(99 days)
The safety lancet is intended for capillary blood sampling.
The safety lancet is single use medical device, which is designed to collect capillary blood sample. The intended users include Healthcare personnel, patients and lay persons. According to surface difference or structure, the Safety lancets have 8 models: XIII, XVII, XXI, XXIII, XXIV, XXV, XXVI. XVII model have sub model according to surface difference. For Model XIII, XVII, XXI, XXII, XXV, the safety lancets consist of needle core, button, housing, bottom, spring and protective cap. For Model XXIII, the safety lancets consist of needle core, button, housing, and spring. For Model XXIV, the safety lancets consist of needle core, button, housing, spring and ring, And for Model XXVI, the safety lancets consist of needle core, button, housing, small lid and spring. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10° by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
The provided text describes the 510(k) summary for a Safety Lancet device, specifically K220370. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and simulated clinical use. It is a regulatory submission for a medical device rather than a report detailing a clinical trial or an AI/software as a medical device (SaMD) study. Therefore, many of the requested details, such as the use of AI, human reader studies, and sophisticated ground truth establishment, are not applicable to this type of device submission.
However, I can extract the relevant information from the provided text regarding acceptance criteria and the studies performed for this specific medical device.
Acceptance Criteria and Device Performance (Non-Clinical Testing)
Here's a table summarizing the acceptance criteria and reported device performance based on the "Non-Clinical Testing" section:
| Items | Acceptance criteria | Reported Device Performance |
|---|---|---|
| Appearance | The surface shall be free of burr and no scratches. | Meet the requirement |
| Dimension | Product dimensions shall be consistent to the drawings. | Meet the requirement |
| Cleanness | No dust, no grease, no hair, no dirt. | Meet the requirement |
| Firmness | Needle should connect firmly with plastic handle. | Meet the requirement |
| Resistance to corrosion | Corrosion resistance of needle of lancet shall show no evidence of corrosion. | Meet the requirement |
| Acidity or Alkalinity | The pH value of an extract prepared refers to ISO 9626 Annex A shall be within one pH unit of that of the control fluid. | Meet the requirement |
| Limits for Extractable Metals | When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meet the requirement |
| Puncture depth | Use calipers to measure and meet the requirements. | Meet the requirement |
| Launch performance | Launch performance should be good, launch button press smoothly, no jam. | Meet the requirement |
| Puncture force | The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Lubricant | Visual, should not be visible droplets. | Meet the requirement |
| Disposable | Safety lancet should be single use, no second launch after used. | Meet the requirement |
| Safety Feature | The force to activate the safety feature: 4 - 15N. Test access to the sharp: the needle shall not touch the sphere. | Meet the requirement |
Summary of Device Performance Study Information:
The provided document describes physical and biological tests for a medical device (Safety Lancet), not an AI/Software as a Medical Device (SaMD). Therefore, many of the questions related to AI performance, human-in-the-loop studies, multi-reader multi-case studies, and ground truth establishment for AI models are not applicable.
Here's the information that is extractable from the provided text:
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Sample size used for the test set and data provenance:
- Simulated Clinical Use: 500 device samples were used for the simulated clinical use study.
- Non-Clinical Testing: The sample sizes for the individual bench tests (e.g., appearance, dimension, firmness) are not explicitly stated, but it's implied that sufficient samples were tested to "Meet the requirement."
- Data Provenance: Not specified in terms of country of origin. The studies are described as "bench testing" and "simulated clinical use," implying lab-based testing rather than clinical patient data. The document is a 510(k) submission to the FDA, from a company in Tianjin, China.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this device's testing. Ground truth for physical characteristics (e.g., dimensions, corrosion) is established by measurement against predefined specifications, not by expert consensus in this specific case.
- For biocompatibility testing, compliance with ISO 10993 series standards is the "ground truth," evaluated by laboratory tests performed by qualified personnel, but not "experts" in the sense of radiologists.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not a study requiring adjudication of interpretations (e.g., imaging reads). The tests are objective measurements or categorical observations (e.g., "no burr," "no corrosion").
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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:
- No. This is a physical medical device (Safety Lancet), not an AI/software. Therefore, no MRMC study with human readers was conducted or is applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm or AI device. The testing described is for the physical performance and safety features of the lancet itself.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Non-Clinical Testing (bench tests): The ground truth is based on engineering specifications, industry standards (e.g., ISO 9626 Annex A for pH, specific limits for extractable metals), and established physical or visual inspection criteria (e.g., "free of burr," "no dust," "no evidence of corrosion").
- For Biocompatibility Testing: Ground truth is established by adherence to and passing results from tests specified in ISO 10993 series standards (e.g., "No Cytotoxicity," "No Skin Sensitization").
- For Simulated Clinical Use: The ground truth is whether the device "met the pre-established criteria" for its safety mechanism, evaluated according to FDA Guidance and ISO 23908.
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The sample size for the training set:
- Not applicable. This is a physical device, not an AI model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As noted above, there is no AI training set for this 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.