DentureID Microchip

{0}------------------------------------------------ October 25, 2017 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. CMP Industries LLC Devon Howe President and CEO 413 N. Pearl St. Albany, New York 12207 Re: K170423 Trade/Device Name: DentureID Microchip Regulation Number: 21 CFR 880.6300 Regulation Name: Implantable Radiofrequency Transponder System For Patient Identification And Health Information Regulatory Class: Class II Product Code: PYQ, OUG Dated: August 8, 2017 Received: August 10, 2017 Dear Devon Howe: 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely, Mary S. Runner -S for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is the logo for Nobilium, a company that specializes in prosthetic dentistry. The logo features a blue emblem on the left, followed by the word "NOBILIUM" in large, blue, bold letters. Below the company name is the tagline "Your Partner In Prosthetic Dentistry" in a smaller, blue font. Division of CMP Industries LLC 413 North Pearl Street Albany, New York, 12207-1311 · USA 800 833-2343 · 518 434-3147 · Fax: 518 434-1288 USA Email: info@nobilum.com Export Email: export@nobilium.com Website: www.nobilium.com ISO 13485:2003 510(k) Summary for DentureID Microchip K170423/S001 ### 1. Applicant Submitter's Name: Devon Howe Date Summary Prepared: Revised August 7, 2017 - Address: CMP Industries LLC 413 N. Pearl St. Albany, NY 12207 Phone: 518-434-3147 ext 128 Email: howed@nobilium.com Fax: 518-434-1288 ### 2. Device Name Proprietary Name: DentureID Microchip Common Name: RFID Tag ISO 14443 micro-transponder embedded into medical grade epoxv Classification Name: Implantable Radiofrequency Transponder System for Patient Identification and Health Information (21 CFR 880.6300) Product Code: PYQ Device Class: 2 (special controls) ### 3. Predicate Devices Primary: VeriChip implantable radio frequency transponder system (DEN040007) by VeriChip Corporation (now called PositiveID) and purchased by Jamm Technologies - Common Name: RFID Tag ISO 11784/85 micro-transponder o - Classification Name: Implantable Radiofrequency Transponder System for O Patient Identification and Health Information (21 CFR 880.6300) - Product Code: NRV O - Device Class: 2 (special controls) с Reference: SMARTSPONGE SYSTEM (K071355) by ClearCount Medical Solutions, Inc. now marketed by Medline Industries, Inc. - Common Name: RFID Tag ISO 15693 micro-transponder embedded into O medical grade epoxy and sewn into surgical sponge - Classification Name: Surgical sponge scale (21 CFR 880.2740) O - Product Code: LWH O {3}------------------------------------------------ - o Device Class: 1 ## 4. Device Description A. Overview: DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. Denture identification is required by many US state governments because dentures are frequently lost. DentureID.com complies with these regulations by discreetly using a microchip instead of a visible patient name. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. This information could be important to identify and contact the owner if a Image /page/3/Picture/4 description: The image shows a close-up of a denture with a small, round sticker on it. The sticker has the text "DENTURE ID.COM" printed around the edge of the circle. In the center of the sticker, there is a small, dark square, possibly a QR code or some other type of identification mark. The denture itself is made of a pinkish material, and some of the teeth are visible at the bottom of the frame. DentureID Microchip placed on the buccal flange of a denture denture is found. Also, if a denture requires repair, this information will be extremely valuable to a dentist or denturist who must match the size and color of denture teeth, denture base or implant/attachment components. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DenturelD.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. The DentureID Microchip is not a tracking system so it will not help in finding a lost denture. It is passive and does not emit any signal until powered by a compatible Smart Phone using NFC (near field communication). B. Explanation of How the Device Functions: DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. A password is not required to read the microchip, however, intimate contact between the smart phone and the microchip is required. The NFC-compliant smart phone emits a low level of energy which "activates" the DenturelD Microchip when placed within intimate contact. The DentureID Microchip responds to the SmartPhone with its serial number. The SmartPhone then requests the information associated with the microchip serial number stored on the DentureID website. The website returns the stored information and displays it on the SmartPhone. Because there is no significant patient risk if the App malfunctions, this App is not considered a "Mobile Medical App." DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flanqe of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient. The process to insert the microchip into a denture is performed with lower labor cost as compared to conventional denture identification methods, and it satisfies denture identification regulations required in 27 US States and federal facilities. Information associated with the unique identification code of the microchip is entered by a dental lab or {4}------------------------------------------------ dentist on the DentureID.com website. This information will appear on a SmartPhone when using the DentureID.com app and holding the SmartPhone directly on the DentureID.com microchip. The patient contact information retrieved from DentureID will greatly assist care givers to locate owners of lost dentures. In addition, information from DentureID Microchips will greatly help a dentist to identify elements of a denture in the case of repair. These elements may include: the type and color of denture base, teeth size and color, clips, attachment housings and implant components. These elements are nearly impossible