(249 days)
The TD-5010 Lancing Device and TD-5084 Sterile Lancets are intended to obtain capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, and the forearm. The single-use TD-5084 Sterile Lancets are to be used with the reusable TD-5010 Lancing Device that is to be cleaned and disinfected between each use, and then the TD-5084 Sterile Lancets are to be disposed of.
For use only on a single patient in a home setting.
Not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
The TD-5010 Lancing Device uses compatible TD-5084 Sterile Lancets to obtain a drop of blood from a fingertip or alternative sites. The TD-5010 Lancing Device consists of two components:
(1)TD-5010 Lancing Device
(2) Alternative Site Testing (AST) Cap
The provided text describes the submission for a medical device (TD-5010 Lancing Device and TD-5084 Sterile Lancets) for clearance by the FDA, based on substantial equivalence to a predicate device (Accu-Chek Softclix Blood Lancing System). The document focuses on non-clinical performance testing rather than a clinical study involving human patients or an AI algorithm.
Therefore, many of the requested fields regarding acceptance criteria, sample sizes for test/training sets, expert involvement, and statistical measures for an AI/ML-based medical device are not applicable to this submission as it pertains to a mechanical lancing device and sterile lancets. There is no AI or software component described in this submission.
However, I can extract the acceptance criteria and performance data for the mechanical and material properties of the lancing device and lancets as described in the non-clinical testing summary.
Here's the breakdown based on the provided document:
Device: TD-5010 Lancing Device and TD-5084 Sterile Lancets
Study Type: Non-clinical (bench) performance testing for substantial equivalence. This is not a study proving the efficacy of an AI model.
Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing):
| Acceptance Criteria Category | Specific Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Appearance | Functional Verification | Should meet the same intended use as the predicate device and not impact safety/effectiveness. | All test results met acceptance criteria, demonstrating that the different appearance design of the candidate device (TD-5010 Lancing Device) met the same intended use as the predicate device and did not impact safety and effectiveness. |
| Biocompatibility | Biocompatibility Tests (TD-5010 Lancing Device) | Housing materials should not affect biocompatibility. | Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect biocompatibility. |
| Biocompatibility | Biocompatibility Tests (TD-5084 Sterile Lancets) | Materials should not affect biocompatibility. | Results demonstrated that the materials of TD-5084 Sterile Lancets would not affect biocompatibility. |
| Cleaning & Disinfection | Disinfection Validation Test | Housing materials should not affect the effectiveness of cleaning and disinfection. | Results demonstrated that the housing materials of TD-5010 Lancing Device would not affect the effectiveness of cleaning and disinfection. |
| Puncture Depth/Needle Length | Mechanical Performance Test | Puncture depths and exposed needle length within specifications. Similar range to predicate device. | Puncture depths and exposed needle length of candidate device met its specifications. The range was similar to the predicate device. |
| Firmness Force | Firmness Force Test (Aging Tests) | Needle firmly fixed in lancet housing. Within acceptance criteria in accelerated and real-time aging tests. | The firmness force was within acceptance criteria in the accelerated and real-time aging tests. The needle of TD-5084 Sterile Lancets was verified to be firmly fixed in the lancet housing at each time point. |
| Lancet Loading | Loading Force and Pulling Force Test | Lancets can be effectively and smoothly loaded by end users. | All test results of lancet loading force met the acceptance criteria, demonstrating that the safety and effectiveness of the loading mechanism (loading force and pulling force) of the candidate device was substantially equivalent to the predicate device. Lancets can be effectively and smoothly loaded by end users. |
| Needle Specification (30G vs 28G) | Percussion and Firmness Force Test | Puncture depths meet specifications. Needle firmly fixed in housing. | Puncture depths of both TD-5084 Sterile Lancets (30G) and predicate device (28G) met specifications. The needle of TD-5084 Sterile Lancets (30G) was firmly fixed in lancet housing at each time point of accelerated and real-time aging tests. |
| Lancet Cap Removal | Lancet Cap Twist Force and Pulling Force Test | Lancet cap can be easily and safely removed by end user. | All test results met acceptance criteria, demonstrating that the lancet cap of the candidate device can be removed by end user smoothly and safely. |
| Drop Testing | Drop Testing | Appearance and performance meet intended use after drop forces. | All test results met acceptance criteria, demonstrating that lancing devices installed with lancets met its intended use after undergoing drop forces during operations. Appearance and performance verified after drop forces. |
| Storage Stability | Storage Stability Test | Safety and effectiveness suitable for use over the claimed shelf life. | Performed to ensure the safety and effectiveness were suitable for use over the shelf life of the device. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile). |
| Robustness | Robustness Test (Cleaning/Disinfection) | Device robust against multiple cleaning and disinfection cycles. | Demonstrated that the TD-5010 Lancing Device was robust against cleaning and disinfection procedures after multiple cleaning and disinfection cycles using EPA-registered disinfecting wipes. (Implied: met acceptance criteria, as the conclusion states the device has a substantially equivalent safety and effectiveness profile). |
Study Details:
-
Sample Size used for the test set and the data provenance:
- The document describes bench testing of physical devices and components, not a "test set" in the context of an AI/ML algorithm.
- Specific numbers of devices or lancets tested for each non-clinical test (e.g., how many lancet caps twisted, how many devices dropped) are not explicitly stated. The provenance is implied to be laboratory testing conducted by the manufacturer. It is non-clinical/bench data.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a mechanical device, not an AI model requiring expert ground truth for image interpretation or diagnosis. Ground truth is based on engineering specifications and physical measurements.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There's no human interpretation or adjudication process described for the device's mechanical performance.
-
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. No AI component. No human reader study described.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No AI algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the non-clinical tests, the "ground truth" or reference standards are the engineering specifications, physical measurements, and established testing protocols (e.g., for sterilization, biocompatibility, mechanical forces, and material properties) for lancing devices, often guided by relevant ISO standards (though not explicitly cited for each test, 21 CFR 878.4850 is mentioned).
-
The sample size for the training set:
- Not applicable. There is no AI component and thus no "training set" in the context of machine learning.
-
How the ground truth for the training set was established:
- 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.