RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:

K970088 · Richard Wolf Medical Instruments Corp. · HWE · Apr 7, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K970088
• Device Name: RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1:
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HWE · General, Plastic Surgery
• Decision Date: Apr 7, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4820
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Riwo Drive System is used for arthroscopic procedures in human joints. It is also used for sinus procedures in the nasal cavity. The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders. Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common: 1. Blades are for removal of soft tissue and cartilage 2. Abraders for bones and bony structures The use of the system is reserved to surgeons with special training in the respective procedures.

Device Story

Riwo Drive Generator powers and controls motor handles for arthroscopic and sinus surgery; system includes generator, motor handle, footswitch, and rotary blades/abraders. Surgeon operates footswitch to control motor direction (forward, reverse, oscillation), speed, and torque. Motor handle features clamping chuck for blades/abraders and integrated suction control. Generator provides digital speed display, automatic torque/speed adaptation based on connected handle, and alarms for overload or connection errors. Used in clinical settings by trained surgeons to resect soft tissue, cartilage, or bone. System benefits include precise tissue removal and ergonomic control during minimally invasive procedures.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC601-1, IEC601-1-2, UL2601-1) and life-cycle testing confirming motor handle functionality for >200 steam sterilization cycles.

Technological Characteristics

DC-powered surgical motor system. Features: 4 selectable speed settings, digital speed display, automatic torque/speed adaptation, acoustic/optical alarms. Motor handle: 360-degree chuck, variable suction control, watertight housing, BF insulation (IEC601-1). Rotary blades/abraders: sterile, single-use, color-coded. Sterilization: steam sterilization for motor handle/cable.

Indications for Use

Indicated for arthroscopic procedures in human joints and sinus procedures in the nasal cavity for the removal of soft tissue, cartilage, and bone/bony structures.

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

• Intra-articulated arthro power system 2161 (K871250)
• Surgical Drive System EP-1
• Shaver System SE 5
• Drive System Apex

Submission Summary (Full Text)

{0}

k970088

Richard Wolf Medical Instruments Corporation

# 510(k) Summary of Safety and Effectiveness

APR - 7 1997

353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

| Submitter: | | | Date of Preparation: December 28, 1996 | |
| --- | --- | --- | --- | --- |
| Company / Institution name: RICHARD WOLF MEDICAL INSTRUMENTS CORP. | | | FDA establishment registration number: 14 184 79 | |
| Division name (if applicable): N.A. | | | Phone number (include area code): [phone] | |
| Street address: 353 Corporate Woods Parkway | | | FAX number (include area code): [phone] | |
| City: Vernon Hills | State/Province: Illinois | Country: USA | | ZIP / Postal Code: 60061 |
| Contact name: Mr. Robert L. Casarsa | | | | |
| Contact title: Quality Assurance Manager | | | | |
| Product Information: | | | | |
| Trade name: Riwo Drive Generator and Accessories | | Model number: 2302, motor handle 8561.121 and various rotary blades and abraders (see section 1: Submitted devices) | | |
| Common name: Drive Generator | | Classification name: Instrument, surgical, orthopedic, DC-powered motor and accessory/attachment | | |
| Information on devices to which substantial equivalence is claimed: | | | | |
| 510(k) Number | Trade or proprietary or model name | | Manufacturer | |
| 1 K871250 | 1 Intra-articulated arthro power system 2161 | | 1 Richard Wolf M.I.C. | |
| 2 | 2 Surgical Drive System EP-1 | | 2 Dyonics | |
| 3 | 3 Shaver System SE 5 | | 3 Stryker | |
| 4 | 4 Drive System Apex | | 4 Linvatec | |

# 1.0 Description

The RIWO Drive Generator is built to efficiently drive and control different motor handles. The handle functions are controlled by a footswitch.

The Motor Handle is a tubular system with a motor and clamping chuck for driving rotary blades and abraders. A suction pump is connected to the built-in suction tube and the suction stream can be controlled by a valve.

The rotary blades consist of a hollow, fenestrated tube, containing a rotating two-edged cylindrical blade or an abrader that spins within the hollow tube.

RICHARD WOLF

{1}

Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

## 2.0 Intended Use

The Riwo Drive System is used for arthroscopic procedures in human joints.
It is also used for sinus procedures in the nasal cavity.

The Riwo Drive generator with motor handle serves to drive WOLF blades or abraders.

Depending on the indication, different styles of blades are attached to the motor handle. Two basic styles are most common:

1. Blades are for removal of soft tissue and cartilage
2. Abraders for bones and bony structures

The use of the system is reserved to surgeons with special training in the respective procedures.

## 3.0 Technological Characteristics

### Riwo Drive Generator:

- Four user specified, selectable settings for the speed
- continuous digital display of desired and actual speed
- automatic adaptation of speed range and maximal torque (current) for three different motor handles, display of speed range with LED
- acoustic and optical alarm for: overload of motor, incorrect cable connection or interrupted cable
- footswitch to control motion forward, reverse, oscillation (3 changes per second), speed and speed range by the surgeon, automatically stored.

### Motor handle:

- 360° rotation of clamping chuck for various cutting position
- variable suction control with one-hand operation
- watertight housing and cable, for steam sterilization
- lightweight design
- detachable cable
- BF insulation according to IEC601-1

### Rotary Blades and Abraders:

- atraumatic design
- colored coding
- sterile, for single use
- various diameters and tip designs

## 4.0 Substantial Equivalence

The submitted devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz.

RICHARD WOLF
(Revised 3/11/97)

{2}

Richard Wolf Medical Instruments Corporation
353 Corporate Woods Parkway
Vernon Hills, Illinois 60061
Telephone: [phone]
Fax: [phone]

## 5.0 Performance Data

The Riwo Drive Generator 2302 with Footswitch 2030.221 and with the Motor handles 8561.121 and 8562.111 were tested according to the specified standards IEC601-1, IEC601-1-2 and UL2601-1. A life-cycle test shows that the function of the motor handle can be guaranteed for more than 200 steam sterilization cycles when using the fractional method.

## 6.0 Clinical Tests

No clinical tests performed.

## 7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the Instruction manual.

By: Robert L. Casarsa
Quality Assurance Manager
Date: Jan 8, 97

RICHARD WOLF