The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.

Device Description

The CMOS Video-Rhino-Laryngoscope System includes two main components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM) and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible with two KARL STORZ CCUs: C-HUB and C-MAC.

AI/ML Overview

The document provided is a 510(k) Summary for the KARL STORZ CMOS Video-Rhino-Laryngoscope System (K182186). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving specific clinical performance or to meet acceptance criteria through a clinical study in the way an AI/ML device would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and multi-reader multi-case studies is not applicable in this context.

This document focuses on comparing the new device's technical specifications and non-clinical performance data (electrical safety, EMC, bench testing, biocompatibility, reprocessing validation) against recognized standards and its predicate device to show that it is substantially equivalent and does not raise new questions of safety or effectiveness.

Here's a summary of the provided information, addressing the spirit of your request where possible, but highlighting the absence of specific clinical performance acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

This type of request for an AI/ML device would typically involve metrics like sensitivity, specificity, AUC, F1-score, etc., with predefined thresholds. For this traditional medical device, the "acceptance criteria" are compliance with established medical device standards and demonstrating substantial equivalence to a predicate device.

Category	Acceptance Criteria (Compliance with Standards/Predicate Equivalence)	Reported Device Performance
Electrical Safety & EM Compatibility	Compliance with ANSI/AAMI ES:60601-1:2005 and IEC 60601-1-2:2007.	Data included in submission in compliance with these standards.
Bench Testing (Performance Standards)	Compliance with ISO 8600-1:2015, ISO 8600-3:1997, ISO 8600-4:2014, ISO 8600-5:2005, IEC 62471:2006, IEC 60601-2-18:2009.	Data included in submission in compliance with these standards.
Biocompatibility	Evaluation performed according to ISO 10993-1 and FDA Guidance, including specific tests (ISO 10993-5, ISO 10993-10, ISO 10993-11) based on contact type and duration.	Tests conducted: ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010.
Reprocessing Validation	Compliance with FDA Guidance and standards for cleaning, sterilization, and high-level disinfection (AAMI TIR 12:2010, ISO 15883-5:2005, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014). For semi-critical device status.	Reprocessing data submitted in compliance with cited standards, validated for cleaning, sterilization, and HLD.
Technological Characteristics (Comparison to Predicate K103467)	Demonstrate substantial equivalence without raising new questions of safety/effectiveness. Key characteristics compared: Type of Scope, Insertion Shaft Diameter, Length, Deflection, Type of Imager, Direction of View, Light Source, Field of View, Depth of Field, On-axis Resolution.	Subject Device K182186 vs. Predicate K103467:- Insertion Shaft Diameter: 2.9 mm (vs. 3.7 mm for predicate)- Field of View: 100° (vs. 85° for predicate)- Depth of Field: 5-50mm (vs. 8-50mm for predicate)- On-axis Resolution: 16 Lp/mm at 5mm, 1.8Lp/mm at 50mm (vs. 8.0 Lp/mm at 8mm, 1.4 Lp/mm at 50 mm for predicate)- Other characteristics (Scope Type, Shaft Length, Deflection, Imager Type, Direction of View, Light Source, Reprocessing Methods) are "Same as the subject device" or "Same as the predicate device" (implied same).

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

Not Applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm evaluation. The assessments are based on engineering bench tests, biocompatibility tests, and reprocessing validations rather than clinical data sets.

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

Not Applicable. Ground truth, in the AI/ML sense, is not established for this type of device submission.

4. Adjudication method for the test set:

Not Applicable.

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 device is a visualization tool, not an AI-assisted diagnostic or interpretive system. Clinical studies comparing human reader performance are not described.

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

Not Applicable. This is a physical endoscope system, not an algorithm.

7. The type of ground truth used:

Not Applicable. The "truth" in this context is defined by adherence to engineering specifications, safety standards, and performance characteristics as verified through non-clinical testing.

8. The sample size for the training set:

Not Applicable. This device does not involve a "training set" as it is not an AI/ML system.

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

Not Applicable.

Summary

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March 22, 2019

KARL STORZ Endoscopy-America, Inc. Nozomi Yagi Sr. Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, California 90245

Re: K182186

Trade/Device Name: CMOS Video-Rhino-Laryngoscope System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: August 9, 2018 Received: August 13, 2018

Dear Nozomi Yagi:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, 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 may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Srinivas Nandkumar -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K182186

Device Name

CMOS Video-Rhino-Laryngoscope System

Indications for Use (Describe)

The CMOS Video-Rhino-Laryngoscope System is indicated to provide visualization of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.

510(k) Summary

This 510(k) Summary 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.

