(55 days)
Lancet is intended for capillary blood sampling.
The Sterile Lancets for Single Use is composed two components: needle and needle holder. Needle holder is plastic part that enclosed the needle. The sterile barrier is the needle holder and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The lancet is together with a lancing device to puncture the skin to obtain a drop of capillary blood from fingertip or from alternative sites. The shelf-life of the product is 5 years.
The provided document is a 510(k) premarket notification for a medical device (Sterile Lancets for Single Use). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" with numerical targets in a formal table corresponding to performance. Instead, it refers to "Performance testing is conducted according to Inspection Specification" and states that "the test sample has undergone accelerated aging for 5.5 years" and "passed all tests." The performance attributes tested are listed.
Here's an interpretation of the performance attributes and the implied acceptance criteria from the text:
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Appearance: Acceptable visual inspection | The device passed tests after accelerated aging. (Implied: Appearance remained acceptable.) |
| Dimension: Within specified tolerances | The device passed tests after accelerated aging. (Implied: Dimensions remained within specified tolerances.) |
| Firmness of needle and main body: Adequate mechanical integrity | The device passed tests after accelerated aging. (Implied: Firmness remained adequate.) |
| Puncture Performance: Satisfactory for capillary blood sampling | The device passed tests after accelerated aging. (Implied: Puncture performance remained satisfactory.) |
| Matching: Compatibility with lancing devices | The device passed tests after accelerated aging. (Implied: Compatibility remained.) |
| Launch Performance: Adequate for intended use | The device passed tests after accelerated aging. (Implied: Launch performance remained adequate.) |
| Bacterial endotoxin: Below specified limits | The device passed tests after accelerated aging. (Implied: Bacterial endotoxin levels were below limits.) |
| Sterilization (SAL=10-6): Achieved | Sterilized by Radiation SAL=10-6. The device passed tests after accelerated aging. (Implied: Sterility was maintained.) |
| Biocompatibility: Conforming to ISO 10993 standards | Conforms to the requirements of ISO 10993 series standards, specifically: Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity. |
| Shelf-life: 5 years | After five years of accelerated aging, the product has passed all tests, so it can be guaranteed that the product can be used normally within five years. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify the numerical sample size used for performance testing. It generally refers to "the test sample."
- Data Provenance: The document indicates that the testing was conducted by Ningbo Caremed Medical Products Co., Ltd., based in China. The data would be retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a medical lancet and the testing involves objective physical, chemical, and biological performance tests, not subjective interpretation by experts to establish a "ground truth" like in imaging or diagnostic AI. The "ground truth" for these tests would be the established scientific and engineering standards and methods.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Adjudication methods are typically used when subjective expert opinion is involved in ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable. An MRMC study is relevant for diagnostic devices, especially those involving human interpretation (e.g., radiologists interpreting images). This device is a sterile lancet for single-use capillary blood sampling, a physical instrument, and does not involve human readers interpreting output that would be improved by AI assistance.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)
This information is not applicable. This device is a physical medical instrument, not a software algorithm.
7. Type of Ground Truth Used
The "ground truth" for the performance testing of the lancet is based on:
- Established scientific and engineering standards: For dimensions, firmness, puncture performance, matching, launch performance.
- Specific ISO standards: For biocompatibility (ISO 10993 series) and sterilization (SAL of 10-6).
- Bacterial endotoxin limits: Established regulatory or compendial limits.
- Accelerated aging protocols: To simulate real-time shelf-life.
8. Sample Size for the Training Set
This information is not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this 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.