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

Device Description

The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures. 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. The endoscopes are made of stainless steel and are comprised of a combined optical (rod-lens system) and illumination system.

AI/ML Overview

The provided text describes a 510(k) submission for the Olympus Neuro Endoscope. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving performance against those criteria as would be expected for a novel device.

Therefore, many of the requested sections cannot be filled from the provided text because the submission explicitly states "Not applicable" for clinical tests and discusses non-clinical tests only in the context of voluntary safety standards.

Here's the breakdown based on the provided information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Expected/Regulatory Standard)	Reported Device Performance (Summary from submission)
Compliance with IEC-601-1 (safety standard)	Meets the requirements of IEC-601-1.
Substantial equivalence to predicate devices	Similar in intended use, design, and construction to predicate devices (Codman Gaso Hopkins Diagnostic Telescope, K#923555 and Neuro Navigational Neuroview 700R Rigid Scope: K#955037). No significant changes in intended use, method of operation, material, or design that could affect safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states "Discussion of Clinical Tests Performed: Not applicable." Therefore, no test set for clinical performance was used, and no data provenance information is available.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical test set was described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical test set was described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a rigid endoscope, not an AI-assisted diagnostic device. No MRMC study was mentioned.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This is a rigid endoscope, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable as no clinical test set requiring ground truth was described. The "ground truth" for this submission focuses on compliance with safety standards and substantial equivalence to predicate devices based on design and intended use.

8. The sample size for the training set

Not applicable. There is no mention of an algorithm or machine learning model that would require a training set.

9. How the ground truth for the training set was established

Not applicable. There is no mention of an algorithm or machine learning model that would require ground truth for a training set.

Summary

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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.

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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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.

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 (800) 638-2041 or (301) 443-6597 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:

. . .

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

Regulation Number and Section

§ 882.1480 Neurological endoscope.

(a)
Identification. A neurological endoscope is an instrument with a light source used to view the inside of the ventricles of the brain.(b)
Classification. Class II (performance standards).