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BD Microtainer® Contact-Activated Lancets: The BD Microtainer® Contact-Activated Lancet is a sterile, single-use, permanently retracting, lancing device used to perform fingerstick punctures in in adults, adolescents, children, and infants (greater than 6 months of age and 10 kg [22 lbs}). The device is intended to be used by a healthcare professional in a clinical setting to obtain capillary blood specimens for testing utilizing small amounts of blood.

BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancet is a sterile, single-use medical device with a push-button activated, permanently retracting blade. The device is intended to be used by healthcare professionals to perform heel sticks in neomates, pre-term (preemie) and full-term infants (non-walking) to obtain capillary blood specimens for testing utilizing small amounts of blood.

BD Microtainer® Contact-Activated Lancets: The BD Microtainer® Contact-Activated Lancets are sterile, single-use lancets with a permanently retracting stainless steel needle or blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Contact-Activated Lancet needle/blade is never visible and remains sterile until the protective tab cap is removed. The BD Microtainer® Contact-Activated Lancet is activated by applying pressure against the puncture site upon contact; after skin puncture, the needle/blade returns into the device. Once activated, the device is auto-disabled and cannot be re-used (when used as intended) to minimize the chance of an accidental fingerstick and contamination.

BD Microtainer® Quikheel™ Lancets: The BD Microtainer® Quikheel™ Lancets are sterile, single-use lancets with a push-button activated, permanently retracting stainless steel blade used for the purpose of obtaining capillary blood specimens for testing utilizing small amounts of blood. The BD Microtainer® Quikheel™ Lancets consist of a front and back housing, a trigger, and a spring onto which a stainless-steel blade is mounted. The stainless-steel blade is non-redeployable to minimize the chance of accidental blade stick injury and contamination. The device is designed to produce a very rapid triggering of the blade along a predictable path, for low-trauma sampling.

The provided document describes the substantial equivalence of BD Microtainer® Contact-Activated Lancets and BD Microtainer® Quikheel™ Lancets to their predicate devices, rather than establishing acceptance criteria and proving performance through a new study with explicit criteria and performance metrics.

The products are blood lancets, which are Class II devices. They were previously Class I exempt but reclassified to Class II, necessitating this 510(k) submission. Therefore, the goal of this submission is to demonstrate that the redesigned devices are substantially equivalent to the predicate devices which were legally marketed before the reclassification. This means that the new devices do not raise new questions of safety and effectiveness.

Here's an analysis of the provided information concerning acceptance criteria and study aspects, keeping in mind that this is a substantial equivalence submission, not a de novo clearance requiring a new comprehensive performance study against specific acceptance criteria.

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

The document does not present a table of explicit acceptance criteria with quantitative performance metrics for the device's function (e.g., blood volume collected, pain level, depth of penetration accuracy). Instead, it relies on demonstrating that the new devices are identical or equivalent to the predicate devices across various characteristics.

The "Comparison" column in Table 1 and Table 2 (Substantial Equivalence Comparison) implicitly indicates that the "acceptance criteria" are "same as predicate" or "no new questions of safety and effectiveness."

Implicit Acceptance Criteria and Reported Performance (based on "Substantial Equivalence" comparison):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify a "test set" in the context of clinical performance or diagnostic accuracy. This is because the submission focuses on substantial equivalence for a reclassified device, not a novel device requiring a de novo clinical validation study.

Instead, the document refers to "Performance Testing - Bench Summary," stating that "Device, biocompatibility, and sterilization testing were conducted on the subject devices to validate that the devices perform as intended over the course of the product shelf life." This implies various engineering and laboratory tests, but the specific sample sizes for these tests are not provided in this summary.

• Test Set Sample Size: Not specified for clinical performance. For bench testing (e.g., sterilization, biocompatibility, packaging integrity), sample sizes appropriate for those types of validation would have been used but are not detailed here.
• Data Provenance: Not specified, as it's primarily bench/laboratory testing against recognized standards rather than human subject data.

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

Not applicable. The submission does not involve a diagnostic or interpretive device that requires expert adjudication to establish ground truth from a test set of cases. The device is a blood lancet, and its performance validation relies on engineering, sterility, and biocompatibility testing against recognized standards, as well as demonstrating equivalence to a predicate.

The indications for use for the BD Microtainer® Contact-Activated Lancets regarding minimum age/weight reference "recommendations outlined for fingerpricks in CLSI GP42-A7: Collection of Capillary Blood Specimens, 7th Edition (FDA Recognition Number 7-301) and WHO Guidelines On Drawing Blood: Best Practices In Phlebotomy." These guidelines represent expert consensus; however, they are being cited as context for intended use update, not experts providing ground truth for a study on the lancet's performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set requiring expert adjudication for ground truth is 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

Not applicable. Blood lancets are not devices that involve human readers or AI assistance.

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

Not applicable. Blood lancets are not algorithmic devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the purpose of this (510k) submission, the "ground truth" or standard for acceptable performance is primarily established by:

• Substantial Equivalence to legally marketed predicate devices: The primary criterion.
• Compliance with recognized international and national consensus standards: (e.g., ISO 13485, ISO 14971, ISO 23908, ISO 11607, ISO 15223, EN 556-1, ISO 11137, ISO 11737, ISO 13004, ISO 10993 series, ASTM standards, CLSI GP42-A7, WHO Guidelines on Drawing Blood), which represent established safe and effective practices and performance parameters for medical devices.
• Absence of new safety and effectiveness concerns: The modifications (e.g., specific age/weight for Contact-Activated Lancets, packaging changes) were evaluated to ensure they do not introduce new risks.

There is no clinical ground truth (e.g., pathology, outcomes data) specifically generated for this submission in the context of human subject testing.

8. The sample size for the training set

Not applicable. There is no AI or machine learning component, and thus no training set.

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

Not applicable. There is no AI or machine learning component.

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