to identify otherwise, so DentureID Microchips will improve the quality of patient care. In the event that a denture is placed in view of others who are not "covered entities" under HIPAA regulations, DentureID Microchips help to improve caregiver compliance with privacy requlations because the denture patient's name is not visible, unlike conventional denture identification methods. C. Scientific Concepts That Form the Basis For The Device: The DentureID Microchip does not hold an electric charge. It remains inactive until energized by an NFC reader using RFID ISO 14443 (a common standard used at 13.56Mhz) that makes intimate contact. The low level of energy emitted by the reader (smart phone in NFC mode) "wakes-up" the microchip which responds with a unique serial number. The reader (smart phone) then communicates the serial number to the DentureID.com database and the database responds with information to display on the reader (smart phone). #### D. Significant Physical and Performance Characteristics i. Device Design - The device design is a standard RFID ISO 14443 which enables NFC communication at very short (< 1cm) distances. ii. Material Used - The microchip is not powered and does not emit any radiation. The following is a list of materials and components used to make DentureID Microchips: 1) Microchip: Chip #NTAG213 — Manufactured by NXP. This chip is RFID ISO 14443 standard that uses NFC (near-field communication). 2) Very thin copper wire 3) Clear film printed with the words "DENTUREID.COM" 4) Medical-Grade Epoxy: LOCTITE® M-31CL™ iii. Physical Properties - The DentureID Microchip emits no energy. It responds to a 13.56Mhz transponder (smart phone and other readers) which emits approximately 40 microwatts (10-6 watts). According to the physical properties data sheet for the LOCTITE M-31CL (primary contents by mass), the Physical Properties are as follows: Image /page/4/Picture/9 description: The image shows a small, round object with the words "Denture ID.co" printed on it. There is a small, dark square in the center of the object. The object appears to be made of clear plastic with a copper coil around the edge. The words are printed in black ink. Glass Transition Temperature, ASTM E 228, °C 70 Elongation, ASTM D 638, % 8 Tensile Strength, ASTM D 638 N/mm² 55.2 (psi) (8,000) {5}------------------------------------------------ E. Duration and Type of Contact: DentureID Microchip does not contact the patient. It is embedded into a denture and completely covered with self-cure PMMA repair resin. Dentures are rarely worn 24-hours per day. They mostly removed during sleep. F. User Procedure: The current standard of care for denture fabrication begins with a dental professional (dentist, denturist, prosthodontist) providing an impression or model and information about the case, generally including the patient's name, to a dental laboratory. The dental professional and dental laboratory are currently bound by confidentiality requlations and are "covered entities" as defined by HIPAA. When using a DentureID Microchip, the dental laboratory will fabricate the denture, insert the DentureID Microchip (dental laboratory technicians are generally familiar with denture base acrylics) and enter key information about the denture, including patient name (if provided by the dental professional), into a secure server which requires a username and password. After data entry, the dental laboratory will verify the information was entered correctly by reading the DentureID Microchip with a reader (smart phone). The dental laboratory keeps one of the 3-part adhesive labels and adheres it to their documentation about the case which they presently safeguard per HIPAA regulations. The lab sends the other two adhesive labels with the dental prosthetic appliance to the dental professional. The dentist will keep one label with the clinical documentation on the case and give the other adhesive label to the patient. The dentist copy has space for the patient to sign and acknowledge that they are consenting to place information on DentureID.com website (consent is required part of HIPAA1). The dental professional, laboratory or patient may edit or remove information stored on the DentureID website. If the username or password is lost, the dentist and dental laboratory will have a record of the username and password. See section 13, Proposed Labeling, for more information and Directions for Use. G. Model Numbers: The model number D1EN is the English version with denture branding. Future models will be other languages and branding for other appliances such as mouthguards and retainers. H. Software - Reader: The person reading the DentureID Microchip embedded into a denture will likely use a smart phone such as an Android capable of NFC communication. The user must first download the DentureID app for Android smart phone from the Google Play store. Apple has NFC on their most modern phones for use with proprietary Apple systems such as ApplePay. Apple is planning to release NFC on their phones to developers for new applications, such as DentureID Microchip. I. Software - Web Server: Data about the denture is entered into and maintained by a secure server hosted by Amazon. There are many healthcare organization who use the same services, including The Centers for Medicare and Medicaid Services (CMS). Details about the web server: - Operating System: Windows server 2008 R2 । - Database: Microsoft SQL Server 2008 R2 Web edition । - Web Server: Internet Information Service 7 । - The SQL database access is restricted through credentials - - -We will purchase an SSL certificate associated with www.dentureid.com domain so {6}------------------------------------------------ that the web app can be accessed over https instead of normal http. This will ensure the data is encrypted over the network. J. Disease Conditions (Devices): The DentureID Microchip will assist dentists to treat patients who are: - 1. Edentulous (Complete Dentures) - 2. Partially Edentulous (Partial Dentures) - 3. Bruxing (Night Guards) - 4. Protecting Teeth During Contact Activity (Sports Guard) - 5. Involved with Teeth or Jaw Alignment Therapy (Retainer, Alignment Tray) ### 5. Intended Use Indication for Use: DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances. General Description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate: Edentulism (people with missing teeth) and people who wear removable dental appliances ### Description of the patient population for which the device is intended: Primary: Full or partially edentulous patients. Secondary: Patients who wear bruxing (night guard) appliances and other removable appliances such as a Sports Guards, Retainers and Alignment Trays, etc. | DentureID<br>Microchip<br>(K170423) | VeriChip<br>(DEN040007)<br>Predicate (Primary) | SmartSponge<br>(K071355) Predicate<br>(Reference) | Comments | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DentureID Microchip<br>is intended to<br>enable access to<br>secure patient<br>identification and<br>device information<br>when used with<br>complete dentures,<br>partial dentures and<br>other removable oral<br>appliances | The VeriChip is indicated<br>for use as a miniature,<br>implantable microchip<br>that is inserted into the<br>subcutaneous tissue of<br>the patient. The<br>VeriChip provides the<br>patient a unique<br>identification number<br>that may be used to<br>access a database<br>containing the patient's<br>identity and health<br>information. | The ClearCount<br>Medical Solutions<br>SmartSpongeTM<br>System is<br>indicated for use in<br>counting and<br>recording the number<br>of RFID tagged<br>surgical sponges,<br>laparatomy sponges<br>and towels used<br>during surgical<br>procedures. | The output portion of<br>the indications for use<br>for VeriChip is virtually<br>identical to DentureID<br>Microchip because both<br>chips respond with a<br>unique identification<br>number corresponding<br>to a patient. | ### 6. Indication Statements Comparison {7}------------------------------------------------ ## 7. Technological Characteristics and Substantial Equivalence | | DentureID Microchip<br>Micro-Transponder<br>Specifications | VeriChip<br>Predicate (Primary)<br>Micro-Transponder<br>Specifications | SmartSponge<br>Predicate (Reference)<br>Micro-Transponder<br>Specifications | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Common<br>Name | RFID Tag ISO 14443<br>micro-transponder<br>embedded into medical<br>grade epoxy | RFID Tag ISO 11784/85<br>micro-transponder | RFID Tag ISO 15693<br>micro-transponder<br>embedded into medical<br>grade epoxy and sewn<br>into surgical sponge | | FDA<br>Classification<br>Number | Implantable<br>Radiofrequency<br>Transponder System for<br>Patient Identification and<br>Health Information (21<br>CFR 880.6300) | Implantable<br>Radiofrequency<br>Transponder System for<br>Patient Identification and<br>Health Information (21<br>CFR 880.6300) | Surgical sponge scale<br>(21 CFR 880.2740) | | 510(k)<br>Number | K170423 | DEN040007 | K071355 | | Operating<br>Frequency | 13.56Mhz | 134.2 kHz ± 3 kHz | 13.56Mhz | | Peak High Op.<br>Temperature | Up to +85° C (+185° F) | Up to +180° C (+356° F) | Up to +125° C (+257° F) | | Electrical<br>Characteristics | Passive - Operates<br>when in presence of<br>compatible SmartPhone<br>in NFC mode | Passive - Operates when<br>in presence of VeriChip's<br>"Pocket Reader" | Passive - Operates<br>when in presence of<br>compatible reader | | Functional<br>Performance | Read Range potential up<br>to 50mm, but max is<br>5mm (≈ 0.5 in) as tested<br>in DentureID applications<br>using Android Smart<br>Phone. | Read Range 63.5mm (≈<br>3.0 in) | Read Range potential up<br>to 1 to 1.5 meters (19 in<br>to 59 in) | | Write<br>Protected | Yes | Yes | Yes | | Self-Powered | No | No | No | | Encapsulating<br>Material | LOCTITE M-31CL<br>Medical Grade Epoxy | None | LOCTITE M-31CL<br>Medical Grade Epoxy | | Tracking<br>Device | No | No | No | | Compatibility | Compatible with various<br>polymers and materials | Compatible with various<br>polymers and materials | Compatible with various<br>polymers and materials | | Patient<br>Contact | Encapsulated Microchip<br>and epoxy shell do not<br>touch human tissue | Encapsulated Microchip<br>does not touch patient,<br>but outer shell does | Encapsulated Microchip<br>does not touch patient,<br>but epoxy shell may | | Anatomical<br>Site | Mouth | Subcutaneous | Intra-abdominal | Source of data from company literature and manufacturer of RFID micro-transponders. {8}------------------------------------------------ Similarities between DentureID Microchip and VeriChip (Primary Predicate) - The indications for use for DentureID Microchip are virtually the same as the Primary ● Predicate because both are RFID micro-transponders and thev both respond with a unique identification number corresponding to a patient. - Both micro-transponders are passive and require energy from an outside source to . respond with a serial number. - o Both micro-transponders are not tracking devices and are write-protected Similarities between DentureID and SmartSponge (Reference Predicate) - Both are RFID micro-transponders and they both respond with a unique identification number. - Both RFID micro-transponders are embedded into LOCTITE M-31CL Medical Grade ● Ероху. ## Differences between DentureID Microchip and VeriChip (Primary Predicate) - The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because VeriChip is designed to be read from a further distance because it is under the skin and the exact location may be unknown. