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510(k) Data Aggregation
(62 days)
gentleheel**®** Adult Incision Device
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.
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