The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

Device Description

The Karl Storz CMOS Video Rhino-Laryngoscope System includes a flexible endoscope and a monitor. The rhino-laryngoscope consists of an integrated light located in the handle. The light is transmitted thought the fiber optic bundles and illuminates the anatomy under visualization. A new Storz specific CMOS imaging sensor located at the distal tip of the endoscope shaft which is inserted into the body cavities. The captured video signal is then transferred to the C-MAC monitor for display purposes. The Karl Storz CMOS Video Rhino-laryngoscope is a Class II device under 21 CFR874.4760, Rhino-Laryngoscope and accessories.

AI/ML Overview

The provided 510(k) summary (K103467) describes a medical device, the Karl Storz CMOS Video Rhino-Laryngoscope System, and its substantial equivalence to a predicate device. However, it does not contain the level of detail requested regarding specific acceptance criteria, a dedicated clinical study proving performance against those criteria, or information related to AI integration.

This submission is for a traditional medical device (an endoscope system), not an AI/ML-powered device. Therefore, many of the questions regarding AI-specific evaluation metrics (e.g., effect size of human readers with AI assistance, standalone algorithm performance, training set details) are not applicable to this 510(k) document.

Here's a breakdown of the information that is available and what is absent from the provided text according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining specific quantitative acceptance criteria for this device's performance against predefined metrics.

Criteria Category / Characteristic	Acceptance Criteria (Implicit)	Reported Device Performance
Intended Use	Must be equivalent to predicate: Endoscopic diagnosis within nasal lumens and airway anatomy, providing visualization via a video monitor.	"The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System ... is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor." (Matches predicate's indicated use).
Technological Characteristics	Must be substantially equivalent for safety and effectiveness, despite minor differences.	Comparison table provided, highlighting differences (CMOS vs. CCD imaging, LED vs. Xenon illumination) but asserting these "raise no issue of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices."
Safety Testing	Compliance with relevant FDA recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, ISO 10993).	"The Karl Storz Flexible Video Rhino-Laryngoscope system has been successfully tested for its functions, performance and safety as per FDA recognized standards." (No specific results or acceptance criteria for each standard are detailed).
Performance Testing	Compliance with ISO 8600.	"The performance of the device is tested by complying with ISO 8600." (No specific results or acceptance criteria for ISO 8600 are detailed).
Biocompatibility	Compliance with relevant ISO 10993 standards.	"Testing has been conducted as per ... ISO 10993 to address the safety aspect of the device." (No specific results or acceptance criteria for each standard are detailed).
Reprocessing	Successful cleaning and high-level disinfection validated according to AAMI TIR 12:2010, AAMI TIR 30:2003, AAMI 7:1999, AAMI E 1837, and FDA draft guidance.	"The cleaning and high-level disinfection studies were perform in accordance with AAMI TIR 12:2010...", etc. (Implies successful validation, but no specific acceptance criteria or results are provided).

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided. This 510(k) submission describes non-clinical performance data (testing to standards) and reprocessing validation, not a clinical study involving a "test set" of patient data in the typical sense for AI/ML devices. Therefore, there's no mention of a test set sample size or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided. As there's no clinical "test set" and ground truth establishment in the context of device performance, this information is not present. The device is for visualization, and its performance is assessed against engineering and cleaning standards.

4. Adjudication method for the test set

Not Applicable / Not Provided. No clinical test set.

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 traditional medical device (endoscope), not an AI-assisted device. Therefore, no MRMC study with AI assistance was performed or described.

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

Not Applicable. This is a traditional medical device, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is based on compliance with established engineering and biocompatibility standards (e.g., IEC 60601 series, ISO 10993, ISO 8600) and reprocessing validation protocols (AAMI TIRs, FDA draft guidance). It's not clinical "ground truth" derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not Applicable / Not Provided. This is not an AI/ML device, so there is no concept of a "training set" in the context of machine learning.

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

Not Applicable / Not Provided. As there is no training set for an AI/ML algorithm, this question is not relevant.

In summary: K103467 is a 510(k) submission for a conventional video rhinolaryngoscope system. The approval is based on demonstrating substantial equivalence to a predicate device and compliance with applicable safety, performance, and reprocessing standards, rather than a clinical study evaluating diagnostic accuracy or AI performance. The detailed questions about AI performance metrics, clinical test sets, ground truth establishment, and training data are not addressed in this type of submission.

Summary

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K103467

JUN 2 8 2012

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.

