(57 days)
The safety lancet is intended for capillary blood sampling.
The safety lancet is single use medical device, which is designed to collect capillary blood sample.
The intended users include Healthcare personnel, patients and lay persons.
According to surface difference or structure, the Safety lancets have 7 models: XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.
XXIX, XXX model have sub model according to surface difference.
For Model XXVIII and XXX, the safety lancets consist of needle core, button, housing and spring. For Model XXIX, the safety lancets consist of needle core, button, housing, spring, and Depth adjuster ring. For Model XXXI, the safety lancets consist of needle core, top cover, bottom and spring. For Model XXXII, the safety lancets consist of needle core, top cover, bottom, small lid and spring. For Model XXXIII, the safety lancets consist of needle core, button, housing, inner sleeve and spring. And for Model XXXIV, the safety lancets consist of needle core, button, housing, bottom, Protective cap and spring.
The sterile part of the safety lancet is the needle tip.The sterile barrier is the needle sleeve and sterilized to a SAL of 10-6 by radiation sterilization. It is intended for single use only. The shelf-life of the product is 5 years.
This document is a 510(k) summary for a medical device called "Safety Lancet," and it does not contain information about an AI/ML powered device. The information provided is for a physical medical device (safety lancets) used for capillary blood sampling. Therefore, many of the requested fields related to AI/ML device studies (such as MRMC studies, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.
However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this physical device.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Launch performance should be good, launch button press smoothly, no jam | Meet the requirement |
| The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Visual, should not be visible droplets. (Lubricant) | Meet the requirement |
| Safety lancet should be single use, no second launch after used. (Disposable) | Meet the requirement |
| The force to activate the safety feature: 4 - 15N | Meet the requirement |
| Test access to the sharp: the needle shall not touch the sphere. | Meet the requirement |
| Not produce cytotoxicity (Biocompatibility - In Vitro Cytotoxicity) | No Cytotoxicity |
| Not produce skin sensitization (Biocompatibility - Skin Sensitization) | No Skin sensitization |
| Not produce irritation (Biocompatibility - Intracutaneous reactivity) | No irritation |
| Not cause acute systemic toxicity (Biocompatibility - Acute Systemic Toxicity) | No Acute Systemic Toxicity |
| Not cause pyrogenic reaction (Biocompatibility - Pyrogenicity) | No thermogenic reaction |
| Safety mechanism evaluation (Simulated Clinical Use) | Met the pre-established criteria |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Simulated Clinical Use Study: 300 device samples each for the Safety Lancet (various models).
- Data Provenance: Not specified in the provided document (e.g., country of origin, retrospective/prospective). This was a bench test and simulated use study, not a human data study.
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. The "ground truth" for this physical device was based on objective physical measurements and established biological safety standards from ISO 10993 and FDA guidance, not expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a non-clinical bench and simulated use study, not a study requiring adjudication of expert opinions.
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 is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For bench testing: Objective physical measurements and adherence to functional specifications.
For biocompatibility testing: Laboratory results following ISO 10993 standards.
For simulated clinical use: Evaluation of the safety mechanism against pre-established criteria defined by FDA Guidance (Medical Device with Sharps Injury Prevention Feature) and ISO 23908.
8. The sample size for the training set
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML powered 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.