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510(k) Data Aggregation
(58 days)
Safety lancet is intended for capillary blood sampling.
The Medifun Safety Lancet (MSL1 series) is designed to obtain capillary blood samples from the fingertip. The intended users include healthcare personnel, patients, and lay persons. According to the needle and color differences, the safety lancets have 6 models : MSL1-30, MSL1-28, MSL1-26, MSL1-23, MSL1-21, and MSL1-18. The safety lancets consist of the needle seat, main body, release platform, spring, and protective cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The lancets contain a safety feature. After use, the puncture mechanism retracts, rendering it unusable for a second time.
The provided text is a 510(k) summary for the Medifun Safety Lancet (MSL1 series). It details the device's characteristics, its comparison to a predicate device, and the performance data that supports its substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Consistent with the drawings. There should be no damage, dirt, or holes and the protective cap must not be pulled open. | Meet the requirement |
| Dimension | Consistent with the drawings. | Meet the requirement |
| Firmness | The needle must remain firmly attached to the plastic part of the needle seat. | Meet the requirement |
| Needle protrusion length | Use calipers to measure and meet the requirements. | Meet the requirement |
| Launch performance | It must be able to fire smoothly, and there should be no abnormal rebound noise after firing. | Meet the requirement |
| Puncture force | The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Disposable | The safety lancet is only allowed to be puncture once, and it becomes invalid and cannot be fired again after it has been punctured. | Meet the requirement |
| Safety Feature | The downward firing force <2 kg. After firing, the needle tip must retract and the needle must not touch the surface of the balloon. | Meet the requirement |
| Protective cap pull test | It must be possible to smoothly open the protective cap within a full cycle. | Meet the requirement |
| Structural strength | The combined force between the protective cap of the needle seat and the main body must be greater than 2.5 kg. | Meet the requirement |
| Drop test | Perform a puncturing test after a fall, it must be able to puncture normally. | Meet the requirement |
| Compression test | After pressing down the protective cap, it must be able to rebound. There should be no shrinkage or jamming. | Meet the requirement |
| Resistance to corrosion | The corrosion resistance of the needle of the lancet shall show no evidence of corrosion. | Meet the requirement |
| Acidity or Alkalinity | The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid. | Meet the requirement |
| Limits for Extractable Metals | When corrected for the metal content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meet the requirement |
| Biocompatibility (Cytotoxicity) | Implicit: No evidence of cytotoxicity. | Tests performed |
| Biocompatibility (Sensitization) | Implicit: No evidence of skin sensitization. | Tests performed |
| Biocompatibility (Intracutaneous) | Implicit: No evidence of intracutaneous reactivity. | Tests performed |
| Biocompatibility (Systemic Tox.) | Implicit: No evidence of acute systemic toxicity. | Tests performed |
| Biocompatibility (Pyrogenicity) | Implicit: No evidence of pyrogenicity. | Tests performed |
| Simulated Clinical Use | The safety mechanism of the proposed device met the pre-established criteria (according to FDA Guidance, Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005). | Met the pre-established criteria |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Physical/Mechanical/Chemical Tests: Not explicitly stated for each individual test. The text generally states "Non-clinical tests were performed on the proposed device."
- Sample Size for Simulated Clinical Use: 500 device samples.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given no specific patient data is mentioned, these are likely laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. For these types of non-clinical, performance-based tests for a lancet, "experts" in the traditional sense (e.g., radiologists for image interpretation) are not typically involved in establishing ground truth. The ground truth for these tests is defined by the physical/mechanical/chemical properties and standards outlined in the acceptance criteria. The tests are conducted by trained technicians or engineers following standard operating procedures.
4. Adjudication Method for the Test Set:
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, where agreement among multiple human readers is required to establish a ground truth for a diagnostic device. For physical performance tests of a lancet, the results are objectively measured against predefined specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic devices (especially those involving image interpretation or AI assistance) to compare performance with and without AI. The Medifun Safety Lancet is a mechanical device for blood sampling, not a diagnostic device requiring human interpretation of results.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This question is not applicable as the device is a physical medical device (safety lancet), not a software algorithm or AI.
7. The Type of Ground Truth Used:
The ground truth for most of the listed tests is based on predefined engineering specifications, international standards (e.g., ISO 9626 Annex A for Acidity/Alkalinity, which implies a standardized method for determining "truth"), and regulatory guidance (e.g., FDA Guidance for simulated clinical use). For the biocompatibility tests, the ground truth is established by the absence of adverse biological reactions according to standardized test protocols.
8. The Sample Size for the Training Set:
This information is not applicable as the device is a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is a physical medical device and does not utilize a training set.
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