(154 days)
Lancet is intended to be used to obtain capillary blood sample for self-monitoring of blood glucose.
Lancing Device is used with lancets to draw a capillary blood sample for testing, utilizing small amounts of blood. The Lancing Device is intended for use by a single patient and should not be shared.
Lance Device have two parts, lancet and lancing device. Lancet is composed of a lancet body, a needle and a protective cap. Lancing device is mainly composed of depth adjustment tip, cap, release button, shield, rear sliding barrel and an ejector. The cover consists of inner cover, cap inner core, rear sliding barrel, inner core, buckle ring and two springs, with 12 depth adjustment gears.
The lancet is provided as sterile state and have four model: Model BYY3, Model BYY4, Model BYB and Model BYC. The lancet body of Model BYY3 and Model BYY4 is circular, and the lancet body of Model BYB and Model BYC is flat. The lancing device is provided as non-sterile state and a reusable medical device for use only on a single patient and have four model: Model CX11B1, Model CX11B2, Model CX11C1 and Model CX11C2. Model CX11 Lancing device is divided into CX11B (threaded connection) and CX11C (buckle connection) according to the different connection structures of the cap and body of the lancing device. Model CX11B is divided into CX11B1 (suitable for round lancet) and CX11B2 (suitable for flat lancet) according to the different structure of the lancet. Model CX11C is divided into CX11C1(suitable for round lancet) and CX11C2(suitable for flat lancet) according to the different structures of the lancet.
The lancet is sterilized by Gamma ray and for single use,the shelf life is 5 years. The lancing device is provided as non-sterile state,for use only on a single patient. The useful life is 5 years or 6000 times.
This document primarily outlines the premarket notification (510(k)) for a Lancing System, focusing on demonstrating its substantial equivalence to a predicate device based on bench testing and biocompatibility assessments. It does not present a study with specific acceptance criteria and reported performance data for a standalone or human-in-the-loop AI/ML device.
The document describes a medical device (Lancing System) used for obtaining capillary blood samples, not an AI/ML-driven diagnostic or assistive system. Therefore, the questions related to AI/ML specific performance, such as MRMC studies, standalone algorithm performance, expert ground truth establishment for test sets, and training set details, are not applicable to the information provided in this 510(k) summary.
The "Performance testing summary" section (8.0 onwards) details bench testing and biocompatibility testing conducted to demonstrate the safety and effectiveness of the physical Lancing System, but these are not related to AI/ML performance.
To address the prompt as much as possible given the provided text, I will describe the performance testing as presented for this physical medical device, acknowledging that it does not fit the AI/ML framework implied by many of the prompt's questions.
Acceptance Criteria and Study for the Lancing System (Physical Device)
This 510(k) submission for the Lancing System primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and biocompatibility assessments, rather than evaluating an AI/ML-driven system. Therefore, the concepts of "acceptance criteria" and "reported device performance" are discussed in the context of the physical device's mechanical and biological properties, not AI/ML precision, recall, or reader improvement.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission for a physical medical device, specific numerical acceptance criteria and precise reported performance values are typically detailed in the full test reports, which are summarized here. The summary provides a list of tests conducted and a general statement that the device meets requirements or the tests show "well" performance.
| Test Item (Bench Testing) | Acceptance Criteria (Implicit from industry standards/predicate) | Reported Performance (Qualitative/Summary) |
|---|---|---|
| Lancet Testing | ||
| Appearance | Conformance to specifications, freedom from defects | "Tested" (Implies successful conformance) |
| Dimension | Conformance to specified dimensions (e.g., needle length) | "Tested" (Implies successful conformance), needle length 3.3 ± 0.5mm |
| Needle-tip | Conformance to specifications for sharpness and integrity | "Tested" (Implies successful conformance) |
| Puncture force | Within acceptable range for patient comfort and effectiveness | "Tested" (Implies successful conformance) |
| Connecting fastness | Secure connection with lancing device | "Tested" (Implies successful conformance) |
| Corrosion resistance feature | Resistance to corrosion for material longevity | "Tested" (Implies successful conformance) |
| Limits for acidity and alkalinity | Within biocompatible limits | "Tested" (Implies successful conformance) |
| Total heavy metal content and Cd content | Below hazardous levels | "Tested" (Implies successful conformance) |
| Sealing strength | Maintenance of sterility barrier | "Tested" (Implies successful conformance) |
| Sterile barrier integrity | Maintenance of sterility barrier | "Tested" (Implies successful conformance) |
| Sterility | Sterile when presented | "Tested" (Implies successful conformance) |
