(85 days)
Transfer, mixing and topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials
The Medimop Mixject with Spray Head device enables injection of a diluent into a drug vial connected to the Dispensing pin (Vial adapter), for reconstitution and aspiration of the reconstituted drug into a syringe attached to the luer-lock end of the body. The vial and the Dispensing pin (Vial adapter) can be removed by turning the Dispensing pin (Vial adapter). The removal of the Dispensing pin (Vial adapter) turns the turning core from the aspiration position to the fixed spray position allowing spray application / delivery of the drug onto the desired surface.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Medimop Mixject with Spray Head device:
Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly list specific quantitative acceptance criteria or a detailed table of device performance results against such criteria. Instead, it relies on a statement of substantial equivalence to predicate devices and general performance claims.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to effectively transfer drugs | Bench testing performed to demonstrate ability to effectively transfer drugs. |
| Ability to effectively mix drugs | Bench testing performed to demonstrate ability to effectively mix drugs. |
| Ability to effectively apply drugs (spray) | Bench testing performed to demonstrate ability to effectively apply drugs (spray). |
| Viscosity handling (up to 4.7 cP) | Indications for Use state "topical spray application / delivery of drugs with a viscosity up to 4.7cP contained in vials." The device presumably met this capability. |
| Operates on the same principle as predicate devices | Stated in Section 7 as a basis for substantial equivalence. |
| No additional concerns regarding safety and effectiveness compared to predicates | Concluded in Section 9. |
Study Information
Based on the provided document, the study conducted was a non-clinical bench test.
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Sample size used for the test set and the data provenance:
- The document does not specify the sample size (number of devices tested, number of repetitions, etc.) for the bench tests.
- The data provenance is not explicitly stated in terms of country of origin, but the company is based in Israel, so it's likely the tests were conducted there or at a laboratory working with them. The study was non-clinical, meaning it focused on the device's physical performance rather than human subject data, so the "retrospective or prospective" designation isn't directly applicable in the typical clinical trial sense. It was a prospective bench study designed to evaluate the device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. As a non-clinical bench test, the "ground truth" would likely be established by engineering specifications, validated test methods, and potentially expert interpretation of results by engineers or scientists, rather than medical experts.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided. Given that it was a bench test for a simple device, formal adjudication by multiple experts is unlikely to have been a primary methodology for determining test outcomes. Performance would be measured against pre-defined engineering criteria.
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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:
- No, an MRMC study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often with AI assistance. The Mixject with Spray Head is a drug delivery and mixing device, not an imaging or diagnostic device, and thus an MRMC study is inappropriate and wasn't conducted.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone study was done in the form of "Bench testing" (non-clinical testing). The device performance was evaluated on its own merits and functionality (transfer, mixing, spray application) without human interaction specifically for the test. The device itself is designed for human use but the performance validation was done in a standalone manner for the device's technical capabilities.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's non-clinical bench testing would be based on engineering specifications, established physical and chemical principles, and validated measurement techniques. For example, drug transfer efficiency would be measured quantitatively, mixing effectiveness could be assessed by homogeneity measurements, and spray application characteristics (e.g., droplet size, spray pattern) would be measured against predefined operational parameters for a spray head. It is not based on expert consensus, pathology, or outcomes data in the clinical sense.
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The sample size for the training set:
- This information is not applicable and not provided. This device is a mechanical medical device, not a machine learning or AI-based algorithm that requires a "training set."
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How the ground truth for the training set was established:
- This information is not applicable and not provided. As mentioned above, there is no "training set" for this type of device.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).