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510(k) Data Aggregation
(181 days)
ROBERT BUSSE & CO., INC.
The Busse Loss of Resistance Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The Syringe will be sold sterile individually packaged, and as part of a sterile kit.
The Busse Loss of Resistance Syringe is a single use device, which is sold as sterile individually packaged and sterile packaged inside a kit/procedure tray. The syringe will be available in luer lock and luer slip tip.
This document is a 510(k) summary for the Busse Loss of Resistance Syringe, which is a medical device. The information provided heavily focuses on the regulatory submission and equivalency to a predicate device, rather than detailed performance study results that would typically be associated with software or AI-driven medical devices.
Based on the provided text, the device is a physical syringe, not an AI or software-driven product, so many of the questions related to acceptance criteria for software performance, sample sizes for test sets, ground truth establishment, MRMC studies, or training data are not applicable.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for performance in the way one might expect for a diagnostic device (e.g., sensitivity, specificity). Instead, the acceptance criteria for this physical medical device are related to its biocompatibility and functional equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (Summary of Testing) |
|---|---|
| Biocompatibility | All materials used were evaluated through biological qualification safety tests: L929 Men Elution Test, Kligman Maximization Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coli Reverse Mutation Assay, and Hemolysis - Rabbit Blood Test. |
| Result: Materials met testing requirements and were found acceptable for intended use. | |
| Technological Characteristics | The subject device has the same Technological Characteristics as a legally marketed predicate device (B-D Loss of Resistance Syringe - K925902). |
| Intended Use | The device is intended for use in conjunction with an epidural needle to verify needle tip placement in the epidural space by the loss of Resistance technique. |
| Result: Deemed substantially equivalent to the predicate device for this intended use. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The "tests" performed are described as biological qualification safety tests on materials, not clinical performance studies with a test set of patient data from a specific provenance.
3. 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)
This is not applicable as the device is a physical syringe, not a diagnostic or AI-based device requiring expert ground truth establishment for a test set. The evaluation is based on material testing and comparison to a predicate device. The FDA's review and determination of substantial equivalence are conducted by regulatory experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no test set in the context of diagnostic performance that would require an adjudication method.
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 is a physical medical device (syringe), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device, "ground truth" would be established through scientific testing standards and regulatory compliance. For biocompatibility, the ground truth is adherence to established biological qualification safety test protocols and their passing criteria. For technological characteristics, the ground truth is direct comparison and equivalence to a legally marketed predicate device in terms of design, materials, and function for the stated intended use.
8. The sample size for the training set
Not applicable. This is a physical medical device. There is no concept of a "training set" in the context of AI/machine learning for this product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this physical medical device.
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