HD Video Rhino Laryngoscope by KARL STORZ Endoscopy - America, Inc.

The KARL STORZ CMOS HD 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 components subject of this submission are: the Flexible HD Video-Rhino-Laryngoscope (Part Number: 11101 HD), and the IMAGE1 S CCU. The CCU consists of the IMAGE1 S Connect Module (Model Number: TC200US) and IMAGE1 S X-Link (Model Number: TC301US).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Flexible HD Video Rhino-Laryngoscope System." This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than clinical trials or AI performance evaluations. Therefore, many of the requested details about acceptance criteria for AI performance, clinical study design, and ground truth establishment for AI models are not applicable to this submission.

However, I can extract information related to the device's technical specifications and the non-clinical tests performed to demonstrate its performance and safety.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria in a pass/fail table for all parameters, but it lists various tests performed and that the device is "in compliance" with recognized standards. This implies that the device met the requirements outlined in those standards for each tested characteristic.

Feature	Acceptance Criteria (Implied by Compliance with Standards)	Reported Device Performance
Physical Characteristics	Not explicitly stated as acceptance criteria, but compared to predicate devices.	Flexible, Insertion Shaft Diameter: 3.7 mm, Length: 300 mm, Deflection: 140° Up/Down
Optical Characteristics	Not explicitly stated as acceptance criteria, but compared to predicate devices.	CMOS Imager, Direction of View: 0°, Internal LED Light Source, Field of View: 100°
On-axis Resolution (minimal)	Must meet performance of predicate devices and/or relevant standards for visualization.	40 lp/mm@3 mm, 2.5 lp/mm@50 mm (Subject Device)
Image Illumination Uniformity	In compliance with IEC 60601-2-18 and general image quality expectations.	Bench tested, "in compliance."
Latency	In compliance with IEC 60601-2-18 and general image quality expectations for real-time use.	Bench tested, "in compliance."
Dynamic Range and Linearity	In compliance with relevant image quality standards.	Bench tested, "in compliance."
Signal to Noise Ratio & Sensitivity	In compliance with relevant image quality standards.	Bench tested, "in compliance."
Color Performance and Color Contrast Enhancement	In compliance with relevant image quality standards.	Bench tested, "in compliance."
System Resolution	In compliance with relevant image quality standards.	Bench tested, "in compliance."
Field of View Distortion	In compliance with relevant image quality standards.	Bench tested, "in compliance."
Safety
Electrical Safety	In compliance with ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18: 2009.	Bench tested, "in compliance."
Electromagnetic Compatibility	In compliance with ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012, IEC 60601-1-2:2014, IEC 60601-2-18: 2009.	Bench tested, "in compliance."
Biocompatibility	In compliance with ISO 10993-1, ISO 10993-5:2009/(R) 2014, ISO 10993-10:2010, ISO 10993-11:2006/(R) 2010.	Biocompatibility evaluation performed, "in compliance."
Reprocessing Validation	In compliance with AAMI TIR 12:2010, ISO 15883-5:2005, AAMI TIR 30:2011, AAMI/ANSI/ISO 11737-1:2006/(R)2011, ASTM E1837-96:2014.	Reprocessing validation performed, "in compliance."

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

Sample Size: Not applicable. The document states "Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications." This indicates that the testing was performed on the device itself and its components, not on a patient test set, and therefore there's no "sample size" in the context of clinical data.
Data Provenance: Not applicable in the context of patient data. The tests are bench tests performed on the device.

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

Not applicable. As no clinical test set was used, there was no need for expert ground truth establishment in this context. The "ground truth" for the non-clinical tests would be the established performance metrics defined by the relevant engineering and medical device standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication.

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 an imaging system (rhino-laryngoscope) and the submission details focus on its technical functionality, safety, and equivalence to predicate devices, not on AI-assisted diagnostic capabilities or human reader performance improvement.

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

Not applicable. This device does not incorporate an AI algorithm for standalone performance evaluation.

7. The Type of Ground Truth Used

For the Device's Functionality and Safety: The ground truth for the non-clinical performance and safety tests (e.g., electrical safety, EMC, biocompatibility, reprocessing validation, optical parameters) is established by adherence to recognized international and national standards (e.g., IEC, ANSI/AAMI, ISO, ASTM). These standards define acceptable limits and methodologies for testing.

8. The Sample Size for the Training Set

Not applicable. This submission does not involve an AI model, and therefore, no training set.

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

Not applicable. As there is no AI model or training set, this information is not relevant to the provided document.

