(254 days)
No
The device is a simple RFID microchip for identification and data access, not involving complex algorithms or learning from data.
No.
The device is intended for identification purposes of dentures/oral appliances, not for treatment, diagnosis, or prevention of any disease or condition in the patient.
No
The device description clearly states its purpose is to enable access to secure patient identification and device information, acting as a digital link to owner contact information and information about the denture. It does not analyze or interpret biological signals or data to make a diagnosis.
No
The device description explicitly states the inclusion of a "microchip" which is permanently embedded into a denture and encased in a medical-grade epoxy resin. This is a physical hardware component, not solely software.
Based on the provided information, the DentureID Microchip is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "enable access to secure patient identification and device information when used with complete dentures, partial dentures and other removable oral appliances." This is for identification and information retrieval, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The device is a microchip embedded in a denture that links to a website for information. It does not interact with biological samples or perform any diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any analysis of biological specimens (blood, urine, tissue, etc.), chemical reactions, or any other processes typically associated with IVD devices.
- Predicate Device: The predicate device (VeriChip implantable radio frequency transponder system) is also a device for identification, not an IVD.
The DentureID Microchip is a device for identification and information management related to a medical device (dentures), not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for 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.
Product codes
PYQ, OUG
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 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 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 (
§ 880.6300 Implantable radiofrequency transponder system for patient identification and health information.
(a)
Identification. An implantable radiofrequency transponder system for patient identification and health information is a device intended to enable access to secure patient identification and corresponding health information. This system may include a passive implanted transponder, inserter, and scanner. The implanted transponder is used only to store a unique electronic identification code that is read by the scanner. The identification code is used to access patient identity and corresponding health information stored in a database.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Radiofrequency Transponder System for Patient Identification and Health Information.” See § 880.1(e) for the availability of this guidance document. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.
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 (