YEUNG ENDOSCOPIC SPINE SYSTEM

K973405 · Richard Wolf Medical Instruments Corp. · HRX · Mar 13, 1998 · Orthopedic

Device Facts

• Record ID: K973405
• Device Name: YEUNG ENDOSCOPIC SPINE SYSTEM
• Applicant: Richard Wolf Medical Instruments Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Mar 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.

Device Story

The Yeung Endoscopic Spine System is a surgical instrument set used for lumbar discectomy. The system includes a telescope, forceps, sheath, obturator, adapter, trephine, punch, scissors, dilator, and cannula. It utilizes a multichannel flow integrated system and working channels to provide visualization of spinal anatomy and pathology. The device is operated by a surgeon in a clinical/surgical setting to visualize and remove herniated discs. By providing clear visualization and access to the lumbar spine, the system facilitates minimally invasive disc removal, potentially reducing patient trauma compared to traditional open procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The system consists of a telescope, forceps, sheath, obturator, adapter, trephine, punch, scissors, dilator, and cannula. It features a multichannel flow integrated system and working channels for visualization. It is a mechanical surgical instrument set; no software or electronic algorithms are described.

Indications for Use

Indicated for visualization and removal of herniated lumbar discs in patients requiring endoscopic spinal surgery.

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

• MED Microendoscopy Disectomy System (K930191)
• Kambin Arthroscopic Microdiscetomy System (K922519)

Reference Devices

• Richard Wolf 8986.401 Operative Scope
• Sofamor Danek MED Endoscope
• Smith & Nephew Richards AMD VideoDiscoscope

Submission Summary (Full Text)

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353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: \$47.913.1143 Fax: [phone]

K9734QS

MAR 1 3 1008

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RICHARD MEDICAL INSTRUMENTS CORP

510(k) Summary of Safety and Effectiveness

| Submitter: | |
|----------------------------------------|----------------------------------------|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country: | USA |
| ZIP / Postal Code: | 60061 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
| Date of Preparation: | January 12, 1998 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | [phone] |
| FAX number (include area code): | [phone] |

| Product Information: | |
|----------------------|-----------------------------|
| Trade name: | Discoscope Set |
| Model number: | |
| Common name: | Spinal Arthroscopic Set |
| Classification name: | Arthroscope and Accessories |

Information on devices to which substantial equivalence is claimed:

| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---------------|-------------------------------------------|---------------|
| K930191 | MED Microendoscopy Disectomy System | Sofamor Danek |
| K922519 | Kambin Arthroscopic Microdiscetomy System | Dyonics |
| 3 | 3 | 3 |
| 4 | 4 | 4 |
| 5 | 5 | 5 |
| 6 | 6 | 6 |
| 7 | 7 | 7 |
| 8 | 8 | 8 |

## 1.0 Description

The set consists of a telescope, forceps, sheath, obturator, adapter, tephine, punch, scissors, dilator, cannula, and caps. It is designed to be compatible with other available systems, but with increased emphasis on superior quality imaging. The scope system is designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.

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#### Intended Use 2.0

Intended Use
The Yeung Endoscopic Spine System is indicated for the visualization and removal of herniated discs in the lumbar region.

## Technological Characteristics 3.0

- T echnological Characteristics
Designed to allow for clear visualization of spinal anatomy and pathology through its unique multichannel flow integrated system and working channels.
### Substantial Equivalence 4.0

Substantial Equivalence

- Richard Wolf 8986.401 Operative Scope .
- Sofamor Danek MED Endoscope .
- Smith & Nephew Richards AMD VideoDiscoscope .

All devices have the same intended use.

#### 5.0 Performance Data

None

## Clinical Tests 6.0 None

#### 7.0 Conclusions Drawn

Concellations branni the instruction manual.

By: Ret. Casana

Robert L. Casarsa Quality Assurance Manager

Date: Jan 9, 1998

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 1998

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

Re : K973405 Yeung Endoscopic Spine System Trade Name: Regulatory Class: II Product Code: HRX Dated: January 9, 1998 Received: January 13, 1998

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, 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 Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 requlation (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,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and
Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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510(k) Number (if known):_ - 10(K) Nambo

Indications for Use:

## Indications for Use:

Indications for USC.
The Yeung Endoscopic Spine System is indicated for the visualization and removal of hemiated discs in the lumbar region.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

luation (ODF)

(Division \$ign-Off)
Division of General Botas D

Division of General Restorative Devices
510(k) Number K67340

Prescription Use
Per CFR 21 CFR 801.109

()ver-The-Counter Use_________________________________________________________________________________________________________________________________________________________