Summary

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August 11, 2020

KARL STORZ Endoscopy - America, Inc. Winkie Wong Manager Regulatory Affairs 2151 E. Grand Avenue El Segundo, California 90245

Re: K200740

Trade/Device Name: Flexible HD 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: July 3, 2020 Received: July 8, 2020

Dear Winkie Wong:

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. Although this letter refers to your product as a device, please be aware 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for

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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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Michael J. Ryan Director DHT1C: Division of ENT, Sleep Disordered Breathing. Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200740

Device Name

Flexible HD Video Rhino-Laryngoscope System

Indications for Use (Describe)

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. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.

K200740 - 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:	Winkie WongRegulatory Affairs ManagerPhone: (424) 218-8379
Date ofPreparation:	August 8th, 2020
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: Flexible HD Video Rhino-Laryngoscope SystemClassification Name: Nasopharyngoscope (flexible or rigid) andaccessories (21 CFR Part 874.4760)
RegulatoryClass:	II
Product Code:	EOB
GuidanceDocument:	Not Applicable for EOB product codes
RecognizedConsensusStandards:	9-114: IEC 60601-2-18: Edition 3.0 2009-08Medical electrical equipment - Part 2-18: Particular requirements forthe basic safety and essential performance of endoscopic equipment
PredicateDevice(s):	Primary Predicate Device: KARL STORZ Endoscopy-America'sCMOS Video Rhino Laryngoscope (K182186)Secondary Predicate Device: KARL STORZ Endoscopy-America'sFlexible CMOS-Video- Rhino-Laryngoscope (K103467)
DeviceDescription:	The components subject of this submission are: the Flexible HDVideo-Rhino-Laryngoscope (Part Number: 11101 HD), and theIMAGE1 S CCU. The CCU consists of the IMAGE1 S ConnectModule (Model Number: TC200US) and IMAGE1 S X-Link (ModelNumber: TC301US).
Intended Use:	The KARL STORZ Flexible HD Video Rhino-Laryngoscope System

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Image /page/4/Picture/0 description: The image shows the logo for KARL STORZ-ENDOSKOPE. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ-ENDOSKOPE" are in smaller, blue letters. The logo is simple and professional.

Comparison Table: Subject vs. Primary and Secondary Predicate Devices
	Subject Device	Primary Predicate Device, K182186	Secondary Predicate Device, K103467
	Physical Characteristics
	Type of Scope	Flexible	Same as the subject device	Same as the subject device
	Insertion Shaft Diameter	3.7 mm	2.9 mm	Same as the subject device
	Insertion Shaft Length	300 mm	Same as the subject device	Same as the subject device
	Deflection	140° Up, 140° Down	Same as the subject device	Same as the subject device
	Optical Characteristics
	Type of Imager	CMOS	Same as the subject device	Same as the subject device
	Direction of View	0°	Same as the subject device	Same as the subject device
	Light Source	Internal LED	Same as the subject device	Same as the subject device
	Field of View	100°	Same as the subject device	85°
	On-axis Resolution (minimal)	40 lp/mm@3 mm2.5 lp /mm@50 mm	16 Lp/mm at 5 mm1.8 Lp/mm at 50 mm	8.0 Lp/mm at 8 mm1.4 Lp/mm at 50 mm
	Reprocessing Methods
	Cleaning	Manual	Same as the subject device	Same as the subject device
	Sterilization	Yes	Yes	Yes
	HLD	Yes	Yes	Yes
Non-ClinicalPerformanceData:	Electrical Safety and Electromagnetic Compatibility SummaryThe electrical safety and EMC data included in the submission is in compliance with the following FDA recognized standards:• ANSI/AAMI ES:60601-1:2005/(R) 2012 and A1:2012• IEC 60601-1-2:2014• IEC 60601-2-18: 2009Bench Testing SummaryThe performance data submitted in the submission is in compliance with the following FDA recognized standards:• IEC 62471:2006Optical Performance Testing:• Image Illumination Uniformity• Latency

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Image /page/5/Picture/0 description: The image contains 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 size.

	Dynamic Range and Linearity Signal to Noise Ratio & Sensitivity Color Performance and Color Contrast Enhancement System Resolution Field of View Distortion
	Biocompatibility SummaryThe biocompatibility evaluation for the patient contacting components of the neuroscope was performed according to ISO 10993-1 and FDA Guidance. The following tests were conducted based contact type and duration: ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010
	Reprocessing Validation SummaryThe Flexible HD Cysto-Urethroscope (Part Number: 11272V(H)) is provided non- sterile and is reusable. The users are required to reprocess it for initial and after each use. The subject device contacts intact mucosal membranes so it is a semi-critical device per Spaulding Classification. We performed validation activities for cleaning and sterilization according to the FDA Guidance. The reprocessing data submitted is in compliance with the following standards: 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 substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Conclusion:	The conclusions drawn from the nonclinical tests demonstrate that the subject device, the Flexible HD Video-Rhino-Laryngoscope System is substantially equivalent to the legally marketed predicate devices.

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.