Tellos ISQ Buddy

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of three human profiles facing right, with flowing lines suggesting movement or connection. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 7, 2016 Tellos Medical AB Mr. Anders Petersson CEO Nedergardsgatan 5 Goteborg, 41654 SWEDEN Re: K143445 Trade/Device Name: Tellos ISQ Buddy Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: November 30, 2015 Received: December 2, 2015 Dear Mr. Petersson: 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 (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. 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 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 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 yours, Tina Kiang -S for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K143445 Device Name Tellos ISO Buddy Indications for Use (Describe) Tellos ISO Buddy is indicated for use in measuring the stability of dental implants in the maxillofacial region. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 1. 510(k) Summary ## 1.1 Submitter Tellos Medical AB Nedergårdsgatan 5 416 54 Göteborg Sweden Ph: +46 709 741269 Email: info@tellosmedical.com Contact person: Anders Petersson This Summary is made on January 2, 2016 # 1.2 Device name | Proprietary name: | Tellos ISQ Buddy | |-----------------------------|-----------------------------------| | Common name: | Dental implant stability analyzer | | Accessories name: | ISQ Peg | | Regulation Number | 872.4200 | | Classification Product Code | EKX | # 1.3 Identification of Predicate Device | The predicate device trade name: | Osstell ISQ | |----------------------------------|-------------| | Accessories name: | SmartPeg | | Predicate Device 510(k) information: | | |--------------------------------------|-------------------------------------| | Device Classification Name | Handpiece, Direct Drive, AC-Powered | | 510(k) Number | K082523 | | Device Name | OSSTELL ISQ IMPLANT STABILITY METER | | Regulation Number | 872.4200 | | Classification Product Code | EKX | # 1.4 Device description ## 1.4.1 Description The Tellos ISQ Buddy measurement system consists of: | Tellos ISQ Buddy Instrument | Hand-held instrument | |-----------------------------|--------------------------------------------------------------------------------------------------------| | ISQ Peg Driver | Driver to attach the ISQ peg to the implant | | Tellos ISQ Buddy Charger | 100-240 VAC to 5VDC charger for the instrument batteries | | ISQ Peg | Measurement pin to attach to the implant. Different pins are available to fit different implant types. | {4}------------------------------------------------ Image /page/4/Picture/2 description: The image shows a digital thermometer with the words "Tellos Medical" printed on the side. The thermometer is white and has a small digital display that reads "82". The thermometer has a probe at the end that is used to take a temperature reading. The background is a solid gray color. Tellos ISQ Buddy Instrument Image /page/4/Picture/4 description: The image shows a cylindrical object with a ribbed pattern on the top half and a smooth surface on the bottom half. The object is light gray and appears to be made of a solid material. The ribbed pattern consists of vertical grooves that run along the circumference of the cylinder. The object is standing upright on a gray surface. Image /page/4/Picture/5 description: The image shows a dental implant. The implant is made of metal and has a cylindrical shape. The top of the implant has a few grooves, and the bottom has screw threads. The implant is set against a gray background. ISQ Peg Driver ISQ Peg Image /page/4/Picture/8 description: The image shows a collection of black power adapters with different plug types. There are four different plug types visible in the image. The adapters are arranged in a way that highlights the variety of plug configurations. The adapters appear to be interchangeable, allowing the user to use the same power supply in different countries. Tellos ISQ Buddy Charger ## 1.4.2 Basic principle and functionality The Tellos ISQ Buddy instrument is a hand-held, battery-driven device for measuring the relative stability of a dental implant. A small pin "ISQ peg" is attached to the dental implant by a screw-connection, with the Peg Driver. The pin has a small magnet incorporated into its top. The instrument is held towards the ISQ Peg, and sends short magnetic pulses that bring the pin into vibration. After a pulse has been sent, the instrument measures the vibration by sampling the signal from the alternating magnetic field that follows from the vibrating pin. The frequency of the signal is determined by the instrument and is presented as an "ISQvalue", 1 to 100, where a higher number means higher stability. The measurement takes about 1 second. {5}------------------------------------------------ Image /page/5/Picture/2 description: In the image, there is a gray background with two gray objects. The object on the right is a cylinder with a rounded end and a black ring around the base. The object on the left is a smaller cylinder with a screw thread at the bottom and a notched top. ## Instrument tip held towards an ISQ Peg ## 1.4.3 Technical details The instrument consists of a microcontroller and circuits to send the magnetic pulses, to receive the measurement signal, and to present the measurement value. A circuit for battery-charging is also included. Two 2-digit LED displays, one on each side of the instrument, show the measurement value and also communicate possible error codes and software id number at start-up. One operating key is used to turn the instrument on and off. The electronics are contained in a plastic body, which is sealed except for the instrument which has a charging connector. The plastic body is made from PC/ABS plastic except for the tip, which is made from PEEK. No part of the instrument is intended to contact the patient; however there can be unintentional contact with the tip of the instrument. The instrument is battery-driven and contains re-chargeable NiMh-batteries can be charged during use, but it should not be attached while measuring due to the risk of power line interference making it impossible to measure. For safety, a charger complying with IEC 60601-1 is used. The charger connector is of a type that does not allow other chargers to be connected, thereby eliminating the risk of the wrong charger being