(87 days)
It is intended for capillary blood sampling.
The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use. The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.
Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the device's performance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device through various non-clinical tests. The "acceptance criteria" are generally implied to be compliance with relevant international standards and FDA guidance, as well as performance comparable to the predicate device. Specific numerical acceptance criteria are not explicitly stated for all tests, but rather the outcome of "met the requirements" or "complies with."
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11, ASTM F756-17) | Tested; results comply with requirements of ISO 10993 |
| Simulated Clinical Use | Compliance with FDA Guidance: "Medical Device with Sharps Injury Prevention Feature" and ISO 23908 to evaluate the safety mechanism. | "The results demonstrated that the proposed device met the requirements." |
| Bench Tests | Limits defined by ISO 7864:2016, ISO 9626:2016, ASTM D4169-16, USP , USP-NF, USP-NF as applicable for: | "The test results demonstrated that the proposed device complies with the following standards and guidance." |
| - Acidity/Alkalinity | (Implied by standard compliance) | Complies |
| - Extractable Metals | (Implied by standard compliance) | Complies |
| - Surface Finish/Visual | (Implied by standard compliance) | Complies |
| - Dimensions | (Implied by standard compliance) | Complies |
| - Corrosion Resistance | (Implied by standard compliance) | Complies |
| - Penetration Force | (Implied by standard compliance) | Complies |
| - Puncture Depth | (Implied by standard compliance) | Complies |
| - Bond Between Needle Connector and Needle | (Implied by standard compliance) | Complies |
| Sterilization | ISO11137-2:2006 (SAL) and Endotoxin limit of 20 EU per device | Complies; radiation sterilization, 10-6 SAL |
2. Sample Size Used for the Test Set and Data Provenance:
- Simulated Clinical Use: 600 device samples.
- Biocompatibility and Bench Tests: Specific sample sizes for individual tests are not detailed beyond "the lancet" or "the proposed device."
- Data Provenance: The document does not specify the country of origin of the data for these studies. The studies are non-clinical (laboratory/bench) and simulated clinical use, not clinical trials on human subjects. They are prospective tests conducted for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This submission describes a medical device (Lancet) and its performance under various non-clinical and simulated clinical conditions. The "ground truth" for these tests relates to objective measurements, standard compliance, and device functionality, not expert interpretation of clinical data. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not relevant here.
4. Adjudication Method for the Test Set:
- Not applicable. As the tests are objective measurements and compliance assessments (e.g., dimensions, force, cytotoxicity), there is no mention or need for an adjudication method like 2+1 or 3+1. The results are directly measured against predefined standards or specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No. An MRMC study is relevant for diagnostic imaging devices where human readers interpret cases. This document pertains to a blood lancet, and no such study was conducted or is relevant for its substantial equivalence claim.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a manual blood lancet, a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" is not relevant.
7. The Type of Ground Truth Used:
- Objective Test Results and Compliance with International Standards/Guidance: The "ground truth" for the performance tests consists of objective measurements (e.g., dimension records, force measurements, chemical analysis results) and direct compliance with the requirements outlined in recognized international standards (ISO 7864, ISO 9626, ISO 10993 series, ISO 23908, ASTM F756-17, ASTM D4169-16, USP , USP-NF, USP-NF) and FDA guidance documents.
8. The Sample Size for the Training Set:
- Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set for an AI/ML model, 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.