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.

Device Description

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.

AI/ML Overview

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.

Summary

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November 5, 2024

GRI-Alleset, Inc. % Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Dr Alpharetta, Georgia 30004

Re: K242664

Trade/Device Name: gentleheel® Adult Incision Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: September 4, 2024 Received: November 1, 2024

Dear Julie Stephens:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products: and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

James H. Digitally signed by
James H. Jang -S
Jang -S Date: 2024.11.05
23:06:11 -05'00'
For

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242664

Device Name

gentleheel® Adult Incision Device

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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GRI-Alleset. Inc. Traditional 510(k) - gentleheel® Adult Incision Device

510(k) Summary - K242664

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.

Submitted By: GRI-Alleset, Inc. 4142 Industry Way Flowery Branch, GA 30542 USA Phone: (678) 523-8977

Contact Person:	Julie Stephens, President/Consultant
Regulatory Resources Group, Inc. - Phone: (678) 513-0693

November 1, 2024 Date Submitted:

Device Name and Classification:

Trade/Proprietary Name:	gentleheel® Adult Incision Device
Common Name:	Blood Lancet with Sharps Prevention Feature
Classification Name:	Blood Lancets - Single use only blood lancet with an integrasharps injury prevention feature
Regulation Number:	21 CFR 878.4850
Class:	II
Product Code:	FMK

Legally Marketed Predicate Device:

Predicate: GRI gentleheel®, 510(k) # K220917 and K172712

Device Description:

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GRI-Alleset, Inc. Traditional 510(k) - gentleheel® Adult Incision Device

510(k) Summary - K242664

The gentleheel® Adult Incision Device comes in the Catalog/Reference Numbers described as follows:

Catalog/ReferenceNumbers	Quantity	CaseColor	Incision Profile
			Length	Depth
AGH10x50	50ea/carton X 10 cartonsTotal 500ea/case	Blue	3.00mm	2.00mm
AGH4X250	250ea/carton X 4 cartonsTotal 1000ea/case

Indications for Use:

Comparison of Indications of Use to the Predicate Device

The Indications for Use statement for the gentleheel® Adult Incision Device [Proposed Device] is an additional Indications for Use from the gentleheel device previously cleared [Predicate Device]. The gentleheel Adult Incision Device [Proposed Device] is indicated for adults as the intended patient population. The gentleheel Adult Incision Devices are intended for lancing the skin on the fingertip area of adults.

Proposed Device510(k) #: Pending	Predicate Device510(k) #: K220917
gentleheel® Adult Incision Device	gentleheel®
The gentleheel® Adult Incision Device is asingle-use lancing device intended to obtainmicroliter capillary blood samples. Thegentleheel® Adult Incision Device has a sharpsprevention feature to protect the user from aneedlestick injury.	The intended use of this device is fornewborn babies and toddlers of any ethnicitywhere a blood sample is desired, and a self-retracting safety feature is desired to protectthe clinician performing the blood sampling.

Technological Characteristics:

The gentleheel® devices [Proposed Device] did not change technological characteristics or material specifications from the previously cleared 510(k) # K220917 [Predicate Device].

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GRI-Alleset. Inc. Traditional 510(k) - gentleheel® Adult Incision Device

510(k) Summary - K242664

Comparison of Technological Characteristics to the Predicate Device

Proposed Device	Predicate Device
510(k) #: Pending	510(k) #: K220917
gentleheel® Adult Incision Device	gentleheel®
Materials
Stainless steels; plastics	Same - No changes
Housing Color
Blue	Same - No changes
Overall Dimensions
Length: 1.25 in (3.18 cm)	Same - No changes
Height: 1.56 in (3.96 cm) - with Lock
Height: 1.20 in (3.05 cm)
Width: 0.48 in (1.22 cm)
Labeled Cut Profiles: Length and Depth (mm)
Length-3.00; Depth-2.00	Same - No changes
Safety Features - Sharps Injury Prevention
Single use only with an integral sharps injuryprevention feature. The blade is not exposedexcept during use, which allows the device tobe used once and then renders it inoperableand incapable of further use as the bladeautomatically retracts at the end of incisionmotion.	Same - No changes

Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA guidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Material-Mediated Pyrogenicity, and Hemolysis testing was completed to demonstrate that the known biocompatible materials maintained compliance through manufacturing and sterilization. Performance and safety testing completed for the gentleheel included tests for cutting profile, trigger force and reverse safety, and drop testing. Clinical use testing was completed on adults for lancing the fingertip areas of adults to obtain microliter capillary blood samples.

Substantial Equivalence Conclusions:

The gentleheel® Adult Incision Device has the same principles of operation and technological characteristics including the materials used, sizes and dimensions, cutting profiles, and sharps injury prevention features (irreversibly disable the device after one use) as the predicate device. The sharps prevention feature was fully tested to the FDA's quidance document as demonstrated in the performance testing. The addition of the Indications for Use for the gentleheel® Adult Incision Device is for lancing the fingertip area of adults which was demonstrated under clinical use testing.

Regulation Number and Section

§ 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.