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510(k) Data Aggregation
(385 days)
Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system.
Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system.
Intellifuse™ Administration Sets and Intellifuse™ Blood Administration Sets are single use, disposable, sterile fluid path, intravenous administration sets used to deliver fluids, medications, blood and blood products from a container into a patient's vascular system depending on the configuration selected. These sets are available in multiple configurations and may be comprised of various components which are broadly used throughout industry tubing, spike assemblies, drip chambers, check valves, clamps, needleless access connector, injection sites, in-line filters, luer connectors, and a tube frame assembly. The administration sets are intended to administer fluids with gravity flow. The IV Administration sets are configured to ensure the intended use of the device is met. The devices are intended for the general patient population.
The provided text describes the 510(k) premarket notification for Smiths Medical's Intellifuse™ Administration and Intellifuse™ Blood Administration Sets. This document from the FDA clears medical devices based on substantial equivalence to legally marketed predicate devices, rather than through extensive clinical trials for effectiveness like drugs. As such, the information you're requesting regarding acceptance criteria and performance studies in the context of an "AI/algorithm-only" or "human-in-the-loop" device is not applicable to this submission.
This device is an intravascular administration set, which is a physical medical device for delivering fluids. The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical performance data and testing to ensure the device functions as intended and is safe, not a comparative effectiveness study involving human readers or AI.
Therefore, many of the requested points, such as AI performance, human expert adjudication, MRMC studies, and ground truth for AI model training, are not relevant to this type of device clearance.
Here's the relevant information based on the provided text, focused on the device's technical specifications and non-clinical testing:
Acceptance Criteria and Device Performance for Smiths Medical Intellifuse™ Administration Sets
The "acceptance criteria" for this device are primarily met through demonstrating substantial equivalence to a predicate device (Hospira Administration Sets K160870) and by non-clinical performance data demonstrating compliance with relevant ISO standards and internal test methods.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics in the format typically seen for AI/algorithm performance. Instead, it relies on demonstrating compliance with established standards and the equivalence of functional characteristics.
| Criterion Type | Specific Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|
| Indications for Use | Delivery of fluids from a container to a patient's vascular system (Administration Sets). Delivery of fluids including blood and blood products (Blood Administration Sets). | Subject Device (K192375) Indications: Intellifuse™ Administration Sets are indicated for the delivery of fluids from a container to a patient's vascular system. Intellifuse™ Blood Administration Sets are indicated for the delivery of fluids including but not limited to blood and blood products from a container to a patient's vascular system. Substantial Equivalence Discussion: The subject sets' indications encompass and are substantially equivalent to the predicate's indications (Hospira Primary, Extension, Burette, and Blood sets). Differences in configurations do not alter the fundamental intended use. |
| Usage | Single Patient Use, Disposable | Reported: Single Patient Use, Disposable. Substantial Equivalence: Identical; substantially equivalent. |
| Priming Volume | Adequate for intended use (no specific numerical limit provided, but comparison to predicate is implicit). | Reported: Primary Sets: 24-29 mL; Blood Sets: 29-30 mL; Secondary Set: 14 mL. Substantial Equivalence: "Priming testing supports acceptability of device for its intended use. Substantially equivalent." (Predicate priming volume was not disclosed). |
| Drops / mL | Standardized drip rates for different set types. | Reported: Burette Sets: 60 drops/mL; All other sets: 20 drops/mL. Substantial Equivalence: "Performance testing supports acceptability of device for its intended use. Substantially equivalent." (Predicate drops/mL was not disclosed). |
| Materials | Biocompatible for patient contact. | Reported (Subject): ABS, DEHT, PVC, HDPE, Acrylic & Nylon, LDPE, MABS, PC, Silicone, Flurosilicone, Clear ABS, LDPE, Polyisoprene, Acrylic, E-PTFE, Polyurethane (biocompatible, non-DEHP, not manufactured with natural rubber latex). Substantial Equivalence: "Similar, all differences supported by ISO 10993 biocompatibility testing. Substantially Equivalent." |
| Sterility | Sterile fluid path, Sterility Assurance Level (SAL) 10⁻⁶ | Reported: Sterile fluid path, EO, SAL 10⁻⁶. Substantial Equivalence: "Predicate sterilization method not disclosed; however, both devices are validated to the same sterility assurance level and the subject sterilization has been validated and is acceptable for its intended use; substantially equivalent." |
| Non-Clinical Testing | Compliance with relevant ISO standards and internal test methods. | Reported: All listed tests passed and results were verified against requirements. This includes compliance with: ISO 8536-4, ISO 1135-4, ISO 594-1, ISO 594-2, USP (Particulate assessment), Microbial Ingress (Internal), Pinch Clamp (Internal), Check Valve (ISO 8536-12), Needleless Access Connector (Internal - Hydrostatic pressure, Translucency, Inspection), Burette Chamber (ISO 8536-5), Biocompatibility (ISO 10993-1, including Pyrogenicity), Sterilization (ISO 11135 - SAL 10⁻⁶), and Packaging (ISO 11607-1). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes for each non-clinical test conducted (e.g., how many sets were tested for priming volume, sterility, etc.). These sizes would typically be determined by statistical methods for validation but are not explicitly stated in this summary.
- Data Provenance: The data is generated from non-clinical laboratory testing performed by Smiths Medical. There is no information about country of origin or whether it's retrospective/prospective data as these terms are usually applicable to clinical studies.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
This question is not applicable. This device is a physical medical device, not an AI or imaging diagnostic tool that requires human expert interpretation or "ground truth" establishment in the context of diagnostic accuracy. The "ground truth" for this device's performance is established by objective engineering and biological testing standards.
4. Adjudication Method for the Test Set
This question is not applicable. As there is no human interpretation or diagnostic decision involved that requires expert consensus or adjudication. The non-clinical tests have predefined acceptance criteria based on engineering specifications and international standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. This device is an administration set, and its clearance is based on demonstrating functional equivalence and safety through non-clinical testing.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical, non-AI medical product. Therefore, there is no "algorithm only" or "human-in-the-loop" performance to evaluate in this context.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Compliance with international standards (e.g., various ISO standards for infusion and transfusion equipment, luer fittings, biocompatibility, sterilization, packaging).
- Compliance with **USP ** for particulate assessment.
- Results from internal test methods for specific functions like Microbial Ingress, Pinch Clamp, and Needleless Access Connector performance, which would be validated against engineering specifications.
- The fundamental physical and chemical properties of the materials used.
8. The Sample Size for the Training Set
This question is not applicable. This device is not an AI/machine learning product, so there is no "training set" in the computational sense. The "development" of the device involves engineering design, prototyping, and testing of physical units.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reason as point 8.
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