(203 days)
The EasyTouch™ Lancing Device is for use with FreeStyle Lancets to collect capillary blood for testing purposes from the fingertip and from alternate sites, such as the palm, the upper arm, or the forearm. The EasyTouch Lancing Device is for single patient use in a home setting.
The EasyTouch Lancing Device is used with the FreeStyle Lancet, which was cleared under 510(k) K221433 under the device name Facet 28GUniversal Lancet. The intended use of the EasyTouch Lancing Device is to function as a single-person reusable device that holds a lancet to puncture the skin for capillary blood sampling for blood glucose testing. It is not to be used for assisted blood draws by healthcare providers or at healthcare provision sites. The EasyTouch Lancing Device is made of ABS plastic and SUS304 stainless-steel springs. The EasyTouch Lancing Device has 8 depth-setting choices. The device requires that the lancing device end cap be removed, a single lancet be inserted into the lancet holder and then the lancing device end cap placed back onto the device. The user is able to set the desired depth penetration level by moving the depth selector. The lancing device is then cocked by pulling the back end of the device away from the lancet body. To fire the device the firing button is depressed. Once the lancet has been fired it moves forward to pierce the patients' test site with the lancet. After piercing the skin, the lancet then travels back into the housing of the lancing device. The lancing device end cap is removed and then the lancet is removed. It is then disposed of into an appropriate container. The body and lancing device end cap are cleaned with soap and warm water and allowed to air dry after each use and disinfected per the IFU, as needed. If the patient is testing from a site other than the finger an optional AST Cap may be put onto the device instead of the "standard" lancing device end cap. The EasyTouch Lancing Device has an Alternative Site Test (AST) Cap, which is not sold separately. The AST Cap id only provided with the meter kit alongside the lancing device. The AST Cap allows the user to obtain a blood sample from parts of the body other than the fingers. The lancing device end cap is cleaned after every use and when visibly dirty and before disinfection. Disinfection is performed between each use. Cleaning involves use of a damp cloth and mild detergent to wipe the outside of the lancing device end cap, followed by wiping dry. The device is disinfected via wiping down with a cloth dampened in a bleach wipes) and allowed to air dry. The Alternate Site Testing (AST) Cap is a single-person multi-use optional plastic accessory for the lancing device. It may be used in place of the original lancing device end cap when a patient is taking a blood sample from a site on the body other than the finger. Proper use of the device requires that the user first verify with their physician and the Instructions for Use of the blood glucose test strips or meter they are using to determine if AST testing is appropriate.
Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them relate to a Class II medical device, the EasyTouch Lancing Device, which is used for collecting capillary blood samples. The document is a 510(k) Premarket Notification from the FDA, focusing on the substantial equivalence of the new device to a legally marketed predicate device.
It's crucial to understand that for a 510(k) submission, the primary goal is to demonstrate "substantial equivalence" to a predicate device, not necessarily to prove absolute efficacy or safety through rigorous clinical trials as would be required for a "PMA" (Premarket Approval) device. Therefore, the "acceptance criteria" and "study" described herein are tailored to this regulatory pathway.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical bench testing for mechanical design verification and validation, as well as biocompatibility. The "acceptance criteria" are implied by the performance of the predicate device and the adherence to special controls and specified requirements. "Reported device performance" is given as meeting these criteria.
| Acceptance Criteria Category | Specific Tests/Evaluations | Reported Device Performance (Implicitly Meets Criteria) |
|---|---|---|
| Mechanical Design & Functionality | Dimensional Measurements | Met specified requirements (implied by "functional reliability," "piercing depth," and "cock force tests"). |
| Function Reliability Drop Test | Met specified requirements. | |
| Piercing Depth Test | Met specified requirements. | |
| Cock Force Test | Met specified requirements. | |
| Biocompatibility | MEM Elution Cytotoxicity | Met ISO 10993-1 requirements. |
| Kligman Maximization (Skin Sensitization) | Met ISO 10993-1 requirements. | |
| Intracutaneous Injection (Irritation) | Met ISO 10993-1 requirements. | |
| Material Compatibility | Compatibility with FreeStyle Lancets (K221433) | Pre-tested and demonstrated compatible under previous 510(k) for the lancets themselves. |
| Regulatory Compliance | Adherence to Special Controls (21 CFR 878.4850) | Satisfied. |
| Risk Management (ISO 14971 equivalent) | Appropriately managed. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document does not specify a numerical sample size for the non-clinical bench tests (e.g., how many lancing devices were drop-tested, or how many samples for biocompatibility). It generally states that "non-clinical bench testing was performed" and "a battery of tests" for biocompatibility.
- Data Provenance: The data is from non-clinical bench testing performed by the manufacturer (STAT Medical Devices). The location/country of origin of this specific testing is not explicitly stated, but it's part of a U.S. FDA 510(k) submission. The testing is assumed to be prospective as it was conducted specifically for this premarket submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this 510(k) submission for a lancing device. Ground truth established by expert consensus (e.g., radiologists interpreting images) is typically relevant for interpretative devices like AI algorithms for diagnostics, not for mechanical devices like lancing devices. The "ground truth" for the performance of this device is based on objective, quantifiable physical and material properties (e.g., piercing depth measurement, force measurement, chemical reactivity).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers are interpreting data (e.g., medical images) to resolve discrepancies and establish a consensus "ground truth." For the mechanical and biocompatibility testing of a lancing device, the results are objectively measured or observed, and therefore do not require human adjudication in this manner.
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 is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems (often involving AI) and human readers. The EasyTouch Lancing Device is a mechanical blood collection device, not an interpretative diagnostic device or AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a mechanical lancing device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for the non-clinical testing of the EasyTouch Lancing Device is primarily established through objective engineering measurements, physical property testing, and established laboratory standards for biocompatibility. This is in contrast to "expert consensus" or "pathology" which are typically used for diagnostic devices. For example, "piercing depth" is measured directly, not subjectively interpreted.
8. The sample size for the training set:
- This is not applicable. "Training set" refers to data used to train machine learning models (AI). The EasyTouch Lancing Device is a mechanical device, not an AI or machine learning product.
9. How the ground truth for the training set was established:
- This is not applicable as there is no AI training set for this mechanical 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.