(82 days)
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.
The provided text is a 510(k) summary for the LDE4 Lancing Device. It details the device's technical characteristics and the performance data submitted to support its substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance in distinct metrics like sensitivity, specificity, accuracy, or F1 score, which are common for AI/ML-based diagnostic devices. This document focuses on demonstrating that the lancing device performs its intended mechanical function, is biocompatible, and can be properly cleaned and disinfected.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific numerical acceptance criteria in the format of a typical diagnostic device performance table (e.g., sensitivity, specificity). Instead, the performance evaluations verify that the device functions as intended and meets safety standards. The "acceptance criteria" are implied by the successful completion and positive results of the various tests.
| Performance Characteristic | Acceptance Criteria (Implied by successful test) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards for medical devices | Cytotoxicity testing: Passed |
| Skin sensitization: Passed | ||
| Intracutaneous reactivity: Passed | ||
| Cleaning and Disinfection | Complete inactivation of HBV and no performance/physical change after 520 cycles | Virus elimination efficacy tests performed: Demonstrated complete inactivation of Hepatitis B Virus (HBV) on ABS and POM. |
| Robustness test: No change in performance or physical appearance of surface materials after 260 cleaning and 260 disinfection cycles (520 total), simulating 5 years of single-patient use. | ||
| Puncture Depth | (Various levels with ±0.3mm tolerance) | 1: 0.5 ± 0.3mm |
| 1.5: 0.7 ± 0.3mm | ||
| 2: 0.9 ± 0.3mm | ||
| 2.5: 1.1 ± 0.3mm | ||
| 3: 1.3 ± 0.3mm | ||
| 3.5: 1.5 ± 0.3mm | ||
| 4: 1.7 ± 0.3mm | ||
| 4.5: 1.9 ± 0.3mm | ||
| 5: 2.1 ± 0.3mm | ||
| Mechanical Performance | Functional performance as described | Appearance: Verified |
| Basic dimensions: Verified | ||
| Compatible performance: Verified | ||
| Bounce performance: Verified | ||
| Puncture Test: Verified | ||
| Adjustable performance: Verified | ||
| Lancet unloading performance: Verified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for each particular test type. For instance, the number of devices or material samples used for biocompatibility or cleaning/disinfection validation is not specified. The studies appear to be prospective bench tests and laboratory evaluations, not clinical trials with human subjects as a "test set" in the context of diagnostic AI. The provenance is implied to be laboratory testing conducted by the manufacturer or its contract labs.
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)
This information is not applicable to the provided document. The LDE4 Lancing Device is a mechanical device, and its performance evaluation does not involve establishing ground truth through expert consensus as would be typical for image-based diagnostic AI. The "ground truth" here is objective physical measurements and established biological/chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretation, which is not relevant for the type of bench testing described for a lancing device.
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
This information is not applicable. The LDE4 Lancing Device is a standalone mechanical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LDE4 Lancing Device is a mechanical lancing device, not an algorithm, and therefore does not have "standalone" AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance described in this document is based on:
- Established physical and chemical standards: For puncture depth measurements, material properties, and mechanical functionality.
- Standardized biological testing methods: For biocompatibility (ISO 10993-1) and virus inactivation efficacy.
8. The sample size for the training set
This information is not applicable. The LDE4 Lancing Device is a mechanical device and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a mechanical 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.