(189 days)
The TRUEdraw Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The Mini Lancing Device is for use with a disposable sterile lancet for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the forearm.
The TRUEdraw Lancing Device/ Mini Lancing Device is for use only on a single patient in a home setting.
The TRUEdraw Lancing Device/ Mini Lancing Device is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
The TRUEdraw Lancing Device/ Mini Lancing Device is a reusable blood lancet holder intended to be used in conjunction with a sterile, single-use blood lancet for obtaining a capillary blood sample for testing purposes from the fingertip and from alternative sites, such as the forearm. TRUEdraw Lancing Device/ Mini Lancing Device is intended for multiple use by a single patient.
This document is a 510(k) Premarket Notification from Trividia Health for their TRUEdraw Lancing Device and Mini Lancing Device. It seeks to demonstrate substantial equivalence to a legally marketed predicate device, the Accu-Chek Softclix Blood Lancing Device (K214022).
The core of the submission revolves around non-clinical bench testing, as clinical testing was deemed not applicable for this device type. Thus, there is no discussion of human-in-the-loop performance, expert ground truth adjudication, or multi-reader multi-case studies typically associated with AI/ML device evaluations.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this type of device are primarily based on special controls outlined in 21 CFR 878.4850(c), which focus on design verification and validation testing. The reported performance indicates that the devices passed these tests.
| Acceptance Criteria Category | Specific Acceptance Criteria (from 21 CFR 878.4850(c) / Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Materials and mechanical characteristics are suitable for intended use. | Pass for both TRUEdraw and Mini Lancing Device. |
| Operation of the lancing device is as intended. | Pass for both TRUEdraw and Mini Lancing Device. | |
| Device withstands product life and shock conditions. | Pass for both TRUEdraw and Mini Lancing Device. | |
| Cosmetic attributes are acceptable. | Pass for both TRUEdraw and Mini Lancing Device. | |
| Lancet Compatibility | Critical dimensions (lancet body diameter, exposed needle length, body length) allow for compatibility with commonly available general use lancets. | Pass. |
| Proper fit with commonly available general use lancets. | Pass. | |
| Blade Change Mechanism | Lancet blade can be manually changed with every use. | (Implied by overall "Operation of the lancing device" pass) |
| Structure and Materials | Structure and materials address the risk of sharp object injuries. | (Implied by overall "Materials and mechanical characteristics" pass) |
| Structure and materials address the risk of bloodborne pathogen transmission. | (Implied by overall "Materials and mechanical characteristics" pass) | |
| Cleaning and Disinfection Validation | Device maintains functionality and integrity after repeated cleaning and disinfection cycles. | Pass (1,095 cycles using Super Sani-Cloth Wipes, demonstrating 3-year daily use capability for both devices). |
2. Sample Size Used for the Test Set and Data Provenance
Given that this is a mechanical safety and performance evaluation of a lancing device, the "test set" refers to the units of the device that underwent the listed mechanical and cleaning/disinfection tests.
- Sample Size: The document does not specify an exact number of devices tested for each category (e.g., how many TRUEdraw devices for mechanical performance, how many Mini Lancing Devices for cleaning validation). It generally states "Nonclinical bench testing was performed." For cleaning and disinfection validation, it specifies "1,095 cleaning and disinfecting cycles," implying multiple devices or a single device undergoing repeated cycles to simulate 3 years of daily use.
- Data Provenance: The data is generated from bench testing conducted by the manufacturer, Trividia Health. The country of origin for the testing is not explicitly stated, but the company is based in Fort Lauderdale, Florida, United States. The testing is prospective in the sense that it was conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a submission for a mechanical device, not an AI/ML device relying on expert interpretation of medical images. Ground truth is established through engineering and manufacturing specifications, and verification through standard bench testing protocols, rather than expert consensus on retrospective data.
4. Adjudication Method for the Test Set
N/A. As this is not an AI/ML device or a diagnostic device requiring human interpretive ground truth, there is no adjudication method in the context of expert review. Performance is measured against predefined engineering and safety specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
N/A. An MRMC study is not relevant for this type of device (a lancing device). The submission focuses on the mechanical and safety equivalence to a predicate device, not on assessing human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
N/A. This is a mechanical lancing device, not an algorithm. There is no software or AI component to evaluate in a standalone manner.
7. The Type of Ground Truth Used
The "ground truth" for this lancing device is based on engineering specifications, design requirements, and established safety and performance standards for lancing devices (e.g., the ability to function mechanically, withstand typical usage, be cleaned effectively, and pose no undue risk of injury or infection). This is verified through objective bench testing.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set, this question is not applicable.
§ 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.