The gentleheel® devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel has a sharps prevention feature to protect the user from a sharps injury.
Device Story
Manual heel incision device for blood sampling in newborns, preemies, and toddlers. Device features welded plastic housing and internal blade mechanism. Operation: user removes trigger lock, places device against infant heel, and presses trigger; blade performs continuous motion (out of housing, into skin, back into housing). Blade remains permanently retracted post-use for sharps injury prevention. Device is single-use and disposable. Used in clinical settings by healthcare professionals. Benefits include standardized incision depth and protection against accidental sharps injury.
Clinical Evidence
Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, acute systemic toxicity, material-mediated pyrogenicity, hemolysis) performed per ISO 10993-1. Performance and safety testing included cutting profile, trigger force, reverse safety, drop testing, and simulated use testing.
Indicated for blood sampling via heel incision in newborns, premature infants, low birth weight infants, and toddlers.
Regulatory Classification
Identification
The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.
Special Controls
*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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.
November 6, 2017
GRI Medical & Electronic Technology Co, Ltd % Julie Stephens President Regulatory Resources Group, Inc. 111 Laurel Ridge Dr. Alpharetta, Georgia 30004
Re: K172712
Trade/Device Name: gentleheel Regulation Number: 21 CFR 878.4800 Regulation Name: Manual Surgical Instrument for General Use Regulatory Class: Class I Product Code: FMK Dated: September 8, 2017 Received: September 8, 2017
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. 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@Ida.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
> Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K172712
Device Name gentleheel®
Indications for Use (Describe)
The gentleheel® devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel has a sharps prevention feature to protect the user from a sharps injury.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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GRI Medical & Electronic Technology Co., Ltd. Traditional 510(k) - gentleheel®
## 510(k) Summary - Revised October 31, 2017
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements under 21 CFR 807.92.
| Submitted By: | | US Agent: |
|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| GRI Medical & Electronic Technology Co., Ltd.<br>Xiuzhou Industry Zone, 1805 Honggao Road<br>Jiaxing Zhejiang 314031 CHINA | | Global Resources International, Inc. (GRI)<br>4142 Industry Way<br>Flowery Branch, GA 30542 USA<br>Phone: (678) 866-0550 |
| Contact Person: | Julie Stephens, President/Consultant<br>Regulatory Resources Group, Inc.<br>Phone: (678) 513-0693 | |
| Date Submitted: | September 8, 2017 | |
Device Name and Classification:
| Trade/Proprietary Name: | gentleheel® |
|-------------------------|-------------------------------------------------------------|
| Common Name: | Infant Heel Stick Lancet with Sharps Prevention Feature |
| Classification Name: | Blood Lancets |
| Regulation: | 21 CFR 878.4800, Manual surgical instrument for general use |
| Class: | 1 and Sharps Prevention Feature |
| Product Code: | FMK |
ITC Tenderfoot®, 510(k) # K883968 & K911997 Legally Marketed Predicate Device:
#### 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 comes in models for Newborn, Preemie, Micro-Preemie and Toddler. The models are differentiated by the styles and colors of the housing (see definitions below).
| Toddler (Color - Blue) | Children between the ages 6 months and 2 years or greater than 19.8<br>lbs. (9 kilograms) |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>pounds (2500 grams), and usually is born prior to 37 weeks of gestation |
| Micro-Preemie (Color -<br>Yellow) | To an NICU medical professional, a micro-preemie is defined as a baby<br>that is under 1.75 lbs. (between 700-800 grams) and is generally born<br>before 26 weeks gestation, but most people prefer to loosen this term up<br>to include any baby under 3 lbs. (1500 grams) or under 29 weeks<br>gestation |
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GRI Medical & Electronic Technology Co., Ltd. Traditional 510(k) - gentleheel®
## 510(k) Summary - Revised October 31, 2017
### Indications for Use:
The gentleheel devices are heel incision devices for blood sampling in newborns, premature and low birth weight infants, and toddlers. The gentleheel has a sharps prevention feature to protect the user from a sharps injury.
#### Similarities and Differences to the Predicate Device:
#### Similarities
The gentleheel (proposed device) has the same basic technology characteristics for newborn infants, premature infants and toddlers heel stick lancets with a sharps injury prevention feature. It is intended for piercing the skin on the heel of newborn infants, premature infants and toddlers, as the Tenderfoot (predicate device), and the indications for use are the same. The materials are comparable in that the blades all use medical grade stainless steel and the housings are made of medical grade plastics.
#### Differences
The gentleheel utilizes some of the same materials, specifically the use of stainless steel for the lancet blades and plastics for the housings and trigger. The gentleheel devices use different types or grades of stainless steel and plastics. Biocompatibility testing was completed which demonstrates that the differences in types or grades of stainless steel and plastics maintain compliance under ISO 10993-1 standards requirements.
#### Summary of Testing:
The biocompatibility risk assessment was completed as directed by FDA guidance 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 as the predicate devices. The sharps prevention feature was fully tested to the FDA's guidance document as demonstrated in the performance testing.
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