(175 days)
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are reusable lancing devices intended to be used with sterile, single-use compatible lancet blades to obtain a capillary blood sample from the fingertip or alternate sites for blood glucose testing or other tests that require small amounts of blood. The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are intended for single person use only.
The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are used with a compatible single-use lancet to puncture the skin and release a small amount of blood. The products are distributed individually or packaged together with blood glucose monitoring systems to obtain capillary whole blood samples required for testing blood glucose levels.
The provided text is an FDA 510(k) premarket notification approval letter for a Multi-Lancet Device 2 and ReliOn Premier Lancing Device. It focuses on demonstrating substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System) through comparisons of intended use, technological characteristics, and non-clinical performance testing.
Crucially, this document focuses on a medical device (lancing device) and not an AI/ML-driven medical device. Therefore, a significant portion of the requested information, such as "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "training set size," and "how ground truth for training set was established," are not applicable to the information provided.
The document primarily describes the physical device and its mechanical and safety performance, not the performance of an AI algorithm.
Here's a breakdown of the available information based on your request, noting where information is not applicable (N/A) due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document mentions "Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life." It also states, "Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use."
However, specific numerical acceptance criteria (e.g., maximum allowed force for puncture, minimum number of uses before failure) and the reported device performance against these criteria are not detailed in this public FDA letter. The letter only confirms that such testing was done and met the requirements.
Table of Acceptance Criteria and Reported Device Performance (Based on provided text)
| Category | Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|---|
| Safety & Usability | Ensure safety and usability for the duration of the claimed service life, addressing all identified risks. | "Non-Clinical bench testing was performed per the special controls (878.4850). Cleaning/Disinfecting and Mechanical Robustness verification testing was completed to ensure the safety and usability for the duration of the claimed service life. The risk analysis contained in the Risk Management Report confirms that all identified risks were addressed and mitigated appropriately. All residual risks after mitigation were acceptable and communicated in the instructions for use." |
| Performance | Meet performance requirements for their intended use. | "Performance testing on the proposed Multi-Lancet Device 2 and ReliOn Premier Lancing Device demonstrate that the devices meet the performance requirements for their intended use." |
| Labeling | Adequately communicate intended use, safety precautions, and directions for use, meeting 21 CFR § 801 and 21 CFR 878.4850 (c)(vi). | "Labeling adequately communicates to the user the device intended use, safety precautions and directions for use. The labeling meets the requirements documented in the: 1. Regulation for Medical Device Labeling (21 CFR § 801) 2. Regulation for multiple use blood lancet for single patient use only (21 CFR 878.4850 (c)(vi))" |
| Substantial Equivalence | Demonstrate substantial equivalence to predicate device based on classifications, intended use, and technological characteristics. | "The Multi-Lancet Device 2 and ReliOn Premier Lancing Device are substantially equivalent to the predicate Accu-Chek Softclix Lancing Device based on comparisons of the device classifications, intended use, and technological characteristics. Non-clinical performance testing successfully confirmed the suitability of the Multi-Lancet Device 2 and ReliOn Premier Lancing Device for the intended uses and demonstrated the devices are as safe, as effective, and perform as well as the predicate device as required per 21 CFR § 807.92(b)(3)." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Non-Clinical bench testing." This typically involves laboratory testing of the physical device rather than a "test set" of clinical data (like medical images). The sample size for these bench tests is not specified, nor is the "data provenance" as it's not a clinical data study. The applicant's address is ARKRAY Factory, Inc., 1480 Koji, Konan-cho, Koka-shi, Shiga 520-3306 Japan, suggesting the company is based in Japan, but this doesn't explicitly state the location of the bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical lancing device, not an AI/ML-driven diagnostic tool that requires ground truth established by experts interpreting data (e.g., radiologists interpreting images). The "ground truth" for this device relates to its mechanical performance and safety, verified through specified testing protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no "test set" of patient data that would require an adjudication method.
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/ML device, and no MRMC study would be conducted. The "assistance" provided by this device is mechanical (blood sampling), not interpretative or cognitive.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a mechanical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance, as implied, is established by bench test standards and regulatory requirements (e.g., 21 CFR 878.4850 special controls) regarding mechanical robustness, cleaning/disinfection effectiveness, and general safety. It's not a "truth" derived from clinical data like pathology or expert consensus.
8. The sample size for the training set
Not applicable. As this is not an AI/ML device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As this is not an AI/ML device, there is no "training set" or corresponding ground truth establishment method.
§ 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.