used. #### 1.4.4 Materials used Instrument body: PC/ABS Instrument tip: PEEK (USP VI) Instrument seal: Silicone (USP VI) Instrument key: Silicone (USP VI) ISQ Peg Driver: Stainless steel, ASTM F899 ISQ Peg: Titanium grade 5, ASTM F136 ## 1.5 Indications for Use Tellos ISQ Buddy is indicated for use in measuring the stability of dental implants in the oral cavity and the maxillofacial region. {6}------------------------------------------------ # 1.6 Comparison and differences to the Predicate Device The instrument functions the same way as the predicate device regarding the measurement principle and technology used. The differences are in the handling; Tellos ISQ Buddy is a hand-held instrument while the predicate device consists of two parts; the instrument and the measurement probe. Tellos ISQ Buddy has no memory to store the measurement values; the predicate device has a memory that stores the measurements. The predicate device also has an inbuilt clock timer, and a computer connection for transferring measurement values. Tellos ISQ Buddy has no timer or computer connection. The lack of these features (memory, timer, data transfer) is not considered to be an inconvenience for the user. Instead, it decreases the risk of mixing up values with each other. | | 510(k) submission | Predicate Device | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device name | Tellos ISQ Buddy | Osstell ISQ | | Company name | Tellos Medical AB | Osstell AB | | Product Code/Class | EKX / Class I | EKX / Class I | | Regulation number | 872.4200 | 872.4200 | | Indications for use | The device is indicated for use in<br>measuring the stability of implants in<br>the oral cavity and the maxillofacial<br>region.<br>The differences in Indications for use<br>are based on clarification of the use of<br>the device with dental implants and the<br>anatomical region appropriate for<br>dental implants. This clarification is<br>within the indications for use of the<br>primary predicate and does not change<br>the intended use of the device. | The device is indicated for use in<br>measuring the stability of implants in<br>the oral cavity and craniofacial region. | | Target population | Same as predicate device | Patients with one or more dental<br>implants | | Anatomical site | Same as predicate device | Oral cavity or craniofacial region | | Usage location | Same as predicate device | Dentists office or hospital | | Energy used/delivered | Same as predicate device | No energy is intended to be delivered.<br>A small amount of energy could reach<br>the dental implant from the self-<br>vibrating measurement pin. | | Technology | Same as predicate device | A microcontroller sends electric pulses<br>to a coil in the instrument tip. As a<br>consequence, magnetic pulses are<br>emitted that affect the pin connected<br>to the implant. The pin then starts to<br>vibrate with its resonance frequency.<br>Vibration creates an alternating<br>magnetic field which is being picked up<br>by another coil in the instrument tip.<br>The electrical signal from the receiving<br>coil is analyzed and the frequency is<br>determined. The Frequency is<br>presented on the display as an "ISQ-<br>value" | | Measurement output | Same as predicate device | Osstell ISQ presents the resonance<br>frequency of the ISQ peg as an ISQ<br>number, 1-100. The ISQ number is | | | | calculated from the resonance | | | | frequency. | | Operation | The operating key is pushed and the | Any key is pushed and the | | | instrument is held towards the | measurement probe is held towards | | | attached ISQ peg. The instrument then | the attached SmartPeg. The instrument | | | presents the ISQ value. | then presents the ISQ value. | | System components | Tellos ISQ Buddy instrument, ISQ Peg, | Osstell ISQ instrument, measurement | | | ISQ Peg Driver and instrument charger. | probe, SmartPeg and instrument | | | | charger. | | Power, weight & size | 3VA, 0.1 Kg, 200 x 30 mm | 8 VA, 0.4 Kg, 195 x 20 x 45 mm | | Materials used | Instrument; PC/ABS and PEEK. | Instrument: Not available | | | Gasket and operating key: Silicone | Measurement probe: Not available | | | ISQ Peg Driver: Stainless steel | SmartPeg driver: Not Available | | | ISQ Peg: Titanium | SmartPeg: Aluminum | | Instrument memory | Tellos ISQ Buddy has no data memory. | Osstell ISQ has a memory for storing | | | The instrument displays the | measurement values. | | | measurement value after the | | | | measurement. The memory is not a | | | | necessary feature and the absence of a | | | | memory decreases the risk of mixing up | | | | values between different implants | | | | during a patient session. | | | Instrument setup-menu | No setup-menu is needed for Tellos ISQ | Instrument has a setup-menu for | | | Buddy. The instrument has one | various instrument parameters such as | | | operating key and no parameters to | display contrast and computer | | | change. | connection. | | Data transfer | Since Tellos ISQ Buddy has no memory, | Osstell ISQ has a cable attachment to a | | | there are no data to transfer. This is not | PC computer, for transferring data. | | | a necessary feature, and the absence of | | | | a data transfer function decreases the | | | | risk of mixing up values between | | | | different implants during a patient | | | | session. | | | Clock Timer | Since Tellos ISQ Buddy has no memory, | Osstell ISQ has a built-in clock timer. | | | there is no need for a clock timer. | | | Number of operating keys | Tellos ISQ Buddy has one operating key, | Osstell ISQ has 5 operating keys, for | | | used for turning on and off the | working the setup-menu and for | | | instrument. Since the instrument has | navigating the instrument memory. | | | no memory or setup-menu, not more | | | | than one key is needed. With one key, | | | | the instrument is more intuitive and | | | | easier to use, which leaves less room | | | | for user errors compared to the | | | | predicate device. | | | Display | Tellos ISQ Buddy has two LED-displays; | Osstell ISQ has one LCD display on the | | | one on each side of the instrument for | instrument. | | | easy reading. | | | Measurement pins | Tellos ISQ Buddy uses the Osstell | Osstell ISQ uses disposable aluminum | | | SmartPegs, or corresponding Tellos | pins, "SmartPegs". | | | pins, "ISQ Pegs" from titanium. | | | Electrical safety | Same as predicate device | Osstell ISQ is designed to the standard | | | | IEC 60601-1 Medical Electrical | | | | Fauinment…