(49 days)
The intended use of this device is for newborn babies of any ethnicity where a blood sample is desired, and a self-retracting safety feature is desired to protect the clinician performing the blood sampling.
The gentleheel® is designed to be an easy to use, safe, one handed heel incision device for acquiring blood samples from the heels of newborns. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with an infant's foot. The user is instructed to remove the trigger lock. When the gentleheel is placed against the infant's heel and the user presses the trigger mechanism it automatically makes the incision by starting the blade in a continuous motion from inside the housing, into the infant's heel, and then back within the housing. The trigger mechanism is no longer functional and the blade remains inside the housing through disposal. The entire device is discarded in a sharps container after use. The gentleheel devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.
The gentleheel comes in models for Newborn (NGH), Preemie (PGH), Micro-Preemie (MPGH), and Toddler (TGH). The models are differentiated by the styles and colors of the housing (see following definitions).
The provided text describes a 510(k) summary for the "gentleheel" device, which is an infant heel stick lancet. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a novel study. Therefore, much of the requested information regarding specific acceptance criteria metrics, detailed study design, and statistical results from a primary clinical study is not available in the provided document.
However, I can extract information related to the device's characteristics and the types of testing performed to support its safety and substantial equivalence.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, or effect sizes for human reader improvement. Instead, it details that performance and safety testing was completed for the gentleheel®.
The categories of performance and safety tests mentioned are:
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Biocompatibility | ISO 10993-1 requirements met for Cytotoxicity, Sensitization, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis. |
| Functionality (Cutting Profile) | Confirmed to have L-Length and D-Depth (mm) cut profiles appropriate for different models (Newborn: L-2.50; D-1.00; Preemie: L-1.75; D-0.85; Micro-Preemie/Newborn: L-1.40; D-0.65; Toddler: L-3.00; D-2.00). These are stated to be "Same - No changes" from the primary predicate. |
| Functionality (Trigger Force and Reverse Safety) | Testing completed (details of specific force values or pass/fail not provided, but implies satisfactory function). |
| Durability / Physical Integrity (Drop Testing) | Testing completed (details not provided, implies satisfactory performance). |
| Simulated Use Testing | Testing completed (details not provided, implies satisfactory performance). |
| Sharps Prevention Feature | Fully tested to FDA's guidance document, demonstrating irreversible disablement after one use and blade retraction after incision. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not describe a clinical "test set" in the context of typical AI/diagnostic device studies. The testing described is primarily mechanical, biocompatibility, and simulated-use testing. Therefore, information on sample size for a test set, data provenance (country of origin, retrospective/prospective), or ground truth establishment based on patient data is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as the provided document does not detail a clinical study with a "test set" requiring expert ground truth establishment for a diagnostic output. The device is a manual surgical instrument, not an AI diagnostic tool.
4. Adjudication Method for the Test Set:
Not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
Not applicable. The gentleheel is a manual surgical instrument, not a device that involves human readers or an AI assistance component in its primary function that would necessitate an MRMC study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Not applicable, as the device does not employ an algorithm or AI.
7. The Type of Ground Truth Used:
For the performance and safety testing mentioned, the "ground truth" would be established by:
- Biocompatibility: Adherence to ISO 10993-1 standards and laboratory test results.
- Functionality (Cutting Profile, Trigger Force, Reverse Safety): Engineering specifications and mechanical measurements.
- Durability (Drop Testing): Pre-defined physical integrity standards.
- Sharps Prevention Feature: Mechanical operational verification against design requirements and FDA guidance.
8. Sample Size for the Training Set:
Not applicable, as the device does not involve training of an algorithm or AI model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the device does not involve training of an algorithm or AI model.
Summary of the Document's Focus:
The document is a 510(k) summary demonstrating substantial equivalence for the gentleheel® device to previously cleared predicate devices (K172712 and K883968/K911997). The core argument is that the proposed device:
- Has the "same principles of operation, intended use, and technological characteristics" as the predicates.
- Maintains the "same" materials (medical grade stainless steel, plastics), dimensions, cut profiles, and safety features (single-use, integral sharps injury prevention, automatic blade retraction).
- Has undergone biocompatibility, cutting profile, trigger force/reverse safety, drop testing, and simulated use testing to demonstrate its continued safety and performance against established standards and its prior clearance.
The "testing" mentioned is to confirm these characteristics and ensure they are maintained or are equivalent to the predicate devices, not to establish novel performance metrics against a clinical ground truth for a new diagnostic capability.
§ 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.