FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

AI/ML Overview

The provided document is a 510(k) summary for the Medipoint Blood Lancets. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria in the same way a new device with novel claims would. The "acceptance criteria" here implicitly refer to the performance and safety characteristics established by the predicate devices and relevant standards.

However, I can extract the information related to the device's performance based on the non-clinical testing sections to address your questions as best as possible within the context of this document.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) summary, the "acceptance criteria" are implied by the performance of the predicate devices and relevant standards (e.g., ISO 10993 for biocompatibility, and expectations for a blood lancet's physical integrity). The study aims to show the subject device performs equivalently.

Acceptance Criteria (Implied by Predicate/Standards)	Reported Device Performance (Subject Device)
Mechanical Integrity (during use)	Withstands forces encountered during use without bending or damage.
Biocompatibility:	Passed Cytotoxicity
- Cytotoxicity	Passed Sensitization
- Sensitization	Passed Irritation or Intracutaneous Reactivity
- Irritation / Intracutaneous Reactivity	Passed Acute Systemic Toxicity (Material-Mediated Pyrogenicity)
- Acute Systemic Toxicity	Individual packages are sterile. Sterilization validated via moist heat.
Sterility

Study Proving Device Meets Acceptance Criteria

The study described is a series of non-clinical tests performed to demonstrate that the Medipoint Blood Lancets perform equivalently to their predicate devices and meet relevant safety standards.

2. Sample Size for the Test Set and Data Provenance:

Performance Testing (Mechanical Integrity): Not explicitly stated, but typically involves a representative sample of devices.
Biocompatibility Testing: Not explicitly stated, but typically involves a sufficient number of samples as per ISO 10993 guidelines to perform the required tests.
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. These are typically bench and lab tests conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

This is not applicable as the studies described are non-clinical bench tests and biocompatibility assessments, not diagnostic performance studies requiring expert interpretation or ground truth establishment in the traditional sense (e.g., imaging interpretation). The "ground truth" for these tests are objective measurements and standardized biological responses.

4. Adjudication Method for the Test Set:

Not applicable, as these are objective non-clinical tests, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, a MRMC comparative effectiveness study was not done. This type of study is typically for evaluating the impact of AI or diagnostic tools on human reader performance, which is not relevant for a blood lancet device.

6. If a Standalone (algorithm only without human-in-the-loop performance) study was done:

Not applicable. This device is a physical blood lancet, not an algorithm or AI. The "standalone performance" here refers to the device's physical and biological performance characteristics as a medical device.

7. Type of Ground Truth Used:

Performance Testing (Mechanical Integrity): The "ground truth" is adherence to predefined engineering specifications and the ability to withstand forces without damage, often compared against predicate device performance.
Biocompatibility Testing: The "ground truth" is established by standard biological assays (e.g., cell viability for cytotoxicity, immune response for sensitization) and regulatory thresholds for acceptable biological reactions as defined in ISO 10993.
Sterility: The "ground truth" is a Sterility Assurance Level (SAL) validated through a microbial challenge and sterility testing as per ISO 11135 or similar standards.

8. Sample Size for the Training Set:

Not applicable. This device is a physical product and does not involve AI or machine learning models that require a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this device.

Summary

Regulation Number and Section

§ 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.