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. Because DentureID Microchip requires close proximity read (<1 cm), it nearly impossible for an unauthorized person to obtain information related to the denture. This feature makes information from DentureID Microchip more secure than VeriChip. - The DentureID micro-transponder and epoxy encapsulating material do not touch the patient because the DFU requires covering the device with dental acrylic. However. the VeriChip encapsulated micro-transponder is located subcutaneously. This difference does not raise any substantial equivalence concerns because DenturelD is not invasive by design and results in lower patient risk. ### Differences between DentureID and SmartSponge (Reference Predicate) - The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because SmartSponge is designed to be read from a further distance because they could be located in the abdomen and the exact location may be unknown or they could be located in the "out scanner bucket" grouped together. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. ### Applicable Standards - 10993-1; Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process - ISO 1993-5; ISO MEM Elution Using L929, Mouse Fibroblast Cell (GLP) Cytotoxicity (2009) - ISO 1993-10; Biological Evaluation Of Medical Devices Part 10: Tests For Irritation ● And Skin Sensitization - ISO 7405 Evaluation of biocompatibility of medical devices used in dentistry ● - IEC 60601-1-2 International Medical Safety Standard 2014 ● - o F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force of Medical Devices in the Magnetic Resonance Environment 2015 {9}------------------------------------------------ # 8. Non-Clinical Performance testing and Compliance The following non-clinical tests were conducted to evaluate the functionality, performance, safety and substantial equivalence as suggested by FDA's guidance for industry and FDA staff titled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information" issued on December 10, 2004. | A. BIOCOMPATIBILITY<br>Description | Standard | Result | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity | ISO 10993-5:2009<br>Biological Evaluation of<br>Medical Devices, Part 5:<br>Tests for In Vitro<br>Cytotoxicity | The test article scored '0'<br>at 24, 48, and 72 ± 4<br>hours and is considered<br>non-cytotoxic under the<br>conditions of this test. | | Irritation | SO 10993-10: 2010<br>Standard, Biological<br>Evaluation of Medical<br>Devices, Part 10: Tests<br>for Irritation and Skin<br>Sensitization | The differences in the<br>mean test and control<br>scores of the extract<br>dermal observations were<br>less than 1.0, indicating<br>that the requirements<br>of the ISO Intracutaneous<br>Reactivity Test have been<br>met by the test article. | | Sensitization | The study was conducted<br>in accordance with ISO<br>10993-10:2010. Biological<br>Evaluation of Medical<br>Devices, Part 10: Tests<br>for Irritation and Skin<br>Sensitization, pp. 18-26 | None of the negative<br>control animals challenged<br>with the control vehicles<br>were observed with a<br>sensitization response<br>greater than '0'. None of<br>the animals challenged<br>with the test article<br>extracts were observed<br>with a sensitization<br>response greater than '0'.<br>The normal saline extract<br>of the test material had a<br>sensitization response of<br>'0' under valid test<br>conditions. The sesame oil<br>extract of the test material<br>had a sensitization<br>response of '0' under valid<br>test conditions. Under the<br>conditions of this protocol,<br>the test article did not elicit<br>a sensitization response. | | Chemical Characterization<br>of Materials (Leachate) | Proprietary standards of<br>Nelson Laboratories and | The incremental<br>substances found in the | | | ChemTech Ford<br>Laboratories | study are presented and<br>compared to toxicity<br>standards for the<br>respective materials. As a<br>result of the study, we feel<br>that the potential toxicity<br>from leaching of harmful<br>chemicals from the | | | | DentureID RFID tag is not<br>significant. | A BIOCOMPATIBILITY {10}------------------------------------------------ ### B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION) -Passed C. SOFTWARE VALIDATION - Passed D. MIGRATION TESTING OF IMPLANTED TRANSPONDER - Passed E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER - Passed F. PERFORMANCE TESTING OF INSERTER - No inserter used G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER - Responsibility of SmartPhone manufacturer H. ELECTROMAGNETIC COMPATIBILITY The following tests were completed on DentureID Microchips: | Description | Standard | Result | |--------------------------------------------|-------------------|--------| | Radiated Emissions | EN 55011:2009 | Pass | | Electrostatic Discharge<br>Immunity | EN 61000-4-2:2008 | Pass | | Radiated Electromagnetic<br>Field Immunity | EN 61000-4-3:2010 | Pass | | Magnetic Field Immunity | EN 61000-4-8:2009 | Pass | In addition, the testing found no loss or corruption of the data, latency or through-put, which was coordinated with the electromagnetic compatibility (EMC) performance of the microchip, scanner and wireless data link. I. ELECTRICAL SAFETY PERFORMANCE TESTING - The DentureID Microchip does not emit any energy, so safety performance testing is not required. J. STERILITY - Device is not sterile K. MAGNETIC RESONANCE IMAGING COMPATIBILITY The following tests were completed on DentureID Microchips: | Description | Standard | Result | |------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Magnetic Field Interactions<br>at 3-Tesla | (ASTM) Designation:<br>F2052-15. Standard<br>Test Method for<br>Measurement of<br>Magnetically Induced<br>Displacement Force on<br>Medical Devices in the<br>Magnetic Resonance<br>Environment. | The qualitatively<br>measured torque at 3-<br>Tesla for the DentureID<br>was 0, no torque. As<br>such, this device will not<br>present an additional risk<br>or hazard to a patient in<br>the 3-Tesla MRI<br>environment or less with | | | | regard to torque. | | MRI-related heating, 1.5-<br>Tesla and 3-Tesla | ASTM International<br>document: American<br>Society for Testing and<br>Materials International,<br>Designation F2182–11a<br>Standard Test Method for<br>Measurement of Radio<br>Frequency Induced<br>Heating On or Near<br>Passive Implants During<br>Magnetic Resonance<br>Imaging | 1.5-Tesla demonstrated a<br>maximum of 1.5°C<br>temperature rise and the<br>3-T system demonstrated<br>a 1.9°C rise. Both of<br>these temperature rises<br>matched the maximum<br>background temperature<br>rise. In conclusion, MRI<br>1.5 and 3 do not induce<br>significant heating to<br>DentureID Microchip | | Artifacts at 3-Tesla | (ASTM) International<br>Designation: F2119-07<br>(Reapproved 2013),<br>Standard Test Method for<br>Evaluation of MR Image<br>Artifacts from Passive<br>Implants | The artifacts that<br>appeared on the MR<br>images were shown as<br>localized signal voids<br>(i.e., signal loss) that<br>corresponded to the size<br>and shape of this device.