(277 days)
Extension Sets are intended to be used with a vascular access device for direction, intermittent infusion, continuous infusion or aspiration. The Extension Sets may be used with power injector procedures to a maximum pressure of 200 kPa (2 bar).
The subject device, Extension sets are single use, sterile, non-pyrogenic, add-on devices used for direct injection, intermittent infusion, continuous infusion or aspiration. The device is to connect the infusion device through the luer lock connector to add length and provide clamping capacities, or added to an intravascular catheter hub as a conduit for flow to and from the catheter. It is available in various lengths and tube dimensions, and may be comprised of various generic components such as connectors, clamps, flow regulators, filters, check valves and needleless injection ports. It can be used for gravity infusion and pressure infusion with pressure up to a maximum of 200 kPa (2 bar).
The provided text is a 510(k) Summary for a medical device called "Extension Set." This document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and biocompatibility assessments, rather than presenting a performance study with acceptance criteria in the context of an AI-powered diagnostic device. Therefore, many of the requested categories (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance with AI) are not applicable to this document.
However, I can extract information related to the device's performance based on the non-clinical tests performed to ensure its safety and effectiveness.
Acceptance Criteria and Device Performance (Derived from Non-Clinical Tests)
The document lists numerous non-clinical tests performed to demonstrate that the device meets its design input requirements and applicable standards. The "reported device performance" in this context refers to the affirmation that the device met the requirements of these tests. Specific quantitative acceptance criteria are generally not explicitly stated in this summary but are implied by adherence to the referenced standards and guidance documents (e.g., ISO, ASTM, FDA guidance).
| Acceptance Criteria Category (Implied by Test) | Reported Device Performance (as stated in the document) |
|---|---|
| Appearance | Met the requirements (per ISO 8536 series) |
| Dimensions | Met the requirements (per FDA guidance, similar devices, characteristics) |
| Particulate Contamination | Met the requirements (per ISO 8536 series and USP ) |
| Leakage | Met the requirements (per ISO 8536 series and FDA guidance) |
| Tensile Strength | Met the requirements (per ISO 8536 series and FDA guidance) |
| Flow Rate | Met the requirements (per FDA guidance) |
| Luer Connector Performance (Size, Fluid leakage, Sub-atmospheric pressure air leakage, Stress cracking, Resistance to separation from axial load, Resistance to separation from unscrewing, Resistance to overriding) | Met the requirements (per ISO 80369-7: 2021 and FDA guidance) |
| Check Valve Performance (Counter flow pressure resistance, Flow rate, Blocking performance, Opening pressure) | Met the requirements (per ISO 8536-12: 2021) |
| Anti-siphon Valve Performance (Counter flow pressure resistance, Flow rate, Blocking performance, Opening pressure) | Met the requirements (per ISO 8536-12: 2021) |
| Liquid Medicine Filter 0.2um (Bacterial interception) | Met the requirements (per ASTM F838-20) |
| Liquid Medicine Filter 1.2um (Retention of latex particles, Candida albicans interception) | Met the requirements (per ISO 8536-4: 2019) |
| Liquid Medicine Filter 5.0um (Retention of latex particles) | Met the requirements (per ISO 8536-4: 2019) |
| Needle Free Injection Port Performance (Flow rate, Test for exposure to IPA, Separation resistance, Backpressure, Fluid leakage, Air leakage, Activation duration and number) | Met the requirements (per ANSI/AAMI CN27:2021 and ISO 80369-7: 2021) |
| Storage Volume | Met the requirements (per ISO 8536-8: 2015 and FDA guidance) |
| Clamp and Flow Regulator Performance | Met the requirements (per ISO 8536-14: 2016) |
| Protective Cap Performance | Met the requirements (per ISO 8536-4: 2019) |
| Chemical Performance | Met the requirements (per ISO 8536-4: 2019) |
| Sterility | Met the requirements (per ISO 11135: 2014) |
| Bacterial Endotoxin | Met the requirements (per ANSI/AAMI ST72: 2019) |
| Package Performance (Shipping, Shelf Life) | Met the requirements (per ISTA 3A: 2018, ISO 11607-1: 2019, ISO 11607-2: 2019, ASTM F1980-21) |
| Biocompatibility (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity, Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Hemolysis) | All tests were performed, and it was "demonstrated that the materials used for the device is biocompatible" (per ISO 10993 series and FDA guidance) |
Here's the relevant information based on your numbered questions, with explanations for why some information is not present:
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A table of acceptance criteria and the reported device performance: See the table above. The acceptance criteria are implicitly defined by the referenced international standards (e.g., ISO 8536 series, ISO 80369-7, ASTM F838-20) and FDA guidance documents, which specify performance requirements (e.g., maximum leakage, tensile strength thresholds, bacterial retention rates). The "reported device performance" is a blanket statement that the device met the requirements of these standards for all tests performed.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not explicitly stated in the summary document. For medical device bench testing, sample sizes are typically determined by statistical methods for quality control or standard requirements, but these details are not provided here.
- Data Provenance: The tests were conducted by MEDCAPTAIN LIFE SCIENCE CO., LTD. which is based in Shenzhen, Guangdong, China. The document does not specify if external labs were used or the specific origin of materials if different. Tests are non-clinical (bench tests).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This device is a physical medical device (Extension Set), not an AI diagnostic tool. Ground truth for its performance is established through adherence to engineering specifications and performance standards via bench testing, not through expert consensus on medical images or diagnoses.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation (often of images) where there can be disagreement, typically in AI/diagnostic studies. Bench testing of a physical device is a direct measurement against defined specifications, not subject to subjective adjudication.
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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:
- Not applicable. MRMC studies are specific to evaluating diagnostic systems, especially those involving AI and human readers. This document concerns a physical "Extension Set" device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. There is no algorithm or AI component in this medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the device's performance is established by the specifications defined in international standards (e.g., ISO, ASTM) and FDA guidance documents. These standards dictate acceptable ranges for physical, chemical, and biological properties (e.g., acceptable leakage rate, minimum tensile strength, non-cytotoxicity). The device's performance is measured directly against these pre-defined, objective criteria.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 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.