(59 days)
Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) is a single use device indicated for capillary blood sampling.
Lianfa Safety Lancet is a single use, sterile, medical devices designed to be used in collecting the blood sample. The products are intended to be used by professionals and home users. They are intended for over the counter use.
Lianfa Safety Lancet is 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 safety lancet is made up of a needle core, spring, a launching part, and a casing. The steel needle is made of SUS304 stainless steel, the spring material is carbon steel, and the other parts are made of plastic components. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable of further use.
Based on the shape and design of the device, there are five different models: PA, PA2, APA, NPA, and TPA. Each model is offered with various gauges of needle.
This document is a 510(k) Premarket Notification for the Lianfa Safety Lancet. The provided information does not describe an AI/ML powered device, but rather a traditional medical device (a blood lancet). Therefore, many of the requested categories for AI/ML device studies (e.g., effect size of human readers with AI, ground truth for training set, adjudication methods, multi-reader multi-case studies) are not applicable.
Here's an analysis based on the provided text, focusing on the acceptance criteria and the study that proves the device meets them, as much as applicable to a non-AI medical device:
Acceptance Criteria and Device Performance for Lianfa Safety Lancet
This submission is a 510(k) premarket notification for a traditional medical device, a blood lancet. As such, the concept of "AI" or "ML" powered assistance, training sets, and human reader performance with AI are not applicable. The studies described are non-clinical engineering and biocompatibility tests.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are derived from a combination of general industry standards (e.g., ISO, 21 CFR regulations) and specific functional requirements for a blood lancet. The performance is reported as meeting these requirements.
| Characteristics / Acceptance Criteria (Specifications) | Reported Device Performance (Results) |
|---|---|
| Appearance | |
| - Surface clean, free of burrs, scratches, rusts, extraneous materials | Meet requirement |
| - Needle clean, straight, without residual debris | Meet requirement |
| Dimension | |
| - Product dimensions consistent to drawings | Meet requirement |
| Puncture Depth | |
| - Measured using calipers and meets requirements | Meet requirement |
| Corrosion | |
| - Steel needle free of signs of corrosion | Meet requirement |
| Puncture Force | |
| - Steel needle puncture force ≤ 2.0 N | Meet requirement |
| Connection Firmness (Needle and Handle) | |
| - Withstand 10N axial static tension for 1 min | Meet requirement |
| Sterility | |
| - Device must be sterile | Meet requirement |
| pH | |
| - pH value between test solution and control solution not > 1 | Meet requirement |
| Extractable Metal | |
| - Not more than 10 µg/device | Meet requirement |
| Launch Performance | |
| - Good launch performance, button pressed smoothly, no jam | Meet requirement |
| Safety Features | |
| - Force to trigger needle launch: 4-10 N | Meet requirement |
| - Deactivation: product cannot be launched after first launch | Meet requirement |
| Biocompatibility | |
| - 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 |
| - Pyrogenicity (ISO 10993-11: 2017) | No thermogenic reaction |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each non-clinical bench test. It generally states that "bench testing performed verifies..." and provides the "Results" as "Meet requirement."
The data provenance is from non-clinical bench testing, presumably conducted internally or by a contracted lab for the manufacturer, Shandong Lianfa Medical Plastic Products Co. Ltd. The country of origin for the manufacturing and testing is not explicitly stated but the company is based in Zhangqiu, Jinan, Shandong Province, China. The studies are retrospective in the sense that they were completed as part of the device development and verification process before this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of medical device. The "ground truth" for the non-clinical tests relies on established engineering standards, material science principles, and biological evaluation protocols (e.g., ISO 10993 series). There are no human "experts" establishing a diagnostic ground truth in the way described for AI/ML devices. The "experts" involved would be technicians, engineers, and scientists conducting the tests according to the specified protocols.
4. Adjudication method for the test set
Not applicable for this type of medical device. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers interpret data, and complex rules are needed to establish a "ground truth" result when there are disagreements. For non-clinical bench testing, results are typically objective measurements against a predefined specification.
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
Not applicable. This device is a manual blood lancet and does not incorporate AI functionality, nor does it involve human readers interpreting AI-generated output.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual blood lancet. There is no algorithm.
7. The type of ground truth used
For the non-clinical and biocompatibility tests:
- Engineering Specifications / Industry Standards: For characteristics like appearance, dimension, puncture depth, puncture force, connection firmness, launch performance, and safety features. These are objective measures against predefined criteria.
- Sterility Standards: Based on a Sterility Assurance Level (SAL) of 10^-6, which is an industry standard.
- Biocompatibility Standards: Based on ISO 10993 series standards (e.g., ISO 10993-5, 10993-10, 10993-11), which define the methodologies and acceptance criteria for biological evaluation of medical devices.
8. The sample size for the training set
Not applicable. This is a traditional medical device, not an AI/ML algorithm. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI/ML algorithm, this question is irrelevant to the Lianfa Safety Lancet.
§ 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.