(62 days)
The gentleheel® Adult Incision Device is a single-use lancing device intended to obtain microliter capillary blood samples. The gentleheel® Adult Incision Device has a sharps prevention feature to protect the user from a needlestick injury.
The gentleheel® Adult Incision Device is designed to be an easy to use, safe, one handed incision device for acquiring blood samples from the patient's finger to obtain sufficient blood volumes for capillary blood draws. The gentleheel Adult Incision Device utilizes a blade resulting in improved blood flow requirements. The welded plastic housing is designed to prevent accidental exposure to the blade, to be ergonomic for improved handling, and compatible with a human fingertip. The user is instructed to remove the trigger lock. When the gentleheel Adult Incision Device is placed against the patient's finger and the user presses the trigger mechanism it automatically makes the incision the blade in a continuous motion from inside the housing, into the fingertip, 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 Adult Incision Devices are provided sterile and are single patient use only. They are sterilized by Ethylene Oxide (EO) sterilization method.
The provided text describes the 510(k) premarket notification for the gentleheel® Adult Incision Device (K242664), which is a single-use lancing device. This device is an additional indication for use of the previously cleared gentleheel® device (K220917 and K172712).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the summary of testing mentioned. The document focuses on demonstrating substantial equivalence to a predicate device, and thus the performance is reported in the context of meeting safety and functional requirements.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Demonstrated compliance through manufacturing and sterilization for Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis testing as per ISO 10993-1. Known biocompatible materials maintained compliance. |
| Cutting Profile | Performance testing was completed for cutting profile. (Specific quantitative results for length and depth are listed in the device description: Length-3.00mm; Depth-2.00mm, which are "Same - No changes" compared to the predicate device.) |
| Trigger Force & Reverse Safety | Performance testing was completed for trigger force and reverse safety. (No specific quantitative results are provided, but the device is described as having a trigger mechanism that automatically makes the incision, and the trigger is no longer functional after use. The blade remains inside the housing through disposal, and it has an integral sharps injury prevention feature that irreversibly disables it after one use. This feature was "fully tested to the FDA’s guidance document.") |
| Drop Testing | Performance testing was completed for drop testing. (No specific quantitative results are provided, but its inclusion implies it met predefined acceptance criteria for durability/integrity after drops.) |
| Sharps Injury Prevention Feature | The device has an integral sharps injury prevention feature that protects the user from a needlestick injury and reversibly disables the device after one use. It was "fully tested to the FDA's guidance document as demonstrated in the performance testing." The blade is not exposed except during use and automatically retracts into the housing. |
| Clinical Use for Adult Fingertip Lancing | "Clinical use testing was completed on adults for lancing the fingertip areas of adults to obtain microliter capillary blood samples." This demonstrates that the device performs its intended function for the newly added adult indication. This testing substantiated the "addition of the Indications for Use for the gentleheel® Adult Incision Device is for lancing the fingertip area of adults." |
| Intended Use (Obtain Capillary Blood Samples) | The device is intended to obtain microliter capillary blood samples. The clinical use testing on adults for lancing the fingertip to obtain microliter capillary blood samples supports this. The device utilizes a blade resulting in "improved blood flow requirements," implying it effectively collects samples. |
| Sterility | Provided sterile and sterilized by Ethylene Oxide (EO) sterilization method. (The acceptance criterion is assumed to be validation to standard sterility assurance levels, consistent with the predicate device and recognized standards, though specific data is not provided in this summary.) |
2. Sample Sizes and Data Provenance for Test Set
- Sample Size for the test set: Not explicitly stated in terms of number of participants for the clinical use testing. It only mentions "clinical use testing was completed on adults."
- Data Provenance: The document does not specify the country of origin for the data. The clinical use testing for the adult indication was "completed on adults." It appears to be a prospective study for a specific cohort (adults) to expand the indication of use.
3. Number of Experts and Qualifications for Ground Truth
- This information is not provided in the document. The studies mentioned are primarily performance and clinical use trials, not studies relying on expert consensus for image interpretation or diagnosis.
4. Adjudication Method for the Test Set
- This information is not applicable and is not provided in the document. The studies described are performance and clinical use studies for a lancing device, not studies requiring adjudication among experts for a diagnostic output.
5. MRMC Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is typically for diagnostic imaging devices where human readers interpret results with and without AI assistance. This device is a lancing device, not an imaging or diagnostic AI-powered device.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only) performance study was not done. This device is a mechanical lancing device, not an AI algorithm.
7. Type of Ground Truth Used
- The "ground truth" for the clinical use testing was the successful collection of microliter capillary blood samples from adults via fingertip lancing, and confirmation that the device's sharps prevention feature functioned as intended. For the performance tests, the ground truth would be adherence to defined engineering specifications (e.g., cutting profile dimensions, trigger force, structural integrity post-drop, and proper function of the sharps prevention feature).
8. Sample Size for the Training Set
- This information is not applicable as this device is a mechanical lancing device and does not involve machine learning or an "algorithm" requiring a training set.
9. How Ground Truth for Training Set was Established
- This information is not applicable as there is no training set for this mechanical 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.