(25 days)
Lancet: The lancet is intended for capillary blood sampling.
Lancing device: The Lancing Device is used with lancets to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII- T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T)
The Lancing Device is used with lancets to draw capillary blood from the fingertip, palm (at the base of the thumb) or forearm, for testing utilizing small amounts of blood. The Lancing Device is intended to be used by a single patient and should not be shared. (HH-XXVII-T)
Lancet: The Lancet (use with lancing device) is a single use, sterile medical device, which is designed for use of micro blood sampling puncture to obtain capillary blood samples from the fingertip. The Lancet is composed three components: needle, main body and protective cap. Main body and protective cap is plastic part that enclosed the needle. The Lancet is intended to be single use and the needle tip is sterilized by Radiation. The shelf-life of the product is 5 years.
Lancing Device: Along with a lancet, the lancing device is used to obtain a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM, PC and PS Resin. And the spring is made of carbon steel. The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first. For Model HH-XIII-T, the service life of the Lancing Device is 10 years or 5000 times of normal use, whichever comes first. The Lancing Device is provided non-sterile.
The provided text is a 510(k) summary for a medical device (Lancet and Lancing Device). This type of submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, rather than extensive clinical studies or AI/software performance evaluations. Therefore, many of the requested details related to "AI performance," "expert ground truth," "MRMC studies," and "training sets" are not applicable to this document.
However, I can extract the relevant acceptance criteria and study information provided for this medical device based on the document's content.
Here's a breakdown of the requested information based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present a formal table of quantitative acceptance criteria and corresponding performance metrics for the device in the format common for AI/software devices. Instead, it generally states that the device "met the performance criteria outlined" and that "all verification and validation tests passed without deviations." The performance evaluation for this device category (lancets and lancing devices) would typically involve mechanical, sterilization, biocompatibility, and functional tests.
Here's an interpretation of the implied acceptance criteria and reported performance based on the "Non-Clinical Testing" section:
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Performance | Device meets all established performance specifications (e.g., proper piercing, blood collection, retraction, durability). | "The testing confirmed that the lancet and lancing device meet the performance criteria outlined." |
| Sterilization | Sterility Assurance Level (SAL) of $10^{-6}$ for lancets sterilized by radiation. | "No Change" from predicate, implying adherence to this SAL. |
| Biocompatibility | New material (PE) is biocompatible and non-toxic (as per ISO 10993-1). | "The results confirmed that the material is nontoxic and safe for use in its intended application." |
| Simulated Clinical Use | Safety mechanism meets pre-established criteria (as per FDA Guidance and ISO 23908). | "The results demonstrated that the proposed device met the pre-established criteria." |
| Durability (Lancing Device) | Service life of 5 years or 5000 uses (or 10 years/5000 uses for model HH-XIII-T). | "The service life of the Lancing Device is 5 years or 5000 times of normal use, whichever comes first." (Specifically mentions HH-XIII-T). |
| Sharp Injury Prevention | Device design prevents sharp injuries after use. | "Lancet retracted after use to prevent sharp injure" (Comparison table), confirming this feature. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the Simulated Clinical Use study, 640 device samples were used for both the Lancet and the Lancing Device. Other performance and biocompatibility tests would have their own sample sizes, but these are not explicitly stated in this summary for each specific test (e.g., mechanical tests, needle integrity, etc.).
- Data Provenance: The studies were conducted by Tianjin Huahong Technology Co., Ltd. (China). The data origin is thus China. The studies described are prospective tests performed on the new device, not retrospective data analysis.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Not applicable. This device is a mechanical medical device, not an AI/software device that requires expert radiological or clinical interpretation to establish ground truth for performance evaluation in the way AI algorithms do. The "ground truth" for this device's acceptance is based on engineering specifications, physical measurements, biological safety tests (biocompatibility), and functional performance tests against established standards.
4. Adjudication Method for the Test Set
Not applicable. As this is not an AI/software performance study relying on human interpretation, there is no "adjudication" in the sense of reconciling expert opinions. Performance is assessed against quantitative engineering specifications and standard test methods.
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 is for a mechanical medical device (lancet and lancing device), not an Artificial Intelligence (AI) or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device. Performance is evaluated through physical and functional testing of the device itself.
7. The Type of Ground Truth Used
The "ground truth" for showing the device meets acceptance criteria is based on:
- Engineering Specifications/Standards: Performance criteria outlined in internal specifications and relevant international standards (e.g., ISO 23908 for sharps injury prevention, ISO 10993-1 for biocompatibility).
- Physical Measurements: E.g., needle length range, gauge range.
- Functional Testing: Demonstrating the device performs its intended action (capillary blood sampling, proper retraction).
- Biocompatibility Testing: Laboratory results confirming non-toxicity and safety of materials.
- Safety Mechanism Testing: Verification that sharps injury prevention features work as intended.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth establishment for a training set.
§ 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.