CMOS Video Esophagoscope SSU

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. January 24, 2020 Karl Storz SE & Co. KG Alexey Davidov Manager Regulatory Affairs, US Submissions Dr.-Karl-Storz-Straße 34 78532 Tuttlingen, Germany Re: K192523 Trade/Device Name: CMOS Video Esophagoscope SSU Regulation Number: 21 CFR 874.4710 Regulation Name: Esophagoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOX Dated: December 24, 2019 Received: December 27, 2019 Dear Alexey Davidov: 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). 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Sincerely, for Michael 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K192523 Device Name CMOS Video Esophagoscope SSU Indications for Use (Describe) The CMOS Video Esophagoscope SSU is intended to provide visualization of nasal sinuses, larynx, esophagus and gastroesophageal junction during diagnostic procedures. The E-Box serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU. 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) | |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. ## 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 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge. | Submitter: | KARL STORZ SE & Co. KG<br>Dr.-Karl-Storz-Straße 34<br>78532 Tuttlingen, Germany | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Alexey Davidov<br>Manager Regulatory Affairs, US Submissions<br>Phone: +49 (0)7461 708-7909<br>Fax: +49 (0)7461 708-75095<br>Email: Alexey.Davidov@karlstorz.com | | Date of Preparation: | September 9, 2019 | | Type of 510(k) Submission: | Traditional | | Device Identification: | Trade Name:<br>CMOS Video Esophagoscope SSU<br>Classification Name:<br>Esophagoscope (Flexible Or Rigid) (21 CFR Part 874.4710) | | Regulatory Class: | II | | Product Code: | EOX | | Guidance Document: | Not Applicable for EOX product codes | | Recognized Consensus Standards: | Not Applicable for EOX product codes | | Predicate Device: | Predicate device: KARL STORZ Endoscopy-America's Trans-Nasal<br>Esophagoscope Model 11302BD1 (K051972).<br>The predicate device has not been subjects to a design-related recalls.<br>No reference devices were used in this submission. | | Device Description: | The CMOS Video Esophagoscope SSU System includes three main<br>components: (1) the CMOS Video Esophagoscope SSU (091370-01),<br>(2) E-Box adaptor (TP010) and (3) the CCU. CMOS Video<br>Esophagoscope SSU is compatible with two KARL STORZ CCUs: C-HUB and C-MAC. CMOS Video Esophagoscope SSU is provided | {4}------------------------------------------------ Image /page/4/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 smaller letters. CMOS Video Esophagoscope SSU | Intended Use: | CMOS Video Esophagoscope SSU is intended for visualization<br>purposes during ENT procedures. | | | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------------------------| | Indications for Use: | The CMOS Video Esophagoscope SSU is intended to provide<br>visualization of nasal sinuses, larynx, esophagus and gastro-<br>esophageal junction during diagnostic procedures.<br><br>The E-Box serves as an adaptor for operating the flexible single-use<br>videoscope on the compatible CCU. | | | | Technological<br>Characteristics: | Comparison Table: Subject vs. Predicate Device | | | | | | Subject Device | Predicate device K051972 | | | | CMOS Video Esophagoscope<br>SSU | Trans-Nasal Esophagoscope<br>11302BD1 | | | | Physical Characteristics | | | | Type of Scope | Flexible video endoscope | Same as the subject device | | | Insertion Shaft Diameter | 3.5 mm | 3.7 mm | | | Insertion Shaft Length | 750 mm | 650 mm | | | Deflection | 210° Up, 140° Down | 140° Up, 140° Down | | | | Optical and System Characteristics | | | | Type of Imager | CMOS | None | | | Direction of View | 0° | Same as the subject device | | | Field of view | 110° | 87° | | | Light Source | Internal LED | External light source | | | | Reprocessing Methods | | | | How device is provided | Sterile single-use | Unsterile, reusable | | | EO Sterilization Cycle | 6.Storz / 1.75 bar / 50° C /<br>80 min / 17.5h" | N/A | | | Sterilizing agent | Mixture of EO in CO2;<br>resulting concentration: 8,5<br>± 0,5 % EO; CO2 added up<br>to 100 % | N/A | | Non-Clinical<br>Performance Data: | Electrical Safety and Electromagnetic Compatibility Summary<br>The electrical safety and EMC data for the subject device and<br>compatible CCUs was provided to FDA and was in compliance with<br>the following FDA recognized standards:<br>✓ ANSI/AAMI ES:60601-1:2005<br>✓ IEC 60601-1-2:2007<br><br>Bench Testing Summary<br>The performance data submitted in the submission is in<br>compliance with the following FDA recognized standards:<br>✓ ISO 8600-1:2015<br>✓ ISO 8600-3:1997<br>✓ ISO 8600-4:2014<br>✓ ISO 8600-5:2005<br>✓ IEC 62471:2006<br>✓ IEC 60601-2-18:2009<br><br>Animal Study<br>Animal study was not required to demonstrate the substantial<br>equivalence to the predicate devices. | | | {5}------------------------------------------------ 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 phrase "KARL STORZ - ENDOSKOPE" in smaller letters. | Biocompatibility Summary<br>The biocompatibility evaluation for the patient contacting<br>components of the CMOS Video Esophagoscope SSU was performed<br>according to ISO 10993-1 and FDA Guidance "Use of International<br>Standard ISO 10993-1, "Biological evaluation of medical devices -<br>Part 1: Evaluation and testing within a risk management process"".<br>Tests in accordance with following standards were conducted<br>based on contact type and duration:<br>✓ ISO 10993-1:2009/(R)2013<br>✓ ISO 10993-5:2009/(R)2014<br>✓ ISO 10993-10:2010/(R)2014<br>✓ ISO 10993-11:2006/(R) 2010<br>✓ ISO 10993-12:2012 | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Sterilization Validation Summary<br>The CMOS Video Esophagoscope SSU is provided sterile and does<br>not require user reprocessing. The subject device is validated to be<br>sterilized with EO in accordance with validated sterilization cycle<br>"6.Storz". Sterilization validation is in compliance with the<br>following standard:<br>✓ ANSI AAMI ISO 11135:2014 | | | Software Verification and Validation Summary<br>Software verification and validation testing were conducted, and<br>documentation was provided as recommended by FDA's Guidance<br>for Industry and FDA Staff, "Guidance for the Content of Premarket<br>Submissions for Software Contained in Medical Devices", issued on<br>May 11, 2005. The software for this device was considered as a<br>"minor" level of concern, since a failure or latent flaw in the<br>software is unlikely to cause any injury to the patient or operator. | | | Clinical Performance Data: | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate device. Non-clinical bench testing and<br>labeling were sufficient to establish the substantial equivalence of<br>the modifications. | | Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that<br>the subject device, the CMOS Video Esophagoscope SSU is<br>substantially equivalent to the predicate device, that is currently<br>marketed for the same intended use. |