(143 days)
The Genteel lancing device is used with disposable sterile lancets to draw capillary blood from the fingertip or alternate sites for blood glucose testing or other testing utilizing small amounts of blood.
The Genteel lancing device is for Single Patient Use Only.
The Genteel® Lancing Device (Genteel) is a dual-spring mechanical blood lancet holder for collecting capillary whole blood sampled from the fingertip or alternate sites. The Genteel lancing device is used with commercially available, sterile, standard square shaft blood lancets.
The provided document is a 510(k) summary for the Genteel Lancing Device. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as typically seen for novel medical devices or AI algorithms.
Therefore, many of the requested sections (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable or not provided in this type of submission.
Below is a response based only on the information available in the provided text, indicating when information is not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Puncture Capability: Demonstrates adequate depth and functionality for drawing capillary blood from fingertip or alternate sites. | Penetration Capability Protocol: "Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence." (Exact metrics/thresholds of penetration capability are not specified in this document.) |
| Material Safety & Biocompatibility: Materials are medical grade and suitable for patient contact. | "Genteel and the predicate devices are primarily made from different plastics which are both medical grade..." |
| Sterility: Disposable lancets used with the device are sterile. | "The Genteel lancing device is used with disposable sterile lancets..." |
| Single Patient Use: Device designed and labeled for single patient use. | "The Genteel lancing device is for Single Patient Use Only." |
| Substantial Equivalence: Device performs as intended, similarly to legally marketed predicate devices, for collecting capillary blood. | "The Genteel Lancing Device... is substantially equivalent to the chosen predicate devices, the On Call® Chosen Lancing Device (K113332) and the Autolet Impression Lancing Device..." "The Genteel 510(k) documents and results of the non-clinical testing demonstrate that Genteel is substantially equivalent..." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the document. The document refers to "Performance testing includes a Penetration Capability protocol," but the sample size for this protocol is not provided.
- Data Provenance: Not specified. This would typically be part of a detailed study report, which is not included here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. This type of information would be relevant for devices demonstrating diagnostic accuracy against an expert-derived ground truth (e.g., imaging devices analyzed by radiologists). The Genteel Lancing Device is a mechanical lancing device, and its performance is evaluated based on physical characteristics and functional tests (like penetration capability) rather than expert interpretation.
4. Adjudication method for the test set
- Not Applicable / Not Provided. Adjudication methods are typically used in studies where multiple human readers or systems interpret data, and their disagreements need to be resolved to establish a definitive ground truth. This is not relevant for the type of device and performance evaluation 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. The Genteel Lancing Device is a mechanical lancing device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. As the Genteel Lancing Device is a mechanical device, there is no "algorithm only" performance to evaluate. Its "standalone" performance would be its functional performance, which is covered by the "Penetration Capability protocol" mentioned as part of non-clinical testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Functional Performance Standards: The "ground truth" for the Genteel Lancing Device's performance would be established functional standards and metrics (e.g., consistent penetration depth, proper blood sample collection) as determined by an engineering or performance testing protocol. The document states, "Performance testing includes a Penetration Capability protocol that demonstrates substantial equivalence." The specific parameters of this "ground truth" (e.g., minimum blood volume, specific depth range) are not detailed in this summary.
8. The sample size for the training set
- Not Applicable / Not Provided. The Genteel Lancing Device is a mechanical medical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant to the Genteel Lancing 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.