(475 days)
K#923555, K#955037
Not Found
No
The description focuses on the physical components and intended use of a rigid endoscope, with no mention of AI, ML, or advanced image processing beyond basic optical viewing. The performance studies section also does not indicate any AI/ML-specific testing.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "performing diagnostic and therapeutic procedures."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "performing diagnostic and therapeutic procedures."
No
The device description explicitly states the device is a rigid endoscope made of stainless steel with an optical and illumination system, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device function: The Olympus Neuro Endoscopes are used inside the body (in vivo) to directly visualize the ventricles of the brain and perform procedures. They are a surgical/diagnostic tool, not a test performed on a sample.
- Intended Use: The intended use clearly states "viewing the ventricles of the brain and performing diagnostic and therapeutic procedures," which are actions performed directly on the patient.
Therefore, based on the provided information, the Olympus Neuro Endoscopes are not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus Neuro Endoscopes are rigid endoscopes indicated for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
Product codes
GWG
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Tests: Testing has been performed in accordance with FDA's Reviewer Guidance, 1993, DCRND, specifically IEC-601-1.
Clinical Tests Performed: Not applicable
Key Metrics
Not Found
Predicate Device(s)
K#923555, K#955037
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
-
- Submitter's Identification:
Prepared By: Mr. Yoshihito Shimizu Product Development Department Endoscope Division Olympus Optical Co., Ltd. 2954 Ishikawa-cho Hachioji-shi, Tokyo, Japan
- Submitter's Identification:
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
1
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.
.
2
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.
3
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.
4
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
پ ۽
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.
··.
. . . . .
(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 |