Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. August 10, 2023 Ambu A/S % Sanjay Parikh Senior Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046 Re: K230428 Trade/Device Name: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: July 10, 2023 Received: July 11, 2023 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. 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 {1}------------------------------------------------ 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, Image /page/1/Picture/5 description: The image shows the name "Joyce C. Lin -S" in a large, clear font. The text is horizontally aligned and appears to be a name or title. The background is plain, ensuring the text is easily readable. 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number: K230428 Device Name Ambu® aScope™ 5 Broncho 4.2/2.2 Ambu® aScope™ 5 Broncho 2.7/1.2 Ambu® aBox™ 2 Indications for Use (Describe) aScope™ 5 Broncho is intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope™ 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of 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) | | |----------------------------------------------------------------------------------|--------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## 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}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the word "Ambu" in a bold, sans-serif font. The color of the text is a vibrant pink or red. The letters are closely spaced, creating a solid block of text. # 510(k) Summary – Ambu® aScope™ 5 Broncho System This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summary has been prepared in accordance with 21 CFR 807.92. | Submitter | Ambu A/S<br>Baltorpbakken 13<br>2750 Ballerup<br>Denmark<br>Tel.: +45 7225 2000<br>Fax.: +45 7225 2050 | | |-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------| | Contact Person | Name: Karina Matthiesen<br>Job Title: Senior Regulatory Affairs Professional<br>Address: Ambu A/S, Baltorpbakken 13, 2750 Ballerup, Denmark<br>Email: kama@ambu.com<br>Tel.: +45 7225 2000 | | | Date Summary<br>Prepared | August 10, 2023 | | | Device Trade<br>Name | Ambu® aScope™ 5 Broncho 2.7/1.2<br>Ambu® aScope™ 5 Broncho 4.2/2.2<br>Ambu® aBox™ 2 | | | Device Common<br>Name | Endoscopy system | | | Device<br>Classification | Bronchoscope (flexible or rigid) and accessories<br>Product Codes: EOQ<br>21 CFR 874.4680<br>Class II | | | Legally<br>Marketed<br>Devices to which<br>the Device is<br>Substantially<br>Equivalent | Ambu® aScope™ 5 Broncho: | Ambu® aBox™ 2: | | | Predicate Device A (K220606): | Predicate Device A (K220606): | | | Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8 | Ambu® aBox™ 2 | | | Reference Device B (K173727): | | | | Ambu® aScope™ 4 Broncho Slim and Regular | | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Ambu" in a bold, sans-serif font. The color of the text is a vibrant pink or red. The letters are closely spaced, creating a compact and easily readable logo. #### Description of The Ambu® aScope™ 5 Broncho System is a combination of a displaying the Device unit, the Ambu® aBox™ 2, and a compatible endoscope, Ambu® aScope™ 5 Broncho. Ambu® aScope™ 5 Broncho is a sterile, single-use flexible bronchoscope designed to conduct endoscopic procedures and examination of the airways and tracheobronchial tree. The endoscope is available in two size confiqurations: Ambu® aScope™ 5 Broncho 4.2/2.2 and Ambu® aScope™ 5 Broncho 2.7/1.2. Apart from the size, the endoscopes share a similar design. The insertion portion is inserted into the patient airway through the mouth, nose, endotracheal tube, tracheostomy tube, etc. There is a working channel system within the endoscope for use with endotherapy instruments or instillation of fluids. An introducer (luer lock adaptor), which is supplied together with the endoscopes, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from airway is possible through the suction system. Ambu® aScope™ 5 Broncho features an integrated camera module with built-in dual LED illumination. The image module provides a cropped 400x400 pixels signal from the 160 Kpixel sensor. The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables. The Ambu® aBox™ 2 has the following physical and performance characteristics: - Displays the image from Ambu® aScope™ 5 Broncho endoscope . on the screen - . Can record snapshots or video of image from Ambu® aScope™ 5 Broncho endoscope - Can connect to an external monitor . - . Is a reusable device Intended aScope 5 Broncho is intended for endoscopic procedures and examination Use/Indications within the airways and tracheobronchial tree. for Use aScope 5 Broncho is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel. The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Ambu" in a bold, sans-serif font. The letters are a bright pink color. The word is centered and takes up most of the frame. | Summary of the<br>technological<br>characteristics<br>in comparison to<br>the