| Lancing Device Testing | ||
| Appearance | Conformance to specifications, freedom from defects | "Tested" (Implies successful conformance) |
| Dimension | Conformance to specified dimensions | "Tested" (Implies successful conformance) |
| Compatibility | Proper function with specified lancets | "Well compatibility" |
| Coaxiality | Proper alignment of lancet for accurate puncture | "Tested" (Implies successful conformance) |
| Depth adjustment | Ability to adjust puncture depth as intended | "Tested" (Implies successful conformance), max range 1.8mm ± 0.5mm with 12 gears |
| Packages and Labels | Conformance to regulatory and labeling requirements | "Tested" (Implies successful conformance) |
| Drop test | Structural integrity after drops | "Tested" (Implies successful conformance) |
| Needle unloading thrust | Proper ejection of used lancet | "Tested" (Implies successful conformance) |
| Torque test (for CX11B1/B2) | Mechanical robustness of threaded connection | "Tested" (Implies successful conformance) |
| Buckle force (for CX11C1/C2) | Mechanical robustness of buckle connection | "Tested" (Implies successful conformance) |
| Separating force (for CX11C1/C2) | Mechanical robustness of buckle connection | "Tested" (Implies successful conformance) |
| Biocompatibility Testing | ||
| In vitro cytotoxicity | Non-toxic to cells | Completed, conformed to ISO 10993 series standards |
| Skin sensitization | Non-sensitizing effects | Completed, conformed to ISO 10993 series standards |
| Intracutaneous reactivity (Lancet) | Non-irritating when implanted/contacting tissue | Completed, conformed to ISO 10993 series standards |
| Acute systemic toxicity (Lancet) | Non-toxic acutely systemically | Completed, conformed to ISO 10993 series standards |
| Pyrogen (Lancet) | Non-pyrogenic | Completed, conformed to ISO 10993 series standards |
| Skin Irritation (Lancing Device) | Non-irritating to skin | Completed, conformed to ISO 10993 series standards |
| Clinical Simulated Use Testing | ||
| Sharps injury prevention features | Prevention of sharps injuries during use and disposal | "Well sharps injury prevention feature" |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes for each bench test. For physical device testing, sample sizes are typically determined by relevant ISO standards (e.g., for sterility, dimensions, mechanical function) and internal quality control procedures.
- Data Provenance: The document does not explicitly state the country of origin for the data collection, but the manufacturing company is "Ningbo Medsun Medical Co., Ltd." in "Ningbo, P.R.China," implying that the testing was likely conducted in China or by labs contracted within the region. The tests are presented as being conducted in support of the 510(k) submission, implying a prospective testing approach designed for regulatory clearance.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable: This pertains to AI/ML ground truth establishment. For a physical medical device, "ground truth" refers to the objective measurement against established standards (e.g., dimension measurements, force measurements, sterility cultures) rather than subjective expert consensus on image interpretation. Expert involvement would be in defining the standards, designing the tests, and interpreting the raw data, but not in establishing a "ground truth" derived from human interpretation.
4. Adjudication Method for the Test Set
- Not Applicable: This pertains to AI/ML test set ground truth. For physical device performance, adjudication is typically through statistical analysis of quantitative measurements against pre-defined acceptance limits, or pass/fail criteria for qualitative tests, not through expert consensus adjudication.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
- Not Applicable: This concept is relevant for AI/ML systems that directly assist human readers (e.g., radiologists interpreting images). This submission is for a physical medical device (lancing system) and does not involve AI assistance for human tasks that would necessitate an MRMC study.
6. Standalone (Algorithm Only) Performance
- Not Applicable: This applies to AI/ML algorithms. The Lancing System is a physical device, and there is no standalone algorithm performance to evaluate.
7. Type of Ground Truth Used
- Objective Measurements/Standards: For this physical device, the "ground truth" is established by:
- Referenced ISO Standards: The document repeatedly mentions adherence to ISO standards (e.g., ISO 10993 series for biocompatibility, ISO 23908:2011 for sharps injury protection, ISO 9626:2016 for needle gauges). These standards define the acceptable performance characteristics and test methods.
- Engineering Specifications: Device dimensions, puncture force, and mechanical functions are measured against design specifications.
- Laboratory Assay Results: Biocompatibility tests yield objective results (e.g., cell viability, presence of pyrogens) against established acceptable ranges.
- Qualitative Assessments: Appearance and functional tests are performed against defined visual and operational criteria.
8. Sample Size for the Training Set
- Not Applicable: There is no "training set" as this is not an AI/ML device.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no AI/ML training set, this question is not relevant.
§ 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.