(59 days)
The Facet 28G Universal Lancet is a sterile, disposable single used to obtain a droplet of capillary blood for subsequent diagnostic testing from the finger or an alternative site, such as the palm, upper arm, or forearm. The Lancet is to be properly disposed of after a single use on an individual child, adolescent, or adult patient in a home setting.
The Facet 28G Universal Lancet) is a sterile, single use, blood sampling device used to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients. The lancets consist of a 28G stainless steel needle overmolded with low density polyethylene (LDPE) and integral sterility cap. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-9.
This document is a 510(k) summary for the Facet 28G Universal Lancet, a medical device. It does not describe an AI/ML-enabled device, nor does it contain information about clinical studies with human participants, expert ground truth establishment, or multi-reader multi-case (MRMC) studies. Therefore, many of the requested points regarding acceptance criteria and study details for AI/ML devices cannot be answered from this document.
However, I can extract the acceptance criteria and performance related to the non-clinical bench testing for this physical device.
Device: Facet 28G Universal Lancet
Nature of the Device: This is a physical medical device (blood lancet), not an AI/ML software device. The acceptance criteria and performance data presented are for physical and material properties, and compatibility, not for diagnostic accuracy or algorithmic performance.
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes non-clinical bench testing, which serves as the "study" to prove the device meets pre-determined criteria. The reported performance is not explicitly given in numerical terms for all tests, but rather stated that "predetermined criteria were met" and "risks were appropriately managed." However, the acceptance criteria (requirements) are provided.
| Property/Characteristic | Acceptance Criteria (Requirement) | Reported Device Performance (Implied) |
|---|---|---|
| Bond Strength of lancet blade (needle) to lancet body | $\geq$ 13.23 N | Met the criteria (stated "predetermined criteria were met") |
| Sterility Cap Torque | $\leq$ 4.9 N-cm | Met the criteria (stated "predetermined criteria were met") |
| Compatibility with lancet bases (lancing devices) | Ensure usability with commercially available lancet bases | Met the criteria (stated "predetermined criteria were met") |
| Biocompatibility | Meet ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 requirements (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity) | Met the criteria (stated "predetermined criteria were met") |
| Sterility | Sterilized by Gamma Radiation SAL = $10^{-6}$ | Met the criteria (Same as predicate) |
Note: The document only states that the criteria were "met" or that the performance was "same" as the predicate. Specific numerical results of the tests (e.g., the exact bond strength measured) are not provided in this summary.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: The document does not specify the numerical sample sizes for each non-clinical test (e.g., how many lancets were tested for bond strength or cap torque). It broadly states that "non-clinical bench testing was performed."
- Data Provenance: This is not applicable in the context of clinical data for an AI/ML device. For this physical device, the data provenance is from internal non-clinical bench testing performed by Facet Technologies, LLC. The testing ensures the device meets specified engineering and biocompatibility requirements.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not applicable. This device is a physical lancet, not an AI/ML system requiring expert interpretation of data. The "ground truth" here is objective measurement of physical properties (e.g., force, torque) and standard biocompatibility testing.
4. Adjudication Method for the Test Set
- Not applicable. There is no human interpretation or adjudication required for the physical property tests or biocompatibility assessments described.
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 not an AI-enabled device and no MRMC studies were performed or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used
- For physical properties (Bond Strength, Cap Torque): The ground truth is established by objective physical measurements against engineering specifications.
- For Biocompatibility: The ground truth is established by standardized international (ISO 10993 series) and FDA-recognized test methods performed in a laboratory setting.
- For Compatibility: The ground truth is established via simulated use with commercially available lancing devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no "training set." The focus is on verifying compliance with design specifications and regulatory standards.
9. How the ground truth for the training set was established
- Not applicable. There is no training set as this is not an AI/ML 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.