Karl Storz Endoscopy-America, Inc. Applicant: 2151 E. Grand Avenue El Segundo. CA 90245

Contact: Shiven Gandhi Regulatory Affairs Associate Telephone: (424) 218-8322 FAX: (424) 218-8519 E-mail:shiven.gandhi@karlstorz.com

Date Prepared: 14th June 2012

Device Identification:

Common Name: Video Rhino-Laryngoscope System

Trade Name: CMOS Video Rhino-Laryngoscope System

Predicate Device: KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM. MODEL11101SERIES (K072387)

Indication: The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

Device Description:

Substantial Equivalence:

The Karl Storz CMOS Video Rhino-Laryngoscope System is substantially equivalent to the predicate device (K072387) since the intended uses and the technological characteristics are the same. The minor differences between the Karl Storz CMOS Video Rhino-Laryngoscope System and predicate device raise no issue of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.

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	Subject Device	Predicate Device (K072387)
Applicant	Karl Storz Endoscopy America,Inc.	Karl Storz Endoscopy America,Inc.
Device Name	Karl Storz CMOS Video Rhino-Laryngoscope	Karl Storz Video Rhino-Laryngoscope
Type of Device	Videoscope System	Videoscope System
Indication for use	For endoscopic diagnosiswithin the nasal lumens andairway anatomy.	For endoscopic diagnosiswithin the nasal lumens andairway anatomy.
Imaging Sensor	CMOS	CCD
Illumination source	LED	Xenon
Working Length	Same	Same
Shaft Diameter	Same	Same
Data Storage	Yes	Yes

Technological Characteristics Comparison Table

Non-Clinical Performance Data:

The Karl Storz Flexible Video Rhino-Laryngoscope system has been successfully tested for its functions, performance and safety as per FDA recognized standards. Testing has been conducted as per IEC 60601-1, IEC 60601-1-2, IEC 60601-2-18, and ISO 10993 to address the safety aspect of the device. The performance of the device is tested by complying with ISO 8600.

Reprocessing:

The CMOS Video Rhino-Laryngoscope is cleaned using manual cleaning with enzymatic detergent and is subjected to high level disinfection using CIDEX OPA. No methods of sterilization are validated for the CMOS Video Rhino-Laryngoscope. The cleaning and highlevel disinfection studies were perform in accordance with AAMI TIR 12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR 30:2003 (A compendium of processes, materials. test methods, and acceptance criteria for cleaning reusable medical devices), AAMI 7: 1999 (Chemical Sterilants and High-Level Sterilants: A Guide to Selection and Use), AAMI E 1837 (Standard Test Method to Determine Efficacy of Disinfection Processes for Reusable Medical Devices) and FDA draft guidance for Processing Medical devices in Healthcare settings (dated: May 2,2011)

Conclusion :

Hence the CMOS Video Rhino-Laryngoscope system is as safe and as effective to the predicate device in terms of its intended use and technological characteristics.

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Image /page/2/Picture/1 description: The image is a circular seal for the Department of Health & Human Services USA. The seal features the department's emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged around the emblem in a circular fashion.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 2 8 2012

Karl Storz Endoscopy America Inc. c/o Mr. Shiven Gandhi, Regulatory Affairs Associate 2151 E. Grand Avenue El Segundo, CA 90245

Re: K103467

Trade/Device Name: Karl Storz CMOS Video Rhino Laryngoscope System Regulation Number: 21 CFR 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: June 14, 2012 Received: June 15, 2012

Dear Mr. Gandhi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, attresses, and include requirements for annual registration, listing of general volurely provincitice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adultieration. Teasoneter ODTE assess that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to additional controls. Existing major regulations affecting your device can be may be subject to additional vehicles, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Dr over and that your device complies with other requirements of the Act that I DA has made a associations administered by other Federal agencies. You must or any I carated and the regirements, including, but not limited to: registration and listing (21 comply with an the rece brequirements on 301); medical device reporting of medical CI'N I all 807), labeling (21 OFF 803); good manufacturing practice requirements as set

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Page 2 - Mr. Gandhi

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

R. A. Khan, M.D., f

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indication for Use

510(k) Number (if known):

Device Name: Karl Storz CMOS Video Rhino-Laryngoscope System

Indication for use: The KARL STORZ CMOS Flexible Video Rhino-Laryngoscope System may only be used by persons with an appropriate medical qualification and who are acquainted with the rhino/laryngoscopic technique. The endoscope is used for endoscopic diagnosis within the nasal lumens and airway anatomy, and is intended to provide visualization via a video monitor.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR ·

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel C Cluff

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K103467

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.