(89 days)
The product is used to obtain capillary blood samples from fingertip in a home. The lancet is assembled with lancing device, once the lancing device is launched, the needle of lancet can prick the skin.
The Disposable Blood Lancets consists of a needle, a body and a cap. The models of the Disposable Blood Lancets are 21G; 23G; 26G; 30G. Disposable Blood Lancets are used to obtain blood samples for testing purposes. It is sterilized by Irradiation and is a single-use product. The device is compatible with the reusable lancing device which met the specification and size requirements of the following figure in the market.
The document provided is a 510(k) summary for a medical device called "Disposable Blood Lancets". It outlines the device's technical characteristics and compares them to a predicate device to establish substantial equivalence.
Based on the provided text, the device is a medical lancet and not an AI/ML powered device. Therefore, a study proving the device meets acceptance criteria related to AI/ML performance (such as MRMC studies, standalone algorithm performance, ground truth establishment methods for AI, or training set sizes) would not be applicable and is not present in this document.
However, I can extract information regarding the acceptance criteria and the studies performed to demonstrate the device's physical performance, biocompatibility, and sterilization for this specific medical device.
1. Table of Acceptance Criteria and Reported Device Performance
| No | Testing Item | Specification (Acceptance Criteria) | Result |
|---|---|---|---|
| 01 | Appearance | Lancet should have the same color, no bubble, no flash, no slip. | Pass |
| 02 | Launch Length | The length of the needles in the Disposable Blood Lancets is different in different gauge. The general depth is 3.2mm | Pass |
| 03 | Sharpness/Penetration testing | Penetration force ≤1.00N. | Pass |
| 04 | Exterior (Needle connection) | The connection between needle and needle body should be firm. | Pass |
| 05 | Exterior (Cap twist) | Cap twist should be smooth. | Pass |
| 06 | Initial bioburden | Initial bioburden of the device shall be less than 100CFU/g. | Pass |
| 07 | Sterile | The sterile blood lancet shall be sterile. | Pass |
| 08 | Cap removal force | The moment for breaking the safe mode should range from 30 Ncm to 35 Ncm. | Pass |
| 09 | Needle removal force | The bond between the lancet body and needle should be greater than or equal to 10N/15s. | Pass |
| 10 | Drop testing | The carton box should have no puncture after the drop test. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., how many lancets were tested for sharpness, bioburden, etc.). It generally states that "The following performance data were provided in support of the substantial equivalence determination."
The data provenance is not specified in terms of country of origin of the data or whether it was retrospective or prospective. It is implied to be internal testing conducted by the manufacturer, Huaian Hening Medical Instruments Co., Ltd.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable for this type of medical device's performance testing. The "ground truth" for these tests is based on objective, measurable physical and biological parameters defined by established standards and internal specifications, not expert consensus on interpretations.
4. Adjudication Method
Not applicable. The tests are objective measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML powered device, so MRMC studies are not relevant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance tests outlined in the table consists of objective physical and biological measurements against predefined specifications and established international standards (e.g., ISO for biocompatibility and sterilization). This is not expert consensus, pathology, or outcomes data in the context of an AI/ML diagnostic device.
8. Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a physical device, not an AI/ML model.
Additional Information on Studies Conducted:
The document also details other non-clinical tests performed:
- Biocompatibility Testing: Evaluated in accordance with ISO 10993-1:2018 for the body contact category. Specific tests performed include:
- Cytotoxic test (ISO 10993-5:2009)
- Skin sensitization test (ISO 10993-23:2021)
- Intracutaneous test (ISO 10993-10:2021)
- Acute systemic toxicity test (ISO 10993-11:2017)
- Hemolysis test (ISO 10993-4:2017)
- Pyrogen Test (ISO 10993-11:2017)
- Sterilization and Shelf Life Testing:
- Irradiation sterilization validation per ISO 11137-1 and ISO 11137-3.
- Pyrogen testing per ISO 10993-11:2017.
- Transportation test per ISTA 2A:2011.
- Shelf life of 5 years determined based on stability study which includes aging test.
These studies support the substantial equivalence claim by demonstrating that the device meets safety and effectiveness requirements through validated physical, chemical, and biological testing, rather than complex AI/ML performance evaluations.
§ 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.