Search Results

Freestyle Lancing Device II: Use with compatible lancets for capillary blood sampling.

Autolet: Use with compatible lancets for capillary blood sampling.

Autolet Lite: Use with compatible lancets for capillary blood sampling.

Unilet Lancets: Use with compatible lancing device for capillary blood sampling.

The FS & A Device is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The ADC Freestyle Lancing Device II variant is sold for use with ADC 'Freestyle' single-use lancets; these are not included in this submission. The OM Autolet variant is sold for use with Unilet Lancets and as 'universally compatible with most lancets'. The lancets are disposed of after each use and the device is maintained by using isopropyl alcohol or soap to wipe the outside of the device. The FS & A Device is for use only on a single patient.

The Autolet Lite is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The device was designed for use as a system with Unilet Lancets (and as 'universally compatible with most lancets') which are included in this 510(k) The Unilet Lancets feature 3 lancet gauges, 3 with labelling "Unilet Lancets" and the same 3 lancet gauges labelled "Unilet ComforTouch Lancets". These lancets have different gauge sizes and styling but are functionally identical and for the purpose of this 510(k), all references to "Unilet Lancets" can be considered to apply to Unilet Lancets and Unilet ComforTouch Lancets.

The provided text describes a 510(k) premarket notification for Owen Mumford Ltd.'s Freestyle Lancing Device II, Autolet, Autolet Lite, and Unilet Lancets. The goal of the submission is to demonstrate substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System (K214022).

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification testing of the FS & A has been carried out to evaluate the performance of the devices against defined acceptance criteria." and "The objective of the design verification testing conducted was to verify that the submission devices met the pre-determined specifications, to support the conclusion that they are fit for purpose and are considered safe and effective for the intended use."

However, the specific "acceptance criteria" (e.g., numerical targets for depth of penetration accuracy, load/fire mechanism reliability) are not explicitly listed in a detailed table or described quantitatively for each test. The table below summarizes the general acceptance and reported performance.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the "design verification testing" for the specific tests (e.g., how many devices were tested for mechanical performance, how many samples for biocompatibility).

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond the fact that the testing was carried out as part of the design verification internally by Owen Mumford Ltd. (UK-based company). The Toxicologist for biocompatibility assessment was from Medwise International Consultancy Limited, York, UK.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes technical performance testing and biocompatibility assessments, not a diagnostic device involving expert interpretation or "ground truth" establishment in a clinical sense. For biocompatibility, an "Expert toxicological review" was conducted by a toxicologist from Medwise International Consultancy Limited, York, UK. Their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

This information is not applicable for the type of technical and biocompatibility testing described.

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 information is not applicable. The submission is for lancing devices and lancets, which are mechanical devices for capillary blood sampling, not AI-powered diagnostic tools requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the technical performance tests, the "ground truth" or reference was the pre-determined specifications and design input IDs for the devices. For biocompatibility, the ground truth was established against ISO 10993-1:2009 and ISO 10993-5:2009 standards and an expert toxicological review. For sterilization, it was against ISO 11137 standards.

8. The sample size for the training set

This information is not applicable as the submission is for a physical medical device (lancing devices and lancets), not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a physical medical device.

Ask a specific question about this device