gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler

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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): {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *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: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 | {4}------------------------------------------------ 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.