predicate<br>devices | Ambu® aScope™ 5 Broncho and the predicate endoscope, Ambu®<br>aScope™ 5 Broncho HD, are both sterile, single-use flexible<br>bronchoscopes. Furthermore, they share the following technological<br>characteristics:<br>Both devices have a maneuverable tip controlled by the user. Both devices have a camera and LED light source located in the<br>distal tip. Both devices have a rotary function enabling the orientation of<br>camera and working channel in relation to the bronchoscope<br>handle to be altered. Both devices have two endoscope buttons to communicate with<br>the displaying unit. Both devices have a suction system activated by a suction button. Both devices are sterilized by Ethylene Oxide. Both devices are compatible with the displaying unit Ambu®<br>aBox™ 2. | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Ambu® aScope™ 5 Broncho has the same handle as the predicate device,<br>but the insertion portion differs in the following ways:<br>The outer diameter of the insertion portion is smaller than for the<br>predicate device. The working channel is smaller than for the predicate device. Due to the smaller endoscope tip, the camera technology differs<br>from the predicate e.g., lower resolution. | | | The Ambu® aBox™ 2 and the predicate displaying unit share the following<br>technological characteristics:<br>Both are video processors displaying live video-imaging data of<br>the connected visualization device to a monitor. Both provide video output formats, recording and data storage<br>and data transport functions. Both share technical functionalities such as brightness control,<br>image contrast and sharpness adjustment and zoom function. Both are portable and have an integrated monitor in addition to<br>the possibility to connect to an external monitor. The differences between the aBox 2 and the predicate device are as<br>follows:<br>The predicate device aBox 2 is not compatible with the applicant<br>device Ambu aScope 5 Broncho | | Performance<br>Data - Bench | Performance requirements were evaluated in accordance with the ISO<br>8600 series:<br>ISO 8600-1 Endoscopes - Medical endoscopes and endotherapy<br>devices - Part 1: General requirements ISO 8600-3 Endoscopes - Medical endoscopes and endotherapy<br>devices - Part 3: Determination of field of view and direction of<br>view of endoscopes with optics | {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Ambu" in a bold, sans-serif font. The color of the text is a bright pink or red. The letters are closely spaced together, creating a compact and solid appearance. - ISO 8600-4 Endoscopes Medical endoscopes and endotherapy . devices - Part 4: Determination of maximum width of insertion portion The following tests were performed to verify/validate the design and evaluate the performance of the Ambu® aScope™ 5 Broncho System: - . Verification tests including: - o Insertion portion dimensions - Bending performance o - o Suction performance - Duration of use o - . Optical performance tests including: - O Field of view - Direction of view o - Depth of field* o - O Resolution* - Color performance* O - o Image intensity uniformity* - Geometric distortion* O - Photobiological safety according to IEC 62471 ● - Transportation study ● - Sterilization validation according to ISO 11135 - Stability study to document shelf life - Performance tests o - Sterile packaging integrity o - Biocompatibility according to ISO 10993-1 including tests for: ● - Cytotoxicity (ISO 10993-5) O - O Irritation (ISO 10993-23) - Sensitization (ISO 10993-10) o - Electrical Safety and performance according to IEC 60601-1 and . IEC 60601-2-18 - . Electromagnetic Compatibility according to IEC 60601-1-2 The camera technology of Ambu® aScope™ 5 Broncho differs from that the predicate device, however, the different technological of characteristics do not raise different questions of safety or effectiveness. The safety and effectiveness of the applicant device was ensured by comparing the results of the optical performance tests marked with * to reference device, Ambu® aScope™ 4 Broncho, thereby the demonstrating substantial equivalence. Overall, the Ambu® aScope™ 5 Broncho System performed as expected and met the test specifications set. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Ambu" in a bold, sans-serif font. The letters are all capitalized and colored in a bright pink. The word is displayed horizontally and appears to be a logo or brand name. ### Conclusion The Ambu® aScope™ 5 Broncho System, consisting of Ambu® aScope™ 5 Broncho and Ambu® aBox™ 2, has the same intended use/indications for use and similar technological characteristics and principles of operation as the predicate device. The minor technological differences between Ambu® aScope™ 5 Broncho System and its predicate device do not raise any different questions regarding safety or effectiveness. Therefore, it is concluded that the Ambu® aScope™ 5 Broncho System is substantially equivalent to the predicate device.