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510(k) Data Aggregation
(137 days)
The Kurin Blood Culture Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needlestick injury if manually activated after the blood collection, the set also includes a safety shield and apparatus for connection to vacuum based collection vials.
The Kurin device is a sterile, single use blood culture collection set. The Kurin includes a winged needle with flexible tubing and an attached vial adapter intended for venipuncture to obtain blood culture samples. Kurin is identical in every way to existing sets used to collect blood culture samples except for the insertion into the tubing of the Kurin blood capture chamber. The Kurin blood capture device sequesters the initial draw of blood upon initial venipuncture. The set is provided with a safety shield for covering the used needle prior to disposal. The amount of blood diverted is very small, estimated at a fraction of 1 ml.
The provided document is a 510(k) premarket notification for a medical device called the "Kurin Blood Culture Collection Set." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than proving performance against specific acceptance criteria for diagnostic accuracy or effectiveness in a clinical context. Therefore, the information typically found in acceptance criteria and detailed study descriptions for AI/ML medical devices (like sensitivity, specificity, F1 score, sample size for test sets, expert qualifications, etc.) is not present in this document.
However, I can extract the non-clinical testing performed and present them as "acceptance criteria" and "reported performance" based on how they are described in the document as meeting specifications.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Non-Clinical Testing) | Reported Device Performance |
|---|---|
| Sterilization: Compliance with ISO 11135-1:2006 for Ethylene Oxide sterilization. | The Kurin device is sterilized using a validated EO sterilization process which complies with ISO 11135-1:2006. |
| Aging/Shelf Life: Achieve a 1-year shelf life for sterility and performance. Protocols for up to 3 years. | The Kurin device was validated to achieve 1-year shelf life with protocols for up to 3 years of shelf life for sterility and performance. |
| Functional, Leakage, and Tensile Test: No compromise to the function of the blood collection device, no leakage, and passing tensile testing in accordance with ISO 1135-3 sections 5.2 and 5.3. | The Kurin set confirmed the addition of the Kurin device shows no compromise to the function of the blood collection device in regards to functionality. With the addition of the device, the product does not leak and passed tensile testing in accordance with sections 5.2 and 5.3 of ISO 1135-3. |
| Packaging Integrity and Shipping Test: Compliance with ISO 11607 and ASTM D4169-14. | This test was completed, and the Kurin device passed all tests in accordance with ISO 11607 and ASTM D4169-14. |
| Biocompatibility Tests: No leachables (MEM Elution Test), no adverse effect on blood constituents (IVH Blood Count Test). | The Kurin device passed two types of biocompatibility tests: the MEM Elution Test demonstrated that no leachables are present from the system, and the IVH Blood Count Test which demonstrated that the blood path did not adversely affect the constituents of blood exposed to the systems fluid path. |
| User Verification Test: Instructions for use are easy to understand, and device functionality is acceptable. | Testing was conducted to evaluate if the instructions for use were easy to understand and the functionality of the device. (Implied success as it "passed") |
| Flow Rate Test: Addition of the Kurin Device does not change the flow rate of liquid compared to the predicate. | Testing verified that the addition of the Kurin Device into the tubing of the FDA cleared BD Vacutainer® brand blood collection set and Safety-Lok™ Blood Collection set did not change the flow rate of liquid passing through the device. |
2. Sample size used for the test set and the data provenance
The document describes non-clinical engineering and bench testing, not a clinical test set with patient data. No specific sample sizes for these tests (e.g., number of devices tested for flow rate, leakage, etc.) are provided in the summary. Data provenance is not applicable in the context of clinical populations as it's not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable as this document describes non-clinical, bench testing, and engineering verification, not a study evaluating expert performance or ground truth established by experts. The "ground truth" here is determined by the specifications of the standards (e.g., ISO, ASTM) and the physical properties of the device.
4. Adjudication method for the test set
Not applicable. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not described here.
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
Not applicable. This device is a blood collection set, not an AI/ML diagnostic tool, and no MRMC studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm, and its performance is assessed via non-clinical testing.
7. The type of ground truth used
The "ground truth" for the non-clinical tests described in this document is based on engineering specifications, compliance with international standards (ISO, ASTM), and predefined performance benchmarks (e.g., no leakage, specific flow rates, successful sterilization).
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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