Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2

{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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. July 25, 2022 Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045 Re: K220606 Trade/Device Name: Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2. Ambu aBox 2 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: June 21, 2022 Received: June 22, 2022 Dear Sanjay Parikh: 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. Although this letter refers to your product as a device, please be aware 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. {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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. for Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT 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) K220606 Device Name Ambu® aScope™ 5 Broncho HD 5.0/2.2 Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aBox™ 2 #### Indications for Use (Describe) Ambu@ aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. Ambu@ aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu® displaying unit, and to allow passing endotherapy instruments via its working channel. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices | 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. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K220606 510(k) Summary This traditional 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summery has been prepared in accordance with 21 CFR 807.92. | Submitter | Ambu A/S<br>Baltorpbakken 13<br>DK-2750 Ballerup<br>Denmark<br>Tel.: +45 7225 2000<br>Fax: +45 7225 2050 | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person | Name: Gurpreet Kaur Rehal<br>Job Title: Senior Regulatory Affairs Professional<br>Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup<br>Telephone number: +45 7225 2116<br>Fax number: +45 7225 2050 | | | Date Summary<br>Prepared | March, 01, 2022 | | | Device Trade<br>Name | Ambu® aScope™ 5 Broncho HD 5.0/2.2<br>Ambu® aScope™ 5 Broncho HD 5.6/2.8<br>Ambu® aBox™ 2 | | | Device Common<br>Name | Endoscopy system | | | Device<br>Classification | Ambu® aScope™ 5 Broncho HD:<br>Bronchoscope (flexible or rigid)<br>and accessories<br>Product Codes: EOQ<br>21 CFR 874.4680<br>Class II | Ambu® aBox™ 2:<br>Bronchoscope (flexible or rigid)<br>and accessories<br>Product Codes: EOQ<br>21 CFR 876.4680<br>Class II | | Legally<br>Marketed<br>devices to which<br>the device is<br>substantially<br>equivalent | Predicate Device A:<br>Ambu® aScope™ 4 Broncho<br>Regular and Large<br>K173727<br>Reference Device B:<br>OLYMPUS EVIS EXERA III<br>Bronchovideoscope BF-H190<br>K121959 | Predicate Device:<br>OLYMPUS EXERA II Light Source<br>(CLV-180) and Video System<br>Center (CV-180)<br>K061313 | | Description of<br>the Device | The Ambu aScope 5 Broncho HD System is a combination of the<br>displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the<br>Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho<br>HD 5.6/2.8<br><br>The Ambu aScope 5 Broncho HD endoscopes are single-use<br>endoscopes designed to be used with Ambu displaying units,<br>endotherapy instruments and other ancillary equipment for endoscopy<br>within the airways and tracheobronchial tree.<br><br>The insertion portion is inserted into the patient airway through the<br>mouth, nose, or a tracheostomy. It is lubricated with a water-soluble<br>medical grade lubricant to ensure the lowest possible friction when<br>inserted into the patient. There is a working channel system within the<br>endoscope for use with endotherapy instruments. An introducer (luer<br>lock adaptor), which is supplied together with the endoscope, can be<br>attached to the working channel port during use. Suctioning of blood,<br>saliva, and mucus from the airway is possible through the suction<br>system.<br><br>Ambu aScope 5 Bronco HD features an integrated camera module,<br>with built-in dual LED illumination. The image module provides a<br>cropped 800x800 Pixels signal from the 1280x800 (1 megapixel)<br>sensor.<br><br>The Ambu aBox 2, also referred to as displaying unit, is a non-sterile<br>digital monitor intended to display live imaging data from Ambu<br>visualization devices. The product consists of a base unit with a 12.8"<br>LCD screen mounted on the top. The device is powered by an<br>integrated power supply and comes with country specific power<br>cables.<br><br>Ambu® aBox 2 displaying unit has the following physical and<br>performance characteristics:<br>Displays the image from Ambu® aScope™ 5 Broncho HD endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 5 Broncho HD endoscope. Can connect to an external monitor. Reusable device | | | Intended<br>use/Indications<br>for use | Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.