KARL STORZ Slim Nasopharyngolaryngoscope by KARL STORZ Endoscopy-America, Inc.

The KARL STORZ Slim Nasopharyngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.

Device Description

The KARL STORZ Slim Nasopharyngolaryngoscope (Model Number: 11161V) is a reusable, flexible videoscope used for examination of the nasal lumens and airway anatomy. The KARL STORZ Slim Nasopharyngolaryngoscope System is identical to the KARL STORZ Flexible Video-Neuro-Endoscope System, which is currently distributed under K161112.

AI/ML Overview

This document pertains to the 510(k) premarket notification for the KARL STORZ Slim Nasopharyngolaryngoscope System (K171402). This device is a flexible videoscope used for visualization during ENT diagnostic and therapeutic procedures.

Important Note: This submission is for a device that is identical in design and performance to a previously cleared device (KARL STORZ Flexible Video-Neuro-Endoscope System, K161112), with the exception of an additional High-Level Disinfection (HLD) method being supported. Therefore, the majority of the acceptance criteria and study data relate to demonstrating this equivalence and validating the new HLD method, rather than a de novo clinical performance study of the device's efficacy.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a device largely identical to a predicate, the "acceptance criteria" here primarily refer to demonstrating equivalence to the predicate and compliance with relevant standards. No performance metrics like sensitivity, specificity, or accuracy (typical for AI/Algorithm-driven devices) are applicable here, as this is an endoscopic visualization device, not an AI diagnostic tool.

The "acceptance criteria" are thus implicitly met by demonstrating that the device is identical in design and performance to the predicate (K161112), and that the new HLD method is validated.

Category	Acceptance Criteria (Implicit from Equivalence/Standards)	Reported Device Performance/Compliance
Physical Characteristics	The device's physical characteristics (Type of Scope, Distal Tip Diameter, Working Shaft Length, Working Channel Diameter, Deflection) must be identical or substantially equivalent to the predicate devices.	Identical to Reference Device (K161112):- Type of Scope: Flexible- Distal Tip Diameter: 8.5 Fr, 2.83 mm (elliptical: 3.2 mm x 2.4 mm)- Working Shaft Length: 350 mm- Working Channel Diameter: 1.2 mm- Deflection: Up: 270°, Down: 270°
Optical Characteristics	The device's optical characteristics (Type of Imager, Field of View, Direction of View, Light Source) must be identical or substantially equivalent to the predicate devices, ensuring equivalent visualization quality.	Identical to Reference Device (K161112):- Type of Imager: CMOS chip- Field of View: 90°- Direction of View: 0°- Light Source: Internal LED
Electrical Safety and EMC	Compliance with recognized electrical safety and electromagnetic compatibility (EMC) standards.	Device design for electrical safety and EMC is unchanged from reference device (K161112). Data from K161112 complied with: - ANSI/AAMI ES 60601-1:2005 (Recognition Number: 19-4)- IEC 60601-1-2:2007 (Recognition Number: 19-8)No additional data needed.
Bench Testing (Performance)	Compliance with recognized performance standards for endoscopes (e.g., image quality, durability).	Device design for performance is unchanged from reference device (K161112). Data from K161112 complied with:- ISO 8600-1:2015 (Recognition Number: 9-110)- ISO 8600-3:1997 (Recognition Number: 9-84)- ISO 8600-4:2014 (Recognition Number: 9-94)No additional data needed.
Biocompatibility	Compliance with recognized biocompatibility standards for medical devices based on patient contact.	Device design for materials is unchanged from reference device (K161112). Data from K161112 complied with:- ISO 10993-1:2009/(R) 2013 (Recognition Number: 2-156)- ISO 10993-5:2009/(R) 2014 (Recognition Number: 2-153)- ISO 10993-10:2010 (Recognition Number: 2-173)- ISO 10993-11:2006/(R) 2010 (Recognition Number: 2-118)No additional data needed.
High Level Disinfection (HLD) Safety & Efficacy	Validation of the safety and efficacy of the additional HLD method (CIDEX) for the semi-critical device, demonstrating effective disinfection and device material compatibility. This is crucial as the device's Spaulding classification changed from "critical" (requiring sterilization) to "semi-critical" (allowing HLD). Compliance with relevant standards for HLD validation.	New HLD validation study performed for CIDEX on a representative device. Data complied with:- AAMI TIR12:2010- ISO 15883-5:2005- AAMI TIR30:2011- AAMI/ANSI/ISO 11737-1:2006/ (R)2011 (Recognition Number: 14-227)- ASTM E1837-96:2014This supports the use of CIDEX as an HLD method for the device.

Specific Study Information (as applicable to this type of device submission):

For this 510(k) submission, the primary "study" is demonstrating substantial equivalence to the predicate and validating the new HLD method. Clinical performance data was not required because non-clinical bench testing was deemed sufficient to establish substantial equivalence. This is not an AI/Algorithm device, so many of the requested points do not apply.