Submitter:	KARL STORZ Endoscopy-America, Inc.2151 E. Grand AvenueEI Segundo, CA 90245
Contact:	Nozomi YagiSr. Regulatory Affairs SpecialistPhone: (424) 218-8351Fax: (424) 218-8519
Date ofPreparation:	March 22, 2019
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: CMOS Video-Rhino-Laryngoscope SystemClassification Name: Endoscope, Neurological (21 CFR Part 882.1480)
RegulatoryClass:	II
Product Code:	EOB
GuidanceDocument:	Not Applicable for EOB product code
RecognizedConsensusStandards:	Not Applicable for EOB product code
Predicate Device:	Primary Predicate Device: KARL STORZ Endoscopy-America'sCMOS Video Rhino-Laryngoscope System Model 11101CM(K103467)
DeviceDescription:	The CMOS Video-Rhino-Laryngoscope System includes two maincomponents: (1) the CMOS Video-Rhino-Laryngoscope (11102CM)and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatiblewith two KARL STORZ CCUs: C-HUB and C-MAC.
Intended Use:	The CMOS Video-Rhino-Laryngoscope System is intended forvisualization purposes during ENT procedures.
Indications ForUse:	The CMOS Video-Rhino-Laryngoscope System is indicated to providevisualization of the nasal lumens and airway anatomy (including

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Image /page/4/Picture/0 description: The image shows the logo for STORZ, a company that specializes in endoscopes. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

nasopharyngeal and trachea) during diagnostic procedures.
TechnologicalCharacteristics:	Comparison Table: Subject vs. Primary Predicate Devices
	Subject Device	Primary Predicate,K103467CMOS V-R-L 11101CM
	Physical Characteristics
	Type of Scope	Flexible	Same as the subject device
	Insertion Shaft Diameter	2.9 mm	3.7 mm
	Insertion Shaft Length	300 mm	Same as the subject device
	Deflection	140° Up, 140° Down	Same as the subject device
	Optical and System Characteristics
	Type of Imager	CMOS	Same as the subject device
	Direction of View	0°	Same as the subject device
	Light Source	Internal LED	Same as the subject device
	Field of View	100	85
	Depth of Field	5-50mm	8-50mm
	On-axis Resolution (minimal)	16 Lp/mm at 5mm1.8Lp/mm at 50mm	8.0 Lp/mm at 8mm1.4 Lp/mm at 50 mm
	Reprocessing Methods
	Cleaning	Manual	Same as the subject device
	Sterilization	Yes	Same as the subject device
	HLD	Yes	Same as the subject device
Non-ClinicalPerformanceData:	Electrical Safety and Electromagnetic Compatibility SummaryThe electrical safety and EMC data included in the submission is in compliance withthe following FDA recognized standards:ANSI/AAMI ES:60601-1:2005 IEC 60601-1-2:2007Bench Testing SummaryThe performance data submitted in the submission is in compliance with the followingFDA recognized standards:ISO 8600-1:2015 ISO 8600-3:1997 ISO 8600-4:2014 ISO 8600-5:2005 IEC 62471:2006 IEC 60601-2-18:2009Biocompatibility SummaryThe biocompatibility evaluation for the patient contacting components of theneuroscope was performed according to ISO 10993-1 and FDA Guidance. Thefollowing tests were conducted based contact type and duration:ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010Reprocessing Validation SummaryThe CMOS Video-Rhino-Laryngoscope (Part Number: 11102CM) is provided non-sterile and is reusable. The users are required to reprocess it for initial and after eachuse. The subject device contacts intact mucosal membranes so it is a semi-criticaldevice per Spaulding Classification, requiring thorough cleaning followed bysterilization or high level disinfection (HLD) after each use. For this reason, weperformed validation activities for cleaning, sterilization, and HLD according to the

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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

	FDA Guidance. The reprocessing data submitted is in compliance with the followingstandards:• AAMI TIR 12:2010• ISO 15883-5:2005• AAMI TIR 30:2011• AAMI/ANSI/ISO 11737-1:2006/ (R)2011• ASTM E1837-96:2014
ClinicalPerformanceData:	Clinical testing was not required to demonstrate the substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of the modifications.
SubstantialEquivalence	As proven by the comparisons, the minor difference between the subjectand predicate devices shown in Technological Characteristics sectionof this summary do not raise new or different questions of safety andeffectiveness because the intended use, operating principles,technological characteristics, and features are similar, if not identical.Both systems also comply with identical standards and safety testing,where applicable.Substantial equivalence on the effectiveness of the subject device issupported by the comparison of performance data between the subjectand predicate devices.
Conclusion:	The conclusions drawn from the nonclinical tests demonstrate that thesubject device, the CMOS Video-Rhino-Laryngoscope System issubstantially equivalent to the legally marketed predicate device.

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.