Electronic Caries Detector

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Ortek Therapeutics, Inc. % Allison Komivama Principal Consultant AcKnowledge Regulatory Strategies 2834 Hawthorn St. San Diego, California 92104 September 11, 2017 Re: K170822 Trade/Device Name: Electronic Caries Detector Regulation Number: 21 CFR 872.1745 Regulation Name: Caries Detection Device Regulatory Class: Class II Product Code: NBL, LFC Dated: August 10, 2017 Received: August 11, 2017 Dear Dr. Allison Komiyama: 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. {1}------------------------------------------------ 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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/MedicalDevices/ResourcesforYou/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, ## Marv S. Runner -S for Lori Wiggins 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K170822 Device Name Electronic Caries Detector Indications for Use (Describe) The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries. Type of Use (Select one or both, as applicable) ال Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below the word "Ortek" is the phrase "Therapeutics, Inc." in a smaller, less stylized font. The logo is simple and professional. 510(k) Summary # 510(k) Summary K170822 ## DATE PREPARED September 5, 2017 ## MANUFACTURER AND 510(k) OWNER Ortek Therapeutics, Inc. 4 Expressway Plaza, Roslyn Heights, NY 11577, USA Telephone: mgoldberg.ortek@gmail.com Email: Official Contact: Mitch Goldberg, President ## REPRESENTATIVE/CONSULTANT Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies Telephone: +1 (619) 208-7888 akomiyama@acknowledge-rs.com Email: ## TRADE/PROPRIETARY NAME OF SUBJECT DEVICE Electronic Caries Detector #### COMMON NAME Laser Fluorescence Caries Detection Device #### DEVICE CLASSIFICATION Laser fluorescence caries detection device ## PRODUCT CODE NBL, LFC REGULATION NUMBER 21 CFR 872.1745 ## PREMARKET REVIEW ODE/DAGRID/DEDB Dental Panel ## INDICATIONS FOR USE The Electronic Caries Detector is for use by dental professionals as an aid in the diagnosis and monitoring of dental caries. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below the word "Ortek" is the text "Therapeutics, Inc." also in blue. The logo is simple and professional. 510(k) Summary ## DEVICE DESCRIPTION The ECD is a portable instrument that provides an electrical current source, a meter with a digital read-out between 00 and 100, and indicator and reference electrodes to aid in the detection and monitoring of non-cavitated and cavitated caries lesions in teeth. The ECD indicator electrode is comprised of a replaceable, single-use, stainless steel probe tip. This component is sized and dimensionally configured to achieve close contact with the tooth being examined. The tip ensures electrical contact with dentinal fluid at sites that are not readily accessible or evaluated using traditional means. The ECD indicator electrode is paired with a reference electrode to complete the necessary electrical circuit. The reference electrode is a stainless steel lip hook that rests on the patient's lower lip. The device is powered by a 9 volt alkaline battery, regulated down to 5 volts. The unit has a 2 ½ digit LCD display, two timer circuits, and a beeper. The first timing circuit is triggered upon circuit completion. The beeper sounds for 3 seconds, the probe is then removed, and the second timer holds the display for 5 seconds. Then the display returns to zero, ready for the next measurement. ## PREDICATE DEVICE IDENTIFICATION The Electronic Caries Detector is substantially equivalent to the following predicates: | 510(k)<br>Number | Predicate Device Name / Manufacturer | Primary<br>Predicate | |------------------|--------------------------------------------------|----------------------| | K090598 | CarieScan Pro - Cariescan LLC | ✓ | | K982105 | Oral Potential Meter - Pertec of Wisconsin, Inc. | | ## SUMMARY OF NON-CLINICAL AND CLINICAL TESTING No FDA performance standards have been established for Electronic Caries Detector. The following tests were performed to demonstrate substantial equivalence, based on current industry standards: - . Biocompatibility (per ISO 10993) - . In vitro performance testing on extracted teeth - In vivo performance testing on teeth before and after extraction The results of these tests indicate that the Electronic Caries Detector is substantially equivalent to the predicate devices. ## EQUIVALENCE TO PREDICATE DEVICES Ortek believes that the Electronic Caries Detector is substantially equivalent to the predicate devices based on the information summarized here: The subject device has similar design, technological characteristics, and uses similar or identical materials as the devices cleared in K090598 and K982105. The subject device has identical indications for use as the device cleared in K090598 and identical intended use as the devices {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Ortek Therapeutics, Inc. The word "Ortek" is written in a stylized, blue font. Below "Ortek" is the text "Therapeutics, Inc." in a smaller, simpler font. The logo is clean and professional. 