<br>The gradient echo pulse<br>sequence produced<br>larger artifacts than the<br>T1-weighted, spin echo<br>pulse sequence for the<br>device. The maximum<br>artifact size (i.e., as seen<br>on the gradient echo<br>pulse sequence) extends<br>approximately 10-mm<br>relative to the size and<br>shape of this device. | | Evaluation of the Effects of<br>MRI at 1.5-Tesla and 3-<br>Tesla on the Function of<br>DentureID Microchip | The goal of this<br>investigation was to<br>determine the effects of<br>exposing the samples of<br>the DentureID Microchips<br>to 1.5-Tesla/64-MHz and<br>3-Tesla MRI conditions<br>and pulse sequences<br>selected to be<br>representative of typical<br>clinical MRI techniques in<br>order to determine if these<br>devices were damaged or<br>if there was a change in<br>function. | DentureID Microchips<br>performed 100% pre and<br>post exposures. | {11}------------------------------------------------ {12}------------------------------------------------ ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process: This standard has been addressed in Section 16. ISO 7405 Dentistry – Evaluation of biocompatibility of medical devices used in dentistry: This standard has been addressed in Section 16. An additional non-clinical performance test was performed outside of the FDA Guidance Document. DentureID Microchips installed in dentures per DFU were subject to 5year simulated wear with a denture cleaning medium and denture brush. The results indicated that the clear self-cure dental acrylic placed over the DentureID Microchip was not affected by the scrubbing action. Therefore, cleaning dentures will not impact the performance of DentureID Microchip. ### 9. Conclusions The DentureID Microchip is substantially equivalent to VeriChip because the technology is functionally the same and the output portion of the indications for use for VeriChip is virtually identical to DentureID Microchip. Benchtop testing proved compliance with FDA's guidance for industry and FDA staff. Because DentureID is not inserted into patients, DentureID Microchip presents significantly less patient risk than VeriChip. DentureID Microchip is more effective and performs better than the predicate device, VeriChip, because: 1. DentureID Microchip does not require a specialized reader 2. After reading a Denture ID Microchip, the information returned to the reader is robust and detailed compared to VeriChip which returns only two rows of 15 character alphanumeric strings. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for Nobilium, a company that specializes in prosthetic dentistry. The logo features a blue emblem with a stylized face and crown, followed by the word "NOBILIUM" in bold, blue letters. Below the company name is the tagline "Your Partner In Prosthetic Dentistry" in a smaller, blue font. Division of CMP Industries LLC 413 North Pearl Street Albany, New York, 12207-1311 · USA 800 833-2343 · 518 434-3147 · Fax: 518 434-1288 USA Email: info@nobilum.com Export Email: export@nobilium.com Website: www.nobilium.com ISO 13485:2003 510(k) Summary for DentureID Microchip K170423/S001 ### 1. Applicant Submitter's Name: Devon Howe Date Summary Prepared: Revised August 7, 2017 - Address: CMP Industries LLC 413 N. Pearl St. Albany, NY 12207 Phone: 518-434-3147 ext 128 Email: howed@nobilium.com Fax: 518-434-1288 ### 2. Device Name Proprietary Name: DentureID Microchip Common Name: RFID Tag ISO 14443 micro-transponder embedded into medical grade epoxv Classification Name: Implantable Radiofrequency Transponder System for Patient Identification and Health Information (21 CFR 880.6300) Product Code: PYQ Device Class: 2 (special controls) ### 3. Predicate Devices Primary: VeriChip implantable radio frequency transponder system (DEN040007) by VeriChip Corporation (now called PositiveID) and purchased by Jamm Technologies - Common Name: RFID Tag ISO 11784/85 micro-transponder O - Classification Name: Implantable Radiofrequency Transponder System for O Patient Identification and Health Information (21 CFR 880.6300) - Product Code: NRV o - Device Class: 2 (special controls) o Reference: SMARTSPONGE SYSTEM (K071355) by ClearCount Medical Solutions, Inc. now marketed by Medline Industries, Inc. - Common Name: RFID Tag ISO 15693 micro-transponder embedded into O medical grade epoxy and sewn into surgical sponge - Classification Name: Surgical sponge scale (21 CFR 880.2740) O - Product Code: LWH O {14}------------------------------------------------ - o Device Class: 1 ## 4. Device Description A. Overview: DentureID Microchip enables access to secure patent identification and device information when used with removable oral appliances. Denture identification is required by many US state governments because dentures are frequently lost. DentureID.com complies with these regulations by discreetly using a microchip instead of a visible patient name. The microchip is permanently embedded into a denture and is a digital link to owner contact information and information about the denture in the event that a repair or replacement is needed. All of the information is controlled on the secure DentureID.com website by the denture owner and dental professional. This information could be important to identify and contact the owner if a Image /page/14/Picture/4 description: The image shows a close-up of a denture. The denture is made of a pink material and has white