AED Sinuscope

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Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {1}------------------------------------------------ ## 510(K) Summary #### General Information | Preparation Date: | June 23, 2017 | |-------------------|--------------------------------------------------------------------| | Owner's Name: | National Advanced Endoscopy Devices, Inc.<br>Registration: 9027397 | | Address: | 22134 Sherman Way | USA Telephone Number: Fax Number: Contact Person: #### Subject Device Name: Trade Name Common/Usual Name: Classification Name: | | 21 CFR 874.4760; Class II | | |-------------------------|-------------------------------------------------------------|--| | Predicate Device Name: | Schoelly Sinuscope | | | Trade Name: | Schoelly Sinuscope | | | Common/Usual Name: | Sinuscope | | | Classification Name: | EOB- Nasopharyngoscope (flexible or rigid) and accessories | | | | 21 CFR 874.4760; Class II | | | Premarket Notification: | K142249, Schoelly Fiberoptic GmbH, SE date January 27, 2015 | | EOB- Nasopharyngoscope (flexible or rigid) and accessories Canoga Park, CA 91303 (818) 227-2720 (818) 227-2724 AED Sinuscope AED Sinuscope Sinuscope Gayle Butler # Premarket Notification: ## Device Description: ## 5700 Series AED Sinuscopes 5700A AED Sinuscope 4.0mm diameter, 0° Angle of View, 175mm working length 5700AXS AED Sinuscope 4.0mm diameter, 0° Angle of View, 50mm working length 5700BAED Sinuscope 4.0mm diameter, 30° Angle of View, 175mm working length 5700CAED Sinuscope 4.0mm diameter, 70° Angle of View, 175mm working length 5700F AED Sinuscope 4.0mm diameter, 45° Angle of View, 175mm working length {2}------------------------------------------------ ### 5727 Series AED Sinuscopes - 5727A AED Sinuscope 2.7mm diameter, 00 Angle of View, 175mm working length 5727AX AED Sinuscope 2.7mm diameter, 0° Angle of View, 100mm working length 5727AXS AED Sinuscope 2.7mm diameter, 0° Angle of View, 50mm working length 5727BAED Sinuscope 2.7mm diameter, 30° Angle of View, 175mm working length 5727BS AED Sinuscope 2.7mm diameter, 30° Angle of View, 100mm working length #### 8800 Series AED Sinuscopes 8800A AED Sinuscope 4.0mm diameter, 0° Angle of View, 175mm working length 8800AXS AED Sinuscope 4.0mm diameter, 0° Angle of View, 50mm working length 8800BAED Sinuscope 4.0mm diameter, 30° Angle of View, 175mm working length 8800CAED Sinuscope 4.0mm diameter, 70° Angle of View, 175mm working length 8800F AED Sinuscope 4.0mm diameter. 45° Angle of View. 175mm working length #### 8827 Series AED Sinuscopes 8827A AED Sinuscope 2.7mm diameter, 0° Angle of View, 175mm working length 8827AX AED Sinuscope 2.7mm diameter, 0° Angle of View, 100mm working length 8827AXS AED Sinuscope 2.7mm diameter, 0° Angle of View, 50mm working length 8827BAED Sinuscope 2.7mm diameter, 30° Angle of View, 175mm working length {3}------------------------------------------------ 8827BS AED Sinuscope 2.7mm diameter, 30° Angle of View, 100mm working length The AED Sinuscope is a reusable rod lens sinuscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem. AED Sinuscopes are manufactured in multiple configurations that differ in insertion tube outer diameter and working length and with respect to optical parameters (direction of view, field of view). The AED Sinuscope is reusable and provided non-sterile. It must be cleaned and sterilized prior to use. ## Technological Characteristics To view the sinus and nasal passages the distal end of the sinuscope with a light source attached is passed into a nasal passage. Images are transmitted to the eyepiece which is typically attached to a camera so the images received through the sinuscope can be displayed on a video screen. Technical parameters of the AED Sinuscope are characterized by the optical view -Direction of View (0° - 70°) and the Field of View (70°). The AED Sinuscopes are available in two different lengths for the insertion tube: 4mm diameter and 2.7mm diameters with working lengths that vary from 50mm, 100mm and 175mm. The AED Sinuscope differs from the predicate device Schoelly Sinuscope (K142249): - . The Schoelly Sinuscope comes in a 2.0mm as well as 2.7mm and 4.0mm diameters. The AED Sinuscope comes in 2.7mm and 4.0mm diameters. - The Schoelly Sinuscope comes in 110mm, 175mm and 187mm working . lengths. The AED Sinuscope comes in 50mm, 100mm and 175mm working lengths. The different diameters and workings lengths do not change the same basic design or use of the AED Sinuscope. The same basic mechanical design, operating