(126 days)
It is intended for capillary blood sampling.
Disposable Sterile Lancet is Class II Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature bearing the product code FMK (21CFR878.4850). The lancet is for single use, disposable sterile devices, which is designed to collect capillary blood samples. The Disposable Sterile Lancet consist of protective cap, housing, bottom, fire button, connection ring, springs (ejection spring and fire spring), and core of lancet (including needle). The sterile part of the 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.
The provided text is a 510(k) summary for a Disposable Sterile Lancet. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Based on the information provided, here's a detailed breakdown of the acceptance criteria and the study that proves the device meets them:
Device: Disposable Sterile Lancet
Intended Use: Capillary blood sampling.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Item | Specific Characteristic | Acceptance Criteria | Reported Performance (Results) |
|---|---|---|---|
| Appearance | Product Appearance | No obvious foreign body, fracture, unformed defects etc. | Meet the requirements |
| Needle-tip | No obvious burrs, curved hooks, oil stains etc. Lancet should be well assembled, no obvious dislocation at the fitting of the shell. | Meet the requirements | |
| Dimensions | Diameter of needle core | Product dimensions shall be consistent with the drawings. | Meet the requirements |
| Length of exposed needle-tip | The length of exposed needle-tip shall be consistent with the drawings. | Meet the requirements | |
| Performance | Puncture Depth | Using A4 printing paper for simulated testing and meet the requirements. | Meet the requirements |
| Launch performance | The operation of Fire should be smooth, after launching, the tip of the needle should be automatically retracted into the housing. | Meet the requirements | |
| Firmness | Needle should connect firmly with plastic handle. | Meet the requirements | |
| Sterility | Sterility | The sterility for the device shall be at SAL (Sterility Assurance Level) of 10^-6. | Meet the requirements |
| Biocompatibility | Cytotoxicity | Undetermined to be non-cytotoxic. | Pass |
| Irritation | Undetermined to be non-irritating. | Pass | |
| Sensitization | Undetermined to be non-sensitizing. | Pass | |
| Acute Systemic Toxicity | Not an acute systemic cytotoxic potential. | Pass | |
| Pyrogenicity | No pyrogenicity reaction. | Pass |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each non-clinical test conducted. It generally refers to "tests" and "results" without specifying the number of units tested.
The data provenance is the manufacturer, Tianjin Rilifine Medical Device Co., Ltd., based in China. The study is a non-clinical study (laboratory testing) rather than a clinical study involving human patients, and therefore, the terms "retrospective" or "prospective" are not directly applicable in the same way they would be for patient data. It is a series of tests performed on the manufactured device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not mention the use of experts to establish "ground truth" for the non-clinical tests. These tests are based on objective measurements and established standards (e.g., ISO standards) rather than subjective expert consensus. For example, sterility is tested to a SAL of 10^-6, not determined by expert opinion.
4. Adjudication Method for the Test Set
Not applicable. As these are non-clinical, objective tests against pre-defined acceptance criteria (often tied to ISO standards), there is no mention of an adjudication method by multiple experts. The results are binary (meets/does not meet requirements, pass/fail).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for AI/image analysis devices where human readers interpret diagnostic images, and the AI assists in that interpretation. The Disposable Sterile Lancet is a physical medical device for blood sampling, and its performance is evaluated through physical and biological testing, not by human reader interpretation of data in a comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. The performance evaluated is the physical function and material properties of the lancet itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by objective measurements against predefined specifications and recognized international standards. For example:
- Dimensions: Comparison to engineering drawings.
- Sterility: Adherence to ISO 11137 standards for a SAL of 10^-6.
- Biocompatibility: Adherence to ISO 10993 standards (e.g., non-cytotoxic, non-irritating, non-sensitizing).
- Functional Performance (Puncture Depth, Launch Performance, Firmness): Measured against internal design specifications and simulated real-world use (e.g., A4 paper for puncture depth, observation of retraction).
8. The Sample Size for the Training Set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for a physical medical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
§ 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.