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510(k) Data Aggregation
(54 days)
MedtFine Safety Lancet
The safety lancet is intended for capillary blood sampling.
Sterile safety lancet consists of outer shell, middle sleeve, needle holder, spring, upper shell, back cover, small cover, needle. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use and single person use only. The shelf-life of the product is 5 years. The device is for medical professionals and lay person use as an OTC use.
This document is a 510(k) Summary for a medical device called "MedtFine Safety Lancet". It details the device's characteristics, intended use, and comparison to a predicate device to demonstrate substantial equivalence.
Here's an analysis of the provided text for acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a "Characters comparison" table (Table 2) that includes performance parameters for both the proposed "MedtFine Safety Lancet" and the predicate device "Safety Lancet (K220370)". This table effectively serves as a comparison against acceptance criteria. The acceptance criterion for each performance characteristic is generally implied to be "same" or within the range of the predicate device, or "meet requirements."
| Acceptance Criteria (Implied from Predicate/Requirement) | Reported Device Performance (MedtFine Safety Lancet) | Comments (from document) |
|---|---|---|
| Product Code: FMK | FMK | Same |
| Indication for Use: Capillary blood sampling | The safety lancet is intended for capillary blood sampling. | Same |
| OTC Use | OTC use | Same |
| Specifications: Needle: 18G, 18G blade, 21G, 23G, 16G, 28G, 30G, 32G | Needle: 18G, 18G blade, 21G, 23G, 16G, 28G, 30G, 32G | Same, within range. |
| Safety protection features: Yes | Yes | Same |
| Reuse durability: Single use for single person | Single use for single person | Same |
| User environments: Home, clinical | Home, clinical | Same |
| Components and materials: (Specific to predicate; proposed device differs) | Outer shell: PP, Middle sleeve: ABS, Needle holder: PE, Spring: carbon steel, Upper Shell: PE, Back cover: PE, Small cover: PP, Needle: Stainless Steel | #1 (The proposed and predicate devices used different materials for manufacturing. The device structures kept the same. The performance testing and biocompatibility testing results demonstrated the proposed device met the requirements of various standards) |
| Sterilization: Radiation SAL=10-6 | Radiation SAL=10-6 | Same |
| Shelf life: 5 years | 5 years | Same |
| Activation force: 4~15N | 4~7N | Same, within range. |
| Puncture force: 18 |
8. The sample size for the training set
This information is not applicable. The MedtFine Safety Lancet is a mechanical medical device, not an AI/ML-based device that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not data-driven learning.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above (not an AI/ML device). The design and development process for such a device relies on established engineering specifications, material selection, and manufacturing processes, which are then validated through the performance and biocompatibility testing outlined.
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