(111 days)
The Disposable Safety Lancet is intended for capillary blood sampling.
The Disposable Safety Lancet is intended for capillary blood sampling. The Disposable Safety Lancet include eleven models as IV, V, W2, M3, M3 PLUS, M4, M5, M5 MINI, M6, M7, E1. The models include different needle core sizes: 21G, 23G, 25G, 26G, 27G, 28G, 30G. Disposable Safety Lancet are spring-loaded lancet. Disposable Safety Lancet are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle.
The provided document is a 510(k) summary for a medical device called "Disposable Safety Lancet". It describes the device, its intended use, and argues for its substantial equivalence to a predicate device based on non-clinical tests.
However, the document does not contain any information regarding clinical studies, acceptance criteria, or performance metrics in a way that typically applies to AI/ML medical devices.
Specifically, it lacks the following information that you requested:
- A table of acceptance criteria and the reported device performance: This document does not specify any performance criteria (e.g., sensitivity, specificity, accuracy) for diagnosis or detection, nor does it present results against such criteria. The "performance" mentioned is in the context of mechanical and biocompatibility testing.
- Sample size used for the test set and the data provenance: No test set (in the context of clinical data for AI/ML) is mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment related to clinical assessment is discussed.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there's no clinical test set mentioned.
- 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: The device is a physical medical lancet, not an AI-powered diagnostic tool. Therefore, MRMC studies are not relevant.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for a physical lancet in this context.
- The sample size for the training set: Not applicable for a physical lancet.
- How the ground truth for the training set was established: Not applicable for a physical lancet.
The "studies" mentioned in the document are non-clinical bench tests and biocompatibility evaluations, not clinical performance studies involving a test set, ground truth acquisition, or expert readers.
Here's a summary of the non-clinical tests that were performed and their conclusions:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
| Acceptance Criteria (Implied by Standards) | Reported Device Performance (Conclusion) |
|---|---|
| Biocompatibility: | |
| - ISO 10993-5:2009 (Tests for in vitro cytotoxicity) | Complies; Biocompatibility established |
| - ISO 10993-10:2010 (Tests for irritation and skin sensitization) | Complies; Biocompatibility established |
| - ISO 10993-11:2017 (Tests for systemic toxicity) | Complies; Biocompatibility established |
| - ISO 10993-4:2017 (Selection of tests for interactions with blood) | Complies; Biocompatibility established |
| - USP34 (Rabbit Pyrogen Test) | Complies; Biocompatibility established |
| Functional/Mechanical Performance: (Implied by "Bench tests were conducted to verify that the proposed device met all design specifications") | Met all design specifications; Substantially Equivalent (SE) to predicate device |
| Sterilization: Sterilized by Radiation to achieve a Sterility Assurance Level (SAL) of 10^-6 | Achieved SAL=10^-6 |
| Reuse durability: Single use | Confirmed single use |
| Shelf-life: 5 years | Confirmed 5 years |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. The document refers to non-clinical bench tests and biological evaluations, not a clinical test set with patient data for performance evaluation.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth for clinical diagnostic purposes or AI model validation is not relevant for this type of device and study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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. This is a physical medical device (lancet), not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable in the context of AI/ML evaluation. The "ground truth" for the non-clinical tests would be the established scientific methods and standards (e.g., cell viability for cytotoxicity, physical measurements for mechanical tests).
8. The sample size for the training set:
- Not applicable. This is a physical medical device.
9. 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.