OLYMPUS NEURO ENDOSCOPE

K971340 · Olympus Optical, Co. · GWG · Jul 29, 1998 · Neurology

Device Facts

• Record ID: K971340
• Device Name: OLYMPUS NEURO ENDOSCOPE
• Applicant: Olympus Optical, Co.
• Product Code: GWG · Neurology
• Decision Date: Jul 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

Device Story

Olympus Neuro Endoscope is a rigid endoscope used for visualization of brain ventricles and performance of diagnostic/therapeutic procedures. Device consists of stainless steel telescope with combined rod-lens optical system and illumination system. Used in clinical settings by physicians. Provides direct visualization to assist in neurosurgical decision-making and intervention. Sold nonsterile; requires cleaning and sterilization before use. Optional trocar accessory available.

Clinical Evidence

No clinical data. Bench testing performed in accordance with FDA's 1993 Reviewer Guidance, specifically IEC-601-1.

Technological Characteristics

Rigid endoscope; stainless steel construction; rod-lens optical system; integrated illumination system. Complies with IEC-601-1 safety standards. Reusable; requires manual cleaning and sterilization.

Indications for Use

Indicated for viewing brain ventricles and performing diagnostic and therapeutic procedures in patients requiring neuroendoscopic intervention.

Regulatory Classification

Identification

A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.

Predicate Devices

• Codman Gaso Hopkins Diagnostic Telescope (K923555)
• Neuro Navigational Neuroview 700R Rigid Scope (K955037)

Submission Summary (Full Text)

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Exhibit #1 Page 1 of 3

## 510(K) SUMMARY

1971340

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 5l0(k) number is:K#971340

- 1. Submitter's Identification:
Prepared By: Mr. Yoshihito Shimizu Product Development Department Endoscope Division Olympus Optical Co., Ltd. 2954 Ishikawa-cho Hachioji-shi, Tokyo, Japan

Date Summary Prepared:

September 8, 1997

- Name of the Device: 2a.
Olympus Neuro Endoscope

- ವಾ Common/Unusual Name:
Neuro Rigid Endoscope

#### 3. Predicate Device Information:

- a) Codman Gaso Hopkins Diagnostic Telescope, K#923555
- b) Neuro Navigational Neuroview 700R Rigid Scope: K#955037

#### 4. Device Description:

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

1

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The telescopes and recommended ancillary equipment will be sold nonsterile and can be reused after proper cleaning and sterilization before usage as outlined in the instruction manual.

# Standard Set

The Olympus Neuro Endoscope standard set includes the following:

Telescope Instruction Manual

# Optional Accessory

Trocar for Neuro Endoscopes

The endoscopes are made of stainless steel and are comprised of a combined optical (rod-lens system) and illumination system.

#### 5. Intended Use:

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

#### ଚ. Comparison to Predicate Devices:

The intended use of the Olympus Neuro Endoscope is similar to the currently marketed Codman Neuro Endoscope which was cleared for marketing under 510(k) #K923555. Both endoscopes are similar in intended use, design and construction.

### Diseussion of Non-Clinical Tests Performed for Determination of Substantial 7. Equivalence are as follows:

Testing has been performed in accordance with FDA's Reviewer Guidance, 1993, DCRND, specifically IEC-601-1.

.

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### Discussion of Clinical Tests Performed: 8.

Not applicable

### 9. Conclusions:

The Olympus Neuro Endoscope is designed, manufactured and tested in compliance with voluntary safety standards. It meets the requirements of IEC-601-1.

When compared to the predicate devices, the Olympus Neuro Endoscope does not incorprate any significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, connected by a flowing ribbon-like shape.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 9 1998

Olympus Optical Company, Ltd. c/o Ms. Susan D. Goldstein-Falk MDI Consultants 55 Northern Boulevard, Suite 410 Great Neck, New York 11021

Re: K971340 Trade Name: Olympus Neuro Endoscope Regulatory Class: II Product Code: GWG Dated: May 28, 1998 Received: June 1, 1998

Dear Ms. Goldstein-Falk:

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 - Ms. Susan D. Goldstein-Falk

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,

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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EXHIBIT A Page 1 of 1

k971340 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Olympus Neuro Endoscope

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s Indications For Use:

. . .

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The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|----------------------------------------------------------|
| Prescription Use | X |
| (Per 21 CFR8O1.109) | OR Over-The-Counter Use. ______ (Optional Format 1-2-96) |
| (Division Sign-Off) | |
| Division of General Restorative Devices | |
| 510(k) Number | K971340 |