(28 days)
It is intended for capillary blood sampling.
Promosemed Blood Lancet is a sterile, handheld, sharply-pointed, nonmechanical, scalpel-like instrument intended to be used by a healthcare provider or patient self to manually puncture the skin to obtain a small blood specimen.
VeriFine Safety lancet and VeriFine Mini-Safety lancet is sterile, single use, spring loaded lancets designed for capillary blood sampling. These lancets are precision sharpened designed for maximum comfort and optimal blood flow. Safety lancets are designed to make taking a blood sample simple and easy. Safety lancets are activated when you press the device against your finger. Once activated the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. The first spring releases the needle into the skin and the second withdraws the needle back into the shield.
Both single-use Promisemed Blood Lancet and VeriFine Safety Lancet/VeriFine Mini-Safety Lancet offers different gauge (needle diameter) options, to allow to choose the lancet which meets blood volume needs.
The provided text is a 510(k) Summary for medical devices (blood lancets) and does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the way described in the request (e.g., performance metrics, sample sizes for test sets, expert ground truth, MRMC studies, standalone algorithm performance).
Instead, this document focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It outlines a comparison of technical characteristics and performance testing that confirms the devices are comparable, not a study designed to establish quantitative performance against defined acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what cannot, based on the input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Comparison to Predicate/Standards) | Reported Device Performance (Summary of Bench Testing) |
|---|---|
| Same intended use as predicate | Same intended use as predicate |
| Same technological characteristics as predicate | Same technological characteristics as predicate |
| Compatible with lancing device (Promisemed Blood Lancet only) | Lancing device compatibility tested |
| Needle dimensions within specifications | Needle dimensions tested |
| Chemical properties within specifications | Chemical properties tested |
| Strong bond between lancet body and needle | Bond between lancet body and needle tested |
| Resistance to corrosion | Resistance to corrosion of needle tested |
| Locking function (VeriFine Safety/Mini-Safety Lancet only) | Locking function tested |
| Spring elasticity (VeriFine Safety/Mini-Safety Lancet only) | Spring elasticity tested |
| Percussive function (VeriFine Safety/Mini-Safety Lancet only) | Percussive function tested |
| Penetrate force (VeriFine Safety/Mini-Safety Lancet only) | Penetrate force tested |
| Biocompatible (ISO 10993 standards) | Biocompatibility (ISO 10993-1, 5, 10) established |
| Sterile (ISO 11137-1, ISO 11737-1, ISO 11737-2 standards) | Sterility (ISO 11137-1, ISO 11737-1, 11737-2) tested |
| 5-year shelf-life (ASTM F1980-07(2011)) | Shelf-life of 5 years validated |
| No new questions of safety/effectiveness compared to predicate | Bench testing verifies substantial equivalence |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document states "The bench testing performed verifies that the performance of the subject devices are substantially equivalent..." but does not provide specific sample sizes for these tests.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is a medical device submission focused on physical and chemical performance, not diagnostic accuracy requiring expert interpretation or ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study requiring adjudication of interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document pertains to blood lancets, which are physical medical devices, not AI-powered diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document pertains to blood lancets, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic performance. For device characteristics, the "ground truth" would be established by physical/chemical measurement standards (e.g., ISO, ASTM standards for dimensions, sterility, biocompatibility).
8. The sample size for the training set
- Not applicable. This is not an AI/algorithm-based device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/algorithm-based 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.