ENDOSTEPPER 1

{0}------------------------------------------------ K993188 phytron # 510(k) SUMMARY per 21 CFR 807.92(a)(2) - Phytron-Elektronik GmbH l. Submitter: Industriestraße 12 D-82194 Gröbenzell Germany Contact Person: Dr. Cornelius Rieß +49-8142-503-159 Telephone: +49-8142-503-190 Fax: E-Mail: riess@phytron.de - II. Date: 510 (k) Summary has been prepared on August 19th, 1999 # III. Reason for 510(k) submission: It is intended to put this device into commercial distribution for the first time. #### IV. Trade Name: EndoStepper® 1 #### V. Classification Name: Dental Handpiece and Accessories (21 C.F.R. § 872.4200 ) #### VI. Classification: The device is a general control of class I according to 21 CFR 872.4200. ## VI. Predicate Device: - TCM 3000/Endo manufacturer: Nouvag AG St. Gallerstraße 23-25 CH-9403 Goldbach Switzerland {1}------------------------------------------------ ## VII. Device Description: The EndoStepper System is an electronically controlled drive for dental drilling applications. The system consists of (1) a console type housing containing the electronics with a LCD display and a keypad, (2) a foot pedal unit, (3) a drive unit to be used with (4) a protective cover and a commercially available contraangle. #### VIII. Intended Use: The EndoStepper 1 system is a microcontroller controlled dental handpiece based on a stepper motor. It's intended use is for dental drilling applications and other dental treatments, where a smooth and slowly rotating drive is required, e.g. the for polishing dental surfaces, caries removal and root canal preparation. The EndoStepper 1 system is to be used by practising dentists only. ## IX. Technological Characteristics: The EndoStepper 1 system consists of a console type desktop housing with the electronics, a motor with a protective cover, a foot pedal and an electric cord and plug. The system can be used with commercially available contra-angles with an internal gear reduction ratio of 1:1. The EndoStepper uses a stepper motor as the driving element. This special motor type has the advantage, that delivered torque as well as speed and angle of rotation can easily be controlled. Therefore the EndoStepper delivers a precisely controlled torque together at a precisely controlled speed of rotation, and, in special operation modes, also a well defined maximum angle of rotation can be quaranteed. {2}------------------------------------------------ #### Principles of Operation After switching on the device, self-tests of the system hardware are performed. After the power-on self test procedure, the system display a menu text on the LCD display. The dentist can now select the dental instrument (e.g. drill) he is going to use by means of the menu driven selection. The operator selects now the manufacturer, the drill series he wants to use and then the special drill identified by its diameter and color code. These selections are made by means of the keypad or - alternatively - by means of the foot pedal. Every selection can be controlled on the LCD display in plain text. The drive unit is locked and will not start to operate until the operator selected one special drill type. After the selection, the motor can be started by means of the foot pedal. The motor will then operate the drill with the speed of rotation and the torque limit set as defined by the drill manufacturer itself, as these values are programmed into the device. The operator has only to select the appropriate parameter record, and this selection is made safe and effective by means of a plain text LCD display. No other parameter settings are necessary, such yielding a safety never seen before while selecting an instrument. The drive unit is based on a stepper motor. This is a special type of a synchonous motor, which will develop a rotational torque directly dependend on the motor current. Because the motor current is controlled in the electronics, the motor will deliver only torque values up to this well defined limit value. If this limit is exceeded, e.g. due to friction on the dental instrument in a root canal, the motor stops immediately due to its physical structure. The subtle root canal instrument is therefore effectively protected and not exposed to mechanical overload. {3}------------------------------------------------ # Overview over Substantial Equivalence Comparison The following table shows the substantial equivalence between the proposed EndoStepper 1 system and the predicate device, the TCM Endo (FDA-No. K981679). | Feature | TCM Endo | EndoStepper® | Substantial<br>Equivalence | |-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|----------------------------| | Intended use | a, micro-processor<br>controlled dental handpiece<br>with controlled electric<br>motor torque<br>b, dental drilling<br>applications | micro-processor<br>controlled dental hand-<br>piece with controlled<br>electric motor torque<br>b, general dental drilling<br>applications | YES | | Input voltage | 115 V / 230 V<br>50/60 Hz | 115 V / 230 V<br>50/60 Hz | YES | | Materials | Electronic parts and<br>components | same | YES | | Indications for<br>use | Dental drilling applications,<br>especially endodontic<br>drilling | same | YES | | Torque control | yes | yes | YES | | Torque control<br>precision | 1 Ncm | better than 0.1 Ncm | YES / Better | | System reaction<br>in case of<br>blocking | Reverse motion with<br>undefined angle of rotation<br>and continuation without<br>dentist intervention | motor stops within several<br>degrees of rotation;<br>dentist can decide by<br>himself how to proceed | YES / Better | {4}------------------------------------------------ # X. Overview over Standards Applied During the Development | Device Safety: | IEC 601-1, IEC 601-1-2, IEC-1-4 (as equivalent and fully<br>corresponding to the European standards EN 60601-1,<br>EN 60601-1-2, EN 60601-1-4) | |-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Effectiveness: | Appendix I of the European Directive for Medical Devices<br>(MDD) | | EMC Compatibility: | IEC 601-1-2 with reference to EN 55011, EN 61000-4-2,<br>EN 61000-4-3, EN 61000-4-4, EN 61000-4-5; conformity<br>has been certified during an independent examination by<br>a competent body. | | Drive Parameters: | ISO 3630-1, ISO 3630-2 ISO 3630-3 and manufacturer's<br>specification if not covered by the standard | Coupling Dimensions: ISO 3964 · : · {5}------------------------------------------------ Image /page/5/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection. SEP 2 8 1999 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Phytron-Elektronik GmbH C/O Ms. Carole Stamp TPR Project manager TUV Product Service, Incorporated 1775 Old Highway 8 New Brighton, Minnesota 55112-1891 Re : K993188 Trade Name: EndoStepper® 1 Regulatory Class: I Product Code: EKX September 23, 1999 Dated: Received: September 23, 1999 Dear Ms. Stamp We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your {6}------------------------------------------------ Page 2 - Ms. Stamp premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ K99318 Attachment 1b Page 1 of 510(k) Number (if known): EndoStepper 1 Device Name: Indications For Use: To be used for dental drilling and other dental drive applications. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number `K973185` Prescription Use ✓ (Per 21 CFR 801.109) OR Over-The-Counter Use *_*_ (Optional Formal 1.