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

The FS & A Device is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The ADC Freestyle Lancing Device II variant is sold for use with ADC 'Freestyle' single-use lancets; these are not included in this submission. The OM Autolet variant is sold for use with Unilet Lancets and as 'universally compatible with most lancets'. The lancets are disposed of after each use and the device is maintained by using isopropyl alcohol or soap to wipe the outside of the device. The FS & A Device is for use only on a single patient.

The Autolet Lite is a hand-held non-sterile, reusable lancing device intended for single patient capillary blood sampling in non-clinical environments. The device was designed for use as a system with Unilet Lancets (and as 'universally compatible with most lancets') which are included in this 510(k) The Unilet Lancets feature 3 lancet gauges, 3 with labelling "Unilet Lancets" and the same 3 lancet gauges labelled "Unilet ComforTouch Lancets". These lancets have different gauge sizes and styling but are functionally identical and for the purpose of this 510(k), all references to "Unilet Lancets" can be considered to apply to Unilet Lancets and Unilet ComforTouch Lancets.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Owen Mumford Ltd.'s Freestyle Lancing Device II, Autolet, Autolet Lite, and Unilet Lancets. The goal of the submission is to demonstrate substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System (K214022).

Based on the provided text, the following information can be extracted regarding acceptance criteria and the study proving the device meets them:

1. A table of acceptance criteria and the reported device performance

The document states: "Design verification testing of the FS & A has been carried out to evaluate the performance of the devices against defined acceptance criteria." and "The objective of the design verification testing conducted was to verify that the submission devices met the pre-determined specifications, to support the conclusion that they are fit for purpose and are considered safe and effective for the intended use."

However, the specific "acceptance criteria" (e.g., numerical targets for depth of penetration accuracy, load/fire mechanism reliability) are not explicitly listed in a detailed table or described quantitatively for each test. The table below summarizes the general acceptance and reported performance.

Acceptance Criteria Category	Reported Device Performance
Mechanical Performance
Design Input IDs (FS & A Device)	Passed all 20 design input IDs testing and verification.
Design Inputs (Autolet Lite)	Passed all 12 design inputs testing and verification.
Design Inputs (Unilet Lancets)	Passed all 12 design inputs testing and verification.
Biocompatibility
Cytotoxicity	All skin contact materials tested for cytotoxicity in accordance with ISO 10993-5:2009. All materials scored 0 (lowest level achievable), indicating non-cytotoxicity. Expert toxicological review concluded no irritation or sensitization risk.
Sterilization (Unilet Lancets)
Sterility Assurance Level (SAL)	10^-6 achieved.
Dose Range	25-50 kGy.
Shelf Life
FS & A Device	Designed to last for 2 years.
Autolet Lite	Designed to last for no less than 3000 complete uses.
Unilet Lancets	Sterile shelf life of 5 years.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the "design verification testing" for the specific tests (e.g., how many devices were tested for mechanical performance, how many samples for biocompatibility).

The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, beyond the fact that the testing was carried out as part of the design verification internally by Owen Mumford Ltd. (UK-based company). The Toxicologist for biocompatibility assessment was from Medwise International Consultancy Limited, York, UK.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the document describes technical performance testing and biocompatibility assessments, not a diagnostic device involving expert interpretation or "ground truth" establishment in a clinical sense. For biocompatibility, an "Expert toxicological review" was conducted by a toxicologist from Medwise International Consultancy Limited, York, UK. Their specific qualifications (e.g., years of experience) are not detailed.

4. Adjudication method for the test set

This information is not applicable for the type of technical and biocompatibility testing described.

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

This information is not applicable. The submission is for lancing devices and lancets, which are mechanical devices for capillary blood sampling, not AI-powered diagnostic tools requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the device is not an algorithm or AI system.

7. The type of ground truth used

For the technical performance tests, the "ground truth" or reference was the pre-determined specifications and design input IDs for the devices. For biocompatibility, the ground truth was established against ISO 10993-1:2009 and ISO 10993-5:2009 standards and an expert toxicological review. For sterilization, it was against ISO 11137 standards.

8. The sample size for the training set

This information is not applicable as the submission is for a physical medical device (lancing devices and lancets), not a machine learning or AI model that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a physical medical 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.