(88 days)
The Accu-Chek Safe-T-Pro Plus lancing device is intended to produce a capillary blood sample for testing utilizing small amounts of blood.
The Accu-Chek Safe-T-Pro Plus lancing device is a sterile, single-use, disposable lancing device intended to be used by non-professional users 18 years and older and healthcare professionals. It is designed for capillary blood sampling from the fingertip of adults and children 1 year and older or, if the patient is a child under 1 year, from the heel. The Accu-Chek Safe-T-Pro Plus lancing device is a needle used for capillary blood sampling for use in diagnostic testing. The Accu-Chek Safe-T-Pro Plus lancing device contains a sharps injury prevention feature where the lancet is retracted and concealed before and after use. Once the lancet is used, it is rendered inoperative. The device is designed for single use only. It has a 23 Gauge needle with 3 depth levels by twisting cap: 1.3 mm, 1.8 mm, 2.3 mm. It is spring-driven and loading/priming is not required. Press release button to activate lancet mechanism.
The provided text is a 510(k) premarket notification for the "Accu-Chek Safe-T-Pro Plus Lancing Device". It focuses on establishing substantial equivalence to predicate and reference devices rather than presenting specific acceptance criteria and a detailed study proving the device meets them in the context of performance metrics like sensitivity, specificity, or reader improvement, which are typical for AI/ML devices.
However, based on the information provided, I can extract the non-clinical testing performed and infer the acceptance criteria and details about the study.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria or performance metrics (like accuracy, sensitivity, specificity) for comparison within a table, as one would expect for an AI/ML device. Instead, it describes "nonclinical bench testing" and "design verification and validation testing" to ensure risk management and mechanical function. The "reported device performance" is broadly stated as "performs as well or better than the legally marketed predicate device and legally marketed reference devices."
However, we can infer acceptance criteria related to safety and functionality from the types of testing mentioned and the characteristics of the device.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Mechanical Design & Functionality: | |
| Proper function of lancing mechanism (needle extension/retraction) | Verified through "design verification and validation testing" ensuring "mechanical functions are suitable for use over the lifetime of the device." |
| Optimal penetration depth for capillary blood sampling | Confirmed through "design verification and validation testing" ensuring "mechanical functions are suitable for use over the lifetime of the device." (Specifically, 1.3 mm, 1.8 mm, 2.3 mm depths are specified in device characteristics) |
| Sharps Injury Prevention: | |
| Lancet retraction and concealment before and after use | Confirmed: Lancet is "retracted and concealed before and after use." Implicitly verified through testing for "sharps injury prevention features." |
| Device rendered inoperative after single use | Confirmed: "Once the lancet is used, it is rendered inoperative." Implicitly verified through testing for "sharps injury prevention features." |
| Passive safety mechanism activation | Confirmed: "passive safety mechanism that automatically activates after the device is used, requiring no action on the part of the user." Implicitly verified through testing. |
| Sterility: | |
| Device sterility (Gamma irradiation) | Confirmed: Device is "sterile" and "sterilized by Gamma irradiation." |
| Risk Management: | |
| All identified risks addressed and mitigated appropriately | Confirmed: "risk analysis confirmed that all identified risks were addressed and mitigated appropriately." |
| Acceptable residual risks | Confirmed: "All residual risks after mitigation were acceptable, and communicated in the instructions for use as warnings." |
| No special performance or safety concerns | Confirmed: "There were no special performance or safety concerns identified." |
| Overall Performance: | |
| Performance "as well or better than legally marketed predicate and reference devices" | The device "performs as well or better than the legally marketed predicate device and legally marketed reference devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical bench testing. It does not provide details on a "test set" in the context of clinical data for performance metrics. For the "nonclinical bench testing," the sample size of devices tested is not specified. The data provenance is also not specified, but it would typically be internal testing conducted by the manufacturer. Since it's bench testing, concepts of retrospective or prospective data usually don't apply in the same way as clinical studies.
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)
This section is not applicable as the document describes a physical medical device (lancing device) and its mechanical and safety performance, not an AI/ML algorithm that requires expert-established ground truth for a test set. There is no mention of experts or ground truth in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reasons as point 3. Adjudication methods are typically used in clinical studies involving interpretation of data, often by multiple readers, which is not the case here.
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
This section is not applicable. The device is a "lancing device," a physical tool for blood sampling. It does not involve AI or software for diagnostic interpretation, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely outside the scope of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable as the device is a lancing device and does not involve any algorithm or software with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This section is not applicable. For a lancing device, the "ground truth" for its performance would be its physical properties, sterility, mechanical reliability, and safety features, which are evaluated through engineering tests and quality control, not clinical "ground truth" like pathology or outcomes data in the sense of diagnostic accuracy.
8. The sample size for the training set
This section is not applicable. The device is not an AI/ML product and does not have a "training set."
9. How the ground truth for the training set was established
This section 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.