Who is the manufacturer of Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2?

Ambu A/S filed the 510(k) submission for Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 (K220606).

What is the FDA product code for Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2?

EOQ. It is classified under 21 CFR 874.4680 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2?

Ambu® aScope™ 4 Broncho Regular and Large (K173727); OLYMPUS EXERA II Light Source (CLV-180) and Video System Center (CV-180) (K061313).

Who can help prepare an FDA 510(k) submission like Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

K220606 · Ambu A/S · EOQ · Jul 25, 2022 · Ear, Nose, Throat

Device Facts

Record ID	K220606
Device Name	Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2
Applicant	Ambu A/S
Product Code	EOQ · Ear, Nose, Throat
Decision Date	Jul 25, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4680
Device Class	Class 2

Intended Use

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.

Device Story

System comprises single-use flexible endoscope (aScope 5 Broncho HD) and reusable display unit (aBox 2). Endoscope features integrated camera module with dual LED illumination; captures 1280x800 sensor data, outputting 800x800 cropped signal. Insertion portion enters airway via mouth, nose, or tracheostomy; includes working channel for endotherapy instruments and suction system for fluid removal. aBox 2 displays live video, records snapshots/video, and supports external monitor connection. Used by clinicians in clinical settings for airway visualization and diagnostic/therapeutic procedures. System provides real-time visualization to guide instrument placement and aspiration, facilitating airway management and sample collection.

Clinical Evidence

Bench testing only. Performance evaluated per ISO 8600 series (field of view, depth of field, resolution, etc.), ISO 10993-1 (biocompatibility: cytotoxicity, irritation, sensitization, systemic toxicity), IEC 60601-1, IEC 60601-2-18 (electrical safety), and IEC 60601-1-2 (EMC). All tests passed.

Technological Characteristics

Single-use flexible endoscope with integrated CMOS camera and dual LED illumination. Reusable display unit (aBox 2) with 12.8" LCD. Sterilization via Ethylene Oxide. Complies with ISO 8600, ISO 10993, IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2.

Indications for Use

Indicated for endoscopic procedures and examination within the airways and tracheobronchial tree in patients requiring visualization and/or passage of endotherapy instruments.

Regulatory Classification

Identification

A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.

Predicate Devices

Ambu® aScope™ 4 Broncho Regular and Large (K173727)
OLYMPUS EXERA II Light Source (CLV-180) and Video System Center (CV-180) (K061313)

Reference Devices

OLYMPUS EVIS EXERA III Bronchovideoscope BF-H190 (K121959)

Related Devices

K230428 — Ambu® aScope 5 Broncho 2.7/1.2, Ambu® aScope 5 Broncho 4.2/2.2, Ambu® aBox 2 · Ambu A/S · Aug 10, 2023
K223299 — Ambu® aScope 5 Broncho HD 5.0/2.2, Ambu® aScope 5 Broncho HD 5.6/2.8, Ambu® aView 2 Advance · Ambu A/S · Jun 1, 2023
K233671 — Ambu® aScope 5 Broncho 4.2/2.2; Ambu® aScope 5 Broncho 2.7/1.2; Ambu® aView 2 Advance · Ambu A/S · Jan 4, 2024
K161656 — Ambu aScope 3 Regular 5.0/2.2, Ambu aScope 3 Slim 3.8/1.2, Ambu aScope 3 Large 5.8/2.8, Ambu aView Monitor · Ambu A/S · Sep 1, 2016
K183256 — GlideScope BFlex Single-Use Bronchoscope System · Verathon Medical (Canada) Ulc · Jan 4, 2019

Submission Summary (Full Text)

{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 Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: +45 7225 2000 Fax: +45 7225 2050 | | |----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | Contact Person | Name: Gurpreet Kaur Rehal Job Title: Senior Regulatory Affairs Professional Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup Telephone number: +45 7225 2116 Fax number: +45 7225 2050 | | | Date Summary Prepared | March, 01, 2022 | | | Device Trade Name | Ambu® aScope™ 5 Broncho HD 5.0/2.2 Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aBox™ 2 | | | Device Common Name | Endoscopy system | | | Device Classification | Ambu® aScope™ 5 Broncho HD: Bronchoscope (flexible or rigid) and accessories Product Codes: EOQ 21 CFR 874.4680 Class II | Ambu® aBox™ 2: Bronchoscope (flexible or rigid) and accessories Product Codes: EOQ 21 CFR 876.4680 Class II | | Legally Marketed devices to which the device is substantially equivalent | Predicate Device A: Ambu® aScope™ 4 Broncho Regular and Large K173727 Reference Device B: OLYMPUS EVIS EXERA III Bronchovideoscope BF-H190 K121959 | Predicate Device: OLYMPUS EXERA II Light Source (CLV-180) and Video System Center (CV-180) K061313 | | Description of the Device | The Ambu aScope 5 Broncho HD System is a combination of the displaying unit, Ambu aBox 2, and a compatible Ambu endoscope, the Ambu aScope 5 Broncho HD 5.0/2.2 or the Ambu aScope 5 Broncho HD 5.6/2.8 The Ambu aScope 5 Broncho HD endoscopes are single-use endoscopes designed to be used with Ambu displaying units, endotherapy instruments and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The insertion portion is inserted into the patient airway through the mouth, nose, or a tracheostomy. It is lubricated with a water-soluble medical grade lubricant to ensure the lowest possible friction when inserted into the patient. There is a working channel system within the endoscope for use with endotherapy instruments. An introducer (luer lock adaptor), which is supplied together with the endoscope, can be attached to the working channel port during use. Suctioning of blood, saliva, and mucus from the airway is possible through the suction system. Ambu aScope 5 Bronco HD features an integrated camera module, with built-in dual LED illumination. The image module provides a cropped 800x800 Pixels signal from the 1280x800 (1 megapixel) 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. Ambu® aBox 2 displaying unit has the following physical and performance characteristics: 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 use/Indications for use | 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. | | | Summary of the technological characteristics in comparison to the predicate devices | The Ambu® aScope™ 5 Broncho HD and the predicate device, Ambu® aScope™ 4 Broncho are single-use devices. Both devices share similar technological characteristics such as optical system, bending section, diameter of insertion cord & distal end and insertion portion length. 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 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 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 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.