(125 days)
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.
§ 878.4850 Blood lancets.
(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.