<br><br>Ambu® aScope™ 5 Broncho HD is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing endotherapy instruments via its working channel.<br><br>The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices. | | | Summary of the<br>technological<br>characteristics<br>in comparison to<br>the predicate<br>devices | The Ambu® aScope™ 5 Broncho HD and the predicate device, Ambu®<br>aScope™ 4 Broncho are single-use devices.<br>Both devices share similar technological characteristics such as optical<br>system, bending section, diameter of insertion cord & distal end and<br>insertion portion length.<br>Furthermore, they have the following same technical characteristics: | | | | Both have maneuverable tip controlled by the user Both have flexible insertion cord Both have camera and LED light source at the distal tip Both are sterilized by Ethylene Oxide Both are single use devices Both devices enable aspiration and sample collection in BAL and BW procedures | | | | The differences between the Ambu® aScope™ 5 Broncho HD and the<br>predicate device are as follows: | | | | Ambu® aScope™ 5 Broncho HD has a rotary function as the reference device Ambu® aScope™ 5 Broncho HD has two endoscope buttons as the reference device | | | | The Ambu® aBox™ 2 and its predicate device have the following same<br>technological characteristics: | | | | Both are video processors displaying live video-imaging data of the connected visualization device to a monitor. Both provide video output formats, recording and data storage and data transport functions. Both share certain technical functionalities as brightness control, image contrast and sharpness adjustment and zoom function. Contrary to the predicate device, the Ambu® aBox™ 2 is portable and has an integrated monitor, therefore, an external monitor is not necessary. | | | Performance<br>Data -Bench | The following tests to verify the design and evaluate the performance of the Ambu® aScope™ 5 Broncho HD system were done. | | | | Performance requirements evaluated in accordance with the ISO 8600 series. ISO 8600-1:2015 Endoscopes - Medical endoscopes and endotherapy devices - Part 1: General requirements ISO 8600-3:2019 Optics and optical instruments - Medical endoscopes and certain accessories - Part 3: Determination of field of view and direction of view of endoscopes with optics ISO 8600-4:2014 Endoscopes - Medical endoscopes and endotherapy devices - Determination of maximum width of insertion portion ISO 8600-5:2005 Optics and photonics - Medical endoscopes and endotherapy devices - Part 5: Determination of optical resolution of rigid endoscopes with optics ISO 8600-6:2020 Optics and photonics - Medical endoscopes and endotherapy devices - Part 6: Vocabulary | | {4}------------------------------------------------ {5}------------------------------------------------ {6}------------------------------------------------ Result: All tests passed. Performance test reports to document the following properties: - Field of view ● - . Direction of view - Depth of Field ● - Insertion cord dimensions - Suction performance . - . Bending performance - . Duration of use Result: All tests passed. - Performance test reports to document shelf life. Tests were performed on finished, sterilized, and aged products: . Performance tests . Sterile packaging integrity Result: All tests passed. Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization, and systemic toxicity: Cytotoxicity (ISO 10993-5) . Irritation (ISO 10993-23) . Sensitization (ISO 10993-10) ● Systemic toxicity test (ISO 10993-11) . Result: All tests passed. Test reports that verify the Electromagnetic Compatibility and Electrical Safety: ● Electromagnetic Compatibility in compliance with IEC 60601-1-2 Electrical Safety in compliance with IEC 60601-1 and IEC ● 60601-2-18 Result: All tests passed. In all instances, the Ambu® aScope™ 5 Broncho HD system performed as expected and met the test specifications set. Conclusion The Ambu® aScope™ 5 Broncho HD system, consisting of Ambu® aScope™ 5 Broncho HD and Ambu® aBox™ 2, has the same intended use and indications for use, and similar technological characteristics and principles of operation as their predicate devices. The minor technological differences between the Ambu® aScope™ 5 Broncho HD system and its predicate devices raise no new concerns regarding safety or effectiveness. Therefore, it is concluded that Ambu® aScope™ 5 Broncho HD system consisting of Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8 and Ambu® aBox™ 2 is substantial equivalent to its predicate devices.