(138 days)
Lancet: 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.
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 (made of stainless steel and silicone oil), main body and protective cap (both made of PE, EVA and calcium powder). 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 collect a capillary blood sample. The body and the active parts of the lancing device are made of ABS, POM and PC Resin. And the spring is made of carbon steel. The service life of lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) is no more than 3000 times or 3 years. The service life of lancing device (HH-XVII-T) is no more than 5000 times or 5 years. The Lancing Device is provided non-sterile.
The provided text describes the non-clinical testing performed to demonstrate that the proposed Lancet and Lancing devices meet acceptance criteria.
Here's the breakdown of the information requested:
1. A table of acceptance criteria and the reported device performance
| Items | Acceptance criteria | Reported Device Performance |
|---|---|---|
| Appearance | The surface shall be free of burr and no scratches. | Meet the requirement |
| Dimension | Product dimensions shall be consistent with the drawings. | Meet the requirement |
| Needle diameter | The diameter of the needle shall be consistent with the requirement. | Meet the requirement |
| Cleanness | No dust, no grease, no hair, no dirt. | Meet the requirement |
| Firmness | Needle should connect firmly with plastic handle. | Meet the requirement |
| Resistance to corrosion | Corrosion resistance of the needle of the lancet shall show no evidence of corrosion. | Meet the requirement |
| Acidity or Alkalinity | When determined with a laboratory pH meter and using a general purpose electrode, the pH value of an extract prepared shall be within one pH unit of that of the control fluid. | Meet the requirement |
| Extractable Metals | When corrected for the metals content of the control fluid, contain not greater than a combined total of 5 mg/l of lead, tin, zinc and iron. The cadmium content of the extract shall, when corrected for the cadmium content of the control fluid, be lower than 0.1 mg/l. | Meet the requirement |
| Puncture force | The needle tip of the needle should have good puncture ability. | Meet the requirement |
| Lubricant | Visual, should not be visible droplets. | Meet the requirement |
| Matching | It should be well assembled with the lancing devices, with no dislocation in the appearance coordination. | Meet the requirement |
Biocompatibility Testing:
| Item | Test method | Reported Device Performance |
|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009 | No Cytotoxicity |
| Skin Sensitization | ISO 10993-10: 2010 | No Skin sensitization |
| Intracutaneous reactivity | ISO 10993-10: 2010 | No irritation |
| Acute Systemic Toxicity | ISO 10993-11: 2017 | No Acute Systemic Toxicity |
| Pyrogenicity | ISO 10993-11: 2017 | no thermogenic reaction |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
For the simulated clinical use study, 500 device samples each for the Lancet and Lancing Device were used. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, but it is a "simulated clinical use study," implying it was conducted as part of the device's development/testing process. The manufacturer is Tianjin Huahong Technology Co., Ltd. in Tianjin, China.
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)
This information is not provided in the document. The studies described are non-clinical bench testing and simulated clinical use for safety mechanisms, which typically do not involve expert-established ground truth in the same way imaging or diagnostic algorithms would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the types of non-clinical bench tests and simulated clinical use study described. Adjudication methods are more pertinent to studies involving human interpretation or subjective assessments.
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
No MRMC comparative effectiveness study was done. The submission explicitely states: "No clinical study is included in this submission." The device being described is a physical medical device (lancet and lancing device), not an AI-powered diagnostic or interpretive system that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device (lancet and lancing device), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (appearance, dimension, needle diameter, cleanness, firmness, corrosion resistance, acidity/alkalinity, extractable metals, puncture force, lubricant, matching) and biocompatibility tests, the "ground truth" is defined by the pre-established physical, chemical, and biological requirements and standards (e.g., drawings, ISO standards, specific chemical limits). For the simulated clinical use, the ground truth is whether the device "met the pre-established criteria" for its safety mechanism, as evaluated against FDA guidance and ISO 23908.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an AI or algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used as this is not an AI/algorithm 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.