(91 days)
The MICROLET®NEXT lancing device is intended for collecting capillary blood from the fingertip or palm for blood glucose testing or other testing utilizing small amounts of blood. The MICROLET NEXT lancing device is for singlepatient use. The MICROLET NEXT lancing device is used with disposable, sterile MICROLET® lancets. The MICROLET NEXT lancing device with the MICROLET lancet are intended for collecting fingertip capillary blood from persons age two years and older. The alternative site testing endcap is intended for collecting capillary blood from the palm in adults only.
Ascensia's blood lancets consists of two components. First component is a re-usable base which is referred as MICROLET® NEXT lancing device and the second component is a sterile single use blade which is referred as MICROLET® Lancet. The subject MICROLET® NEXT Lancing Device is a pen-like instruments to be used with the compatible subject MICROLET® NEXT Lancets (28 G) for the controlled puncture of the skin to obtain the capillary blood droplet sample for testing. The MICROLET® NEXT Lancing Device is available with two endcaps: the Black/White cap for fingertip sampling and the Clear Alternative Site Testing (AST) for palm sampling. The Black/White cap has a dial control that allows the user to adjust the blade penetration depth for comfort when obtaining the blood droplet. The subject MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is intended to be used with compatible lancing devices. The lancets are sterile, single-use devices. They must be discarded after each use. The lancet comprises the following elements: a steel needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. They are available with 28G (0.36mm) diameter lancets. Together, they are intended for obtaining a capillary blood sample for blood glucose testing or other testing utilizing small amounts of blood. The lancet needle consists of stainless steel which is coated with medical grade silicone for smooth penetration of the skin. The lancet needle is siliconized. This is encased in a plastic cover. The proposed MICROLET® Lancets are offered in a variety of colors. Figure-2 shows different colored lancets (seven colors-Yellow. Orange, Red, Green, Blue, Purple and Pink). The needle tip is hidden by a protective cap, which has to be removed before usage and creates the sterile barrier. After usage the lancet can be placed back into the protective cap for disposal. thereby protecting users from unintended injuries. The proposed MICROLET® Lancet can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® Lancet is a disposable single-use sterile device intended for drawing a blood sample. It is Intended to be used with compatible lancing device. The lancet comprises the following elements: a steel needle, needle body with a protective cap. The lancet remains sterile until the cap is removed. The product is sterilized with gamma radiation. The product can be stored for 5 years without losing its function or sterility if the protective cap is not removed. The MICROLET® NEXT lancing device is used for obtaining capillary blood samples from the fingertip. Capillary samples can be obtained from the palm as well The lancing device is for use only on a single patient.
Ascensia Diabetes Care's MICROLET® NEXT Lancing Device and MICROLET® Lancet were evaluated through a clinical study and extensive non-clinical performance testing to demonstrate their safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a table of acceptance criteria for the clinical study with specific quantitative targets (e.g., "X% of subjects must obtain sufficient blood volume"). However, the study aims and conclusions implicitly serve as the acceptance criteria for clinical performance related to blood collection, while non-clinical tests have pass/fail criteria.
Here's a summary:
| Acceptance Criteria (Implied from Study Objectives/Results) | Reported Device Performance (Clinical) |
|---|---|
| Ability to obtain sufficient capillary blood from fingertips for blood glucose testing using the adjustable cap. | 119 out of 119 adult subjects (100%) were able to obtain sufficient capillary blood volume from fingertips. |
| Ability to obtain sufficient capillary blood from the palm for blood glucose testing using the AST (Alternative Site Testing) endcap. | 116 out of 119 adult subjects (97.5%) were able to obtain sufficient capillary blood volume from the palm. |
| System is safe and effective for at-home use by people with diabetes, without serious use errors or problems. | Human factors validation testing concluded the system is safe and effective for at-home use by people with diabetes, without serious use errors or problems under expected use conditions. |
| All non-clinical performance and biocompatibility tests passed. | All 24 non-clinical performance tests (e.g., Vibration, Ejector Arm force, Puncture Depth Setting, Corrosion Resistance, Shipping Simulation) and 9 biocompatibility tests (Cytotoxicity, Sensitization, Intracutaneous, Pyrogenicity, Systemic Toxicity, Hemolysis) passed. |
| No new questions of safety or effectiveness are raised compared to the predicate device. | The differences between the proposed device and the predicate device do not raise any new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Study): 119 lay persons.
- Data Provenance: The study was conducted at the "Mishawaka site," which generally refers to a clinical study location within the country where the submission is made (USA in this case, given the FDA filing). The document doesn't explicitly state the country for the clinical study, but it is implied to be within the US. The study appears to be prospective as participants were enrolled and tested with the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document refers to "study staff testing the blood on a Contour next family of blood glucose meters" to determine the acceptability of capillary blood volume.
- It does not specify the number or qualifications of these "study staff" experts. It also doesn't mention expert review of images or specific clinical diagnoses by independent experts to establish ground truth in the way one might see for diagnostic AI. In this context, "acceptability" refers to whether enough blood was collected for a meter reading, which is a functional assessment rather than a diagnostic one requiring expert consensus on a disease state.
4. Adjudication Method for the Test Set
- The document does not describe an adjudication method for the clinical study results in the traditional sense of resolving discrepancies between multiple readers or systems. The determination of "sufficient capillary blood volume" was made by "study staff testing the blood on a Contour next family of blood glucose meters." This implies a direct, objective assessment by the meters and observation by staff, rather than a subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is not applicable here as the device is a lancing device and lancet, not an AI diagnostic tool. The clinical study focused on the device's ability to collect blood and its safe usage by lay persons.
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. The device is a physical medical device (lancing device and lancet), not a software algorithm. Its performance is assessed through mechanical, biological, and user experience testing, not algorithmic accuracy.
7. The Type of Ground Truth Used
- For the clinical study, the "ground truth" for success was defined by the ability to obtain sufficient capillary blood volume as determined by a blood glucose meter ("Contour next family of blood glucose meters"). This is a form of outcomes data pertaining to device functionality (i.e., whether the device successfully facilitates blood collection for testing).
- For non-clinical tests, the ground truth was adherence to predetermined acceptable ranges or conditions (e.g., "no external damage or deterioration," "results were within the acceptance range," "no corrosion," "all devices met min 1.3 mm needle tip distance").
8. The Sample Size for the Training Set
- The document is for a physical medical device (lancing device and lancets), not an AI/ML algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As the device is not an AI/ML algorithm, there is no training set and thus no ground truth established for a training set. The development of the device would have involved engineering specifications, materials science, and usability design, leading to the device submitted for testing.
§ 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.