OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT

K982133 · The Olympus Optical Co. · HRX · Oct 22, 1998 · Orthopedic

Device Facts

• Record ID: K982133
• Device Name: OLYMPUS ENDOSCOPIC SYSTEM LUMBAR HERNIA DISCECTOMY AND ITS ANCILLARY EQUIPMENT
• Applicant: The Olympus Optical Co.
• Product Code: HRX · Orthopedic
• Decision Date: Oct 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.

Device Story

System consists of endoscopic visualization components and manual surgical instruments for lumbar hernia discectomy. Inputs include optical images of lumbar disc/paravertebral tissue captured via telescope. Device transforms inputs into visual output for surgeon. Used in surgical settings by physicians. Components include guide needles, dilators, mandolins, flexible/side sheaths, pushers, telescopes, light guide adaptors, and surgical holder adaptors. System aids surgeon in locating and removing vertebral bone and nucleus material. Benefits include minimally invasive visualization and access to surgical site.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes endoscope (arthroscope), manual surgical hand instruments (XELSPAS series), light guide adaptors, and surgical holder adaptors. Materials are standard medical-grade materials identical to those used in previously cleared Olympus devices. Connectivity is via standard light systems and surgical holders. Sterilization method not specified.

Indications for Use

Indicated for patients requiring visualization of lumbar discs, lumbar herniated disc material, and lumbar paravertebral tissue, and for the search and removal of vertebral bone and nucleus material.

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

• Sofamor Danek's MED MicroEndoscopic Discectomy System
• Sofamor Danek's INCL Endoscopic System (K955471)
• Rigid Arthroscope (K950501)
• MICRO-ENDO Instruments (K950130)

Reference Devices

• Olympus Endoscope (K951354)
• Olympus surgical holder device (K960068)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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Olympus Optical Company, Ltd. Mr. James R. Veale Vice President, Regulatory Services c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K982133 Trade Name: Olympus Endoscopic Systems for Lumbar Hernia Discectomy Regulatory Class: II Product Code: HRX and KOG Dated: August 27, 1998 Received: August 28, 1998

Dear Mr. Veale:

This letter corrects our substantially equivalent letter of October 22, 1998 regarding the regulatory classification of your device, which is changed from HRZ to HRX. This device is regulated under 21 CFR 888.1100, Arthroscope and 21 CFR 876.1500, endoscope.

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

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Page 2 - Mr. James R. Veale

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,

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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982133 510(k) Number (if known): J

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

Olympus Endoscopic System for Lumbar Hernia Discectomy and its ancillary equipment are intended for visualizing lumbar disc, lumbar herniated disc material and lumbar paravertebral tissue, and aiding in search and removal of vertebral bone and nucleus material.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sion-Off of General Re 1982133 510(k) Numbe

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

Optional Format (1-2-96)

CONFIDENTIAL

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OCT 2 2 1998

K982133

# 510(k) Summary for Olympus Endoscopic System for Lumbar Hernia Discectomy

#### SPONSOR/APPLICANT NAME, ADDRESS 1.

Olympus Optical Co. Ltd. Endoscope Division 2951 Ishikawa-Cho Hachioji, Tokyo 192-8507 Japan

Contact Person: Shigeyoshi Terawaki 0426-42-5101 Telephone: Facsimile: 0426-42-9979

DATE OF SUMMARY PREPARATION: June 16, 1998

- Endoscopic System for Lumbar Hernia 2. TRADE/PROPRIETARY NAME: Discectomy and its Ancillary Equipment Endoscopic System for Lumbar Hernia COMMON/USUAL NAME: Discectomy Arthroscope and Accessories CLASSIFICATION NAME:
- IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE TO WHICH 3. EQUIVALENCE IS BEING CLAIMED:

Sofamor Danek's MED MicroEndoscopic Discectomy System, Sofamor Danek's INCL Endoscopic System (K955471), Rigid Arthroscope (K950501), and MICRO-ENDO Instruments (K950130).

#### 4. DEVICE DESCRIPTION

The Olympus Endoscopic System for Lumbar Hernia Discectorny and Accessories consist of the following components:

- . Initial Placement Instruments

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| Instrument | Function |
|-----------------|--------------------------------------------------------------|
| Guide Needle | Guide to target site |
| Dilators | Dilation of tissues |
| Mandolin | Guide of Flexible Sheath, and Dissection of tissue on lamina |
| Flexible Sheath | Delivery of Endoscope |
| Pusher | Delivery of Flexible Sheath |
| Side Sheath | Delivery of Endoscope |

- Olympus XELSPAS Series Manual Surgical Hand Instruments .
- Telescope to view operative site .
- Light Guide Adaptor an adaptor to be used with commercially . available light systems to provide illumination
- Surgical Holder Adaptor an adaptor to be used to attach the endoscope . to Olympus surgical holder device (510(k) K960068)

### 5. INTENDED USE

The Olympus Endoscopic System for Lumbar Hernia Discectomy is intended for visualizing lumbar disc, lumbar herniated disc material, and lumbar paravertebral tissue and for aiding in search and removal of vertebral bone and nucleus material.

## ર. STATEMENT OF HOW TECHNOLOGICAL CHARACTERISTICS COMPARE TO PREDICATE

The Olympus Endoscopic System for Lumbar Hernia Discectomy is substantially equivalent to Sofamor Danek's MED MicroEndoscopic Discectomy System in technological characteristics. Both include an endoscope (arthroscope) for visualizing lumbar discs, lumbar herniated disc material, and lumbar paravertebral tissue. The proposed Olympus Endoscope is also substantially equivalent to the Olympus Endoscope described in 510(k) K951354, in optical characteristics and

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design. Both systems offer several surgical instruments for aiding in search and removal of vertebral bone and nucleus materials of manufacture of the Olympus system are all standard material used in medical products. Additionally, the materials in the proposed Olympus Endoscopic System for Lumbar Hernia Discectomy are identical to those cleared in legally marketed Olympus devices.

Additionally, the components of the Olympus Endoscopic System for Lumbar Hernia Discectomy are substantially equivalent in design and dimensions to other Olympus devices.