(62 days)
Not Found
No
The device description and performance studies focus on mechanical function, safety features, and biocompatibility. There is no mention of AI or ML in the intended use, device description, or performance summaries.
No.
The device is described as a lancing device intended to obtain microliter capillary blood samples, which is a diagnostic tool, not a therapeutic intervention.
No
The device is a lancing device intended to obtain blood samples, not to analyze or diagnose conditions from those samples.
No
The device description clearly details a physical, single-use lancing device with a blade, housing, and trigger mechanism, intended for obtaining blood samples through a physical incision. It is sterilized and discarded after use, indicating it is a hardware device, not software.
Based on the provided information, the gentleheel® Adult Incision Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain microliter capillary blood samples." This describes a device used to collect a sample from the body.
- Device Description: The description focuses on the mechanical action of lancing the fingertip to get blood. It doesn't describe any process of analyzing or testing the blood sample itself.
- Lack of Diagnostic Function: An IVD device is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function stops at obtaining the sample; it doesn't perform any diagnostic test on the blood.
The gentleheel® is a medical device used for sample collection, but it does not perform an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMK
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.
The gentleheel® Adult Incision Device comes in the Catalog/Reference Numbers described as follows:
AGH10x50: 50ea/carton X 10 cartons Total 500ea/case, Blue Case Color, Incision Profile Length 3.00mm, Depth 2.00mm
AGH4X250: 250ea/carton X 4 cartons Total 1000ea/case, Blue Case Color, Incision Profile Length 3.00mm, Depth 2.00mm
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Fingertip area
Indicated Patient Age Range
Adults
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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
2
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
3
Indications for Use
Submission Number (if known)
Device Name
gentleheel® Adult Incision Device
Indications for Use (Describe)
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.
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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4
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 integra |
| sharps 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:
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.
5
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/Reference
Numbers | Quantity | Case
Color | Incision Profile | |
|------------------------------|-----------------------------------------------|---------------|------------------|--------|
| | | | Length | Depth |
| AGH10x50 | 50ea/carton X 10 cartons
Total 500ea/case | Blue | 3.00mm | 2.00mm |
| AGH4X250 | 250ea/carton X 4 cartons
Total 1000ea/case | | | |
Indications for Use:
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.
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 Device
510(k) #: Pending | Predicate Device
510(k) #: K220917 |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| gentleheel® Adult Incision Device | gentleheel® |
| 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 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. |
Technological Characteristics:
The gentleheel® devices [Proposed Device] did not change technological characteristics or material specifications from the previously cleared 510(k) # K220917 [Predicate Device].
6
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 injury | |
| prevention feature. The blade is not exposed | |
| except during use, which allows the device to | |
| be used once and then renders it inoperable | |
| and incapable of further use as the blade | |
| automatically retracts at the end of incision | |
| motion. | 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.