aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8

K210883 · Ambu A/S · EOQ · Jun 17, 2021 · Ear, Nose, Throat

Device Facts

• Record ID: K210883
• Device Name: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8
• Applicant: Ambu A/S
• Product Code: EOQ · Ear, Nose, Throat
• Decision Date: Jun 17, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.4680
• Device Class: Class 2

Intended Use

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.

Device Story

Sterile, single-use flexible endoscope with integrated sample container (aScope BronchoSampler); used for airway/tracheobronchial tree examination and fluid aspiration (BAL/BW). Device features maneuverable tip, insertion cord, distal camera, and LED light source. Operated by clinicians in hospital settings; connects to Ambu Displaying Unit for real-time visualization. BronchoSampler attaches to endoscope handle to facilitate fluid collection. Provides direct visualization to guide procedures and enables diagnostic sample acquisition. Benefits include reduced cross-contamination risk due to single-use design and streamlined workflow for specimen collection.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including ISO 8600-1/3/4 (endoscope performance), EN 14254 (receptacles), IEC 60601-1/2-18 (electrical safety), and IEC 60601-1-2 (EMC).

Technological Characteristics

Single-use flexible video endoscope; distal camera and LED illumination; suction functionality. Sterilized via Ethylene Oxide. Complies with ISO 8600-1, ISO 8600-3, ISO 8600-4, IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2. Connects to external Ambu Displaying Unit.

Indications for Use

Indicated for endoscopic procedures and examination of the airways and tracheobronchial tree in adults in a hospital environment, including aspiration of fluid samples during BAL or BW procedures.

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)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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/S<br>Baltorpbakken 13<br>DK-2750 Ballerup<br>Denmark<br>Tel.: [phone]<br>Fax.: [phone] | | | |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|-------------------------------------------------|-------------|
| Contact Person | Name: Gurpreet Kaur Rehal<br>Job Title: Regulatory Affairs Professional<br>Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup<br>Telephone number: [phone]<br>Fax number: [phone] | | | |
| Date Summary<br>Prepared | March, 23, 2021 | | | |
| 510(k) no. | K210883 | | | |
| Device Trade<br>Name | Ambu® aScope™ 4 Broncho Regular Sampler Set 5.0/2.2<br>Ambu® aScope™ 4 Broncho Large Sampler Set 5.8/2.8 | | | |
| Device Common<br>Name | Flexible Endoscope and Specimen Sampling System - Single Use | | | |
| 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 | Predicate<br>A: | Manufacturer | Trade Name | 510k number |
| | | Ambu A/S | Ambu® aScope™ 4<br>Broncho Regular and<br>Large | K173727 |

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| Description of the Device | The Ambu® aScope™ 4 Broncho Sampler Set consists of:<br>• aScope 4 Regular/Large endoscope<br>• aScope BronchoSampler ™<br><br>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.<br><br>Ambu® aScope™ 4 Broncho Sampler Set has the following physical and performance characteristics:<br>• Maneuverable tip controlled by the user<br>• Flexible insertion cord<br>• Camera and LED light source at the distal tip<br>• Sterilized by Ethylene Oxide<br>• For single use<br>• Enables aspiration and sample collection in BAL and BW procedures<br><br>The differences between the endoscope sizes are as follows:<br>• Distal end outer diameter<br>• Insertion tube outer diameter<br>• Working channel inner diameter<br>• 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.<br><br>It is designed for use in adults and intended for use in a hospital environment.<br><br>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:<br>• They are all single-use devices delivered sterile.<br>• They are all flexible endoscopes with a maneuverable tip.<br>• They are all video endoscopes with a camera located in the distal tip to provide an image on a separate displaying unit.<br>• They all provide illumination from the distal tip.<br>• They all have suction functionality<br>• They all have the same insertion tube working length |
| | They all have equivalent inner and outer diameters in their<br>corresponding sizes.<br>The endoscope of Ambu® aScope™ 4 Broncho Sampler Set differs from<br>the predicate device A in the following areas:<br>Bronchosampler is added in Ambu® aScope™ 4 Broncho Sampler<br>Set which can be attached to the handle of the endoscope. |
| Performance<br>Data -Bench | The following data are described for the product line extension Ambu®<br>aScope™ 4 Broncho Sampler Set in the premarket notification: |
| | Declaration of Conformity with the product specific standards ISO<br>8600-1, 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 EN<br>14254 |
| | Result: All tests were passed. |
| Performance<br>Data - Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics,<br>performance data and comparison to predicate device it has been<br>concluded that the functionality and intended use of Ambu® aScope™ 4<br>Broncho Sampler Set is substantially equivalent to the predicate device.<br>It is concluded that Ambu® aScope™ 4 Broncho Sampler Set is as safe<br>and as effective and performs as well as the predicate device. |

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