(100 days)
Disposable Blood Lancet is used for capillary blood collection.
Disposable Blood Lancet is a single use, sterile medical device designed to be used for capillary blood collection. The device comprises a stainless needle encapsulated with a plastic needle body and protective cap, the protective cap is twisted off to expose the needle for use.
The device was sterilized by Radiation. The needle body and protective cap form a sterile barrier to maintain the needle sterile.
The provided text describes the regulatory clearance of a medical device, the "Disposable Blood Lancet," and details its non-clinical testing for substantial equivalence to a predicate device. It does not involve AI or algorithms, and therefore, the requested information regarding AI-specific criteria, such as MRMC studies, training/test set details, and expert adjudication, is not applicable.
Here's an analysis based on the information provided regarding the non-AI device:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly derived from the non-clinical tests performed to demonstrate substantial equivalence to the predicate device. The "reported device performance" is the result of these tests.
| Acceptance Criteria (Implicit from Tests) | Reported Device Performance (Test Result) |
|---|---|
| Appearance and Cleanliness | Conforms to specifications |
| Needle tip appearance | Conforms to specifications |
| Needle dimension | Conforms to specifications |
| Exposed length of product | Conforms to specifications |
| Cap site | Conforms to specifications |
| Needle tip sharpness | Conforms to specifications |
| Binding Strength | Conforms to specifications |
| Double needles | None detected |
| Empty needle | None detected |
| Reverse needle | None detected |
| Compatibility test with Lancing Device | Compatible |
| In Vitro Cytotoxicity (ISO 10993-5: 2009) | No Cytotoxicity |
| Skin Sensitization (ISO 10993-10: 2010) | No Skin sensitization |
| Intracutaneous reactivity (ISO 10993-10: 2010) | No irritation |
| Acute Systemic Toxicity (ISO 10993-11: 2017) | No Acute Systemic Toxicity |
| Material-Mediated Pyrogenicity (ISO 10993-11: 2017) | Absence of pyrogen |
| Shelf life (5 years) | Performance and sterile barrier integrity remain stable (verified per ASTM F1980) |
2. Sample sized used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical performance test. It only states that "bench testing performed verifies that the performance of the proposed device is substantially equivalent." For biocompatibility, it states "biocompatibility evaluations were conducted." The provenance of the data is from non-clinical lab testing conducted by the manufacturer, SteriLance Medical (Suzhou) Inc., likely in China. The nature of these tests is retrospective in the context of the 510(k) submission, as they were completed prior to the review.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the device is a physical medical device, not an AI/algorithm-driven one. Ground truth is established through standardized laboratory testing and measurement procedures defined by the relevant ISO and ASTM standards. Experts in laboratory testing and quality assurance would perform and evaluate these tests, but their qualifications are not detailed beyond their adherence to the standards.
4. Adjudication method for the test set
This question is not applicable for a non-AI physical device. The testing described involves objective measurements and standardized biological evaluations.
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 question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve AI assistance or human readers in an interpretive capacity.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not contain an algorithm.
7. The type of ground truth used
For the performance tests (e.g., appearance, dimensions, sharpness, binding strength, etc.), the "ground truth" is established by engineering specifications, design requirements, and applicable international standards (e.g., ISO 9626 for needle size). For biocompatibility, the ground truth is established by standardized biological evaluation methods and criteria outlined in ISO 10993 series.
8. The sample size for the training set
This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is a physical "Disposable Blood Lancet" and does not involve an AI training set.
§ 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.