(56 days)
Lancing device is used with disposable blood lancet to obtain capillary blood samples.
Lancing device is used with disposable blood lancet to obtain capillary blood samples. It has multiple penetration depth levels, normally 6 or 9. Lancing device is for single patient use only.
This document describes the FDA 510(k) clearance for a lancing device (K221970). As such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study that proves the device meets specific acceptance criteria in the context of an AI/ML-based medical device (which this lancing device is not).
Therefore, many of the requested elements for an AI/ML device study (like MRMC studies, effect sizes of AI assistance, expert adjudication for ground truth of an AI model, or sample sizes for training sets) are not applicable to this submission.
However, I can extract the relevant information regarding the performance data provided for this specific medical device (a lancing device) and present it in a similar structured format, adapting the questions where necessary.
Device: Lancing device (SteriLance Medical (Suzhou) Inc.)
FDA 510(k) Number: K221970
Predicate Device: ACON Laboratories, Inc., On call® Lancing device (K113332)
1. Acceptance Criteria and Reported Device Performance
For this medical device (a lancing device), the "acceptance criteria" are implied by the non-clinical bench testing conducted to demonstrate substantial equivalence to the predicate device. The performance data is reported as successful completion of these tests.
| Acceptance Criteria (Implied) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility | |
| - Cytotoxicity | Pass |
| - Skin Sensitization | Pass |
| - Intracutaneous reactivity | Pass |
| Non-Clinical Bench Testing | |
| - Appearance and Printing Appearance | Verified |
| - Basic Dimensions | Verified |
| - Compatible performance | Verified |
| - Bounce performance | Verified |
| - Puncture performance | Verified |
| - Adjustable performance | Verified (specifically addressing depth differences from predicate) |
| - Lancet unloading performance | Verified |
| Puncture Depth | Varied by model, within specified ±0.30mm tolerance for each gear/model (e.g., LDE 1-gear: 0.60±0.30mm, LDE 6-gear: 2.10±0.30mm, etc.) |
Note on Puncture Depth: The specific depth values for each gear setting (e.g., LDE model: 1-gear 0.60±0.30mm, 2-gear 0.90±0.30mm, etc.) serve as the specific functional performance criteria for this device, and the testing verified that these were met.
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the exact number of units or repetitions for each non-clinical bench test (e.g., how many lancing devices were tested for bounce performance, or how many punctures were performed). It only lists the types of tests conducted.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This type of data typically comes from in-house lab testing, not patient data in the sense of AI/ML models.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
- Applicability: Not applicable in the context of this device and testing. "Ground truth" in this context refers to engineering specifications, physical measurements, and standard biocompatibility test results, not expert interpretation of medical images or data.
4. Adjudication Method for the Test Set
- Applicability: Not applicable. There is no human interpretation or subjective assessment that would require an adjudication method. Test results are based on objective measurement or established lab protocols (e.g., passing ISO 10993 tests).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Applicability: Not applicable. This is a physical medical device (lancing device), not an AI/ML-based diagnostic or assistive technology for human readers.
6. Standalone (Algorithm Only) Performance
- Applicability: Not applicable. This device does not contain an algorithm in the sense of AI/ML. Its performance is determined by its mechanical and material properties.
7. Type of Ground Truth Used
- Ground Truth: For biocompatibility, the ground truth is established by adherence to the FDA guidance on ISO 10993-1 and the results of standardized biological tests (Cytotoxicity, Skin Sensitization, Intracutaneous Reactivity).
- For non-clinical bench testing, the ground truth is the device's design specifications for dimensions, performance characteristics (e.g., puncture depth tolerance), and comparison to the known performance of the predicate device.
8. Sample Size for the Training Set
- Applicability: Not applicable. This device is not an AI/ML model, so there is no "training set" in the computational sense. The device is manufactured based on design specifications and then tested.
9. How Ground Truth for the Training Set Was Established
- Applicability: Not applicable. As there is no AI/ML training set, there is no corresponding ground truth establishment process required.
§ 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.