(120 days)
Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers. For medical device use. For healthcare professional use, prescription only.
Tenderfoot is an automated skin incision device used to collect capillary blood from infants and toddlers by heel stick. The device produces an arc-like incision at a controlled depth to provide blood flow for obtaining a blood sample. The incision is made by a surgical blade that is completely enclosed in a plastic housing and deployed by pressing a trigger. Following deployment, the blade permanently retracts within the housing, rendering the device inoperable for further use. Tenderfoot is provided as a sterile, single-use disposable device intended for use by healthcare professionals only. Sterilization is achieved by gamma irradiation. Tenderfoot is offered in four models covering a range of incision depths sized for different infant populations: Micro-Preemie, Preemie, Newborn, and Toddler.
The provided text is a 510(k) summary for a medical device called "Tenderfoot". This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets strict acceptance criteria through a clinical or algorithmic performance study in the way one might for a novel AI/ML device.
Therefore, the information requested in the prompt, particularly regarding MRMC studies, standalone performance, ground truth establishment for test/training sets, and expert adjudication, is not present in this document. This typically applies to AI/ML software as a medical device (SaMD) where performance is measured against reference standards. The Tenderfoot device is a physical, mechanical blood lancet.
However, I can extract the information that is available about the "performance data" provided.
Understanding the Context
The Tenderfoot device is a physical medical device (a heel incision device/lancet), not a software or AI/ML product. The "performance data" referred to in Section VII of the 510(k) summary are non-clinical bench testing and biocompatibility/sterilization/packaging validation, relevant for mechanical devices and their safety, not for evaluating algorithmic performance or diagnostic accuracy.
The FDA's review for this type of device (a Class II blood lancet, product code FMK) primarily focuses on demonstrating that the device is substantially equivalent to a legally marketed predicate device, meaning it is as safe and effective as the predicate. This often involves comparing technological characteristics and validating that the device meets relevant performance standards (e.g., incision depth/length accuracy, sharps injury prevention features, sterility, biocompatibility).
What Can Be Extracted from the Provided Text:
Given the nature of the device and the document, the acceptance criteria and supporting study details will pertain to physical performance and safety, not diagnostic accuracy or AI/ML performance.
1. A table of acceptance criteria and the reported device performance:
The document states: "Nonclinical bench testing was performed for cut depth, cut length, trigger activation, and blade retraction before and after stress conditions, such as simulated distribution and aging. The testing met all acceptance criteria."
While the specific numerical acceptance criteria and reported numerical performance values are not detailed in this summary, the statement confirms that the device did meet predefined standards for these physical aspects.
| Acceptance Criterion (Category) | Reported Device Performance |
|---|---|
| Nonclinical Bench Testing | |
| Cut Depth | Met all acceptance criteria |
| Cut Length | Met all acceptance criteria |
| Trigger Activation | Met all acceptance criteria |
| Blade Retraction | Met all acceptance criteria |
| Performance after Stress Conditions | |
| (Simulated distribution & aging) | Met all acceptance criteria |
| Biocompatibility | |
| Cytotoxicity | Successfully completed |
| Sensitization | Successfully completed |
| Irritation | Successfully completed |
| Acute systemic toxicity | Successfully completed |
| Material-mediated pyrogen testing | Successfully completed |
| Hemocompatibility | Successfully completed |
| Sterilization | |
| Sterility Assurance Level (SAL) | 10-6 (validated per ISO 11137-1) |
| Packaging Performance | |
| Visual inspection of seal width | Successfully completed (per ISO 11607-1) |
| Seal strength (ASTM F88/F88M) | Successfully completed |
| Gross leaks (ASTM F2096) | Successfully completed |
| Microbial barrier (ASTM F1608) | Successfully completed |
| Shelf Life | |
| Packaging shelf life | 4 years (established through accelerated aging per ASTM F1980) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. The summary only mentions "Nonclinical bench testing was performed..." without specifying the number of units tested.
- Data Provenance: Not applicable in terms of "country of origin of the data" or "retrospective/prospective" for this type of physical device testing. The tests are bench tests performed on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the device is a physical lancet, not an AI/ML diagnostic or image interpretation device that requires human expert-established ground truth. The "ground truth" for physical properties like cut depth/length would be measured directly by instruments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for this type of device and testing. Adjudication methods are typically used for establishing ground truth in clinical image or data analysis.
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:
- No, an MRMC study was not done. This type of study is specifically for evaluating the performance of diagnostic devices, often AI-assisted, where human readers interpret medical images or data. The Tenderfoot device is a physical instrument for blood collection.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a "standalone" study in the context of an algorithm was not done because the Tenderfoot is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For physical attributes like incision depth and length, the "ground truth" would be direct physical measurement using appropriate metrology tools, not expert consensus or pathology. For biocompatibility and sterilization, the ground truth is established by validated laboratory assays and standards (e.g., ISO 10993, ISO 11137).
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set (for AI/ML), there is no ground truth establishment for it.
Summary of missing information and reasons:
The prompt's questions are largely tailored to the evaluation of AI/ML-based medical devices or diagnostic software. The provided document is a 510(k) summary for a physical, mechanical blood lancet. Therefore, many of the requested details (especially those regarding AI performance, human reader studies, and expert ground truth establishment for data sets) are fundamentally not applicable to this type of device or the regulatory pathway it followed. The performance validation documented here pertains to the physical and safety characteristics of the device, demonstrated through bench testing and compliance with recognized standards.
§ 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.