Sample Size Used for the Test Set and Data Provenance:
- Test Set (for HLD validation): The document states an "HLD validation study was performed using a representative device." It does not specify the exact sample size (number of devices or test cycles) but implies rigorous testing in compliance with the listed standards (e.g., AAMI TIR12, ISO 15883-5).
- Data Provenance: Not explicitly stated, but typically such validation studies are done in a controlled laboratory environment by the manufacturer or a contracted lab. The document implies it's a prospective validation study to support the new HLD method for this specific device. Country of origin for the HLD study data is not provided.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. For this type of device and submission, "ground truth" as it relates to clinical diagnosis or imagery (like in AI/Algorithm studies) is not established by expert readers. The "ground truth" for HLD validation is established through microbiological testing (e.g., absence of viable microorganisms after disinfection) and material compatibility testing, which are performed by qualified lab personnel following validated protocols, not clinical experts.
Adjudication method (e.g. 2+1, 3+1, none) for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical image interpretation studies, typically for AI where there's a need to reconcile discordant expert reads against a reference standard. Here, the "test set" is for HLD validation, not for image interpretation.
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 endoscope for direct human visualization, not an AI-assisted diagnostic tool. No MRMC study was performed or required.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual endoscopic instrument; it does not have a standalone algorithm component.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the HLD validation, the "ground truth" for efficacy is the microbiological sterility or reduction level achieved, as determined by validated laboratory methods (e.g., culture, spore count reduction). For material compatibility, the "ground truth" is the absence of degradation or adverse effects on device components after repeated HLD cycles.
The sample size for the training set:
- Not applicable. This device does not have a "training set" in the context of an AI/machine learning algorithm. The design of the existing predicate device (K161112) served as the "base" or "trained" design, and this submission focuses on demonstrating equivalence and validating a new cleaning process.
How the ground truth for the training set was established:
- Not applicable. (Same reasoning as above).

Summary

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February 2, 2018

KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin Regulatory Engineer 2151 E. Grand Avenue El Segundo, CA 90245

Re: K171402

Trade/Device Name: KARL STORZ Slim Nasopharyngolaryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: January 2, 2018 Received: January 3, 2018

Dear AnnaLisa Smullin:

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 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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 yours,

Eric A. Mann -S

for Malvina B. 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) K171402

Device Name

KARL STORZ Slim Nasopharyngolaryngoscope System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)X 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 STORZ. The logo is blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional.

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:	AnnaLisa SmullinRegulatory EngineerPhone: (424) 218-8376Fax: (424) 218-8519
Date ofPreparation:	January 30, 2018
Type of 510(k)Submission:	Traditional
DeviceIdentification:	Trade Name: KARL STORZ Slim NasopharyngolaryngoscopeSystemClassification Name: Nasopharyngoscope (21 CFR Part 874.4760)
RegulatoryClass:	II
Product Code:	EOB
GuidanceDocument:	Not Applicable for EOB product code
RecognizedConsensusStandards:	Not Applicable for EOB product code
PredicateDevice(s):	Primary Predicate Device: KARL STORZ Endoscopy-America'sKarl Storz Rhino-Laryngo-Broncho-Fiberscope (K981458)Secondary Predicate Device: MAHE INTL., INC's MAHE PediatricNaso Pharyngoscope (K030857)Reference: KARL STORZ Endoscopy-America's KARL STORZFlexible Video-Neuro-Endoscope System (K161112)
DeviceDescription:	The KARL STORZ Slim Nasopharyngolaryngoscope (ModelNumber: 11161V) is a reusable, flexible videoscope used forexamination of the nasal lumens and airway anatomy. The KARLSTORZ Slim Nasopharyngolaryngoscope System is identical to the

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Image /page/4/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

