(217 days)
Stat Medical Lancing Device Systems are intended for the hygienic collection of capillary blood for testing purposes from the side of a finger and from alternate site, such as the palm, the upper arm, and the forearm. The Stat Medical Lancing Device Systems are for single patient use in a home setting.
The Stat Medical Lancing Device Systems consist of two types of lancing devices: ULTIMATE Lancing Device and TRIO Lancing Device. Both are single-person, multiple-use devices made of ABS plastic and SUS304 stainless-steel springs. The ULTIMATE has 8 depth-setting choices, and the TRIO has 5 depth-setting choices and a Lancet Ejector. The systems also consist of two types of representative (generic) lancets: COMFORT THIN Twist-Off Lancets and COMFORT THIN Pull-Off Lancets. Both are sterile, single-person, single use devices made of plastic with a SUS304 stainless-steel needle tip and a protective plastic cover. The ULTIMATE and TRIO Lancing Devices have optional Alternative Site Test (AST) Caps.
The provided text is a 510(k) summary for the "STAT Medical Lancing Device Systems." It discusses the device's intended use, technological comparison to predicate devices, and results of non-clinical testing. However, it explicitly states that clinical testing was not applicable and therefore, it does not contain information about a study that proves the device meets specific acceptance criteria based on clinical performance metrics such as reader studies or algorithm performance.
The document mainly focuses on demonstrating substantial equivalence to predicate devices through technical specifications and non-clinical performance (mechanical testing and biocompatibility).
Therefore, I cannot fulfill the request to describe the acceptance criteria and a study that proves the device meets the acceptance criteria in the context of clinical performance (like a multi-reader multi-case study, standalone algorithm performance, or human-in-the-loop improvement) because such information is not present in the provided text.
The information that is available and can be extracted relates to the acceptance criteria for non-clinical performance tests.
Non-Clinical Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful completion and compliance with the listed ISO standards and the performance tests. The reported performance indicates that the device met these criteria.
| Acceptance Criteria Category | Specific Test/Standard | Reported Device Performance/Conclusion |
|---|---|---|
| Biocompatibility | ISO 10993-5: Tests for in vitro cytotoxicity | The device is identical to a previously cleared device (EasyTouch Lancing Device K222617) in formulation, processing, sterilization, and geometry. No other chemicals were added. |
| Complies with listed ISO standards. | ||
| ISO 10993-23: Tests for irritation | ||
| ISO 10993-11: Tests for systemic toxicity | ||
| ISO 10993-12: Sample preparation and reference materials | ||
| ISO 10993-10: Tests for skin sensitization | ||
| Mechanical Performance | Pen/Punt Testing | Performed successfully, implying that the device penetres as intended. |
| Cock Force Testing | Performed successfully, implying the force required to cock the device is within acceptable limits. | |
| Insertion Force Testing | Performed successfully, implying appropriate force for lancet insertion. | |
| Removal Force Testing | Performed successfully, implying appropriate force for lancet removal. | |
| Migration Distance Testing | Performed successfully, implying the lancet tip moves and retracts as designed within specified distances. | |
| Depth Penetration | Range of Depth (mm) - Ultimate Lancing Device (30 samples) | Depth 1: Min: 0.095, Max: 0.665 |
| Depth 2: Min: 0.285, Max: 0.855 | ||
| ... | ||
| Depth 8: Min: 0.665, Max: 0.95 | ||
| Range of Depth (mm) - TRIO Lancing Device (30 samples) | Depth 1: Min: 0.095, Max: 0.38 | |
| Depth 2: Min: 0.38, Max: 0.76 | ||
| ... | ||
| Depth 5: Min: 0.57, Max: 0.95 | ||
| Range of Depth + AST Cap (mm) - Ultimate Lancing Device (30 samples) | Depth 1: Min: 0, Max: 0 | |
| Depth 2: Min: 0, Max: 0.095 | ||
| ... | ||
| Depth 8: Min: 0.38, Max: 0.665 | ||
| Range of Depth + AST Cap (mm) - TRIO Lancing Device (30 samples) | Depth 1: Min: 0, Max: 0 | |
| Depth 2: Min: 0, Max: 0 | ||
| ... | ||
| Depth 5: Min: 0.285, Max: 0.57 | ||
| Sterility | Gamma irradiation | Yes, confirms the method of sterilization. |
| Sharps Injury Prevention | Design features | Lancets covered by sterile barrier, contained within housing until firing, automatically retracted after firing, ejector sleeve for contactless disposal (TRIO Lancing Device has ejector, Ultimate does not). This is a design feature, not a quantitative test result. |
Regarding the specific points asked for in the prompt, based on the provided text:
- A table of acceptance criteria and the reported device performance: See table above, derived from the "Non-clinical Testing Summary and Conclusions" and the "Similarities and Differences" table.
- Sample sized used for the test set and the data provenance:
- Sample Size: For "Range of Depth (mm)" and "Range of Depth + AST Cap (mm)" measurements, a sample size of 30 samples is explicitly mentioned for both the Ultimate and TRIO Lancing Devices. For other mechanical tests (Pen testing, cock force, insertion force, removal force, migration distance), sample sizes are not explicitly stated but are implied to be sufficient for compliance.
- Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. These are non-clinical lab tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This document is about a lancet device, not an AI/imaging device requiring expert ground truth for image interpretation. The testing performed is mechanical and biocompatibility, which does not involve human expert interpretation as ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no expert adjudication process described for the mechanical or biocompatibility testing.
- 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: No. The device is a lancing system, not an AI-assisted diagnostic tool. Clinical testing was explicitly stated as "not applicable."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. The device is a lancing system.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. For mechanical tests, the "ground truth" is adherence to engineering specifications and performance within defined ranges. For biocompatibility, it's compliance with ISO standards.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable. This is not an AI/machine learning 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.