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510(k) Data Aggregation
(155 days)
Medifun Lancing Device, Model No. LD-E1 is a reusable lancing device for the single user. Itshould be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.
Medifun Lancing Device, Model No. LD-E1 is a mechanical blood lancet holder. It is used with a single use sterile lancet to puncture the skin for collecting capillary whole blood sampled from the fingertip or alternate sites. Medifun Lancing Device LD-E1 can be adjusted for 6 levels of depth. This device is for single user only.
This 510(k) summary is for a lancing device, which is a mechanical device used to obtain blood samples. The document focuses on showing substantial equivalence to existing predicate devices, primarily through non-clinical bench testing. It does not involve AI or human-in-the-loop performance studies. Therefore, many of the requested categories related to such studies are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|
| Biocompatibility | Meets ISO 10993-1, ISO 10993-5 (In vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization), ISO 10993-23 (Skin Irritation) standards. | Non-clinical bench testing specifically for ISO 10993-5, ISO 10993-23, and ISO 10993-10. |
| Cleaning Validation | Successful validation of cleaning procedures. | Non-clinical bench testing for cleaning validation. |
| Risk Management | Adheres to ISO 14971:2019 standard. | Risk management activities performed according to ISO 14971:2019. |
| Mechanical Design & Functionality | Meets specified requirements (e.g., 6 levels of depth adjustment from 0.5mm-1.7mm, 'lancet retract after use'). | Non-clinical bench testing including "Specification and functional tests" and "mechanical design verification and validation testing." |
| Substantial Equivalence (Overall) | The device is deemed substantially equivalent to predicate devices in intended use, technology, operation principle, and similar technical characteristics, with all verification tests meeting required acceptance criteria. | Comparative analysis with predicate devices (RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device K221062) and comprehensive non-clinical bench testing. The document states that "all tests were verified to meet the required acceptance criteria." |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of clinical data or patient samples. The testing described is primarily non-clinical bench testing. Therefore, details about sample size (e.g., number of devices tested for mechanical properties) and data provenance (country of origin, retrospective/prospective) for these bench tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the studies were non-clinical bench tests; there was no "test set" requiring expert ground truth in the clinical sense.
4. Adjudication method for the test set
This is not applicable for the same reasons as point 3.
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
This is not applicable. The device is a mechanical lancing device, not an AI-assisted diagnostic or therapeutic tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" would be established by the criteria defined in the respective ISO standards (e.g., ISO 10993 for biocompatibility) and the device's own internal specifications for functional performance. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. The sample size for the training set
This is not applicable. There is no concept of a "training set" for a mechanical lancing device as there are no algorithms being trained.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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