RIWO DRIVE GENERATOR

K984304 · Richard Wolf Medical Instruments Corp. · HRX · Aug 12, 1999 · Orthopedic

Device Facts

• Record ID: K984304
• Device Name: RIWO DRIVE GENERATOR
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Aug 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.

Device Story

Power Cutters and Burrs consist of hollow, fenestrated tubes containing rotating two-edged cylindrical blades or abraders. Driven by RIWO Drive Generator motor handle; used during endoscopic procedures to remove, sever, or abrade tissue. Operated by physicians in clinical settings. Device provides mechanical tissue resection; benefits include precise tissue removal during minimally invasive surgery.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Atraumatic design; color-coded; multiple diameters and tip designs. Available as reusable or sterile single-use models. Mechanical actuation via motor handle.

Indications for Use

Indicated for patients undergoing endoscopic procedures including arthroscopy (meniscus resection, soft tissue removal, intra-articular bone severing/abrading for ACL or shoulder procedures), sinus surgery (polyp removal), and spine surgery (arthroscopic micro disectomy, spinal endoscopy). Contraindicated when patient clinical condition or specific case significantly increases risk of motorized instrumentation.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• RIWO Drive Generator w/ Footswitch, Motor Handles & Single Use Rotary Blades & Abraders (K970088)

Submission Summary (Full Text)

{0}------------------------------------------------

1 2 1999

P.04 1 847 913 0924 .> >> < < < proruce woods l'arkway Vernon Hills, Illinois 60061 Phone: 847,913.1413 Fax: [phone]

K9 84304

RICHARD V MEDICAL INSTRUMENTS CORP

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# 510(k) Summary of Safety and Effectiveness

| Submitter: | | Date of Preparation: | August 10, 1999 | | | | |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------------|----------|-----|--------------------|-------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. | FDA establishment registration number: | 1418479 | | | | |
| 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: | Power Cutters and Burrs for RIWO Drive System | Model number: | Reusable: 8564, 8566, 8567, 8568, 8569, 8571<br>Single Use: 4567, 4568, 4569, 4571 | | | | |
| Common name: | Cutters and Burrs | Classification name: | Cutters and Burrs | | | | |
| Information on devices to which substantial equivalence is claimed: | | | | | | | |
| 510(k) Number | Trade or proprietary or model name | Manufacturer | | | | | |
| 1 K970088 | RIWO Drive Generator w/ Footswitch, Motor Handles & Single Use Rotary Blades & Abraders | 1 Richard Wolf GmbH | | | | | |
| 2 | 2 | 2 | | | | | |

#### 1.0 Description

The power Cutters and Burrs consist of a hollow, fenestrated tube, containing a rotating twoedged cylindrical blade (cutter) or an abrader (burr) that spins within the hollow tube. They are driven by a motor handle.

#### 2.0 Intended Use

The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.

{1}------------------------------------------------

## Indication and field of application:

For therapy with endoscopic accessories:

- in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intral articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
- . in sinus surgery, e.g. for removal of polyps
- . in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)

## 3.0 Technological Characteristics

- · atraumatic design
- color coding .
- sterile, for single use models .
- . multiple diameters and tip designs

## 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 devices sold by Richard Wolf.

### 5.0 Performance Data

No known performance standard exists.

## 6.0 Clinical Tests

No clinical tests were performed.

#### 7.0 Conclusions Drawn

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

By: Ret. Casasa

Robert L. Casarsa Quality Assurance Manager

Date: Aug 10, 1999

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1.2 1999

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

Re: K984304 Trade Name: RIWO Drive Generator Regulatory Class: II Product Code: HRX Dated: May 14, 1999 Received: May 17, 1999

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 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 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 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 requirement, 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.

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#### Page 2 - Mr. Robert L. Casarsa

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/dsmamain.html".

Sincerely yours,

f
Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Dastanatine Davise

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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fors

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K984304

Device Name:__________________________________________________________________________________________________________________________________________________________________ Single Use or Reusable Power Cutters and Burrs

#### Intended Use:

The RIWO Drive Generator with motor handle serves to drive Wolf Power Cutters and Burrs to remove tissue during endoscopic procedures.

### Indication and field of application:

For therapy with endoscopic accessories:

- . in arthroscopy, e.g., for resection of meniscus, for removal of soft tissue, as well as for intra-articular severing or abrading of bone tissue, e.g., ACL or shoulder procedures
- . in sinus surgery, e.g. for removal of polyps
- . in spine surgery (arthroscopic mirco disectomy (AMD), spinal endsoscopy)

#### Contraindications:

Contraindications are given in cases where the clinical condition of the patient or the specific case increases significantly the risk to the patient if motorized instrumentation is applied. This might result in an absolute or a relative contraindication.

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K984304

Prescription Use
Per 21 CFR 801.109

OR

Over-The Counter_

Revised 8/10/99