(116 days)
The safety lancet is intended for capillary blood sampling.
The safety lancet consists of needle core, protective cap, plug, trigger, spring, outer case and end cap. The sterile part of the safety lancet is the needle tip. The sterile barrier is the needle sleeve and sterilized to a SAL of 10^-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years. The safety lancet is intended for capillary blood sampling. The device was designed to minimize the risk from accidental needle sticks with a used needle by application of a sharp injury prevention feature. The needle tip back into the safety lancet body automatically after launch and cannot be reused. The safety lancet can be disposed safely.
This document is a 510(k) summary for a "Safety Lancet" (K223208). It aims to demonstrate substantial equivalence to a predicate device (Tianjin Huahong Safety Lancet – K220370).
Here's an analysis of the acceptance criteria and study information provided and what's missing, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might expect for a diagnostic or AI device. Instead, it discusses various performance tests and compliance with standards. The "acceptance criteria" are implied by the standards and internal requirements, and "reported device performance" is summarized as meeting these requirements.
Here's a best effort to extract and present this information based on the provided text, recognizing that specific numerical results or direct comparisons to predicate device values (beyond "same" or "similar") are often not included in 510(k) summaries unless there's a significant difference to justify.
| Acceptance Criterion (Implied Standard/Requirement) | Reported Device Performance (Summary) |
|---|---|
| Physical Performance: | |
| Cap removal force | Meets internal requirements of 3-9 N (for easy user removal). |
| Needle removal force/Firmness (ISO 7864:2016) | Meets ISO 7864:2016 requirements (ensuring needle firmness). |
| Drop testing (IEC 60068-2-32:1993) | Meets IEC 60068-2-32:1993 requirements (needle not exposed after drop). |
| Puncture force (ISO 7864:2016) | Meets ISO 7864:2016 requirements (force as low as possible for skin puncture). |
| Safety Feature testing (ISO 23908:2011, FDA Guidance Aug 9, 2005) | Verified against requirements (ensures safe use, force to activate = 8.8N). |
| Needle Tubing (ISO 9626:2016) | Complies with ISO 9626:2016. |
| Sterility & Shelf-life: | |
| Sterilization (ISO 11737-1/2, ISO 11137-1/2/3) | SAL = 10⁻⁶ (sterilized by gamma radiation), meets standards. |
| Packaging (ISO 11607-1:2019) | Complies with ISO 11607-1:2019. |
| Accelerated Aging (ASTM F1980) | Complies, supports 5-year shelf life. |
| Shipping/Performance Testing (ASTM D4169-16) | Complies with ASTM D4169-16. |
| Sterility Test (USP ) | Complies with USP . |
| Biocompatibility: | |
| Biological evaluation (ISO 10993-1, 10993-5, 10993-10, 10993-11) | No cytotoxicity, no irritation, no skin sensitization, no acute systemic toxicity, no thermogenic reaction. Meets standards. |
| Bacterial Endotoxins (USP ) | Complies with USP . |
| Particulate matter (USP ) | Complies with USP . |
| Pyrogen tests (USP ) | Complies with USP . |
| Functional/Safety Features: | |
| Sharps injury prevention function | Verified (needle back into body automatically, cannot be reused). |
| Exposed needle length/penetration depth | Range 1.2-2.4 mm, within range of predicate (1.0-3.0 mm). |
| Simulated Clinical Use: | |
| Safety and effectiveness in simulated conditions | Demonstrated. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The document refers to "non-clinical testing results" primarily for physical performance, sterility, shelf-life, and biocompatibility. Additionally, a "simulated clinical use study" was conducted.
- Sample Size for Simulated Clinical Use Study: 500 device samples.
- Data Provenance for Simulated Clinical Use Study: Not explicitly stated, but it's a "simulated clinical use study," implying it wasn't conducted on actual patients. The company is based in China, so it's likely conducted there. It is a prospective study in the sense that the testing was performed on new samples according to a protocol.
- Other Testing Sample Sizes: For other physical, sterility, and biocompatibility tests, specific sample sizes are not provided in this summary, but implied by adherence to the referenced ISO and ASTM standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a medical device like a safety lancet, "ground truth" (as typically thought of in AI/diagnostic studies) isn't directly applicable in the same way. The "truth" is established by adherence to engineering standards and safety requirements (e.g., "is the needle exposed after drop test?"). The "experts" would be the engineers, quality control personnel, and lab technicians conducting the tests and interpreting results against the objective standards. Their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (physical, sterility, biocompatibility), results are typically objective measurements against a standard, rather than subjective interpretations requiring adjudication.
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 comparative effectiveness study was not done. This device is a mechanical safety lancet and does not involve AI or "human readers" in the context of interpretation of diagnostic images or data.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. This device is a mechanical safety lancet and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Adherence to recognized international and national standards: ISO standards (e.g., for needle tubing, sterility, biocompatibility), ASTM standards (e.g., for packaging), and USP standards (e.g., for sterility, endotoxins).
- Manufacturer's internal requirements: For specific features like cap removal force (3-9 N).
- FDA Guidance Documents: Particularly for sharps injury prevention features.
- Objective measurements and observations: Such as force measurements, visual inspections after drop tests, biological test results (e.g., "no cytotoxicity").
Essentially, the ground truth is defined by the fulfillment of these established safety and performance benchmarks.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. This device is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided. As above, there is no "training set" for a physical medical 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.