(57 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 XA Pro and Model ZF.Each model has sharps protection features that it can reduce the occurrence of accidental needle sticks. The device is sterilized by Co-60 or e-beam gamma ray and for single use.The shelf life is 5 years. Model XA Pro has four versions according to the different three penetration depths, version XA1 Pro,version XA3 Pro,version XA5 Pro and version XA11 Pro. Model ZF also has four versions according to the different need type and material of slider, version ZF1,version ZF2,version ZF1 Blade and version ZF2 Blade.
Model XA Pro is composed of a protective cap, a knob (for depth settings), a front spring, housing, needle body with tri-bevel edge needle, a rear spring and a back cover (push button). The needle body with needle or blade is hidden inside the housing/protective cap. The device is colour coded for different versions.There is an integrated automatic inactivation system to prevent lancet reuse. When the back cover is pressed down, it drives the rear spring to compress downwards. The back cover support legs are flush with the inclined surface of the protruding line head of the housing. The needle is rotated and slided downwards under the force of the rear spring until it is disengaged from the inclined surface and fired forward for blood sampling, while compressing the front spring. The needle will be retracted automatically back into the housing after the puncture due to the force from the pressed front spring. The needle cannot go back to the starting position and stays between the relaxed rear spring and front spring. Therefore, the device cannot be re-used.
Model ZF lancet is composed of spring, three-facet needle or blade, housing, and slider. The needle body with needle or blade is concealed within housing/slider. The lancets of different specifications are in different colors. There is an integrated automatic inactivation system to prevent lancet reuse. The spring is fixed at the bottom of the housing, and when the slider is pressed down, which drives the spring to compress downwards.The two locking points(blocked the needle) on the slider will be opened along the slope of the housing, the needle will be released to fire under the force of the spring for blood sampling. After the puncture is completed, the spring retracts to a relaxed state and synchronously pulls the needle body back into the housing. Therefore, the device cannot be re-used.
The provided document is a 510(k) summary for a "Safety Lancet" (K242627). It details the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device (K222090).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Acceptance Criteria (Requirements) | Reported Device Performance (Results) |
|---|---|---|
| Dimension | Dimension should meet the requirements. | Passed |
| Appearance | The needle holder should be smooth and free of defects such as burrs, oil stains, rust spots, and bending. The housing should be smooth, free of burrs, bubbles, impurities and cracks. With normal or corrected to normal vision, there should be no visible accumulation of lubricant on the outer surface of the needle tip. | Passed |
| Needle-tip | The tip of the lancet should have no flat head, burrs, and hooks. Penetration Force should meet the requirements. | Passed |
| Trigger force | The lancet should be activated against 2N~20N axial pressure. | Passed |
| Corrosion resistance feature | Needle should have good corrosion resistance feature. | Passed |
| Retractable | After use, the needle can be automatically retracted. | Passed |
| Penetration Depth | Penetration depth should meet the requirements. | Passed |
| Challenge Safe Mode - Resistance | Apply a 15N force horizontally at the raised platform of the lancet, and the back cover must not be detached. | Passed |
| Challenge Safe Mode - Needle Tip Exposed | After the needle tip of the lancet is retracted, the needle tip cannot be exposed. Observe the needle tip after removing the protective cap, the needle tip should not be exposed. | Passed |
| Anti-activation test | The lancet should not activate when it is mistakenly pushed the button before use. | Passed |
| Self-destruct performance test | The lancet should not be activated again after use. | Passed |
| Fall Performance | The product falls freely to a smooth hard surface at a height of 1 meter, then test the appearance, triggering force, retraction, and penetration depth should meet the requirements. | Passed |
| pH and total heavy metal content and Cd content | pH (difference of blank solution) ≤ 1, Total heavy metal content ≤ 5mg/L and Cd content ≤ 0.1mg/L | Passed |
| Sterility | After the safety lancet has been sterilized by radiation, the needle tip should be sterile. | Passed |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual test within the "Performance Test" section. It broadly states that "All non-clinical bench testing performed on the subject device is to demonstrate the substantial equivalence to the predicate devices."
For the "Performance of Clinical Simulated Use Testing for Sharps Injury Protection," it states: "Select the most widely sold in the market of each model as typical product for study." This suggests a limited sample size focused on representative models, but the exact number isn't provided.
The data provenance is not explicitly stated as originating from a specific country or being retrospective/prospective. Given the manufacturer is Ningbo Medsun Medical Co., Ltd. in China, it's highly likely the testing was conducted in China. The "non-clinical bench testing" and "clinical simulated use testing" imply a prospective testing approach dedicated to this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not involve expert-established ground truth in the traditional sense for diagnostic AI/software. The testing described is for a physical medical device (safety lancet) and focuses on engineering and performance criteria. The "ground truth" for the performance tests would be objective measurements and observations against pre-defined engineering and safety standards. No human expert consensus for a diagnostic outcome is relevant here.
4. Adjudication method for the test set
Not applicable. This is not a diagnostic study requiring human adjudication for interpretation. The performance tests involve objective physical and chemical measurements.
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 is a submission for a physical medical device (safety lancet), not an AI-powered diagnostic tool, and therefore an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
The ground truth used for these tests are the pre-defined technical specifications, engineering requirements, and safety standards (e.g., ISO 23908:2011, ISO 10993 series, and 21 CFR 801). The "Passed" results indicate that the device met these objective criteria.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for a physical safety lancet.
§ 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.