(64 days)
Not Found
Not Found
No
The description focuses on manual operation and fiber-optic technology, with no mention of AI, ML, or related concepts.
No
The device is described as being for "viewing the ventricles and cavities of the brain," which indicates a diagnostic or observational purpose rather than a therapeutic one. It does not perform any treatment or therapy.
No
The device is used for "viewing the ventricles and cavities of the brain," which is an observational function, but the description explicitly states it is a "surgical device." Diagnostic devices are used to identify a condition or disease, not to perform surgical procedures.
No
The device description explicitly states it is a "manually operated surgical device" and a "flexible fiberoptic telescope," indicating it is a physical hardware device utilizing fiber-optic technology.
Based on the provided information, the Neuro-Fiberscope is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "viewing the ventricles and cavities of the brain." This is a direct visualization of internal body structures, not the examination of specimens in vitro (outside the body).
- Device Description: The description details a "flexible fiberoptic telescope" used as a "manually operated surgical device." This aligns with a surgical instrument used for direct observation during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. The Neuro-Fiberscope's function is to provide visual access to internal anatomy during surgery.
N/A
Intended Use / Indications for Use
The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.
Product codes (comma separated list FDA assigned to the subject device)
GWG
Device Description
The KSEA Neuro-Fiberscope is a manually operated surgical devices. The KSEA Neuro-Fiberscope is a flexible fiberoptic telescope which utilizes fiber-optic technology. The body contact portions of the KSEA Neuro-Fiberscope are composed of medical grade polyurethane.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles and cavities 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The word "STORZ" is written in large, bold, white letters at the top of the logo. Below that, the words "Karl Storz Endoscopy" are written in a smaller, less bold font. The background of the image is black and has a grainy texture.
JUN 3
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Flexible Fiberscope |
| | Trade Name: (optional)
Karl Storz Neuro-Fiberscope |
Indication: The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.
Device Description: The KSEA Neuro-Fiberscope is a manually operated surgical devices. The KSEA Neuro-Fiberscope is a flexible fiberoptic telescope which utilizes fiber-optic technology. The body contact portions of the KSEA Neuro-Fiberscope are composed of medical grade polyurethane.
Substantial Equivalence: The KSEA Neuro-Fiberscope is substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Neuro-Fiberscope and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
Kevin Kennan
Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head in profile, facing right, with three parallel lines forming the body and wing. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Kevin A. Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230
Re: K991069 Trade Name: KSEA Neuro-Fiberscope Regulatory Class: II Product Code: GWG Dated: March 30, 1999 Received: March 31, 1999
Dear Mr. Kennan:
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.
2
Page 2 - Mr. Kevin A. Kennan
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
3
Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo consists of the word "STORZ" in a stylized font, with the letter "O" replaced by a target symbol. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The logo is in white against a black background.
510(k) Number (if known): 991069
Device Name: KSEA Neuro-Fiberscope
Indications for Use: The Neuro-Fiberscope is indicated for use in viewing the ventricles and cavities of the brain.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
, ****************************************************************************************************************************************************************************
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign | |
|---|---|
| Division | |
| 510(k) Number | K991069 |
| Prescription Use:
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------- | --- |
OR Over-The-Counter Use:
(Optional Format 1-2-96)(Optional Format 1-2-96)