Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance

K223299 · Ambu A/S · EOQ · Jun 1, 2023 · Ear, Nose, Throat

Device Facts

• Record ID: K223299
• Device Name: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance
• Applicant: Ambu A/S
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jun 1, 2023
• 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 Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

Device Story

System comprises single-use Ambu® aScope™ 5 Broncho HD endoscope and reusable Ambu® aView™ 2 Advance displaying unit. Endoscope features integrated camera module with dual LED illumination; captures 1280x800 sensor data, outputting 800x800 pixel signal. Insertion portion enters airway via mouth, nose, or tracheostomy; includes working channel for endotherapy instruments and suctioning. Displaying unit (12.8" LCD) processes and displays live imaging data; supports snapshot/video recording, brightness/contrast/sharpness/zoom adjustments, and external monitor connectivity via 3G-SDI/HDMI. Used in clinical settings by healthcare professionals. System benefits include high-definition visualization and integrated workflow for airway procedures.

Clinical Evidence

Bench testing only. Evaluated performance per ISO 8600-1, -3, -4, -5, -6. Verified field of view, direction of view, depth of field, insertion dimensions, suction, bending, duration of use, image uniformity, distortion, resolution, and color. Biocompatibility (ISO 10993-1: cytotoxicity, irritation, sensitization, systemic toxicity) and electrical safety/EMC (IEC 60601-1, 60601-2-18, 60601-1-2) testing passed.

Technological Characteristics

System: single-use flexible endoscope and reusable 12.8" LCD monitor. Endoscope: integrated camera, dual LED illumination, working channel. Monitor: Li-ion battery or power adapter, 3G-SDI/HDMI video outputs. Standards: ISO 8600 series (endoscopes), ISO 10993-1 (biocompatibility), IEC 60601-1/2-18 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

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

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™ 5 Broncho HD 5.0/2.2 (K220606)
• Ambu® aScope™ 5 Broncho HD 5.6/2.8 (K220606)
• Ambu® aBox™ 2 (K220606)

Reference Devices

• Ambu® aView™ (K173727)

Submission Summary (Full Text)

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June 1, 2023

Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045

Re: K223299

Trade/Device Name: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: April 27, 2023 Received: May 1, 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.

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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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Joyce C. Lin -S

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known)

#### K223299

Device Name Ambu® aScope™ 5 Broncho HD 5.0/2.2 Ambu® aScope™ 5 Broncho HD 5.6/2.8 Ambu® aView™ 2 Advance

#### 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 Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 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) summary 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.: [phone]<br>Fax.: [phone] | |
|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Magnus Lynge<br>Job Title: Regulatory Affairs Professional<br>Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup<br>Telephone number: [phone] | |
| Date Summary<br>Prepared | April 26th, 2023 | |
| 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® aView™ 2 Advance | |
| Device Common<br>Name | Endoscopy system | |
| Device<br>Classification | Ambu® aScope™ 5 Broncho HD:<br>Bronchoscope (flexible or rigid) and accessories<br>Product Codes: EOQ<br>21 CFR 874.4680<br>Class II | Ambu® aView™ 2 Advance:<br>Bronchoscope (flexible or rigid) and accessories<br>Product Codes: EOQ<br>21 CFR 874.4680<br>Class II |
| Legally Marketed<br>devices to which<br>the device is<br>substantially<br>equivalent | Predicate Device:<br>Ambu® aScope™ 5 Broncho HD 5.0/2.2<br>Ambu® aScope™ 5 Broncho HD 5.6/2.8<br>K220606 | Predicate Device:<br>Ambu® aBox™ 2<br>K220606<br>Reference Device:<br>Ambu® aView™<br>K173727 |
| Description of the<br>Device | The Ambu® aScope™ 5 Broncho HD system is a combination of the<br>displaying unit, Ambu® aView™ 2 Advance, and a compatible Ambu<br>endoscope, the Ambu® aScope™ 5 Broncho HD 5.0/2.2 or the Ambu®<br>aScope™ 5 Broncho HD 5.6/2.8. The Ambu® aScope™ 5 Broncho HD<br>bronchoscopes are the same devices as cleared in K220606. The only<br>change is that the bronchoscopes are now also compatible to<br>Ambu® aView™ 2 Advance. | |
| | 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. | |
| | 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. | |
| | 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. | |
| | The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a<br>non-sterile digital monitor intended to display live imaging data from<br>Ambu visualization devices. The product consists of a 12.8" LCD<br>screen. The device is powered through a Lithium-ion (Li-ion) battery<br>or a separate power adapter. | |
| | Ambu® aView™ 2 Advance displaying unit has the following physical<br>and performance characteristics: | |
| | Displays the image from Ambu® aScope™ 5 Broncho HD<br>•<br>endoscope on the screen.<br>Can record snapshots or video of image from Ambu® aScope™<br>•<br>5 Broncho HD endoscope.<br>• Can connect to an external monitor.<br>• Reusable device. | |
| Intended<br>use/Indications<br>for use | Ambu® aScope™ 5 Broncho HD is intended for endoscopic procedures<br>and examination within the airways and tracheobronchial tree. | |
| | Ambu® aScope™ 5 Broncho HD is intended to provide visualization via<br>a compatible Ambu® displaying unit, and to allow passing endotherapy<br>instruments via its working channel. | |
| | The Ambu® aView™ 2 Advance is intended to display live imaging data<br>from compatible Ambu visualization devices. | |

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| Summary of the technological characteristics in comparison to the predicate devices |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| The Ambu® aScope™ 5 Broncho HD and its predicate device, are identical devices. The only difference is, that now the devices are also compatible with the Ambu® aView™ 2 Advance displaying unit. |
| The subject device Ambu® aView™ 2 Advance and its predicate device, the Ambu® aBox™ 2, have the following same technological characteristics:<br>Both are 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 such as brightness control, image contrast adjustment, live image sharpness adjustment and zoom function. Both have a built-in LCD screen that provides live imaging data from the connected supported visualization device. The LCD screens are identical. |
| The differences between the Ambu® aView™ 2 Advance and the predicate device are as follows:<br>Ambu® aView™ 2 Advance can be hung on an IV pole by means of a bracket. Ambu® aView™ 2 Advance has both 3G-SDI and HDMI video outputs to allow connection with external medical monitors, whereas the predicate device offers the video output through 3G-SDI and DVI. Ambu® aView™ 2 can be powered through a Lithium-ion (Li-ion) battery. |
| Performance Data – Bench |
| The following tests to verify the design and evaluate the performance of the Ambu® aScope™ 5 Broncho HD system were done.<br><br>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 Result: All tests passed. |

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Performance- and comparison 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
- Image Intensity Uniformity
- Geometrical Distortion .
- . Resolution
- Color Performance .

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.

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#### Conclusion The Ambu® aScope™ 5 Broncho HD system, consisting of Ambu® aScope™ 5 Broncho HD and Ambu® aView™ 2 Advance, 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 rnerelory it is concluded that Annual " assope" - 5 Brondho HD System"
E Provincial UD F 6 0 0 - 1 1 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8 and Ambu® aView™ 2 Advance is substantial equivalent to its predicate devices.