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.

To be used for dental drilling and other dental drive applications.

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.

AI/ML Overview

The medical device in question is the Phytron EndoStepper 1, a microcontroller-controlled dental handpiece based on a stepper motor.

1. Table of Acceptance Criteria and Reported Device Performance

Feature	Acceptance Criteria (Predicate Device: TCM Endo)	Reported Device Performance (EndoStepper®)
Intended Use	Micro-processor controlled dental handpiece with controlled electric motor torque; dental drilling applications	Micro-processor controlled dental handpiece with controlled electric motor torque; general dental drilling applications
Input Voltage	115 V / 230 V, 50/60 Hz	115 V / 230 V, 50/60 Hz
Materials	Electronic parts and components	Same
Indications for Use	Dental drilling applications, especially endodontic drilling	Same
Torque Control	Yes	Yes
Torque Control Precision	1 Ncm	Better than 0.1 Ncm
System Reaction in case of Blocking	Reverse motion with undefined angle of rotation and continuation without dentist intervention	Motor stops within several degrees of rotation; dentist can decide how to proceed

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not detail a specific test set, its sample size, or data provenance for performance evaluation. The comparison appears to be based on an analysis of device specifications and characteristics against a predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the use of experts to establish ground truth for a test set. This type of submission relies on technical specifications and comparison to an already cleared predicate device.

4. Adjudication Method for the Test Set

As there is no explicit test set discussed in terms of human performance or expert review, an adjudication method is not described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for the EndoStepper 1. The submission focuses on device characteristics and substantial equivalence to a predicate.

6. Standalone (Algorithm Only) Performance Study

The EndoStepper 1 is a physical dental handpiece system; therefore, the concept of an "algorithm only" or standalone performance study in the context of AI is not applicable to this device. Its performance is inherent to its mechanical and electronic design.

7. Type of Ground Truth Used

The "ground truth" for the EndoStepper 1's performance claims is primarily based on engineering specifications and measurements of its physical characteristics (e.g., torque control, speed, blocking reaction) as compared to the stated specifications of the predicate device. Compliance with recognized standards (IEC, ISO) also serves as a form of performance validation.

8. Sample Size for the Training Set

As this device is a physical electromechanical system and not an AI/machine learning algorithm that requires training data, the concept of a "training set" and its sample size is not applicable.

9. How Ground Truth for the Training Set Was Established

Since there is no training set for an AI algorithm, the question of how its ground truth was established is not applicable.

Summary

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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

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VII. Device Description:

VIII. Intended Use:

The EndoStepper 1 system is a microcontroller controlled dental handpiece based on a stepper motor.

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.

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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.

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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®	SubstantialEquivalence
Intended use	a, micro-processorcontrolled dental handpiecewith controlled electricmotor torqueb, dental drillingapplications	micro-processorcontrolled dental hand-piece with controlledelectric motor torqueb, general dental drillingapplications	YES
Input voltage	115 V / 230 V50/60 Hz	115 V / 230 V50/60 Hz	YES
Materials	Electronic parts andcomponents	same	YES
Indications foruse	Dental drilling applications,especially endodonticdrilling	same	YES
Torque control	yes	yes	YES
Torque controlprecision	1 Ncm	better than 0.1 Ncm	YES / Better
System reactionin case ofblocking	Reverse motion withundefined angle of rotationand continuation withoutdentist intervention	motor stops within severaldegrees of rotation;dentist can decide byhimself how to proceed	YES / Better

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X. Overview over Standards Applied During the Development

Device Safety:	IEC 601-1, IEC 601-1-2, IEC-1-4 (as equivalent and fullycorresponding to the European standards EN 60601-1,EN 60601-1-2, EN 60601-1-4)
Device Effectiveness:	Appendix I of the European Directive for Medical Devices(MDD)
EMC Compatibility:	IEC 601-1-2 with reference to EN 55011, EN 61000-4-2,EN 61000-4-3, EN 61000-4-4, EN 61000-4-5; conformityhas been certified during an independent examination bya competent body.
Drive Parameters:	ISO 3630-1, ISO 3630-2 ISO 3630-3 and manufacturer'sspecification if not covered by the standard

Coupling Dimensions: ISO 3964

: ·

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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

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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

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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](https://510k.innolitics.com/device/K973185)

Prescription Use ✓
(Per 21 CFR 801.109)

Over-The-Counter Use __

(Optional Formal 1.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.