(129 days)
The ImPress is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
The LetsGetChecked ImPress is a single-use blood lancing tool equipped with an integral sharps injury prevention feature. It is intended for use by health care professionals in producing capillary whole blood samples from the upper arm. To use the device, the user first removes the device tabs to expose the two internally contained lancets. The plastic strip liner is then removed, exposing a layer of medical adhesive. The device is then placed on the upper arm. Activation occurs when the device is compressed against the arm, causing two contact-activated lancets to puncture the skin. The lancets automatically retract to a safe position, preventing sharps injury and re-activation. The device operates solely through mechanical means. During activation, the device generates a vacuum against the skin, which facilitates the emergence of microliter quantities of capillary blood from the puncture site.
The provided FDA 510(k) summary for the LetsGetChecked ImPress blood lancing device (K242680) outlines several non-clinical performance studies conducted to demonstrate substantial equivalence to its predicate device (TAP Lancet, K223201). However, it does not include a table of acceptance criteria and reported device performance for the usability study, nor does it provide detailed information regarding the study design elements typically found for a study proving acceptance criteria.
The information provided primarily focuses on the device's technical characteristics and the types of non-clinical tests performed. It mentions usability testing but lacks specific performance metrics or acceptance criteria for that test.
Based on the provided text, here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not explicitly provided in the given document. While it states that "Usability Testing was performed to verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device," it does not specify the quantitative or qualitative acceptance criteria for these aspects or the actual performance results against those criteria.
2. Sample size used for the test set and the data provenance
For the Usability Testing: The document does not specify the sample size used for this test. It also does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided for the usability testing or any other test. "Ground truth" in the context of usability would typically refer to expert evaluation of user performance or validated criteria for "good" usability.
4. Adjudication method for the test set
This information is not provided.
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
An MRMC study is relevant for diagnostic imaging devices where human readers interpret results, often with AI assistance. This device is a blood lancing device, not an imaging diagnostic tool. Therefore, an MRMC study was not performed, and this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is also more relevant for AI/ML-driven diagnostic or assistive devices. As the LetsGetChecked ImPress is a mechanical blood lancing device, it does not involve algorithms or AI. Therefore, a standalone algorithm-only performance study was not performed, and this question is not applicable.
7. The type of ground truth used
For the usability testing, the "ground truth" would likely be defined by a set of pre-established usability goals and criteria, as the device is mechanical and its function is to produce blood samples. The document states the usability testing aimed to "verify user comprehensions for use, validate the ability to produce blood samples from the upper arm when device is used according to the instructions for use, and to measure the devices ease of use and user satisfaction with the device." This implies a combination of:
- Performance-based criteria: Successful production of blood samples.
- Qualitative user feedback: Ease of use and user satisfaction.
- Compliance with instructions: Verification of user comprehension.
However, the specific methods for establishing these "truths" (e.g., expert observation, direct measurement, user questionnaires with pre-defined success rates) are not detailed.
8. The sample size for the training set
This question is applicable to devices involving machine learning or AI. As the ImPress is a mechanical device, there is no training set in the context of AI/ML.
9. How the ground truth for the training set was established
As there is no training set (see point 8), this question is not applicable.
Summary of what is available and what is missing:
The document lists several non-clinical studies conducted (Shelf-life, Transport, Biocompatibility, Usability, Accidental Drop) and states their purpose (confirm specifications, intended use, substantial equivalence). For the Usability Testing, it broadly describes the goals (user comprehension, ability to produce samples, ease of use, satisfaction). However, it lacks the specific quantitative or qualitative acceptance criteria and the detailed results of these tests, which would directly "prove" the device meets acceptance criteria. Furthermore, details regarding sample sizes, ground truth establishment, expert involvement, and adjudication methods for the usability study are not provided in this specific FDA letter and summary.
§ 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.