(101 days)
The NeatNick Heel Safety Lancet is a single use device with a sterile blade that is used by medical professionals to obtain a blood sample from the heel of neonates and infants for subsequent diagnostic testing.
The NeatNick Heel Safety Lancet is a single use, blood sampling device with a sterile blade that are used by medical professionals to obtain a blood sample from the feet of neonates and infants for diagnostic purposes. The NeatNick Lancet incorporates an integral sharps injury prevention feature that also prevents reuse of the lancet.
The NeatNick Lancet has been in commercial distribution since 2006.
NeatNick Lancets are available in two configurations (Preemie and Full Term) are intended to be used by medical professionals to obtain a blood sample for diagnostic testing. The lancets consist of a stainless steel blade overmolded with low density polyethylene (LDPE) which protects the blade until use and functions as a sterile barrier. The lancet is single use, disposable and is sterilized by gamma radiation to a SAL of 10-6.
Biocompatibility testing has been conducted per ISO 10993 at a GLP testing facility. The lancet is classified as Class II.
The lancet is currently in commercial distribution in the United States and Canada. Since commercial distribution of the current lancets began, there have been no design changes.
The provided text is a 510(k) Pre-Market Notification for the NeatNick Heel Safety Lancet. This type of FDA submission focuses on demonstrating substantial equivalence to an already legally marketed device (predicate device) rather than proving general safety and effectiveness through extensive clinical trials with specific acceptance criteria and detailed study results.
Therefore, the document does not contain the detailed information typically associated with a study proving a device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would. It explicitly states, "Clinical testing is not applicable as the risk analysis confirmed that all identified risks were addressed and mitigated appropriately."
However, based on the non-clinical testing mentioned and the comparison table, here's what can be inferred and what information is missing:
1. Table of acceptance criteria and the reported device performance:
The document describes "predetermined criteria" being met for non-clinical bench testing and satisfaction of "special controls (21 CFR 878.4850)". The comparison table (Table 1) essentially serves as a performance comparison against the predicate device, where "Same" for the subject device implies it meets or performs comparably to the predicate for those characteristics.
| Acceptance Criteria (Implied from Predicate Characteristics/Special Controls) | Reported Device Performance (Subject Device) |
|---|---|
| Indication for Use: Obtain blood sample from heel of neonates and infants for diagnostic testing. | Same (as predicate) |
| Intended Use: Single-use, by medical professionals, for blood sample from neonates and infants for diagnostic testing, with spring-actuated sterile sweeping action blade that retracts and renders device inoperable. | Same (as predicate) |
| Trigger Actuation Force: 8N-36N | Same (as predicate) |
| Length of Cut (Full term): 2.9mm-4.1mm | Same (as predicate) |
| Length of Cut (Preemie): 1.8mm-3.0mm | Same (as predicate) |
| Depth of Cut (Full term): 1.0mm-1.5mm | Same (as predicate) |
| Depth of Cut (Preemie): 0.65mm-1.25mm | Same (as predicate) |
| Biocompatibility: Conforms to ISO10993-1 | Same (as predicate) |
| Blade Sterility: Sterilized by Gamma Radiation, SAL = 10^-6 | Same (as predicate) |
| Mechanical Design: Verification and validation to ensure risks managed and mechanical functions suitable for shelf life. | Non-clinical bench testing performed to ensure criteria met and special controls satisfied. |
Missing Information:
- Specific quantitative acceptance limits for the "mechanical design verification and validation testing" are not provided. The document only states these tests were performed and criteria were met.
- Actual measured values for the subject device's Trigger actuation force, Length of cut, and Depth of cut are not provided, only that they are "Same" as the predicate, which also presents a range.
The following questions cannot be answered from the provided document as it describes a 510(k) submission for a physical medical device (lancet), not an AI/software device or a study involving human readers or ground truth derived from expert consensus/pathology. The document explicitly states "Clinical testing is not applicable".
2. Sample size(s) used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not Applicable/Not Provided: This type of information is relevant for clinical or algorithm performance studies, which were not conducted for this 510(k) submission. Non-clinical bench testing was performed, but sample sizes for these tests are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not Applicable/Not Provided: This information pertains to studies where ground truth is established by experts (e.g., in imagery or diagnostic tasks). This submission relies on engineering specifications and bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not Applicable/Not Provided: This is relevant for expert-based ground truth establishment or clinical trial adjudication, neither of which occurred.
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/Not Provided: This is specific to AI-assisted diagnostic tools and human reader performance studies. The device is a physical lancet.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable/Not Provided: This is specific to AI algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not Applicable/Not Provided (in the context of clinical "ground truth"): For the non-clinical testing, the "ground truth" would be the engineering specifications and established test standards (e.g., ISO 10993-1 for biocompatibility, SAL of 10^-6 for sterility, and the specified ranges for cut length/depth and actuation force).
8. The sample size for the training set
Not Applicable/Not Provided: This is specific to machine learning/AI models.
9. How the ground truth for the training set was established
Not Applicable/Not Provided: This is specific to machine learning/AI models.
§ 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.