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510(k) Data Aggregation
(125 days)
SafetiCET Safety Lancet
The device is designed for obtaining capillary blood sample.
The SafetiCET Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a needle encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use.
The provided text describes the SafetiCET Safety Lancet and its substantial equivalence to a predicate device (VeriFine Safety Lancet) based on performance testing. However, it does not provide specific acceptance criteria values or detailed study results that prove the device meets these criteria in a quantitative sense for each test. Instead, it lists the types of performance tests conducted and generally states that the device's performance is comparable to the predicate or meets requirements.
Here's a breakdown of the requested information based on the provided text, with notes on what is not available:
Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The SafetiCET Safety Lancet is a single-use blood lancet designed to obtain capillary blood samples. Its substantial equivalence to the predicate device (VeriFine Safety Lancet, K221368) is asserted based on similarities in intended use, indications for use, sterilization methods, and performance characteristics.
The testing conducted aimed to confirm the safety and effectiveness of the device by evaluating various physical and mechanical properties relevant to its function and specified safety features. While specific numerical acceptance criteria for each test are not explicitly stated, the summary implies that the results of these tests were found to be acceptable and comparable to the predicate device's performance.
1. A table of acceptance criteria and the reported device performance
| Performance Test Category | Acceptance Criteria (Implicit from context) | Reported Device Performance (from text) |
|---|---|---|
| Sterilization | Sterility Assurance Level (SAL) of 1$0^{-6}$ as per ISO 11137-1:2006 | Meets the Sterility Assurance Level of 1$0^{-6}$ as per the requirement of ISO 11137-1:2006. |
| Penetration Depth | In the same range as the needle length of the predicate device. | Results are in the same range of the needle length of the predicate device. |
| Twist Break Force | Allows the protective cap to break the encapsulation and detach, preparing the device for activation. | Measured as part of device performance assessment (implies it met functional requirements for cap detachment). |
| Drop Test | (Not explicitly stated, but implies structural integrity and functionality retention after drops) | Test conducted (implies satisfactory outcome for substantial equivalence). |
| Joint Strength of Needle-to-Needle Holder | (Not explicitly stated, but implies sufficient strength to prevent needle detachment during use) | Test conducted (implies satisfactory outcome for substantial equivalence). |
| Joint Strength of Top Cover to Housing | (Not explicitly stated, but implies sufficient strength for proper assembly and function) | Test conducted (implies satisfactory outcome for substantial equivalence). |
| Puncture Resistance | (Not explicitly stated, but implies proper functioning of the needle) | Test conducted (implies satisfactory outcome for substantial equivalence). |
| Needle Retraction | Automatic retraction into the housing after penetration to prevent re-use and needlestick injuries. | Return Spring pushes the needle back into the housing preventing any needlestick issue. Needle cannot be pushed out for a second round. |
| Mechanical Properties Test of Material | (Not explicitly stated, but implies materials meet specifications for intended use) | Test conducted (implies satisfactory outcome for substantial equivalence). |
| Biocompatibility | Compliance with ISO 10993 series. | ISO 10993 series testing performed. |
Note: The document only lists the types of tests and generally states that the device's performance is comparable to or meets the requirements, rather than providing specific numerical acceptance thresholds or detailed performance metrics. For example, for "Penetration depth test," it says "results...are in the same range," but doesn't provide the range itself or the specific measurements.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the performance tests.
- Data Provenance: Not specified. It can be inferred that the testing was performed by NSP Tech Pte Ltd, based in Singapore, but details about the origin of test data (e.g., country, retrospective/prospective) are not provided.
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)
Not applicable. The performance tests described are mechanical and physical property tests of the medical device itself, not diagnostic performance tests requiring expert interpretation or ground truth establishment by clinical experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this refers to clinical evaluation requiring adjudication (e.g., in cases of disagreement among expert readers). The tests described are objective, physical, and mechanical performance evaluations of the device.
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 device is a blood lancet, a mechanical instrument, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a blood lancet, a mechanical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the clinical sense. For the physical and mechanical tests, the "ground truth" would be established by objective measurements against predefined engineering specifications and relevant ISO standards (e.g., ISO 11137-1:2006 for sterility, ISO 10993 series for biocompatibility).
8. The sample size for the training set
Not applicable. This device is a physical medical instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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