(112 days)
The Glass 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 Glass 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.
The provided 510(k) summary for the "Glass Loss of Resistance Syringe" (K063018) does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way that an AI/algorithm-based medical device would.
This submission is for a physical medical device (a syringe) and the safety and effectiveness are established primarily through biocompatibility testing and substantial equivalence to a pre-amendment predicate device. There is no "algorithm" or "AI" involved, so many of the requested fields are not applicable.
Here's an analysis based on the provided text, highlighting what is present and what is absent:
Acceptance Criteria and Device Performance (Not Applicable for this type of device/submission)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified by the FDA or the manufacturer in this document for performance metrics. The acceptance is based on meeting biocompatibility and substantial equivalence. | Not applicable in the typical sense of performance metrics. The device is deemed acceptable based on its materials meeting biocompatibility standards and its similarity to a legally marketed predicate. |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The "tests" were biological qualification safety tests on the materials, not a performance study on a 'test set' of data.
- Data Provenance: Not applicable in the context of clinical data. The summary mentions "All materials used in the fabrication... were evaluated through biological qualification safety tests." The origin of these tests (e.g., country) is not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no concept of "ground truth" or "experts" establishing it for this type of physical device's initial regulatory submission. The assessment is based on standardized biological safety tests.
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Adjudication method for the test set:
- Not applicable. No expert adjudication process is described or implied.
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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. This device is a physical syringe, not an AI/algorithm-based diagnostic tool. No MRMC study was conducted or is relevant.
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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.
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The type of ground truth used:
- Not applicable. The "truth" in this context is the pass/fail result of standardized biological safety tests for materials: L929 Men Elution Test, Intracutaneous Injection Test, Systemic Injection Test, Salmonella Typhimurium and Escherichia Coil Reverse Mutation Assay, Hemolysis - Rabbit Blood Test, and Kligman Maximization Test.
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The sample size for the training set:
- Not applicable. There is no training set for an AI/algorithm.
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How the ground truth for the training set was established:
- Not applicable. There is no training set or ground truth in the AI sense.
Summary of the K063018 Submission:
The Busse Hospital Disposables Glass Loss of Resistance Syringe (K063018) received FDA clearance primarily based on:
- Substantial Equivalence: The device was found substantially equivalent to a pre-amendment predicate device (BD Glass Loss of Resistance Syringe). This implies that its design, materials, and intended use are sufficiently similar to a device that was legally marketed before May 28, 1976 (the enactment date of the Medical Device Amendments).
- Biocompatibility Testing: The materials used in the syringe's fabrication underwent several biological qualification safety tests. The summary explicitly states: "These materials have met the testing requirements and were found to be acceptable for the intended use." The tests listed are standard biocompatibility assays to ensure the materials are not toxic or harmful when in contact with the human body.
In essence, this submission focuses on the safety of the materials and the functional similarity to an existing device, rather than performance metrics for an intelligent system.
§ 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).