(81 days)
The device is used to obtain capillary blood samples from the heel of newborn and neonatal infants in the healthcare setting by qualified healthcare providers.
The SafetiHeel Safety Lancet is single use only blood lancet used to puncture the skin to obtain a drop of blood for diagnostic purposes. It is a disposable blood lancet intended for a single use and the device is comprised of a blade encased in a housing made with plastic material commonly used for medical devices. The mechanism of the device includes an integral sharps injury prevention feature which allows the device to be used only once and then renders it inoperable and incapable of further use. The SafetiHeel Safety Lancet is a sterile device and the sterilization is done using the Gamma Irradiation means. The SafetiHeel device is marketed under model numbers SH-065, SH-100 and SH-150. The device is also marketed under trade names such as MediHeel and Novaplus in the USA market. The models for the MediHeel include model number 1003, 1004, 1005 and 1006. For the Novaplus device, the model numbers are 10041 and 10051.
The document provided describes the SafetiHeel, MediHeel, and Novaplus blood lancets, which are intended for obtaining capillary blood samples from the heel of newborn and neonatal infants. The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are essentially the "Predicate Device (specification)" column, and the reported device performance is indicated in the "SafetiHeel performance," "MediHeel performance," and "Novaplus performance" columns.
SafetiHeel Device Performance
| Test | Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (SafetiHeel) | Meets Criteria? |
|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | ||
| SH-065 | 0.65 to 0.85 | 0.63 to 0.80 | Yes (close) | |
| SH-085 | 1.00 to 1.20 | 1.04 to 1.19 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.42 to 1.59 | Yes | |
| SH-150 | 1.60 to 1.80 | 1.66 to 1.79 | Yes | |
| Trigger Force Test | (grams) | (grams) | ||
| SH-065 | 450 to 750 | 475 to 575 | Yes | |
| SH-085 | 450 to 750 | 494 to 578 | Yes | |
| SH-100 | 450 to 750 | 496 to 565 | Yes | |
| SH-150 | 450 to 750 | 494 to 586 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | Yes |
MediHeel Device Performance
| Test | Predicate Device Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (MediHeel) | MediHeel Model | Meets Criteria? |
|---|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | |||
| SH-065 | 0.65 to 0.85 | 0.67 to 0.81 | 1003 | Yes | |
| SH-085 | 1.00 to 1.20 | 1.05 to 1.16 | 1004 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.45 to 1.58 | 1005 | Yes | |
| SH-150 | 1.60 to 1.80 | 1.65 to 1.75 | 1006 | Yes | |
| Trigger Force Test | (grams) | (grams) | |||
| SH-065 | 450 to 750 | 475 to 588 | 1003 | Yes | |
| SH-085 | 450 to 750 | 496 to 591 | 1004 | Yes | |
| SH-100 | 450 to 750 | 488 to 585 | 1005 | Yes | |
| SH-150 | 450 to 750 | 492 to 596 | 1006 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | All Models | Yes |
Novaplus Device Performance
| Test | Predicate Device Model | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Novaplus) | Novaplus Model | Meets Criteria? |
|---|---|---|---|---|---|
| Cutting Depth Test | (mm) | (mm) | |||
| SH-085 | 1.00 to 1.20 | 1.06 to 1.15 | 10041 | Yes | |
| SH-100 | 1.40 to 1.60 | 1.44 to 1.57 | 10051 | Yes | |
| Trigger Force Test | (grams) | (grams) | |||
| SH-085 | 450 to 750 | 492 to 597 | 10041 | Yes | |
| SH-100 | 450 to 750 | 486 to 589 | 10051 | Yes | |
| Blade Retraction Test | All Models | Blade must retract into housing after incision. | All tested samples retracted the blade. | All Models | Yes |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample size for the test set beyond stating that "The samples of all the models tested show..." for the Blade Retraction Test, and presenting ranges for Cutting Depth and Trigger Force. This implies that multiple units were tested for each model.
Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission and the tests described (physical performance tests on the devices themselves), it is highly likely these were prospective laboratory or engineering tests conducted on manufactured devices, rather than clinical studies involving human patients or existing datasets.
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 to the type of performance testing described. The "ground truth" for these physical performance tests (cutting depth, trigger force, blade retraction) is established by direct measurement against known engineering specifications, not by expert interpretation.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers/interpreters to resolve discrepancies when establishing ground truth for diagnostic decisions. The tests here are physical measurements of device specifications.
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 is not applicable. The device is a physical blood lancet, not an AI-powered diagnostic or assistance tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical blood lancet, not an algorithm.
7. The type of ground truth used
The ground truth for these performance tests is based on engineering specifications and direct physical measurements. Specifically:
- Cutting Depth: Measured depth of blade protrusion.
- Trigger Force: Measured force required to activate the blade.
- Blade Retraction: Visual and/or mechanical confirmation of the blade returning into the housing.
- Sterility: Adherence to established sterility assurance levels (SAL) based on ISO standards.
8. The sample size for the training set
This information is not applicable. The device is a physical product, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no training set for this type of 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.