teeth. There is a small, round sticker on the denture that says "DENTURE ID.COM" in black letters. The sticker also has a small black square in the center. DentureID Microchip placed on the buccal flange of a denture denture is found. Also, if a denture requires repair, this information will be extremely valuable to a dentist or denturist who must match the size and color of denture teeth, denture base or implant/attachment components. The DentureID Microchip can be read by any NFC compatible Android Smart Phone (after downloading the DentureID.com App from Google Play) and holding the phone against the microchip. The information on the DenturelD.com website may be modified at any time by the patient or dental professional by entering a username and password. The information that is on the website will appear on the smart phone when reading the DentureID Microchip. The DentureID Microchip is not a tracking system so it will not help in finding a lost denture. It is passive and does not emit any signal until powered by a compatible Smart Phone using NFC (near field communication). B. Explanation of How the Device Functions: DentureID Microchips are classified as RFID ISO 14443 which use NFC (near-field-communication). DentureID Microchips are designed to be read by ISO 14443 NFC-compliant smart phones with DentureID App installed. A password is not required to read the microchip, however, intimate contact between the smart phone and the microchip is required. The NFC-compliant smart phone emits a low level of energy which "activates" the DentureID Microchip when placed within intimate contact. The DentureID Microchip responds to the SmartPhone with its serial number. The SmartPhone then requests the information associated with the microchip serial number stored on the DenturelD website. The website returns the stored information and displays it on the SmartPhone. Because there is no significant patient risk if the App malfunctions, this App is not considered a "Mobile Medical App." DentureID Microchips are encased in a medical-grade epoxy resin. The size is 1.5mm X 6 mm in diameter. They are inserted into the buccal flange of a denture and completely covered with self-cure repair resin. The DentureID Microchip does not directly contact the patient. The process to insert the microchip into a denture is performed with lower labor cost as compared to conventional denture identification methods, and it satisfies denture identification requlations required in 27 US States and federal facilities. Information associated with the unique identification code of the microchip is entered by a dental lab or {15}------------------------------------------------ dentist on the DentureID.com website. This information will appear on a SmartPhone when using the DentureID.com app and holding the SmartPhone directly on the DentureID.com microchip. The patient contact information retrieved from DentureID will greatly assist care givers to locate owners of lost dentures. In addition, information from DentureID Microchips will greatly help a dentist to identify elements of a denture in the case of repair. These elements may include: the type and color of denture base, teeth size and color, clips, attachment housings and implant components. These elements are nearly impossible to identify otherwise, so DentureID Microchips will improve the quality of patient care. In the event that a denture is placed in view of others who are not "covered entities" under HIPAA requlations, DentureID Microchips help to improve caregiver compliance with privacy requlations because the denture patient's name is not visible, unlike conventional denture identification methods. C. Scientific Concepts That Form the Basis For The Device: The DentureID Microchip does not hold an electric charge. It remains inactive until energized by an NFC reader using RFID ISO 14443 (a common standard used at 13.56Mhz) that makes intimate contact. The low level of energy emitted by the reader (smart phone in NFC mode) "wakes-up" the microchip which responds with a unique serial number. The reader (smart phone) then communicates the serial number to the DentureID.com database and the database responds with information to display on the reader (smart phone). #### D. Significant Physical and Performance Characteristics i. Device Design – The device design is a standard RFID ISO 14443 which enables NFC communication at very short (< 1cm) distances. ii. Material Used - The microchip is not powered and does not emit any radiation. The following is a list of materials and components used to make DentureID Microchips: 1) Microchip: Chip #NTAG213 – Manufactured by NXP. This chip is RFID ISO 14443 standard that uses NFC (near-field communication). 2) Very thin copper wire 3) Clear film printed with the words "DENTUREID.COM" 4) Medical-Grade Epoxy: LOCTITE® M-31CL™ iii. Physical Properties - The DentureID Microchip emits no energy. It responds to a 13.56Mhz transponder (smart phone and other readers) which emits approximately 40 microwatts (10-6 watts). According to the physical properties data sheet for the LOCTITE M-31CL (primary contents by mass), the Physical Properties are as follows: Image /page/15/Picture/9 description: The image shows a small, round, clear object with the words "Denture ID.CO WO" printed around the edge. There is a small, dark square in the center of the object. The object appears to be made of plastic or glass and has a smooth, shiny surface. The text is printed in black and is slightly blurred. Glass Transition Temperature, ASTM E 228, °C 70 Elongation, ASTM D 638, % 8 Tensile Strength, ASTM D 638 N/mm² 55.2 (psi) (8,000) {16}------------------------------------------------ E. Duration and Type of Contact: DentureID Microchip does not contact the patient. It is embedded into a denture and completely covered with self-cure PMMA repair resin. Dentures are rarely worn 24-hours per dav. They mostly removed during sleep. F. User Procedure: The current standard of care for denture fabrication