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510(k) Data Aggregation
(118 days)
Disposable Sterile Lancet: The lancet is intended for capillary blood sampling.
Lancing Device:
The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is single patient use only and should not be shared with anyone else, even a family member.
Disposable Sterile Lancet is Class II Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature bearing the product code ORK (21CFR 878.4850), and The Disposable Sterile Lancet and lancing device is Class II Multiple Use Blood Lancet For Single Patient Use Only bearing the product code QRL (21CFR878.4850).
The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. And the lancing device is intended for capillary blood sampling with Disposable Sterile Lancet. The lancet can be used independently, or used together with lancing device.
The intended users include healthcare personnel, patients and lay users.
The lancet is provided sterile. 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 lancet is 5 years.
This document describes a 510(k) submission for a Disposable Sterile Lancet and Lancing Device. The submission aims to demonstrate substantial equivalence to a predicate device (K220475).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Items | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | ||
| Product Appearance | No obvious foreign body, fracture, unformed defects etc. | Meet the requirements |
| Needle-tip | No obvious burrs, curved hooks, oil stains etc. Lancet should be well assembled, no obvious dislocation at the fitting of the shell | Meet the requirements |
| Dimensions | ||
| Diameter of needle core | Product dimensions shall be consistent to the drawings | Meet the requirements |
| Length of exposed needle-tip | The length of exposed needle-tip shall be consistent to the drawings. | Meet the requirements |
| Performance | ||
| Puncture Force | 17-20G≤4N 21-25G<1.5N 26-38G≤1N | Meet the requirements |
| Firmness | Needle should connect firmly with plastic handle | Meet the requirements |
| Sterility | The sterility for the device shall be at SAL of 10-6 | Meet the requirements |
| Biocompatibility | ||
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Acute Systemic Toxicity | Under the conditions of the study, the subject device is no acute systemic toxicity | Pass |
| Pyrogen | Under the conditions of the study, the subject device is no pyrogenicity reaction | Pass |
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 the sample size used for the non-clinical performance and biocompatibility tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The studies conducted are non-clinical (performance and biocompatibility), which do not typically involve human expert ground truth establishment in the same way clinical studies or AI diagnostic device studies would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. The studies are non-clinical laboratory tests, not clinical evaluations requiring adjudication of expert opinions.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical medical device (lancet and lancing device), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical medical device. There is no algorithm or AI component involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was established by objective measurements and standardized testing procedures against defined acceptance criteria (e.g., measuring puncture force, examining appearance for defects, confirming sterility via standard methods, and conducting biocompatibility tests according to ISO standards). It's essentially objective laboratory measurements and adherence to international standards.
8. The sample size for the training set
This is not applicable as there is no mention of a training set. This is a traditional medical device submission, not an AI/machine learning device that requires training data.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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