO, USP.
- N/A (in the AI/ML context). For this device, "ground truth" is based on:
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The sample size for the training set:
- N/A. This is not an AI/ML device. There is no "training set."
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How the ground truth for the training set was established:
- N/A. This is not an AI/ML device. There is no "training set" or "ground truth" for AI training. The safety and effectiveness of this device are established through direct physical, chemical, and biological testing, manufacturing controls, and adherence to design specifications and regulatory standards.
§ 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.