SERVOTRONIC EC100 SYSTEM

K962087 · Medicon, Inc. · HWE · Apr 23, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K962087
• Device Name: SERVOTRONIC EC100 SYSTEM
• Applicant: Medicon, Inc.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Apr 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, and plastic surgery.

Device Story

Servotronic EC 100 is a microprocessor-controlled microsurgical system for cutting, sawing, drilling, and manipulating soft tissue and bone. System components include a control unit with an integrated irrigation pump, a micromotor, a foot switch, and various hand pieces (e.g., oscillating saws, mucotome, screwing instruments). The operator sets micromotor speed, gear ratios, and irrigation flow rate via the console. The foot switch controls motor start/stop, rotation direction, and irrigation. The system uses a saline solution for internal/external irrigation. Used in OR settings by surgeons. The microprocessor manages motor electronics and safety monitoring (temperature, current limits, speed-dependent rotation changes).

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes control unit, micromotor, foot switch, and hand pieces. Power: 110V or 230/240V AC. Features integrated safety monitoring for temperature, current, and speed-dependent rotation stops. Irrigation: pump-driven saline delivery. Microprocessor-controlled.

Indications for Use

Indicated for patients undergoing microsurgical procedures requiring high-speed cutting, sawing, drilling, or manipulation of soft tissue and bone, including maxillofacial, ENT, orthopedic, and plastic surgery.

Regulatory Classification

Identification

Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.

Predicate Devices

• Aesculap Microtron System
• Jedmed Fisch Drill System

Submission Summary (Full Text)

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APR 23 1997
k962087

# 510(k) SUMMARY FOR MEDICON eG'S SERVOTRONIC EC 100

## Submitter's Name, Address, Telephone Number, And Contact Person

Michael Vogel
Medicon eG
P.O. Box 4455
D-78509 Tuttlingen
Germany

Contact: Howard M. Holstein
Hogan & Hartson
Phone: [phone]
Facsimile: [phone]

## Date Prepared

March 3, 1997

## Name of the Devices

Servotronic EC 100

## Common or Usual Name

Microprocessor-Controlled Microsurgical System

## Classification Name

Surgical Instrument Motors and Accessories/Attachments (21 C.F.R. § 878.4820)

## Predicate Devices

Aesculap Microtron System and Jedmed Fisch Drill System

## Intended Use

The Servotronic EC 100 System is intended to be used for high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures including maxillofacial surgery, ENT surgery, orthopedic surgery, and plastic surgery.

## Technological Characteristics

The Servotronic EC 100 System's primary components are: (1) a control unit with irrigation pump; (2) a micromotor; (3) a foot switch for remote control; and (4) various hand pieces and tools. The hand pieces to be used with the Servotronic EC 100 System include the following: (1) Sachse Micro Oscillating Saw; (2) Sachse

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Micro Osseoscalpel Saw; (3) Micro Compass Saw; (4) Steinhauser Mucotome; (5) Micro Sagittal Saw; and (6) Hauenstein Angular Screwing Instrument.

The Servotronic EC 100 requires an AC current of 110V or 230/240V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is connected to the back of the control unit. The Servotronic EC 100 has integrated safety and monitoring functions for excess temperature, current limitations within the main supply circuit and within the motor electronics, and a speed-dependent stop used during a change of direction.

## Principles of Operation

Operation of the Servotronic EC 100 System is accomplished by setting different micromotor speeds, irrigation pump flow rate, and transmission/reduction ratios. Various hand pieces can be attached to the micromotor depending upon the procedure. Tools, such as saw blades and drills, are attached to the hand pieces. The micromotor transmits power to the hand pieces to be used in the manipulation of body tissue during microsurgical procedures.

The console houses a microprocessor and an irrigation pump motor. The buttons for setting the micromotor speed, transmission/reduction gear ratio, and irrigation pump flow rate are located on the front panel of the console. The switches that are used to start and stop the irrigation pump and the motor(s) and change the direction of rotation of the hand piece are located on the foot switch.

A standard saline solution bottle is attached to the bottle holder attached to the console with tubing connected to an irrigation pump. The tubing is then attached to a port on the micromotor and hand piece assembly. The saline solution flows through the tubing at the rate set by the operator to provide internal and external irrigation.

## Summary of the Basis for the Finding of Substantial Equivalence

The Servotronics EC 100 and the predicate devices have the same intended use and substantially equivalent principles of operation. The device is operated by setting the motor speed, transmission/reduction gear ratio, and the irrigation pump flow rate. The console and foot pedal have buttons to operate the hand piece and irrigation pump. The Servotronic and predicate device microprocessors implement the commands from operation of the foot pedal or console. Although there are some minor differences in their some characteristics, namely the range of micromotor speeds and the quantity of handpiece gear ratios, these differences do not present any new issues of safety or effectiveness. Thus, the Servotronic EC 100 is substantially equivalent to the predicate devices.

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