principles and indications for use are the same for both devices. A detailed comparison of the technological characteristics with the predicate device is shown in the table below: {4}------------------------------------------------ | Attribute | Proposed<br>Device<br>(current Submission) | Predicate<br>Device<br>K142249 | |---------------------------------|-------------------------------------------------------------|-------------------------------------------------------------| | Light<br>Transmission | Fiberoptics | Fiberoptics | | Light Source | External, connected via light post to light guide connector | External, connected via light post to light guide connector | | Image<br>Transmission | Rigid Rod Lens | Rigid Rod Lens | | Diameter | 4mm, 2.7mm | 4mm, 2.7mm, 2.0mm | | Direction of View | 0° - 70° | 0° - 70° | | Field of View | 70° | 80° - 100° | | Image Display | Camera/monitor connected via the eyepiece of the sinuscope | Camera/monitor connected via the eyepiece of the sinuscope | | Working Length | 50mm, 100mm, 175mm | 110mm, 175mm, 187mm | | Working<br>Channel | None | None | | Single Use/Reusable | Reusable | Reusable | | Reprocessing | Cleaning, sterilization (steam) | Cleaning, sterilization (steam, STERRAD®) | | Materials | | | | Insertion Tube (outer surface) | stainless steel | stainless steel | | Insertion Part (distal surface) | stainless steel, glass | stainless steel, glass | | Fiberoptics | glass/acrylic | glass/acrylic | | Lens bonding | epoxy | epoxy | | Temperature Testing | IEC 60601-2-18 compliant | IEC 60601-2-18 complaint | | Packaging | Case with foam insert | Case with foam insert | # Technological Characteristics of the Proposed Device and the Predicate Device # Indications for Use The AED Sinuscope is intended for use in otolaryngology and Head and Neck procedures, including rhinology, and endoscopic plastic and reconstructive surgery. {5}------------------------------------------------ ## Non-clinical Performance Testing Temperature testing: The device was measured for surface temperatures at various locations over time and found to meet the requirements specified in IEC 60601-2-18: Medical Electrical Equipment - Part 2: Particular Requirements For The Basic Safety And Essential Performance Of Endoscopic Equipment. Edition 3.0 2009-08 Optical parameter testing: The device was tested for all relevant optical parameters and found to meet the minimum requirements defined in internal specifications and as specified in the ISO 8600-3:1997 and ISO 8600-3: Amendment 1: 2003 standards (field of view, direction of view ). # Reprocessina The AED Sinuscope is the subject of completed reprocessing validations including manual cleaning and steam sterilization. The cleaning study has been performed in accordance with AAMI TIR12:2010 (Designing, Testing and Labeling Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Device Manufacturers), AAMI TIR30:2011 (A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable devices) and FDA Guideline on General Principles of Process Validation, January 2011, Rev 1. The sterilization study has been performed in accordance with ISO 14937:2009 (Sterilization of health care products - General requirements for characterization of sterilizing agent and the development, validation and routine control of a sterilization process for medical devices), ANSI/AAMI/ISO 17665-1:2006 (Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of sterilization process for medical devices),AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing in health care facilities) and ISO 17665-2:2009 (Sterilization of health care products - Moist heat - Part 2: Guidance of the application of ISO 17665-1). ## Conclusion The AED Sinuscope meets all the pre-determined acceptance criteria to demonstrate substantial equivalence to the predicate device. {6}------------------------------------------------ Public Health Service Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with flowing lines suggesting hair or clothing. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 1, 2017 National Advanced Endoscopy Devices. Inc. Gayle Butler Compliance Officer 22134 Sherman Way Canoga Park, CA 91303 Re: K170285 Trade/Device Name: AED Sinuscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: June 29, 2017 Received: July 3, 2017 Dear Gayle Butler: 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. {7}------------------------------------------------ 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, 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