(59 days)
The SurgiLance® Safety Lancet is a puncture device to obtain micro blood samples. The SurgiLance® Safety Lancet has a sharps prevention feature to protect the user from a needlestick injury. Single patient use only.
The SurgiLance® Safety Lancet is a needle or blade device used to prick a patient's finger to draw a micro-sample of blood which can then be tested for an array of diagnostic assays. Lancets are commonly used in hospitals, clinics, physician offices, laboratories, OB/GYN practices, oncology departments, emergency medical services, nursing homes and blood banks. The outside plastic casing is designed to be ergonomic for the user and compatible with the test site, usually a human finger. The device is available with either a needle or blade, each with different depths of penetration, to provide optimal blood flow for different applications and skin types. The SurgiLance® Safety Lancet comes in seven (7) models: two low flow, two medium flow, and three high flows. The seven models are differentiated by their casing color. SurgiLance® Safety Lancets are safely retracted and concealed before and after use. The user simply removes the protective cap, places the red raised platform end onto the patient's test site, and gently pushes the lancet down against the test site to activate the lancet mechanism. Once the lancet is used, it is rendered inoperative, providing added safety for patient and clinician. The device is discarded in a sharps container after use. SurgiLance Safety Lancets are provided sterile and are single patient use only. They are sterilized using irradiation (R) sterilization method.
This document is a 510(k) summary for the SurgiLance® Safety Lancet. It does not describe an AI/ML device, therefore, the requested information elements related to AI/ML device testing are not applicable.
The document indicates that the device is a puncture device used to obtain micro blood samples and has a sharps prevention feature. The 510(k) submission establishes substantial equivalence to a primary predicate device (MediPurpose SurgiLance® Safety Lancet, K101145) and an additional predicate device (BD Autolancet [Microtainer® Lancet], K822209), stating that the proposed device did not change technological characteristics or material specifications from the primary predicate.
Here's the information that can be extracted relevant to acceptance criteria and device performance:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that the device was tested to meet performance and safety requirements. However, it does not provide specific quantitative acceptance criteria or detailed reported performance values for each test. Instead, it states that testing was "completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization" and lists the types of tests performed.
| Acceptance Criteria Category | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated compliance through manufacturing and sterilization for cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, and hemolysis testing as per ISO 10993-1. |
| Performance and Safety | Tests for drop, trigger force and reverse safety, penetration and depth force measurements, and simulated use were completed. The sharps prevention feature was fully tested to FDA's guidance document. |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for performance and safety testing. It also does not mention data provenance (e.g., country of origin, retrospective/prospective). This is common for this type of device where performance is typically evaluated through laboratory testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This device is a physical medical device, and its performance and safety are assessed through engineering and laboratory testing against established standards and predicate devices, not by expert interpretation of patient data to establish "ground truth."
4. Adjudication method for the test set:
Not applicable. This is not an AI/ML device or a device requiring expert adjudication of results.
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 is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable in the context of typical AI/ML ground truth. For this device, "ground truth" would be defined by engineering specifications, material properties, and functionality benchmarks established in industry standards and by predicate device performance. For instance, penetration depth would be measured directly, or sharps retraction would be visually confirmed as per design.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This is not an AI/ML 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.