begins with a dental professional (dentist, denturist, prosthodontist) providing an impression or model and information about the case, generally including the patient's name, to a dental laboratory. The dental professional and dental laboratory are currently bound by confidentiality requlations and are "covered entities" as defined by HIPAA. When using a DentureID Microchip, the dental laboratory will fabricate the denture, insert the DentureID Microchip (dental laboratory technicians are generally familiar with denture base acrylics) and enter key information about the denture, including patient name (if provided by the dental professional), into a secure server which requires a username and password. After data entry, the dental laboratory will verify the information was entered correctly by reading the DentureID Microchip with a reader (smart phone). The dental laboratory keeps one of the 3-part adhesive labels and adheres it to their documentation about the case which they presently safeguard per HIPAA regulations. The lab sends the other two adhesive labels with the dental prosthetic appliance to the dental professional. The dentist will keep one label with the clinical documentation on the case and give the other adhesive label to the patient. The dentist copy has space for the patient to sign and acknowledge that they are consenting to place information on DentureID.com website (consent is required part of HIPAA1). The dental professional, laboratory or patient may edit or remove information stored on the DentureID website. If the username or password is lost, the dentist and dental laboratory will have a record of the username and password. See section 13, Proposed Labeling, for more information and Directions for Use. G. Model Numbers: The model number D1EN is the English version with denture branding. Future models will be other languages and branding for other appliances such as mouthguards and retainers. H. Software - Reader: The person reading the DentureID Microchip embedded into a denture will likely use a smart phone such as an Android capable of NFC communication. The user must first download the DentureID app for Android smart phone from the Google Play store. Apple has NFC on their most modern phones for use with proprietary Apple systems such as ApplePay. Apple is planning to release NFC on their phones to developers for new applications, such as DentureID Microchip. I. Software - Web Server: Data about the denture is entered into and maintained by a secure server hosted by Amazon. There are many healthcare organization who use the same services, including The Centers for Medicaid Services (CMS). Details about the web server: - Operating System: Windows server 2008 R2 । - . Database: Microsoft SQL Server 2008 R2 Web edition - Web Server: Internet Information Service 7 . - The SQL database access is restricted through credentials - - -We will purchase an SSL certificate associated with www.dentureid.com domain so {17}------------------------------------------------ that the web app can be accessed over https instead of normal http. This will ensure the data is encrypted over the network. J. Disease Conditions (Devices): The DentureID Microchip will assist dentists to treat patients who are: - 1. Edentulous (Complete Dentures) - 2. Partially Edentulous (Partial Dentures) - 3. Bruxing (Night Guards) - 4. Protecting Teeth During Contact Activity (Sports Guard) - 5. Involved with Teeth or Jaw Alignment Therapy (Retainer, Alignment Tray) ### 5. Intended Use Indication for Use: DentureID Microchip is intended to enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances. General Description of the diseases or conditions that the device will diagnose, treat, prevent, cure, or mitigate: Edentulism (people with missing teeth) and people who wear removable dental appliances ### Description of the patient population for which the device is intended: Primary: Full or partially edentulous patients. Secondary: Patients who wear bruxing (night guard) appliances and other removable appliances such as a Sports Guards, Retainers and Alignment Trays, etc. | DentureID<br>Microchip<br>(K170423) | VeriChip<br>(DEN040007)<br>Predicate (Primary) | SmartSponge<br>(K071355) Predicate<br>(Reference) | Comments | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DentureID Microchip<br>is intended to<br>enable access to<br>secure patient<br>identification and<br>device information<br>when used with<br>complete dentures,<br>partial dentures and<br>other removable oral<br>appliances | The VeriChip is indicated<br>for use as a miniature,<br>implantable microchip<br>that is inserted into the<br>subcutaneous tissue of<br>the patient. The<br>VeriChip provides the<br>patient a unique<br>identification number<br>that may be used to<br>access a database<br>containing the patient's<br>identity and health<br>information. | The ClearCount<br>Medical Solutions<br>SmartSpongeTM<br>System is<br>indicated for use in<br>counting and<br>recording the number<br>of RFID tagged<br>surgical sponges,<br>laparatomy sponges<br>and towels used<br>during surgical<br>procedures. | The output portion of<br>the indications for use<br>for VeriChip is virtually<br>identical to DentureID<br>Microchip because both<br>chips respond with a<br>unique identification<br>number corresponding<br>to a patient. | ### 6. Indication Statements Comparison {18}------------------------------------------------ # 7. Technological Characteristics and Substantial Equivalence | | DenturelD Microchip<br>Micro-Transponder<br>Specifications | VeriChip<br>Predicate (Primary)<br>Micro-Transponder<br>Specifications | SmartSponge<br>Predicate (Reference)<br>Micro-Transponder<br>Specifications | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | Common<br>Name | RFID Tag ISO 14443<br>micro-transponder<br>embedded into medical<br>grade epoxy | RFID Tag ISO 11784/85<br>micro-transponder | RFID Tag ISO 15693<br>micro-transponder<br>embedded into medical<br>grade epoxy and sewn<br>into surgical sponge | | FDA<br>Classification<br>Number | Implantable<br>Radiofrequency<br>Transponder System for<br>Patient Identification and<br>Health Information (21<br>CFR 880.6300) | Implantable<br>Radiofrequency<br>Transponder System for<br>Patient Identification and<br>Health Information (21<br>CFR 880.6300) | Surgical sponge scale<br>(21 CFR 880.2740) | | 510(k)<br>Number | K170423 | DEN040007 | K071355 | | Operating<br>Frequency | 13.56Mhz | 134.2 kHz ± 3 kHz | 13.56Mhz | | Peak High Op.