(77 days)
Safety Lancet is intended to be used to obtain capillary blood sample to perform medical testing, including blood glucose monitoring and for tests using small amounts of blood.
Safety Lancet, could be divided into Model XY, Model XH and Model XA according to the design features and key functional elements.The device is sterilized by Gamma ray(Co-60 or e-beam) and for single use. The shelf life is 5 years.
The provided document is a 510(k) summary for the "Safety Lancet" device, which makes an equivalence claim to previously cleared predicate devices. Since this is an equivalence claim, the studies described are primarily non-clinical bench testing to demonstrate that the subject device performs as safely and effectively as the predicate devices. It does not contain information about clinical studies with human participants.
Therefore, many of the requested fields related to clinical efficacy studies, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, are not applicable to the information provided in this 510(k) summary. These types of studies are typically conducted for new technologies or to demonstrate clinical efficacy, which is not the primary purpose of a 510(k) submission based on substantial equivalence.
Here's the information extracted from the document based on the request:
1. Table of acceptance criteria and the reported device performance:
The document lists performance tests conducted but does not explicitly state "acceptance criteria" and "reported device performance" in a direct side-by-side format with quantitative measures for each criterion. Instead, it states that the performance data were "provided in support of the substantial equivalence determination" and that "The test results show that the product had well sharps injury prevention feature." This implies that the device met the internal (or external standard-based) acceptance criteria for each test.
| Test Item | Implied Acceptance Standard/Goal | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993 series standards, demonstrating no adverse biological reactions. | Met requirements. "The biocompatibility evaluation items of proposed device were completed for each model and each sterilization method (Co-60 and e-beam) individually. The testing included the following tests: In vitro cytotoxicity, Skin sensitization, Intracutaneous reactivity, Acute systemic toxicity, Pyrogen." The document also notes that the subject device's biocompatibility testing was "more strict" than Predicate Device A. |
| Dimension | To meet specified dimensions and potentially ISO 9626:2016 for needles. | Met requirements. "Dimension/gauge of the needles all meet the requirements ISO 9626:2016." |
| Appearance | To meet visual inspection standards (e.g., no defects, damage). | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Needle-tip | To meet specified characteristics (e.g., sharpness, integrity). | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Trigger force | To be within a functional range for intended use. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Corrosion resistance feature | To prevent corrosion during shelf life and use. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Retractable | To ensure the needle retracts automatically after puncture. | Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the design description). |
| Penetration Depth | To meet specified penetration depths for different models/gauges. | Met requirements. The range for the subject device (1.2mm to 2.8mm) is noted as "the same as the penetration depth of predicate device A." Specific depths for various models are listed in the comparison table. |
| Challenge Safe Mode-Resistance | To ensure the sharps injury prevention feature functions correctly, resisting attempts to expose the needle after use. | Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test). |
| Challenge Safe Mode-Needle Tip Exposed | To ensure the needle tip remains shielded after use. | Met requirements. "The test results show that the product had well sharps injury prevention feature." (General statement for sharps injury protection features, including this test). |
| Anti-activation test (Model XH and XA) | To ensure the device does not activate accidentally. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Self-destruct performance test | To ensure the device cannot be reused after initial activation. | Met requirements. (Implied, as it's listed as a conducted test without issues, and part of the automatic inactivation mechanism description). |
| Sterility | To achieve a Sterility Assurance Level (SAL) of 10^-6. | Met requirements. "Sterilization SAL:10-6" with Irradiation Sterilization (Co-60 or e-beam). |
| pH and total heavy metal content, Cd content | To meet safety standards for leachable substances. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Bacterial Endotoxins | To ensure endotoxin levels are below specified limits. | Met requirements. (Implied, as it's listed as a conducted test without issues). |
| Clinical simulated use testing for sharps injury protection | Compliance with ISO 23908:2011 and FDA Guidance for Medical Devices with Sharps Injury Prevention Features. To demonstrate prevention of sharps injuries. | Met requirements. "we have completed the test of clinical simulated use testing for sharps injury protection for each model. The test results show that the product had well sharps injury prevention feature." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is typically provided in detailed test reports, not in a 510(k) summary. The document does not specify exact sample sizes for each bench test. The studies were non-clinical bench tests. The country of origin for the studies is not explicitly stated, but the manufacturer is Ningbo Medsun Medical Co., Ltd. in China.
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, as this was a non-clinical bench study for a physical medical device (safety lancet), not an AI/software device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this was a non-clinical bench study.
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, as this was a non-clinical bench study for a physical medical device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable, as this was a non-clinical bench study for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is based on established engineering standards (e.g., ISO, internal specifications) for mechanical function, material properties, sterility, and biocompatibility. For example, ISO 9626:2016 for needle dimensions or ISO 10993 series for biocompatibility.
8. The sample size for the training set
Not applicable, as this was a non-clinical bench study for a physical medical device, not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as this was a non-clinical bench study for a physical medical device.
§ 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.