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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.

The MediPurpose SurgiLance® Safety Lancets 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. Point-of-Care (POC) tests currently using micro-sample quantities of whole blood include glucose, cholesterol, HIV, Hepatitis, A1C, Allergies, Lactate, HgB, H.Pvlori. Creatinine, Mono, PT, D-Dimer, Anemia, Thyroid, Triglycerides, Ketones, Prostate, IgE. Chagas and more. 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 is 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 push 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.

The SurgiLance® Safety Lancet comes in six models: two low flow, one medium flow, one medium-high flow, and two high flows. The six models are differentiated by their casing color.

The provided text describes the MediPurpose SurgiLance® Safety Lancet, a device designed to obtain micro blood samples while incorporating a sharps prevention feature. However, it does not include information about specific acceptance criteria or a study proving that the device meets those criteria.

The information primarily focuses on:

• Device Description: What the device is, its purpose (pricking a patient's finger for micro-sample blood draws for various diagnostic assays), its target users, and its functionality (safely retracted and concealed needle/blade, rendered inoperative after use). It also mentions different models based on depth of penetration and blood flow.
• Intended Use: "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."
• Similarities and Differences to Predicate Devices: Discusses technological characteristics, materials (medical grade stainless steel for needles/blades, plastics for housing), and biocompatibility.
• Conclusion: States that the device has the "same principles of operation, intended use, and technological characteristics as the predicate devices." It also explicitly mentions that "The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance testing."

Missing Information:
The document mentions performance testing for the sharps prevention feature but does not provide any details about:

• Specific acceptance criteria (e.g., success rate of sharps prevention, penetration depth accuracy, blood volume obtained, usability metrics).
• The actual results of the "performance testing."
• Study design details (sample size, data provenance, expert involvement, adjudication, standalone vs. MRMC, ground truth type, training set details).

Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and study details. The document confirms that testing occurred for the sharps prevention feature, but the results and methodologies are not described.

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