(86 days)
Not Found
No
The summary describes manually operated surgical devices made of standard medical materials, with no mention of AI, ML, image processing, or any computational capabilities.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "performing diagnostic and therapeutic procedures."
Yes
The intended use explicitly states "viewing the ventricles of the brain and performing diagnostic and therapeutic procedures," indicating its use for diagnosis.
No
The device description explicitly states it is a manually operated surgical device composed of surgical grade stainless steel and medical grade silicone, indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "viewing the ventricles of the brain and performing diagnostic and therapeutic procedures." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The device is described as "manually operated surgical devices" composed of surgical grade materials. This aligns with a surgical instrument, not a device used for analyzing biological samples.
- Anatomical Site: The anatomical site is the "ventricles of the brain," which is an internal part of the body being directly accessed during surgery. IVDs typically analyze samples like blood, urine, tissue, etc.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used during a surgical procedure on the patient's body.
N/A
Intended Use / Indications for Use
The KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets are intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
Product codes
GWG
Device Description
The Karl Storz GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are manually operated surgical devices. The body contact portions of the KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are composed of surgical grade stainless steel and medical grade silicone, which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
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
qualified surgeons
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "Karl Storz Endoscopy" in a smaller font. The background of the image is black.
Nir 6 1998 510(k) SUMMARY OF SAFETY AND EFFEC
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) 410-2769 | | |
|------------------------|---------------------------------------------------------------------------------------------------------------|--|--|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist | | |
| Device Identification: | Common Name:
Neuroendoscope | | |
| | Trade Name: (optional)
Karl Storz GAAB Neuroendoscope and CHAVANTES-
ZAMORANO Neuro-endoscope Sets | | |
Indication: The KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets are intended for use by qualified surgeons for viewing the ventricles of the brain and performing diagnostic and therapeutic procedures.
Device Description: The Karl Storz GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are manually operated surgical devices. The body contact portions of the KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuro-endoscope Sets are composed of surgical grade stainless steel and medical grade silicone, which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
The Karl Storz GAAB Neuroendoscope and CHAVANTES-Substantial Equivalence: ZAMORANO Neuro-endoscope Sets are substantially equivalent to the predicate devices since the basic features and intended uses are the same.
Signed:
Surj Kennan
Kevin Kennan
Senior Regulatory Affairs Specialist
000086
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 6 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy 600 Corporate Pointe Culver City, California 90230-7600
Re: K982837
Trade Name: KSEA GAAB Neuroendoscope and CHAVANTES-ZAAMORANO Neuroendoscope
Regulatory Class: II Product Code: GWG Dated: August 07, 1998 Received: August 12, 1998
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 (OS) 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.
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.
Image /page/1/Picture/12 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird-like figure.
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Page 2 - Mr. Kevin Kennan
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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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white text on a black background. The word "STORZ" is in large, bold letters, and the words "Karl Storz Endoscopy" are in smaller letters below. The logo is simple and modern.
510(k) Number (if known): K 982837
Device Name: KSEA GAAB Neuroendoscope and CHAVANTES-ZAMORANO Neuroendoscope Sets
Indications for Use: These instruments are manually operated surgical devices intended for use by qualified surgeons 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)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | 14982837 |
| Prescription Use:
| (Per 21 CFR 801.109) | X | OR Over-The-Counter Use: | |
|---|---|---|---|
| ------------------------------------------- | --- | -------------------------- | -- |
(Optional Format 1-2-96)
000000