(187 days)
The TAP Lancet is a single-use blood lancing device intended for producing microliter capillary whole blood samples. It does not collect or transport such samples.
The TAP Lancet is a single-use blood lancing device with an integral sharps injury prevention feature intended for producing microliter capillary whole blood samples. The TAP Lancet comprises a lancing module and a vacuum creation module which operate in an entirely mechanical fashion. The device uses a lancet and vacuum to initiate blood flow from the capillary bed in the upper arm. To use the device, the user removes that TAP Lancet from a sterile barrier package. Next, the user removes a protective liner from the bottom of the device to expose a layer of medical adhesive and places the device onto the
Let's break down the information regarding the acceptance criteria and the study proving the device meets them for the TAP Lancet.
The provided text is a 510(k) Summary for the TAP Lancet, a blood lancing device. The summary focuses on demonstrating substantial equivalence to a predicate device and includes details about non-clinical and clinical performance testing.
Here's the breakdown of the acceptance criteria and study as presented in the document:
1. Acceptance Criteria and Reported Device Performance
The document describes the performance of the device in a clinical study primarily under the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section. The key metric reported related to the device's functional performance in producing blood samples.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to successfully produce blood samples | Total success rate of 95.0% |
| Device performs as intended | "demonstrated that they performed as intended" |
| Compliance with functional requirements | "met all functional requirements evaluated" |
| Safety and effectiveness for intended use | "found to be safe and effective for the intended use" |
| Residual risks deemed acceptable | "all residual risks were deemed acceptable" |
Note: The document doesn't explicitly state quantitative 'acceptance criteria' in a table format for the clinical study results, but rather presents the study outcome as meeting the overall performance goals.
2. Sample Size and Data Provenance
-
Test Set (Clinical Study):
- Sample Size: Not explicitly stated as a number of subjects. The text mentions "human subjects" and "The devices had a total success rate of 95.0%". From the information on the training set (380 samples), this seems to be a separate smaller study for usability.
- Data Provenance: Not specified regarding country of origin. The study was an "actual-use study" where "Subjects produced their blood samples following the TAP Lancet instructions for use," indicating a prospective study design.
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Training Set (Usability Study, from context of "clinical testing" section related to usability):
- Sample Size: 380 samples (This is the only specific number of "samples" mentioned in relation to a study that isn't device/material testing).
- Data Provenance: Not specified regarding country of origin. The study was a "human use study" that also seems prospective, as subjects were producing blood samples using the device.
3. Number of Experts and Qualifications for Ground Truth
The document does not indicate the use of experts to establish ground truth for the clinical performance. The "ground truth" for the clinical study appears to be the successful production of microliter capillary whole blood samples by the device itself when used by human subjects according to instructions. This implies a direct observational assessment of the device's primary function rather than interpretation by human experts.
4. Adjudication Method for the Test Set
No adjudication method is mentioned. The success of blood sample production is likely a direct, measurable outcome, not requiring interpretation or adjudication by multiple reviewers.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed or described. The study focused on the performance of the device itself (ability to produce blood samples) and its usability, not on comparing human readers with and without AI assistance. This device is a physical lancing device, not an AI/imaging diagnostic tool.
6. Standalone Performance (Algorithm Only)
Not applicable. This is a physical medical device (lancet), not an algorithm or software. Its performance is inherent to its mechanical function.
7. Type of Ground Truth Used
The ground truth for the clinical performance assessment was outcomes data related to the device's primary function: the successful production of microliter capillary whole blood samples. This was a direct, observable outcome of the device's use.
8. Sample Size for the Training Set
As mentioned above, if we interpret "training set" as the data used for the usability study which informed product improvements or finalized the design:
- Sample Size: 380 samples.
9. How Ground Truth for the Training Set Was Established
The "training set" (presumably the samples from the usability study) ground truth was established by direct observation and assessment of the device's ability to produce blood samples and its usability when used by human subjects. The phrase "Subjects produced their blood samples following the TAP Lancet instructions for use" and "The devices had a total success rate of 95.0% and demonstrated that they performed as intended" suggests that success was a direct observation of whether a sample was obtained as specified. The usability portion would have involved feedback or evaluation based on the instructions for use.
§ 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.