	KARL STORZ Flexible Video-Neuro-Endoscope System, which iscurrently distributed under K161112.
Intended Use:	The KARL STORZ Slim Nasopharyngolaryngoscope System isintended for visualization purposes during ENT diagnostic andtherapeutic procedures.
Indications ForUse:	The KARL STORZ Slim Nasopharyngolaryngoscope System isindicated to provide visualization and access of the nasal lumens andairway anatomy (including nasopharyngeal and trachea) duringdiagnostic and therapeutic procedures in adult and pediatric patients.
TechnologicalCharacteristics:		Subject Device	PrimaryPredicateDevice,K981458	SecondaryPredicateDevice,K030857	ReferenceDevice,K161112
		KARL STORZSlimNasopharyngo-laryngoscopeSystem	KARL STORZRhino-Laryngo-Broncho-Fiberscope	MAHEPediatricNasopharyngo-scope	KARL STORZFlexible Video-Neuro-EndoscopeSystem
		Physical Characteristics
	Type ofScope	Flexible	Flexible	Flexible	Flexible
	Distal TipDiameter	8.5 Fr, 2.83 mm(elliptical:3.2 mm x 2.4 mm)	3.5 mm	2.8 mm	8.5 Fr, 2.83 mm(elliptical:3.2 mm x 2.4 mm)
	WorkingShaftLength	350 mm	340 mm	300 mm	350 mm
	WorkingChannelDiameter	1.2 mm	1.2 mm	No workingchannel	1.2 mm
	Deflection(°)	Up: 270°Down: 270°	Up: 180°Down: 100°	Up: 120°Down: 100°	Up: 270°Down: 270°
	Optical Characteristics
	Type ofImager	CMOS chip	Fiberscope	Fiberscope	CMOS chip
	Field ofView	90°	85°	95°	90°
	Direction ofView	0°	0°	0°	0°
	LightSource	Internal LED	External Xenon	External LED	Internal LED
	Cleaning and Sterilization Methods
	Cleaning	Manual	Manual	Manual	Manual
	Sterilization	- STERRAD NX- STERRAD100NX- STERISSYSTEM 1E- V-PRO maX- V-PRO 60- EtO	- EtO	Unknown	- STERRAD NX- STERRAD100NX- STERISSYSTEM 1E- V-PRO maX- V-PRO 60- EtO
	HLD	- CIDEX	- CIDEX	Unknown	No HLD

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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 phrase "KARL STORZ - ENDOSKOPE" in a smaller font.

Non-ClinicalPerformanceData:	Electrical Safety and Electromagnetic Compatibility SummaryThe device design, including the electrical safety andelectromagnetic compatibility (EMC), has not changed sinceclearance of the reference device, the KARL STORZ Flexible Video-Neuro-Endoscope System in K161112. The electrical safety andEMC data submitted in K161112 was in compliance with thefollowing FDA recognized standards:• ANSI/AAMI ES 60601-1:2005 (Recognition Number: 19-4)• IEC 60601-1-2:2007 (Recognition Number: 19-8)As the subject device remains identical to the reference device, noadditional electrical safety or EMC data is needed for the KARLSTORZ Slim Nasopharyngolaryngoscope System.Bench Testing SummaryThe device design, including the performance has not changed sinceclearance of the reference device, the KARL STORZ Flexible Video-Neuro-Endoscope System in K161112. The performance datasubmitted in K161112 was in compliance with the following FDArecognized standards:• ISO 8600-1: Fourth edition: 2015-10-15 (RecognitionNumber: 9-110)• ISO 8600-3: First edition: 1997-07-01 (Recognition Number:9-84)• ISO 8600-4: Second edition: 2014-03-15 (RecognitionNumber: 9-94)As the subject device remains identical to the reference device, noadditional performance data is needed for the KARL STORZ SlimNasopharyngolaryngoscope System.Biocompatibility SummaryThe device design, including the materials, has not changed sinceclearance of the reference device, the KARL STORZ Flexible Video-Neuro-Endoscope System in K161112.The Biological Evaluationdata submitted in K161112 was in compliance with the followingFDA recognized standards:• ISO 10993-1:2009/(R) 2013 (Recognition Number: 2-156)• ISO 10993-5:2009/ (R) 2014 (Recognition Number: 2-153)• ISO 10993-10:2010 (Recognition Number: 2-173)• ISO 10993-11:2006/ (R) 2010 (Recognition Number: 2-118)As the subject device remains identical to the reference device, noadditional biological evaluation data is needed for the KARLSTORZ Slim Nasopharyngolaryngoscope System.
	High Level Disinfection (HLD) Summary
	The reference device, the KARL STORZ Flexible Video-Neuro-Endoscope System (K161112), is a critical device per SpauldingClassification, whereas the subject device is a semi-critical device,requiring a thorough cleaning followed by sterilization or high leveldisinfection (HLD). In order to support an additional HLD method(CIDEX), a new HLD validation study was performed using arepresentative device. The HLD data submitted was in compliancewith the following FDA standards. Where applicable, FDA standardrecognition numbers are noted:• AAMI TIR12: 2010• ISO 15883-5:2005• AAMI TIR30:2011• AAMI/ANSI/ISO 11737-1:2006/ (R)2011 (RecognitionNumber: 14-227)• ASTM E1837-96:2014
ClinicalPerformanceData:	Clinical testing was not required to demonstrate substantialequivalence to the predicate devices. Non-clinical bench testing wassufficient to establish the substantial equivalence of themodifications.
Conclusion:	The conclusions drawn from the nonclinical tests demonstrate thatthe subject device, KARL STORZ Slim NasopharyngolaryngoscopeSystem performs as well as or better than the legally marketedpredicate devices.

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Image /page/6/Picture/0 description: The image is a logo for "STORZ KARL STORZ - ENDOSKOPE". The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.

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.