(58 days)
The RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
The proposed device, RightLance Blood Lancing System is intended for the hygienic collection of capillary blood for testing purposes from the side of a fingertip and from alternative sites, such as the palm, the upper arm, and the forearm.
The sterile, single-use lancets are to be used with the reusable lancing device that is to be cleaned and disinfected between each use, and then the lancets are to be disposed of.
This system is for use only on a single patient in a home setting.
This system is not suitable for use by healthcare professionals with multiple patients in a healthcare setting.
The RightLance Blood Lancing System is made up of Lancing Device and Disposable Lancet.
The Model of Lancing Device: RC-AD-III; RC-AD-IIIT; RC-AD-VIU; RC-AD-VIX; RC-AD-VIXT; RC-AD-VII; RC-AD-XI; RC-AD-XII; RC-AD-XIV; Sinodraw; RC-LD-16; RC-LD-17; RC-LD-18; RC-LD-19
The Model of Disposable Lancet: I Size: 21G, 23G, 25G, 26G, 27G, 28G, 30G, 31G, 32G, 33G
This is a 510(k) premarket notification for a medical device called the RightLance Blood Lancing System. The document focuses on establishing substantial equivalence to a predicate device, the Accu-Chek Softclix Blood Lancing System, rather than providing a detailed study that proves the device meets specific acceptance criteria as one might find for an AI/ML powered device.
Therefore, many of the requested elements for AI/ML device studies (like effect size for MRMC studies, training set details, or complex ground truth establishment) are not applicable to this type of submission.
Here's an analysis based on the provided text, focusing on what is relevant for a non-AI medical device submission:
Acceptance Criteria and Device Performance
There isn't a table of quantitative performance acceptance criteria in the typical sense of measuring algorithm accuracy (e.g., sensitivity, specificity). Instead, the "acceptance criteria" are implied by the comparison to the predicate device and compliance with recognized international standards and internal design specifications. The device is accepted if it performs "as well as or better than" the predicate device and meets its own design specifications.
The comparison table provided (page 4) details the technological characteristics, highlighting similarities and differences with the predicate.
Table of Acceptance Criteria (Implied by Predicate Comparison and Standards) and Reported Device Performance
| Acceptance Criterion (Implied) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Indications for Use (IFU) | The RightLance Blood Lancing System has the same IFU as the predicate device (Accu-Chek Softclix Blood Lancing System) for hygienic collection of capillary blood from fingertip and alternative sites, single-patient home use, and not for healthcare professionals with multiple patients. |
| Technological Characteristics (Design, Mechanism, Operation, Energy, Features, Form, Fit, Function) | "The RightLance Blood Lancing System and predicate device share the same technological characteristics including their design, mechanical mechanism, principle of operation, energy source and usage, features, form, fit, and function." (Page 5) Detailed comparison provided in table on page 4 (Needle size, depth adjustment, mechanical loading, load/firing, anatomical sites, sharps injury prevention). |
| Biocompatibility | Complies with ISO 10993-5 (cytotoxicity), ISO 10993-10 (irritation and skin sensitization), ISO 10993-11 (systemic toxicity), ISO 10993-4 (interactions with blood). |
| Sterilization | Complies with ISO 11137-2 for establishing sterilization dose (gamma irradiation). |
| Pyrogenicity | Complies with USP34 Rabbit Pyrogen Test. |
| Performance (Functional Safety & Efficacy based on physical attributes) | Bench tests conducted for: Basic Size, Puncture Depth, Lancing Device Cap Removal, Lancing Device Firing Force, Drop, Drawing Force, The tightness of lancing device. These tests "demonstrated that the proposed device complies with its design specification." (Page 7) Specific quantitative results are not provided in this summary. |
| Shelf Life (Aging) | Validation performed. |
Study Details (as applicable)
-
Sample size used for the test set and the data provenance:
- No "test set" in the context of an AI/ML algorithm evaluation.
- For the non-clinical bench testing, the sample sizes are not specified in the provided summary.
- Data provenance: Not applicable for this type of device where laboratory bench testing is the primary evidence.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment by experts for this type of mechanical lancing device. The performance is assessed against engineering specifications and international standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No expert adjudication process is described or relevant for this device.
-
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. This is not an AI/ML powered device, so MRMC studies are not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a manual mechanical device, not an algorithm. The non-clinical tests assess the device's physical and functional performance directly.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, "ground truth" would be defined by engineering specifications, international standards (e.g., ISO, USP), and the performance characteristics of the predicate device. For example, a "puncture depth" test would have an expected range based on design, and the device's output would be measured against that.
-
The sample size for the training set:
- Not applicable. This is not an AI/ML device, so there is no training set.
-
How the ground truth for the training set was established:
- Not applicable. No 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.