RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351

K984521 · Richard Wolf Medical Instruments Corp. · EQL · Mar 17, 1999 · Ear, Nose, Throat

Device Facts

• Record ID: K984521
• Device Name: RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: EQL · Ear, Nose, Throat
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4750
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions. Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

Device Story

RIWO Drive System 2302 is an electrosurgical drill system for endoscopic procedures. System comprises a drive generator and modular motor handles. Surgeon operates system via footswitch to control rotary blade/abrader motion (forward, reverse, oscillation). Generator provides power, speed control, and torque management for motor handles; handles feature suction/irrigation adapters for tissue evacuation. Used in OR settings by surgeons for tissue/bone resection. Output is mechanical rotation of surgical accessories; visual/acoustic alarms alert surgeon to motor overload or connection errors. System facilitates minimally invasive tissue removal, potentially reducing patient trauma.

Clinical Evidence

No clinical data. Bench testing performed according to IEC601-1 and UL2601-1 standards.

Technological Characteristics

Electrosurgical drill system. Features: four speed settings, digital speed display, automatic torque/speed adaptation for different handles, footswitch control (forward/reverse/oscillation). Motor handles: modular, 360-degree rotation, irrigation control, watertight for steam sterilization, BF insulation per IEC601-1. Connectivity: removable cable between handle and generator.

Indications for Use

Indicated for endoscopic tissue removal in arthroscopy (meniscus resection, soft tissue removal, osseous tissue abrasion), thoracic surgery (hematoma removal), sinus surgery (polyp/cyst removal), and spine surgery (micro disectomy, spinal endoscopy).

Regulatory Classification

Identification

A laryngostroboscope is a device that is intended to allow observation of glottic action during phonation. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. The light and microphone that amplifies acoustic signals from the glottic area may or may not contact the patient.

Predicate Devices

• RIWO Drive Generator with Footswitch, Motor handles and single use rotary blades and abraders (K970088)
• Hummer ENT micro debrdier (K972584)
• XPS Straightshot Microresector (K973499)
• Karl Storz Paranasal Sinus Shaver (K953370)

Submission Summary (Full Text)

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3/17/99

E

# 1984521

| 510(k) Summary of Safety and Effectiveness | | RICHARD WOLF<br>MEDICAL INSTRUMENTS CORPORATION |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | Date of Preparation:<br>December 18, 1998 |
| Division name (if applicable): | N.A. | FDA establishment registration number:<br>14 184 79 |
| Street address: | 353 Corporate Woods Parkway | Phone number (include area code):<br>[phone] |
| City: | Vernon Hills | FAX number (include area code):<br>[phone] |
| State/Province: | Illinois | ZIP / Postal Code:<br>60061 |
| Country: | USA | |
| Contact name: | Mr. Robert L. Casarsa | |
| Contact title: | Quality Assurance Manager | |
| Product Information: | | |
| Trade name: | RIWO Drive System 2302 with small motor handles | Model number:<br>2302, 8563.111, 8563.351, 8563.351 / .451 / .551 |
| Common name: | Drive Generator, Motor Handles | Classification name:<br>ENT electric surgical drill |
| Information on devices to which substantial equivalence is claimed: | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
| 1 K970088 | 1 RIWO Drive Generator with Footswitch, Motor handles and single use rotary blades and abraders | 1 Richard Wolf |
| 2 K972584 | 2 Hummer ENT micro debrdier | 2 Stryker |
| 3 K973499 | 3 XPS Straightshot Microresector | 3 Xomed |
| 4 K953370 | 4 Karl Storz Paranasal Sinus Shaver | 4 Karl Storz |

#### 1.0 Description

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

The motor handle is a tubular system. The modular system consists of:

- motor unit
- · motor housing
- · suction adapter (8563.111) And/Or suction /irrigation adapter (8563.311)

The suction and irrigation stream are controlled by slide valves. The motor handle is connected to the RIWO Drive 2302 by a removable cable.

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#### 2.0 Intended Use

The RIWO Drive with motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

#### Technological Characteristics 3.0

## RIWO Drive Generator

- four speed settings, user selected .
- continuous digital display of selected and true speed .
- automatic adaptation of speed range and maximum torque (current) for three different . motor handles, display of speed range with LED
- . acoustic and optical alarm for, 1) motor overload, 2) incorrect cable connection or interrupted cable
- footswitch, operated by surgeon, to control motion forward, reverse, oscillation (3 changes . per second), speed and speed range automatically stored.

## Motor Handle

.

- 360° rotation of clamping chuck for various cutting positions (8561.121 and 8562.111) .
- modular construction (8563.111/.311) .
- variable irrigation control with one-hand operation (8563.331) .
- watertight housing and motor unit, for steam sterilization .
- . lightweight design
- . detachable cable
- . BF insulation according to IEC601-1

#### 4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices sold by Richard Wolf and sold by Stryker, Xomed, or Karl Storz.

#### 5.0 Performance Data

The RIWO Drive Generator with the motor handles were tested according to the standards IEC601-1 and UL2601-1.

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#### 6.0 Clinical Tests

Clinical tests performed were not performed.

#### 7.0 Conclusions Drawn

These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.

By: Robert L. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Dec 17, 98

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

Robert L. Casarsa Manager of Quality Assurance Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, IL, 60061

Re:

K984521 RIWO Drive Small Motor Handle Dated: December 18, 1999 Received: December 21, 1999 Regulatory class: II 21 CFR 874.4250/Procode: 77 EQL 21 CFR 878.4820/Procode: 79 GEY

Dear Mr. Casarsa:

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 legally marketed predicate 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If vour device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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**Indications for Use**

ag 4521 510(k) Number (if known):

Device Name: ___Small Motor Handles for RIWO Drive System 2302

### Intended Use:

The RIWO Drive with small motor handle is used for driving Wolf rotary blades and abraders for the removal of pathological tissue during endoscopic interventions.

Simultaneous suction (evacuation) allows continuous removal of ablated tissue, with motor handle 8563.311 additionally supported by irrigation.

## Indications and Fields of Application:

For therapy with endoscopic accessories:

- · in arthroscopy, e.g. for meniscus resection, removal of soft tissue, as well as intra-articular severing or abrasion of osseous tissue, e.g. ACL or shoulder procedures.
- thoracic surgery, e.g. for removing hematomas .
- sinus surgery (ENT), e.g. for removing polyps or cysts.In cases, bone structures are . removed or trimmed.
- spine surgery (arthroscopic micro disectomy (AMD), spinal endoscopsy) e.g. removal of . pathological tissue.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

David C. Syverson

(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number

Prescription Use
Per 21 CFR 801.109

ર - I

Over-The Counter_