510(k) Summary cleared in K090598 and K982105. The ECD uses electrical conductance similar to the device cleared in K982105. The power source of the subject device differs compared to both predicates, however, it uses a lower voltage battery (9V) than the primary predicate (110V). Performance testing of the subject device is similar to the performance of the primary predicate, however, the ECD used a comparison to biopsy whereas the primary predicate compared to visual-tactile scores of the evaluated teeth. Ortek believes that biopsy is considered the current gold standard and the performance scores are more significant compared to visual-tactile readings. ## CONCLUSION The Electronic Caries Detector is considered substantially equivalent to the predicate devices based on the testing performed, the identical indications for use, and similar technological characteristics. Based on the testing performed, including biocompatibility, performance and clinical testing, it can be concluded that the subject device does not raise new issues of safety or efficacy compared to the predicate devices. {6}------------------------------------------------ | Substantial<br>Equivalence Summary | Subject Device | Primary Predicate | Reference Predicate | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Ortek Therapeutics, Inc.<br>Electronic Caries Device<br>K170822 | CarieScan Ltd<br>CarieScan PRO<br>K090598 | Pertec of Wisconsin, Inc.<br>Oral Potential Meter (OPM)<br>K982105 | | Indications for Use | The Electronic Caries Detector<br>is for use by dental<br>professionals as an aid in the<br>diagnosis and monitoring of<br>dental caries. | For use by dental<br>professionals as an aid in<br>the diagnosis and<br>monitoring of dental<br>caries. | The Oral Potential Meter aids the dental professional in detecting potential caries. Measurements<br>above 10 millivolts, 1 microamp and 0.01 microwatts x seconds indicates a need for the dental<br>professional to look at potentially carious leasions by also using other means, such as direct<br>exploration, radiographs, etc. The OPM aids in determining potentially active caries and can not<br>detect mineralized caries that have no potenial energy. Remineralized teeth are no longer<br>considered carious. The OPM is a device that measures and displays voltage and conducts through<br>caries related to metallic restorations in the oral cavity. The dentist may be able to, on visual<br>exam, detect caries at the margins or with x-ray under a restoration with these readings. It also<br>provides a power measurement (energy or joules) integrated over a measured period of time and<br>displays it. The meter has two probes that are used to make the measurements. One is a reference<br>probe, Red, with push-button switch to turn on the meter and initiate the measurements. The<br>other is used as the primary input, Black to the meter's electronics | | Device Info | | | | | ProCodes / Reg # | NBL / 21 CFR 872.1745 | NBL / 21 CFR 872.1745 | LFC / 21 CFR 872.1740 | | Class | II | II | II | | Intended use | Aid in caries detection | Aid in caries detection | Aid in caries detection | | Where used | Dental office | Dental office | Dental office | | Energy used and/or<br>delivered | Electrical conductance | Electrical impedance | Electrical conductance | | Technological Characteristics | | | | | Power source | 9 V, alkaline battery | 110 V, Lithium polymer<br>rechargeable battery | Alternating current (AC) | | Measurement method | Measurement of<br>conductance | Comparison of<br>impedance at multiple<br>frequencies | Measurement of conductance, voltage, and time | | Performance | When compared to biopsy:<br>92% sensitivity<br>100% specificity | When compared to<br>visual-tactile:<br>92.5% sensitivity<br>92.5% specificity | Unknown | | Maximum applied<br>current | < 10 μΑ | < 10 μΑ | 10 μΑ | | Indicator electrode | Probe tip (stainless steel) | Probe tip sensor | Probe tip (stainless steel) | | Provided sterile? | No | Yes | No | | Sterilization method | Steam | Steam | Steam | | Single use? | Yes | Yes | No | | Reference electrode | Stainless steel lip hook<br>(reusable) | Stainless steel lip hook<br>(reusable) | Stainless steel | | Test range | 0-100 | 0-100 | Unknown |