(131 days)
MedtFine Blood Lancet is intended for use together with a lancing device of skin to obtain a drop of capillary blood from fingertip or from alternative sites.
MedtFine Blood Lancet is a small medical device used for capillary blood sampling. It is similar to a small scalpel with a double-edged needle used to make punctures, such as a fingerstick, to obtain small blood specimens. The device consists of a needle sheath, a hub, and a needle and provided sterility that is sterilized by gamma radiation. The device has three types listed in table 1 with recognized color. The device is an over-the-counter instrument equipped with a lancing device that patients mostly use during blood monitoring. However, in this case, it doesn't contain a lancing device, only the lancet. The proposed device is a universal device that can be fitted with most common marked lancing devices.
This document is a 510(k) Pre-market Notification for a medical device called "MedtFine Blood Lancet." It aims to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
Here's the breakdown 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 acceptance criteria are primarily derived from various ISO standards. The reported device performance is presented in comparison to these standards and the predicate devices.
| Acceptance Criteria Standard/Test | Device Performance (MedtFine Blood Lancet) |
|---|---|
| Physical Performance Tests | |
| ISO 9626:2016 (Stainless Steel Needle Tubing) - Visual inspection | Smooth, clean, free from contamination, no color fading, sharp edge, free from burrs, hooks, blunt, straight, no slanting. Meets visual checking requirements of ISO 9626, ISO 7864, and internal requirements. |
| ISO 9626:2016 (Needle outer dimension) | 33G: 0.20 mm, 30G: 0.32 mm, 28G: 0.36 mm. Meets needle outer dimension requirements of ISO 9626. |
| ISO 7864-2016 (Sterile Hypodermic Needles) - Chemical Characters (Acidity/Alkalinity) | 33G: 0.31, 30G: 0.29, 28G: 0.34. Meets requirements of ISO 7864. |
| ISO 7864-2016 (Needle bond force) | 33G: 12.15 N, 30G: 15.87 N, 28G: 15.39 N. Meets requirements of ISO 7864. |
| ISO 9626:2016 (Corrosion resistance) | No corrosion in NaCl solution for 7 hours. Meets corrosion resistance requirements of ISO 9626. |
| ISO 7864-2016 (Penetrate force/puncture force) | 33G: 0.388 N, 30G: 0.543 N, 28G: 0.545 N. Meets requirements of ISO 7864. (Noted as lower than predicate, leading to less pain). |
| ISO 11608-1:2014 & ISO 11608-2 (Needle-based injection systems) | Tested in conformance. (Specific performance metrics not detailed, but referenced for compliance). |
| Lancing device compatibility | As a universal device, compatible with various commercially marketed lancing devices verified in usability testing. |
| Sterility Tests | |
| ISO 11737-1:2018 (Determination of microorganisms on products) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| ISO 11737-2:2019 (Tests of sterility) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| ISO 11137-1:2006, ISO 11137-2:2013, ISO 11137-3:2006 (Radiation sterilization) | Sterilized by gamma radiation, SAL = 10^-6. Tested in conformance. |
| ISO 11607-1:2019, ISO 11607-2:2019 (Packaging for terminally sterilized medical devices) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| ASTM F1980 (Accelerated Aging of Sterile Barrier Systems) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| ASTM F1929:2015 (Detecting Seal Leaks in Porous Medical Packaging) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| ASTM D4169-16 (Performance Testing of Shipping Containers) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| USP (Sterility Test) | Tested in conformance. |
| Biocompatibility Tests | |
| ISO 10993-1:2018 (Biological evaluation of medical devices) | No hemolysis, no cytotoxicity, no irritation and no skin sensitization, no acute systemic toxicity, no pyrogens. Tested in conformance. |
| ISO 10993-4:2017 (Interactions with blood) | No hemolysis. Tested in conformance. |
| ISO 10993-5:2009 (In vitro cytotoxicity) | No cytotoxicity. Tested in conformance. |
| ISO 10993-10:2010 (Irritation and Skin Sensitization) | No irritation and no skin sensitization. Tested in conformance. |
| ISO 10993-11:2017 (Systemic toxicity) | No acute systemic toxicity. Tested in conformance. |
| USP (Bacterial Endotoxins Test) | No pyrogens. Tested in conformance. |
| USP (Particulate matter in injection) | Tested in conformance. (Specific results not detailed, but referenced for compliance). |
| USP (Bacterial endotoxin and pyrogen tests) | Tested in conformance. |
| Population Evaluation | Results support the intended wider population (child older than 2 years, adolescent, adult). |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each individual non-clinical test conducted for the MedtFine Blood Lancet. It generally states that "all proposed device types' performance testing is run" for the different gauge sizes.
The data provenance is from non-clinical testing conducted by the manufacturer, Shanghai Carelife International Trading Co. Ltd. (China). The data is prospective in the sense that these tests were performed specifically for this 510(k) submission to demonstrate compliance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This detailed information is not provided in the document. The non-clinical testing appears to be primarily laboratory-based measurements and evaluations against established ISO standards and internal requirements, rather than relying on expert consensus for "ground truth" in the way a clinical study might for image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable in the context of this 510(k) submission. The non-clinical tests described are objective measurements against predefined standards, which do not typically involve human adjudication or consensus methods like those used in clinical studies for diagnostic accuracy.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical testing is available for this device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as this describes a physical medical device (blood lancet), not a software algorithm or AI-driven system.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests is established by:
- International Standards: Primarily ISO standards (e.g., ISO 9626, ISO 7864, ISO 10993, ISO 11137, ISO 11607, ISO 11737).
- National Standards/Pharmacopoeias: ASTM standards (e.g., ASTM F1980, ASTM F1929, ASTM D4169) and USP (United States Pharmacopeia) tests (e.g., USP , USP , USP , USP ).
- Internal Requirements: For visual checking, additional internal requirements "derived from the visual checking sections of ISO 9626 and ISO 78664" were used.
These standards define the acceptable range or qualitative outcome for each test (e.g., "no corrosion," "meets requirements," specific numerical limits).
8. The Sample Size for the Training Set
This question is not applicable. This is a submission for a physical medical device. The concepts of "training set" and "validation set" are relevant to machine learning/AI models, which are not involved here. The manufacturer performed a series of tests on the device itself to demonstrate its inherent properties and safety.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
§ 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.