CMOS Video-Rhino-Laryngoscope System

K182186 · KARL STORZ Endoscopy-America, Inc. · EOB · Mar 22, 2019 · Ear, Nose, Throat

Device Facts

• Record ID: K182186
• Device Name: CMOS Video-Rhino-Laryngoscope System
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Mar 22, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2

Intended Use

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 Story

The CMOS Video-Rhino-Laryngoscope System is a flexible endoscope used for visualizing nasal lumens and airway anatomy. It consists of a CMOS video-rhino-laryngoscope (11102CM) and a Camera Control Unit (CCU), specifically the C-HUB or C-MAC. The device captures visual data via an internal LED light source and CMOS imager at the distal tip. It is operated by physicians in a clinical setting to perform diagnostic procedures. The output is a real-time video feed displayed for the clinician, facilitating direct visualization of the airway to aid in clinical assessment and decision-making. The device is reusable and requires manual cleaning followed by sterilization or high-level disinfection (HLD) between uses.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was established through non-clinical bench testing, including electrical safety (ANSI/AAMI ES:60601-1, IEC 60601-1-2), performance testing (ISO 8600 series, IEC 62471, IEC 60601-2-18), biocompatibility (ISO 10993), and reprocessing validation (AAMI TIR 12/30, ISO 15883-5, ASTM E1837).

Technological Characteristics

Flexible endoscope with 2.9 mm insertion shaft diameter and 300 mm length. Features CMOS imager, internal LED light source, 140° up/down deflection, 100° field of view, and 5-50 mm depth of field. Compatible with C-HUB and C-MAC CCUs. Biocompatibility per ISO 10993. Reprocessing via manual cleaning followed by sterilization or HLD. Complies with ISO 8600-1, 8600-3, 8600-4, 8600-5, IEC 62471, and IEC 60601-2-18.

Indications for Use

Indicated for visualization of nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic procedures in patients requiring ENT examination.

Regulatory Classification

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.

Predicate Devices

• KARL STORZ Endoscopy-America's CMOS Video Rhino-Laryngoscope System Model 11101CM (K103467)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☐</span> 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.<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi<br>Sr. Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone] |
| Date of<br>Preparation: | March 22, 2019 |
| Type of 510(k)<br>Submission: | Traditional |
| Device<br>Identification: | Trade Name: CMOS Video-Rhino-Laryngoscope System<br>Classification Name: Endoscope, Neurological (21 CFR Part 882.1480) |
| Regulatory<br>Class: | II |
| Product Code: | EOB |
| Guidance<br>Document: | Not Applicable for EOB product code |
| Recognized<br>Consensus<br>Standards: | Not Applicable for EOB product code |
| Predicate Device: | Primary Predicate Device: KARL STORZ Endoscopy-America's<br>CMOS Video Rhino-Laryngoscope System Model 11101CM<br>(K103467) |
| Device<br>Description: | The CMOS Video-Rhino-Laryngoscope System includes two main<br>components: (1) the CMOS Video-Rhino-Laryngoscope (11102CM)<br>and (2) the CCU. The CMOS Video-Rhino-Laryngoscope is compatible<br>with two KARL STORZ CCUs: C-HUB and C-MAC. |
| Intended Use: | The CMOS Video-Rhino-Laryngoscope System is intended for<br>visualization purposes during ENT procedures. |
| Indications For<br>Use: | The CMOS Video-Rhino-Laryngoscope System is indicated to provide<br>visualization 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. | | | |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|----------------------------------------|
| Technological<br>Characteristics: | Comparison Table: Subject vs. Primary Predicate Devices | | |
| | Subject Device | Primary Predicate,<br>K103467<br>CMOS V-R-L 11101CM | |
| | <b>Physical Characteristics</b> | | |
| | 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 |
| | <b>Optical and System Characteristics</b> | | |
| | 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 5mm<br>1.8Lp/mm at 50mm | 8.0 Lp/mm at 8mm<br>1.4 Lp/mm at 50 mm |
| | <b>Reprocessing Methods</b> | | |
| | Cleaning | Manual | Same as the subject device |
| | Sterilization | Yes | Same as the subject device |
| | HLD | Yes | Same as the subject device |
| Non-Clinical<br>Performance<br>Data: | <b>Electrical Safety and Electromagnetic Compatibility Summary</b><br>The electrical safety and EMC data included in the submission is in compliance with<br>the following FDA recognized standards:<br>ANSI/AAMI ES:60601-1:2005 IEC 60601-1-2:2007<br><b>Bench Testing Summary</b><br>The performance data submitted in the submission is in compliance with the following<br>FDA recognized standards:<br>ISO 8600-1:2015 ISO 8600-3:1997 ISO 8600-4:2014 ISO 8600-5:2005 IEC 62471:2006 IEC 60601-2-18:2009<br><b>Biocompatibility Summary</b><br>The biocompatibility evaluation for the patient contacting components of the<br>neuroscope was performed according to ISO 10993-1 and FDA Guidance. The<br>following tests were conducted based contact type and duration:<br>ISO 10993-5:2009/(R) 2014 ISO 10993-10:2010 ISO 10993-11:2006/(R) 2010<br><b>Reprocessing Validation Summary</b><br>The CMOS Video-Rhino-Laryngoscope (Part Number: 11102CM) is provided non-<br>sterile and is reusable. The users are required to reprocess it for initial and after each<br>use. The subject device contacts intact mucosal membranes so it is a semi-critical<br>device per Spaulding Classification, requiring thorough cleaning followed by<br>sterilization or high level disinfection (HLD) after each use. For this reason, we<br>performed 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 following<br>standards:<br>• AAMI TIR 12:2010<br>• ISO 15883-5:2005<br>• AAMI TIR 30:2011<br>• AAMI/ANSI/ISO 11737-1:2006/ (R)2011<br>• ASTM E1837-96:2014 |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate devices. Non-clinical bench testing was<br>sufficient to establish the substantial equivalence of the modifications. |
| Substantial<br>Equivalence | As proven by the comparisons, the minor difference between the subject<br>and predicate devices shown in Technological Characteristics section<br>of this summary do not raise new or different questions of safety and<br>effectiveness because the intended use, operating principles,<br>technological characteristics, and features are similar, if not identical.<br>Both systems also comply with identical standards and safety testing,<br>where applicable.<br>Substantial equivalence on the effectiveness of the subject device is<br>supported by the comparison of performance data between the subject<br>and predicate devices. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the<br>subject device, the CMOS Video-Rhino-Laryngoscope System is<br>substantially equivalent to the legally marketed predicate device. |