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

RIGHTEST Lancing Device GD500 is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

GE Lancing Device is a reusable lancing device for the single used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user. Alternative site testing (palm or forearm) can be performed by installing the clear cap on the lancing device.

iGlucose Lancing Device is a reusable lancing device for the single user. It should be used with the proper sterile lancet for the capillary blood sampling. It could automatically inject the lancet into and retract it from the fingertip to obtain a capillary blood sample for glucose monitoring or other test that require one or two drops of blood. A depth adjustable cap allows the best depth of skin penetration for each individual user.

Device Description

RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device is a mechanical device holding and firing a single-use lancet linearly ahead to prick the skin to collect capillary whole blood from target sites. RIGHTEST Lancing Device GD500/ GE Lancing Device/ iGlucose Lancing Device can be adjusted for 7 levels of depth for a user collecting different amount of capillary blood.

AI/ML Overview

This document describes the FDA's 510(k) clearance for the BIONIME Corporation's RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device. It specifically focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device's performance against specific acceptance criteria for AI or diagnostic accuracy.

Therefore, many of the requested elements for an AI/diagnostic accuracy study (such as MRMC studies, effect size of human reader improvement with AI, specific ground truth methods, sample sizes for training/test sets related to AI model development, etc.) are not applicable to this document, as it pertains to a lancing device, not an AI-powered diagnostic tool.

However, I can extract the relevant information regarding the performance data and the basis for substantial equivalence for this medical device.

Device Under Review: RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device (reusable lancing devices for capillary blood sampling)

A table of acceptance criteria and the reported device performance:

Since this is a lancing device and not a diagnostic or AI device, the "acceptance criteria" here relate to safety, functionality, and biocompatibility, rather than diagnostic performance metrics like sensitivity/specificity. The document states that performance data demonstrated safety and efficacy but does not provide quantitative "acceptance criteria" for each test with reported values. Instead, it lists the types of tests performed.

Acceptance Criteria (Implied by regulatory requirements for lancing devices)	Reported Device Performance (Summary from document)
Biocompatibility (In vitro Cytotoxicity)	C. ISO 10993-5 In vitro Cytotoxicity A. was completed.
Biocompatibility (Skin Irritation)	A. ISO 10993-23 Skin Irritation B. was completed.
Biocompatibility (Skin Sensitization)	B. ISO 10993-10 Skin Sensitization (Maximization Test) was completed.
Functional Performance	D. Functional tests were validated and completed.
Cleaning and Disinfection Efficacy	E. The cleaning and disinfections on the materials of device were evaluated and tested.

The document concludes that the device is "substantially equivalent to predicate devices in regard to indications for use, design, and technology, without raising any safety and efficacy risks or concerns," implying that the performance tests met the necessary standards for these types of devices.

Sample size used for the test set and the data provenance:

This information is not provided in the document as it's not a study on diagnostic accuracy or AI performance. The tests mentioned (biocompatibility, functional tests) would have their own sample sizes based on standard testing protocols for medical devices. The data provenance would be from laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. Ground truth establishment by experts is relevant for diagnostic accuracy studies, especially for image interpretation. For a lancing device, "ground truth" would relate to measurable physical properties or biological responses (e.g., cytotoxicity, successful blood draw) determined by validated test methods, not expert consensus on images.
Adjudication method for the test set:

This is not applicable as there is no expert adjudication process for the performance tests of a lancing device in this context.
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:

This is not applicable. This document is for a lancing device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

This is not applicable. There is no AI algorithm in this device.
The type of ground truth used:

For this type of device, the "ground truth" is defined by standardized laboratory test results for biocompatibility (e.g., cell viability assays, skin patch tests) and engineering validation for functional performance (e.g., consistency of lancing depth, successful lancet injection/retraction). It is not pathology or outcomes data in the sense of a diagnostic device.
The sample size for the training set:

This is not applicable. This is not an AI/machine learning device that requires a training set.
How the ground truth for the training set was established:

This is not applicable. No training set is used for this type of device.

Summary of Substantial Equivalence (as reported in the document):

The submission argues for substantial equivalence based on the following:

Same "intended use/indication(s) for use": To obtain capillary blood samples for glucose monitoring or other tests requiring small amounts of blood, for single user, with depth adjustment and alternative site testing capabilities.
Similar Technological Characteristics: Both the proposed and predicate devices are mechanical devices that hold and fire a single-use lancet linearly to prick the skin, automatically inject and retract the lancet, have a clear cap for alternative site testing, retract the lancet after use to prevent sharp injury, have mechanical loading and firing functions, and eject the used lancet without touching it.
Differences noted: The primary difference is the "depth of penetration." The proposed device offers 7 different depths (0.5 mm to 1.7 mm) compared to the predicate devices' 6 different depths or interchangeable contact tips. The submission states this difference "did not raise other concerns on safety and efficacy."
Performance Data: The provided performance data (biocompatibility and functional tests) demonstrated safety and efficacy consistent with the predicate devices and regulatory requirements.

The document concludes that the RIGHTEST Lancing Device GD500, GE Lancing Device, and iGlucose Lancing Device are "substantially equivalent to the predicate devices On Call Lancing Device and the Genteel Lancing Device (K113332 and K153670)."

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.