KARL STORZ Slim Nasopharyngolaryngoscope

• K Number: K171402
• Device Name: KARL STORZ Slim Nasopharyngolaryngoscope
• Manufacturer: KARL STORZ Endoscopy-America, Inc.
• Date Cleared: 2018-02-02 ( 266 days)
• Product Code: EOB
• Regulation Number: 874.4760
• Type: Traditional
• Panel: EN
• Reference & Predicate Devices: K161112 , K981458 , K030857

Intended Use

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 E1837-96:2014
  This 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.

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

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

   • Not applicable. (Same reasoning as above).

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.