(110 days)
OneTouch® Delica® Safety is a single use blood lancet with sharps prevention feature to protect the user from a needlestick injury and that is intended for capillary blood sampling from a fingertip.
HemoCue® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Assure® Lance Plus Safety Lancets are single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Capiject® Safety Lancet is single use and intended for capillary blood sampling from a fingertip. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Newborn is single use and intended for capillary blood sampling from a heel for newborn. Sharps prevention feature protects the user from needlestick injury.
Heel Lancet Preemie is single use and intended for capillary blood sampling from a heel for preemie. Sharps prevention feature protects the user from needlestick injury.
The Single Use Blood Lancets are hand-held, sterile, needle or blade-like devices with a pull-off or twistoff cap and integral sharps injury prevention feature for controlled skin puncture to obtain a capillary blood specimen; typically at the fingertip or heel of the patient. The housing of the devices are made of plastic and have a spring-loaded mechanism which enables the tip of the needle or blade to puncture the fingertip or heel to a predetermined depth, whereby blood is subsequently squeezed out of the puncture site. These devices are made available in various needle and blade sizes which are distinguished by their different colors. Until activation, the lancet is contained within its housing (holder). Immediately after use, the needle or blade is automatically retracted back into its holder until the device is disposed of in an appropriate manner.
This document is a 510(k) premarket notification for "Single Use Blood Lancets" by Asahi Polyslider Company, Ltd. It seeks to demonstrate substantial equivalence to a legally marketed predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly provide a table of acceptance criteria in the format of pass/fail metrics. Instead, it states that "Results confirm that the design inputs and performance specifications for the subject devices are met." and "The Single Use Blood Lancets passed all required testing in accordance with internal requirements, national standards, and international standards shown below, supporting their safety and effectiveness and substantial equivalence to the predicate device."
The tests performed and their outcomes are listed in Section 9 "Non-Clinical Performance Data":
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Material Specifications | Materials of Construction Specifications met |
| Visual, Physical & Dimensional Verification | Specifications met |
| Functional Testing | Specifications met |
| Performance Testing | Specifications met |
| Cytotoxicity Testing (ISO 10993-5) | Passed |
| Sensitization Testing (ISO 10993-10) | Passed |
| Irritation Testing (ISO 10993-10) | Passed |
| Sterilization Validation (ISO 11137-1/-2) | Demonstrates SAL 10⁻⁶ |
| Product Sterility (ISO 11737-1) | Demonstrates product is free of microorganisms |
| Shelf-life Testing (ASTM F1980) | Supports a shelf-life of 5 years |
| Transportation Testing (ASTM 4169) | Demonstrates package integrity is maintained |
| Risk Analysis (ISO 14971) | Hazards identified, ranked and risk mitigation measures implemented |
2. Sample sizes used for the test set and the data provenance
The document does not specify the exact sample sizes used for each test. It broadly states that "Asahi Polyslider completed the following verification and validation activities, including non-clinical tests." and "The Single Use Blood Lancets passed all required testing...".
Data provenance: The tests were conducted to support a submission by a Japanese company (Asahi Polyslider Company, Ltd. located in Japan). The nature of the non-clinical tests (e.g., cytotoxicity, sterilization, shelf-life) suggests they are laboratory-based and likely prospective, specifically designed to evaluate the subject devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and biocompatibility evaluations, which are typically performed by qualified laboratory personnel and statisticians, rather than clinical experts establishing a ground truth in the context of diagnostic performance.
4. Adjudication method for the test set
This information is not provided as it's not relevant for the type of non-clinical tests detailed (e.g., material testing, sterilization validation). Adjudication methods are typically used in clinical studies or image-based diagnostic studies to resolve discrepancies in expert interpretations.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for a mechanical blood lancet.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This device is a manual surgical instrument (blood lancet), not an algorithm or AI system. Its performance is entirely mechanical and physical.
7. The type of ground truth used
The "ground truth" for the non-clinical tests listed are based on:
- Established standards and specifications: e.g., ISO 10993-5 for cytotoxicity, ISO 11137-1/-2 for sterilization validation, ASTM F1980 for shelf-life, and ASTM 4169 for transportation.
- Internal requirements: "internal requirements... supporting their safety and effectiveness" (Section 9).
- Predicate device characteristics: The substantial equivalence comparison heavily relies on showing similar technological characteristics and performance to the SurgiLance® Safety Lance (K101145) and other reference devices.
For example, for cytotoxicity, the ground truth is simply whether the device material exhibits cytotoxic effects above defined thresholds in the ISO standard. For sterilization, it's achieving a specified Sterility Assurance Level (SAL).
8. The sample size for the training set
This information is not applicable as this device is a physical medical instrument, 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 for the same reason as point 8.
§ 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.