<br>Temperature | Up to +85° C (+185° F) | Up to +180° C (+356° F) | Up to +125° C (+257° F) | | Electrical<br>Characteristics | Passive - Operates<br>when in presence of<br>compatible SmartPhone<br>in NFC mode | Passive - Operates when<br>in presence of VeriChip's<br>"Pocket Reader" | Passive - Operates<br>when in presence of<br>compatible reader | | Functional<br>Performance | Read Range potential up<br>to 50mm, but max is<br>5mm (≈ 0.5 in) as tested<br>in DentureID applications<br>using Android Smart<br>Phone. | Read Range 63.5mm (≈<br>3.0 in) | Read Range potential up<br>to 1 to 1.5 meters (19 in<br>to 59 in) | | Write<br>Protected | Yes | Yes | Yes | | Self-Powered | No | No | No | | Encapsulating<br>Material | LOCTITE M-31CL<br>Medical Grade Epoxy | None | LOCTITE M-31CL<br>Medical Grade Epoxy | | Tracking<br>Device | No | No | No | | Compatibility | Compatible with various<br>polymers and materials | Compatible with various<br>polymers and materials | Compatible with various<br>polymers and materials | | Patient<br>Contact | Encapsulated Microchip<br>and epoxy shell do not<br>touch human tissue | Encapsulated Microchip<br>does not touch patient,<br>but outer shell does | Encapsulated Microchip<br>does not touch patient,<br>but epoxy shell may | | Anatomical<br>Site | Mouth | Subcutaneous | Intra-abdominal | Source of data from company literature and manufacturer of RFID micro-transponders. {19}------------------------------------------------ Similarities between DentureID Microchip and VeriChip (Primary Predicate) - The indications for use for DentureID Microchip are virtually the same as the Primary ● Predicate because both are RFID micro-transponders and thev both respond with a unique identification number corresponding to a patient. - Both micro-transponders are passive and require energy from an outside source to . respond with a serial number. - Both micro-transponders are not tracking devices and are write-protected Similarities between DentureID and SmartSponge (Reference Predicate) - Both are RFID micro-transponders and they both respond with a unique identification number. - Both RFID micro-transponders are embedded into LOCTITE M-31CL Medical Grade ● Ероху. ## Differences between DentureID Microchip and VeriChip (Primary Predicate) - The micro-transponders use a different ISO standard. This difference does not raise any substantial equivalence concerns because VeriChip is designed to be read from a further distance because it is under the skin and the exact location may be unknown. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. Because DentureID Microchip requires close proximity read (<1 cm), it nearly impossible for an unauthorized person to obtain information related to the denture. This feature makes information from DentureID Microchip more secure than VeriChip. - The DentureID micro-transponder and epoxy encapsulating material do not touch the patient because the DFU requires covering the device with dental acrylic. However. the VeriChip encapsulated micro-transponder is located subcutaneously. This difference does not raise any substantial equivalence concerns because DenturelD is not invasive by design and results in lower patient risk. ### Differences between DentureID and SmartSponge (Reference Predicate) - The micro-transponders use a different ISO standard. This difference does not raise ● any substantial equivalence concerns because SmartSponge is designed to be read from a further distance because they could be located in the abdomen and the exact location may be unknown or they could be located in the "out scanner bucket" grouped together. DentureID Microchip is visible in a denture or other appliance so it is designed for close proximity read. ### Applicable Standards - 10993-1; Biological evaluation of medical devices Part 1: Evaluation and testing ● within a risk management process - ISO 1993-5; ISO MEM Elution Using L929, Mouse Fibroblast Cell (GLP) Cytotoxicity (2009) - ISO 1993-10; Biological Evaluation Of Medical Devices Part 10: Tests For Irritation ● And Skin Sensitization - ISO 7405 Evaluation of biocompatibility of medical devices used in dentistry ● - IEC 60601-1-2 International Medical Safety Standard 2014 ● - . F2052-15 Standard Test Method for Measurement of Magnetically Induced Displacement Force of Medical Devices in the Magnetic Resonance Environment 2015 {20}------------------------------------------------ # 8. Non-Clinical Performance testing and Compliance The following non-clinical tests were conducted to evaluate the functionality, performance, safety and substantial equivalence as suggested by FDA's guidance for industry and FDA staff titled "Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information" issued on December 10, 2004. | A. BIOCOMPATIBILITY | | | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Standard | Result | | Cytotoxicity | ISO 10993-5:2009<br>Biological Evaluation of<br>Medical Devices, Part 5:<br>Tests for In Vitro<br>Cytotoxicity | The test article scored '0'<br>at 24, 48, and $72 \pm 4$<br>hours and is considered<br>non-cytotoxic under the<br>conditions of this test. | | Irritation | SO 10993-10: 2010<br>Standard, Biological<br>Evaluation of Medical<br>Devices, Part 10: Tests<br>for Irritation and Skin<br>Sensitization | The differences in the<br>mean test and control<br>scores of the extract<br>dermal observations were<br>less than 1.0, indicating<br>that the requirements<br>of the ISO Intracutaneous<br>Reactivity Test have been<br>met by the test article.…