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Medine Personal Protection Kits are intended for use by, but not limited to, hospitals and medical centers. The original intended use of the medical products assembled in these kits will not be changed.

Medline Employee Protection Kits are an assemblage of medical and non-medical materials to be used by employees who may need protection from body fluids or other potentially hazardous situations where employee protection may be needed. The kits will be assembled using Medline and other manufacturer's medical devices and materials.

The devices are custom to our customers who specify the contents, quantity and placement of the individual items kit. Attached is a list of individual components that are likely to be in any of these kits. These items are standard and we expect that only quantities will change from one kit to another. The customer may also specify a specific brand of similar items or minor variations of items.

These kits are non-sterile and are shrink-wrapped to maintain kit integrity and cleanliness.

The provided documents describe a 510(k) premarket notification for the "Medline Employee Protection Kit" and claim substantial equivalence to a predicate device, the "EZ Personal Protection Kit" (K952962) by Safetec of America, Inc.

Regarding acceptance criteria and a study proving the device meets them, the provided documents do not contain this information.

Here's why and what can be extracted from the documents:

• Type of Submission: This is a 510(k) submission, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with defined acceptance criteria.
• Device Description: The Medline Employee Protection Kit is an assemblage of medical and non-medical materials. Its "performance" is inherently tied to the performance of its individual components and the proper usage of the kit.
• Technological Characteristics: The submission explicitly states: "There are no technological differences between the new device and the predicate device." This is a key argument for substantial equivalence, implying that the safety and effectiveness are similar because the technology is similar.
• Safety and Effectiveness Claim: "The safety and effectiveness of Medline Employee Protection Kit is dependent upon proper usage of the products and medical devices that are present in each type of kit." This statement further reinforces that the submission isn't presenting new performance data for the kit as a whole, but rather relying on the established performance of its components and the predicate device.

Therefore, the documents do not provide:

1. A table of acceptance criteria and the reported device performance: There are no specific performance criteria or tests for the "kit" itself mentioned.
2. Sample size used for the test set and the data provenance: No test data is presented for the kit.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no ground truth establishment for a study is described.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not done; this type of study would be for evaluating reader performance, which isn't the scope of this 510(k).
6. Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device kit, not an algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided documents serve as a regulatory submission demonstrating substantial equivalence based on the similarity of the device and its components to a predicate device, not on specific performance testing of the assembled kit against acceptance criteria.

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