Search Results

The HumaPen Luxura HD is a reusable pen injector designed for use by diabetics for the self-injection of a desired dose of insulin. The pen injector uses 3.0 mL cartridges of Lilly insulin and a single use detachable and disposable pen needle (supplied separately). The pen injector allows the user to dial the desired dose from 1 to 30 units in one-half (1/2) unit increments.

HumaPen Luxura HD is a reusable mechanical pen-injector designed for the selfinjection of insulin. The pen-injector is intended for use with Eli Lilly and Company 3 mL insulin cartridges and single-use, detachable and disposable pen needles (supplied separately).

The provided text does not contain information about acceptance criteria or a study proving that the HumaPen Luxura HD device meets acceptance criteria. The document is a 510(k) summary for a premarket notification for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than detailed performance study results against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

To be able to answer your questions, I would need a section of the submission that details performance testing, including:

1. Acceptance Criteria Table: A table outlining the predefined performance targets the device needed to meet.
2. Study Results: Data showing how the device performed against those criteria.
3. Study Design Details: Information on sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, and whether standalone or MRMC studies were conducted.

Ask a specific question about this device