(110 days)
The Busse Plastic LOR 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 Busse Plastic LOR syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged and as part of a sterile kit.
The LOR plastic 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.
This document describes a 510(k) premarket notification for the Busse Plastic LOR Syringe. The information provided heavily emphasizes the device's substantial equivalence to a predicate device and safety testing of its materials, rather than detailed performance criteria or clinical study results in the context of typical AI/ML device evaluations.
Therefore, many of the requested categories for acceptance criteria and the study proving device meets acceptance criteria cannot be fully addressed in the way they would for an AI/ML or diagnostic device. I will extract what is available and note where information is absent or not applicable given the nature of the submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Derived from safety and technological equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility for materials used in fabrication: | |
| - Kligman Maximization Test | Met testing requirements. |
| - Intracutaneous Injection Test | Met testing requirements. |
| - Systemic Injection Test | Met testing requirements. |
| - Rabbit Pyrogen Test | Met testing requirements. |
| - L929 Mem Elution Test | Met testing requirements. |
| Technological Characteristics: | |
| - Same as legally marketed predicate device (K061737) | Confirmed. |
| Intended Use: | |
| - For use in conjunction with an epidural needle to verify needle tip placement in the epidural space by the loss of Resistance technique. To be filled with air and/or saline. Not for injection or aspiration. | Intended use matches predicate; validated implicitly by substantial equivalence. |
| Sterility: | Sold as sterile. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly provided in the document. The testing mentioned (biocompatibility tests) are bench/laboratory tests, not clinical performance studies with patient data.
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 information is not applicable. The "ground truth" for this type of device (a mechanical/physical medical device) is based on its physical properties, material safety, and functional equivalence, not on expert interpretation of clinical data in the same way an AI/ML diagnostic device would be. The biocompatibility tests have established protocols and pass/fail criteria, likely interpreted by laboratory specialists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept pertains to resolving discrepancies in expert interpretations for establishing ground truth in diagnostic studies, which is not relevant for this device's submission.
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 not an AI-assisted device, nor is it a diagnostic device that would typically undergo MRMC studies. The submission is for a physical medical device (syringe).
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's submission is based on:
- Material Biocompatibility Standards: Compliance with established biological qualification safety tests (Kligman Maximization, Intracutaneous Injection, Systemic Injection, Rabbit Pyrogen, L929 Mem Elution Tests).
- Technological Equivalence: Direct comparison to a legally marketed predicate device (Loss of Resistance Syringe - K061737) to demonstrate similar design, materials, and functional characteristics.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of this device being a physical syringe. The submission relies on substantial equivalence and material safety testing.
9. How the ground truth for the training set was established
Not applicable, as there is no training set. The "ground truth" for the device's suitability is established through adherence to recognized biocompatibility standards and demonstration of technological equivalence to a predicate device already on the market.
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).