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.

Device Description

The Ambu® aScope™ 5 Broncho System is a combination of a displaying 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

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and study details for the Ambu® aScope™ 5 Broncho System.

Much of the information requested, particularly regarding specific numerical acceptance criteria and the detailed outcomes of human-in-the-loop studies (MRMC), is not explicitly present in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence through design and performance testing against recognized standards and a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and overall conclusions but does not provide a table with specific numerical acceptance criteria alongside reported numerical performance for each. Instead, it generally states that the device "performed as expected and met the test specifications set."

Acceptance Criteria (General Description)	Reported Device Performance (General Description)
Adherence to ISO 8600-1 (General requirements)	Performed in accordance with ISO 8600-1
Adherence to ISO 8600-3 (Field/Direction of View)	Performed in accordance with ISO 8600-3
Adherence to ISO 8600-4 (Insertion Portion Width)	Performed in accordance with ISO 8600-4
Insertion portion dimensions	Met test specifications
Bending performance	Met test specifications
Suction performance	Met test specifications
Duration of use	Met test specifications
Optical performance (Field of view, Direction of view)	Met test specifications
Optical performance (Depth of field, Resolution, Color performance, Image intensity uniformity, Geometric distortion*)	Results compared to reference device (Ambu® aScope™ 4 Broncho) demonstrating substantial equivalence.
Photobiological safety (IEC 62471)	Met test specifications
Transportation study	Met test specifications
Sterilization validation (ISO 11135)	Met test specifications
Stability study (shelf life, packaging integrity)	Met test specifications
Biocompatibility (ISO 10993-1, -5, -10, -23)	Met test specifications
Electrical Safety and performance (IEC 60601-1, -2-18)	Met test specifications
Electromagnetic Compatibility (IEC 60601-1-2)	Met test specifications

Note: For the optical performance marked with an asterisk, the document states these were compared to a reference device (Ambu® aScope™ 4 Broncho) to demonstrate substantial equivalence, rather than directly stating a specific numerical acceptance criterion was met against a pre-defined threshold.

2. Sample Size for the Test Set and Data Provenance

The document does not specify the sample sizes used for the various performance and verification tests. It lists the types of tests performed (e.g., optical performance tests, mechanical tests) but not the number of units or data points included in each test.

The provenance of the data is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device and the types of tests listed (bench testing, sterilization validation, biocompatibility), these are typically prospective laboratory and bench studies conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The listed tests are primarily objective engineering and performance evaluations. There is no mention of expert human assessment or ground truth establishment in the context of diagnostic performance or clinical interpretation, as this device primarily provides visualization.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The listed tests are primarily objective performance evaluations (e.g., measuring dimensions, suction flow, optical parameters) and do not involve human adjudication for establishing ground truth from subjective observations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned in the document. The device (Ambu® aScope™ 5 Broncho System) is an endoscope and display unit for visualization and therapeutic interventions. Its primary function is to provide images for a clinician to interpret and act upon. The document focuses on the device's technical performance and safety, not on human interpretive performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm-only performance study is not mentioned or applicable. This device is an imaging tool used by a human operator; it does not contain AI algorithms that would operate standalone for diagnostic purposes.

7. The Type of Ground Truth Used

For the various performance tests (e.g., dimensions, optical parameters, suction, electrical safety), the ground truth is established by objective measurements against engineering specifications and international standards (ISO, IEC). These are not clinical "ground truths" in the sense of pathology or outcomes but rather engineering and performance "ground truths" defined by validated measurement methods.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. As explained, this device does not contain AI/ML components that would require a "training set" for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable and therefore not provided, as there is no mention of a training set for an AI/ML algorithm.

Summary

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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

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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

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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)

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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/SBaltorpbakken 132750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050
Contact Person	Name: Karina MatthiesenJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, 2750 Ballerup, DenmarkEmail: kama@ambu.comTel.: +45 7225 2000
Date SummaryPrepared	August 10, 2023
Device TradeName	Ambu® aScope™ 5 Broncho 2.7/1.2Ambu® aScope™ 5 Broncho 4.2/2.2Ambu® aBox™ 2
Device CommonName	Endoscopy system
DeviceClassification	Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II
LegallyMarketedDevices to whichthe Device isSubstantiallyEquivalent	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

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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 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 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.

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Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices	Ambu® aScope™ 5 Broncho and the predicate endoscope, Ambu®aScope™ 5 Broncho HD, are both sterile, single-use flexiblebronchoscopes. Furthermore, they share the following technologicalcharacteristics:Both devices have a maneuverable tip controlled by the user. Both devices have a camera and LED light source located in thedistal tip. Both devices have a rotary function enabling the orientation ofcamera and working channel in relation to the bronchoscopehandle to be altered. Both devices have two endoscope buttons to communicate withthe 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®aBox™ 2.
	Ambu® aScope™ 5 Broncho has the same handle as the predicate device,but the insertion portion differs in the following ways:The outer diameter of the insertion portion is smaller than for thepredicate device. The working channel is smaller than for the predicate device. Due to the smaller endoscope tip, the camera technology differsfrom the predicate e.g., lower resolution.
	The Ambu® aBox™ 2 and the predicate displaying unit share the followingtechnological characteristics:Both are video processors displaying live video-imaging data ofthe connected visualization device to a monitor. Both provide video output formats, recording and data storageand data transport functions. Both share technical functionalities such as brightness control,image contrast and sharpness adjustment and zoom function. Both are portable and have an integrated monitor in addition tothe possibility to connect to an external monitor. The differences between the aBox 2 and the predicate device are asfollows:The predicate device aBox 2 is not compatible with the applicantdevice Ambu aScope 5 Broncho
PerformanceData - Bench	Performance requirements were evaluated in accordance with the ISO8600 series:ISO 8600-1 Endoscopes - Medical endoscopes and endotherapydevices - Part 1: General requirements ISO 8600-3 Endoscopes - Medical endoscopes and endotherapydevices - Part 3: Determination of field of view and direction ofview of endoscopes with optics

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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.

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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.

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
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.(b)
Classification. Class II.