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510(k) Data Aggregation
(59 days)
SurgiLance**®** Safety Lancet
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color. SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.
This document is a 510(k) summary for the SurgiLance® Safety Lancet. It does not describe an AI/ML device, therefore, the requested information elements related to AI/ML device testing are not applicable.
The document indicates that the device is a puncture device used to obtain micro blood samples and has a sharps prevention feature. The 510(k) submission establishes substantial equivalence to a primary predicate device (MediPurpose SurgiLance® Safety Lancet, K101145) and an additional predicate device (BD Autolancet [Microtainer® Lancet], K822209), stating that the proposed device did not change technological characteristics or material specifications from the primary predicate.
Here's the information that can be extracted relevant to acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that the device was tested to meet performance and safety requirements. However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that testing was "completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization" and lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated compliance through manufacturing and sterilization for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemolysis testing as per ISO 10993-1. |
| Performance and Safety | Tests for drop, trigger force and reverse safety, penetration and depth force measurements, and simulated use were completed. The sharps prevention feature was fully tested to FDA's guidance document. |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for performance and safety testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is common for this type of device where performance is typically evaluated through laboratory testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical medical device, and its performance and safety are assessed through engineering and laboratory testing against established standards and predicate devices, not by expert interpretation of patient data to establish "ground truth."
4. Adjudication method for the test set:
Not applicable. This is not an AI/ML device or a device requiring expert adjudication of results.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of typical AI/ML ground truth. For this device, "ground truth" would be defined by engineering specifications, material properties, and functionality benchmarks established in industry standards and by predicate device performance. For instance, penetration depth would be measured directly, or sharps retraction would be visually confirmed as per design.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML device.
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