KSEA GAAB NEUROENDOSCOPE AND CHAVANTES-ZAAMORANO NEUROENDOSCOPE SETS by KARL STORZ ENDOSCOPY

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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the provided 510(k) summary and FDA clearance letter, it's important to note that this submission is for a medical device (neuroendoscopes), not a software or AI-based diagnostic device. Therefore, many of the typical acceptance criteria and study components associated with AI performance metrics (like sensitivity, specificity, F1-scores, or human reader improvement with AI assistance) are not applicable here.

The core of this 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific diagnostic performance against quantifiable metrics.

Here's a breakdown of the requested information based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

Given this is a 510(k) for a physical surgical instrument, the "acceptance criteria" are not reported in terms of diagnostic performance metrics like those for AI software. Instead, they relate to safety, functionality, and equivalence to predicate devices.

Acceptance Criteria Category	Reported Device Performance
Intended 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. This matches the intended use of predicate devices as implied by substantial equivalence.
Device Description	Manually operated surgical devices. Body contact portions composed of surgical grade stainless steel and medical grade silicone. These materials have a long history of biocompatibility for human use. This description is consistent with common surgical instruments and predicate devices.
Biocompatibility	Materials (surgical grade stainless steel, medical grade silicone) are commonly used in medical devices and have a long history of biocompatibility for human use. While no specific test results are provided in this summary, the claim implies meeting established biocompatibility standards.
Substantial Equivalence	"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." This is the primary "acceptance criterion" for 510(k) submissions; the device is deemed safe and effective if it is substantially equivalent to a legally marketed predicate device.
Regulatory Class	Class II (Product Code: GWG - Neurological Endoscope)
Prescription Use	X (indicated by the checkbox on the Indications for Use page)

2. Sample Size Used for the Test Set and Data Provenance

Not applicable to this 510(k) submission. No "test set" in the context of diagnostic data (images, signals, etc.) was used because this is a physical medical device. The submission relies on design specifications, material biocompatibility, and comparison to predicate devices, not clinical data from a "test set" in the AI sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no "test set" with ground truth in the context of diagnostic accuracy for this device. Ground truth for surgical instrument design generally relies on engineering standards, material science, and clinical surgical practice, not expert labeling of data.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication was used.

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 physical neuroendoscope, not an AI diagnostic tool. No MRMC study was performed, and there is no AI component to improve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For a physical device like a neuroendoscope, the "ground truth" for its safety and effectiveness is established through:

Engineering design principles and specifications: Ensuring its physical construction, optical clarity (for viewing), and functional mechanics meet required standards.
Material biocompatibility: Chemical and biological testing of materials to ensure they are safe for human contact, typically against ISO standards.
Clinical experience with predicate devices: The "ground truth" that predicate devices are safe and effective in their intended use forms the basis for demonstrating substantial equivalence.
Regulatory standards: Compliance with general controls and recognized standards for medical devices.

No "expert consensus," "pathology," or specific "outcomes data" in the typical AI diagnostic sense would be explicitly outlined in this type of 510(k) summary for a manually operated surgical instrument.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device is not an AI algorithm and does not have a "training set" or corresponding ground truth establishment process.

Summary

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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 DriveCulver City, CA 90230(310) 410-2769
Contact:	Kevin KennanSenior 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

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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:
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(Optional Format 1-2-96)
000000

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).