(330 days)
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No
The description focuses on mechanical and electrical components and safety features, with no mention of AI/ML terms or functionalities.
Yes
The device is used for high-speed cutting, sawing, drilling, and manipulation of soft tissue and bone in various surgical procedures, which are therapeutic actions.
No
The Servotronic EC 100 System is described as a surgical tool for cutting, sawing, drilling, and manipulation of tissue and bone, not for diagnosis. Its components are operational tools (control unit, micromotor, handpieces), and its indicated use is in microsurgical procedures.
No
The device description clearly outlines multiple hardware components including a control unit, micromotor, foot switch, and various hand pieces and tools. It also requires an AC current and has integrated safety and monitoring functions related to hardware performance.
Based on the provided information, the Servotronic EC 100 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "high speed cutting, sawing, drilling, and manipulation of soft tissue and bone in microsurgical procedures." This describes a surgical tool used directly on a patient's body.
- Device Description: The description details a system with a control unit, motor, foot switch, and various surgical hand pieces and tools. These are all components of a surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze samples (like blood, urine, tissue, etc.) in vitro (outside the living body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are specifically designed for testing biological samples to provide diagnostic information. The Servotronic EC 100 System is a surgical instrument used for physical manipulation of tissue and bone during surgery.
N/A
Intended Use / Indications for 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.
Product codes
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Device Description
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
soft tissue and bone
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Aescular Microtron System, Jedmed Fisch Drill System
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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510(k) SUMMARY FOR MEDICON eG'S SERVOTRONIC EC 100
962087
Submitter's Name, Address, Telephone Number, And Contact Person
Michael Vogel Medicon eG P.O. Box 4455 D-78509 Tuttlingen Germany
Howard M. Holstein Contact: Hogan & Hartson (202) 637-5813 Phone: (202) 637-5910 Facsimile:
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 Aescular 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
1
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.