KARL STORZ Slim Nasopharyngolaryngoscope

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font. 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171402 Device Name KARL STORZ Slim Nasopharyngolaryngoscope System Indications for Use (Describe) 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. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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: | AnnaLisa Smullin<br>Regulatory Engineer<br>Phone: (424) 218-8376<br>Fax: (424) 218-8519 | | Date of<br>Preparation: | January 30, 2018 | | Type of 510(k)<br>Submission: | Traditional | | Device<br>Identification: | Trade Name: KARL STORZ Slim Nasopharyngolaryngoscope<br>System<br>Classification Name: Nasopharyngoscope (21 CFR Part 874.4760) | | 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<br>Device(s): | Primary Predicate Device: KARL STORZ Endoscopy-America's<br>Karl Storz Rhino-Laryngo-Broncho-Fiberscope (K981458)<br>Secondary Predicate Device: MAHE INTL., INC's MAHE Pediatric<br>Naso Pharyngoscope (K030857)<br>Reference: KARL STORZ Endoscopy-America's KARL STORZ<br>Flexible Video-Neuro-Endoscope System (K161112) | | Device<br>Description: | The KARL STORZ Slim Nasopharyngolaryngoscope (Model<br>Number: 11161V) is a reusable, flexible videoscope used for<br>examination of the nasal lumens and airway anatomy. The KARL<br>STORZ Slim Nasopharyngolaryngoscope System is identical to the | {4}------------------------------------------------ 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 is<br>currently distributed under K161112. | | | | | | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------|--| | Intended Use: | The KARL STORZ Slim Nasopharyngolaryngoscope System is<br>intended for visualization purposes during ENT diagnostic and<br>therapeutic procedures. | | | | | | | Indications For<br>Use: | The KARL STORZ Slim Nasopharyngolaryngoscope System is<br>indicated to provide visualization and access of the nasal lumens and<br>airway anatomy (including nasopharyngeal and trachea) during<br>diagnostic and therapeutic procedures in adult and pediatric patients. | | | | | | | Technological<br>Characteristics: | | Subject Device | Primary<br>Predicate<br>Device,<br>K981458 | Secondary<br>Predicate<br>Device,<br>K030857 | Reference<br>Device,<br>K161112 | | | | | KARL STORZ<br>Slim<br>Nasopharyngo-<br>laryngoscope<br>System | KARL STORZ<br>Rhino-<br>Laryngo-<br>Broncho-<br>Fiberscope | MAHE<br>Pediatric<br>Nasopharyngo-<br>scope | KARL STORZ<br>Flexible Video-<br>Neuro-<br>Endoscope<br>System | | | | | Physical Characteristics | | | | | | | Type of<br>Scope | Flexible | Flexible | Flexible | Flexible | | | | Distal Tip<br>Diameter | 8.5 Fr, 2.83 mm<br>(elliptical:<br>3.2 mm x 2.4 mm) | 3.5 mm | 2.8 mm | 8.5 Fr, 2.83 mm<br>(elliptical:<br>3.2 mm x 2.4 mm) | | | | Working<br>Shaft<br>Length | 350 mm | 340 mm | 300 mm | 350 mm | | | | Working<br>Channel<br>Diameter | 1.2 mm | 1.2 mm | No working<br>channel | 1.2 mm | | | | Deflection<br>(°) | Up: 270°<br>Down: 270° | Up: 180°<br>Down: 100° | Up: 120°<br>Down: 100° | Up: 270°<br>Down: 270° | | | | Optical Characteristics | | | | | | | | Type of<br>Imager | CMOS chip | Fiberscope | Fiberscope | CMOS chip | | | | Field of<br>View | 90° | 85° | 95° | 90° | | | | Direction of<br>View | 0° | 0° | 0° | 0° | | | | Light<br>Source | Internal LED | External Xenon | External LED | Internal LED | | | | Cleaning and Sterilization Methods | | | | | | | | Cleaning | Manual | Manual | Manual | Manual | | | | Sterilization | - STERRAD NX<br>- STERRAD<br>100NX<br>- STERIS<br>SYSTEM 1E<br>- V-PRO maX<br>- V-PRO 60<br>- EtO | - EtO | Unknown | - STERRAD NX<br>- STERRAD<br>100NX<br>- STERIS<br>SYSTEM 1E<br>- V-PRO maX<br>- V-PRO 60<br>- EtO | | | | HLD | - CIDEX | - CIDEX | Unknown | No HLD | | {5}------------------------------------------------ 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-Clinical<br>Performance<br>Data: | Electrical Safety and Electromagnetic Compatibility Summary<br>The device design, including the electrical safety and<br>electromagnetic compatibility (EMC), has not changed since<br>clearance of the reference device, the KARL STORZ Flexible Video-<br>Neuro-Endoscope System in K161112. The electrical safety and<br>EMC data submitted in K161112 was in compliance with the<br>following FDA recognized standards:<br>• ANSI/AAMI ES 60601-1:2005 (Recognition Number: 19-4)<br>• IEC 60601-1-2:2007 (Recognition Number: 19-8)<br>As the subject device remains identical to the reference device, no<br>additional electrical safety or EMC data is needed for the KARL<br>STORZ Slim Nasopharyngolaryngoscope System.<br><br>Bench Testing Summary<br>The device design, including the performance has not changed since<br>clearance of the reference device, the KARL STORZ Flexible Video-<br>Neuro-Endoscope System in K161112. The performance data<br>submitted in K161112 was in compliance with the following FDA<br>recognized standards:<br>• ISO 8600-1: Fourth edition: 2015-10-15 (Recognition<br>Number: 9-110)<br>• ISO 8600-3: First edition: 1997-07-01 (Recognition Number:<br>9-84)<br>• ISO 8600-4: Second edition: 2014-03-15 (Recognition<br>Number: 9-94)<br>As the subject device remains identical to the reference device, no<br>additional performance data is needed for the KARL STORZ Slim<br>Nasopharyngolaryngoscope System.<br><br>Biocompatibility Summary<br>The device design, including the materials, has not changed since<br>clearance of the reference device, the KARL STORZ Flexible Video-<br>Neuro-Endoscope System in K161112.The Biological Evaluation<br>data submitted in K161112 was in compliance with the following<br>FDA recognized standards:<br>• ISO 10993-1:2009/(R) 2013 (Recognition Number: 2-156)<br>• ISO 10993-5:2009/ (R) 2014 (Recognition Number: 2-153)<br>• ISO 10993-10:2010 (Recognition Number: 2-173)<br>• ISO 10993-11:2006/ (R) 2010 (Recognition Number: 2-118)<br>As the subject device remains identical to the reference device, no<br>additional biological evaluation data is needed for the KARL<br>STORZ Slim Nasopharyngolaryngoscope System. | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | High Level Disinfection (HLD) Summary | | | The reference device, the KARL STORZ Flexible Video-Neuro-<br>Endoscope System (K161112), is a critical device per Spaulding<br>Classification, whereas the subject device is a semi-critical device,<br>requiring a thorough cleaning followed by sterilization or high level<br>disinfection (HLD). In order to support an additional HLD method<br>(CIDEX), a new HLD validation study was performed using a<br>representative device. The HLD data submitted was in compliance<br>with the following FDA standards. Where applicable, FDA standard<br>recognition numbers are noted:<br>• AAMI TIR12: 2010<br>• ISO 15883-5:2005<br>• AAMI TIR30:2011<br>• AAMI/ANSI/ISO 11737-1:2006/ (R)2011 (Recognition<br>Number: 14-227)<br>• ASTM E1837-96:2014 | | Clinical<br>Performance<br>Data: | Clinical testing was not required to demonstrate substantial<br>equivalence to the predicate devices. Non-clinical bench testing was<br>sufficient to establish the substantial equivalence of the<br>modifications. | | Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that<br>the subject device, KARL STORZ Slim Nasopharyngolaryngoscope<br>System performs as well as or better than the legally marketed<br>predicate devices. | {6}------------------------------------------------ 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.