aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.

It is designed for use in adults and intended for use in a hospital environment.

It is intended to provide visualization via Ambu Displaying Unit.

Device Description

The Ambu® aScope™ 4 Broncho Sampler Set consists of:
• aScope 4 Regular/Large endoscope
• aScope BronchoSampler ™

Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.

Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:
• Maneuverable tip controlled by the user
• Flexible insertion cord
• Camera and LED light source at the distal tip
• Sterilized by Ethylene Oxide
• For single use
• Enables aspiration and sample collection in BAL and BW procedures

The differences between the endoscope sizes are as follows:
• Distal end outer diameter
• Insertion tube outer diameter
• Working channel inner diameter
• Angulation range

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML performance. The document is a 510(k) summary for the Ambu® aScope™ 4 Broncho Sampler Set, which is a medical device, but it is not an AI/ML powered device.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to a predicate device through bench testing for physical and performance characteristics, sterility, electrical safety, and electromagnetic compatibility. It explicitly states "Not applicable" for clinical performance data.

Summary

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June 17, 2021

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

Re: K210883

Trade/Device Name: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: May 17, 2021 Received: May 18, 2021

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/cdrl/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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Shu-Chen Peng 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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Indications for Use

510(k) Number (if known) K210883

Device Name

Ambu® aScope™ 4 Broncho Regular Sampler Set 5.0/2.2 Ambu® aScope™ 4 Broncho Large Sampler Set 5.8/2.8

Indications for Use (Describe)

aScope 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration of fluid sample(s) from the bronchial or alveolar part of the lung.

It is designed for use in adults and intended for use in a hospital environment.

It is intended to provide visualization via Ambu Displaying Unit.

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)

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510(k) Summary

This Special 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/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050
Contact Person	Name: Gurpreet Kaur RehalJob Title: Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2116Fax number: +45 7225 2050
Date SummaryPrepared	March, 23, 2021
510(k) no.	K210883
Device TradeName	Ambu® aScope™ 4 Broncho Regular Sampler Set 5.0/2.2Ambu® aScope™ 4 Broncho Large Sampler Set 5.8/2.8
Device CommonName	Flexible Endoscope and Specimen Sampling System - Single Use
DeviceClassification	Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II
LegallyMarketeddevices to whichthe device issubstantiallyequivalent	PredicateA:	Manufacturer	Trade Name	510k number
		Ambu A/S	Ambu® aScope™ 4Broncho Regular andLarge	K173727

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Description of the Device	The Ambu® aScope™ 4 Broncho Sampler Set consists of:• aScope 4 Regular/Large endoscope• aScope BronchoSampler ™Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. Both of the aScope 4 Broncho and BronchoSampler are already marketed separately.Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:• Maneuverable tip controlled by the user• Flexible insertion cord• Camera and LED light source at the distal tip• Sterilized by Ethylene Oxide• For single use• Enables aspiration and sample collection in BAL and BW proceduresThe differences between the endoscope sizes are as follows:• Distal end outer diameter• Insertion tube outer diameter• Working channel inner diameter• Angulation range
Indications for Use	Ambu® aScope™ 4 Broncho Sampler Set consists of sterile, single use, flexible endoscope with sample containers (aScope BronchoSampler), intended for endoscopic procedures and examination within the airways and tracheobronchial tree. aScope BronchoSampler is designed as an add-on to aScope 4 Broncho during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedure which enables aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung.It is designed for use in adults and intended for use in a hospital environment.It is intended to provide visualization via Ambu Displaying Unit.
Summary of the technological characteristics in comparison to the predicate devices	The endoscope of Ambu® aScope™ 4 Broncho Sampler Set is similar to the predicate device A in the following areas:• They are all single-use devices delivered sterile.• They are all flexible endoscopes with a maneuverable tip.• They are all video endoscopes with a camera located in the distal tip to provide an image on a separate displaying unit.• They all provide illumination from the distal tip.• They all have suction functionality• They all have the same insertion tube working length
	They all have equivalent inner and outer diameters in theircorresponding sizes.The endoscope of Ambu® aScope™ 4 Broncho Sampler Set differs fromthe predicate device A in the following areas:Bronchosampler is added in Ambu® aScope™ 4 Broncho SamplerSet which can be attached to the handle of the endoscope.
PerformanceData -Bench	The following data are described for the product line extension Ambu®aScope™ 4 Broncho Sampler Set in the premarket notification:
	Declaration of Conformity with the product specific standards ISO8600-1, ISO 8600-3 and ISO 8600-4Aging performance testSterile Packaging IntegrityElectromagnetic Compatibility according to IEC 60601-1-2Electrical Safety according to IEC 60601-1 and IEC 60601-2-18.Performance test for Single-use receptacles according to EN14254
	Result: All tests were passed.
PerformanceData - Clinical	Not applicable.
Conclusion	Based on the indication for use, technological characteristics,performance data and comparison to predicate device it has beenconcluded that the functionality and intended use of Ambu® aScope™ 4Broncho Sampler Set is substantially equivalent to the predicate device.It is concluded that Ambu® aScope™ 4 Broncho Sampler Set is as safeand as effective and performs as well as the predicate device.

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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.