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.

Device Description

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).

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".

May 18, 2022

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

Re: K220917

Trade/Device Name: gentleheel Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument For General Use Regulatory Class: Class II Product Code: FMK Dated: March 30, 2022 Received: March 30, 2022

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 (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 located 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 c lass 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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,

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

510(k) Number (if known) K220917

Device Name gentleheel®

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summarv

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/ConsultantRegulatory Resources Group, Inc. - Phone: (678) 513-0693
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Date Submitted: May 18, 2022

Device Name and Classification:

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

Legally Marketed Predicate Device:

Primary Predicate: GRI gentleheel®, 510(k) # K172712 Additional Predicate: ITC Tenderfoot®, 510(k) # K883968 & K911997 [Current: Accriva Diagnostics, Inc.]

Device Description:

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GRI-Alleset, Inc. 510(k) # K220917 - gentleheel®

510(k) Summarv

Toddler (Color - Blue)	Children between the ages 6 months and 2 years or greater than 19.8 lbs. (9kilograms)
Newborn (Color - Green)	A full term baby is born at 37 weeks or after
Preemie (Color - Pink)	The technical term for preemie is defined as a baby that is under 5.5 pounds(2500 grams), and usually is born prior to 37 weeks of gestation
Micro-Preemie (Color -Yellow)	To an NICU medical professional, a micro-preemie is defined as a baby thatis under 1.75 lbs. (between 700-800 grams) and is generally born before 26weeks gestation, but most people prefer to loosen this term up to include anybaby under 3 lbs. (1500 grams) or under 29 weeks gestation

Indications / Intended Use:

The intended use of this device is for newborn babies and toddlers 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 Indications / Intended Use statements for the gentleheel [Proposed Device] is substantial equivalent to the gentleheel device previously cleared in 510(k) # K172712 [Primary Predicate Device] and to the Tenderfoot [Additional Predicate Device]. The gentleheel devices and predicates, are intended for piercing the skin on the heel of newborn babies and the Indications for Use / Intended Use statements are substantially equivalent.

Comparison of Indications of Use to the Predicate Devices

Proposed Device510(k) #: K220917	Primary Predicate Device510(k) #: K172712	Additional Predicate Device510(k) #: K883968 & K911997
gentleheel®	gentleheel®	Tenderfoot®
The intended use of this deviceis for newborn babies andtoddlers of any ethnicity where ablood sample is desired, and aself-retracting safety feature isdesired to protect the clinicianperforming the blood sampling.	The gentleheel® devices are heelincision devices for blood samplingin newborns, premature and lowbirth weight infants, and toddlers.The gentleheel has a sharpsprevention feature to protect theuser from a sharps injury.	Tenderfoot® is a fully automatedheel incision device for bloodsampling from the heels ofnewborns, premature, low birthweight infants, and toddlers.

Technological Characteristics:

The gentleheel® devices [Proposed Device] did not change technological characteristics or material specifications from the previously cleared 510(k) # K172712 [Primary Predicate Device]. The gentleheel® devices are substantially equivalent to the Tenderfoot devices [Additional Predicate Device] as they have the same basic technology characteristics for newborn babies and toddlers heel stick lancets with a sharps injury prevention feature. The materials are comparable in that the blades all use medical grade stainless steel and the housings are made of medical grade plastics.

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510(k) Summarv

Comparison of Technological Characteristics to the Predicate Devices

Proposed Device510(k) #: K220917	Primary Predicate Device510(k) #: K172712	Additional Predicate Device510(k) #: K883968 & K911997
gentleheel®	gentleheel®	Tenderfoot®
Materials
Stainless steels; plastics	Same - No changes	Surgical steels; plastics
Housing Colors
Newborn - GreenPreemie - PinkMicro-Preemie - YellowToddler - Blue	Same - No changes	Newborn - Pink/BluePreemie - WhiteMicro-preemie - BlueToddler - Pink
Overall Dimensions
Length: 1.25 in (3.18 cm)Height: 1.56 in (3.96 cm) - with LockHeight: 1.20 in (3.05 cm)Width: 0.48 in (1.22 cm)	Same - No changes	Length: 1.24 in (3.15 cm)Height: 1.56 in (3.96 cm) - with LockHeight: 1.20 in (3.05 cm)Depth: 0.45 in (1.14 cm)
Labeled Cut Profiles: L-Length and D-Depth (mm)
Newborn: L-2.50; D-1.00Preemie: L-1.75; D-0.85Newborn: L-1.40; D-0.65Preemie: L-3.00; D-2.00	Same - No changes	Newborn: L-2.50; D-1.00Preemie: L-1.75; D-0.85Newborn: L-1.40; D-0.65Preemie: L-3.00; D-2.00
Safety Features
Single use only with an integralsharps injury prevention feature. Theblade is not exposed except duringuse, which allows the device to beused once and then renders itinoperable and incapable of furtheruse as the blade automaticallyretracts at the end of incision motion.	Same - No changes	Single use only with an integralsharps injury prevention feature. Theblade is not exposed except duringuse, which allows the device to beused once and then renders itinoperable and incapable of furtheruse as the blade automaticallyretracts at the end of incision motion.

Summary of Testing:

The biocompatibility risk assessment was completed as directed by FDA quidance under ISO 10993-1 biocompatibility requirements. Cytotoxicity, Sensitization, 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, drop testing, and simulated use testing,

Substantial Equivalence Conclusions:

The gentleheel® has the same principles of operation, intended use, 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 devices. The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance 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.