(59 days)
The Facet Manatee Reusable Lancet Base (commonly referred to as a lancing device) is a non-sterile reusable device which provides a spring-loaded mechanism to quickly eject and retract a standard or regular version lancet to effect a lancing event for the purpose of obtaining a blood sample for diagnostic testing in children, adolescents (use on children and adolescents should be by or under supervision of an adult), and adults in a home setting. The device is designed to be cleaned and disinfected between uses on a single patient.
The Facet Manatee Reuseable Lancet Base is a reuseable blood sampling device used in conjunction with a standard or universal lancet blade to obtain a sample of capillary blood for diagnostic purposes, primarily for blood glucose monitoring in diabetic patients.
The provided text describes the Facet Manatee Reusable Lancet Base, a reusable lancing device for obtaining blood samples for diagnostic testing. The submission is a 510(k) premarket notification, which aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested regarding AI/CAD efficacy studies, such as effects on human readers, ground truth establishment for AI models, and training set details, is not applicable or present in this document.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical bench testing performed to ensure the device meets predetermined criteria and satisfies special controls. While specific numerical acceptance values are not provided, the "Importance" column outlines the intended performance. The conclusion states that the tests demonstrate the candidate device is substantially equivalent to the predicate.
| Property/Characteristic | Test Method | Importance (Acceptance Criteria) | Reported Performance (Implied by Conclusion) |
|---|---|---|---|
| Endcap Removal Force | Tensile strength tester | Ensure cap can be removed easily to insert lancet blade. | Test was performed and criteria met (device is substantially equivalent). |
| Endcap Attachment Force | Tensile strength tester | Ensure cap will remain on lancet base during lancing event. | Test was performed and criteria met (device is substantially equivalent). |
| Depth of Puncture | Calibrated High Speed Video | Ensure depth of puncture is repeatable for various depth settings. | Test was performed and criteria met (device is substantially equivalent). |
| Over-Charging Force | Tensile force gauge | Ensure that device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Charging Force | Tensile force gauge | Ensure device can be charged to engage actuation spring. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Insertion Force | Tensile force gauge | Ensure lancet can be easily inserted. | Test was performed and criteria met (device is substantially equivalent). |
| Depth Adjust Torque | Torque gauge | Ensure that depth adjustment can be easily adjusted and that adjustment will not change during use. | Test was performed and criteria met (device is substantially equivalent). |
| Button Activation Force | Tensile force gauge | Ensure activation force is within specification. | Test was performed and criteria met (device is substantially equivalent). |
| Lancet Rotation | Torque gauge | Ensure lancet does not rotate during device actuation. | Test was performed and criteria met (device is substantially equivalent). |
| Drop Test | Simulated Use after drop | Ensure that device can withstand a 1 meter drop to a hard surface and still function. | Test was performed and criteria met (device is substantially equivalent). |
| Life Cycle Test | Simulated use | Ensure device can withstand 3 years of expected use. | Test was performed and criteria met (device is substantially equivalent). |
| Chemical Test | Cleaning and disinfection studies | Ensure device can withstand recommended cleaning and disinfection over useful life. | Test was performed and criteria met (device is substantially equivalent). |
| Storage Temperature Test | Simulated Use | Ensure device can function after exposure to heat and cold cycles. | Test was performed and criteria met (device is substantially equivalent). |
| Biocompatibility | Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity, Acute Systemic toxicity (materials mediated pyrogen) | Ensure material of construction are biocompatible for their intended use. | Conducted per ISO 10993 at a GLP testing facility; tests were performed and criteria met (device is substantially equivalent). |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical bench testing. It does not specify a "test set" in the context of patient data or clinical trials, nor does it provide details on sample sizes for each bench test beyond the phrase "non-clinical bench testing was performed." The provenance of this data would be laboratory testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a non-clinical device submission not involving expert review of diagnostic images or interpretations.
4. Adjudication method for the test set:
Not applicable. This is a non-clinical device submission.
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:
No MRMC study was done. This device is a mechanical lancing device, not an AI-assisted diagnostic tool. Clinical testing was deemed "not applicable" as per the document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used:
For the non-clinical tests, the "ground truth" is defined by the engineering specifications and performance requirements for the device (e.g., specific force values for button activation, a device functioning after a 1-meter drop). For biocompatibility, the ground truth is established by the relevant ISO 10993 standards and the results from GLP testing, demonstrating the material's biological safety.
8. The sample size for the training set:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
9. How the ground truth for the training set was established:
Not applicable. This is a non-clinical device submission and does not involve AI/ML training.
§ 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.