Ambu® aScope 5 Broncho 4.2/2.2 Sampler Set by Ambu A/S

Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

Device Description

The Ambu® aScope™ 5 Broncho Sampler Set consists of:

Ambu® aScope™ 5 Broncho endoscope .
Two Sample Containers (Ambu® aScope BronchoSampler™ 60 SC)
Suction Connection Tube (SCT)
Bronchoscope Attachment Part (BAP)
2 Luer lock adapters (Introducers) .

Ambu® aScope™ 5 Broncho is currently being sold on its own as a sterile, single use, flexible endoscope intended for endoscopic procedures and examination within the airways and tracheobronchial tree (K230428).

The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.

The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.

BronchoSampler 60 is a sterile, single-use medical component designed as an accessory to aScope™ 5 Broncho single-use endoscopes. It is used for fluid sampling in bronchoscopic procedures such as 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.

The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.

The Bronchoscope Attachment Part (BAP) is inserted into the suction pathway between the Ambu® aScope™ 5 Broncho endoscope and the vacuum source. It functions to maintain the connections and the controls for the suction pathway and the Ambu® aScope BronchoSampler™ 60 SC, where the aspirated sample is stored.

The Suction Connection Tube (SCT) facilitates connection to suction tubing.

The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.

Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:

Maneuverable Ambu® aScope™ 5 Broncho endoscope tip controlled by the user
Flexible Ambu® aScope™ 5 Broncho endoscope insertion cord
Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
Sterilized by Ethylene Oxide
For single use
Enables aspiration and sample collection in BAL and BW procedures

AI/ML Overview

The provided document is a 510(k) summary for the Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new device's performance benchmarks. Therefore, many of the requested categories are "Not Applicable" or information is unavailable from this document.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed performance results in the format requested for a software device or diagnostic tool. Instead, it lists types of bench testing performed to verify design input requirements related to safety and functionality due to the addition of sampling functionality.

Acceptance Criteria Category	Reported Device Performance / Verification Status
Transportation Testing	Performed. Results indicate successful verification.
Packaging Testing	Performed. Results indicate successful verification.
Suction Testing	Performed. Results indicate successful verification.
Connectivity Testing	Performed. Results indicate successful verification.
Basic Function of	Performed. Results indicate successful verification for BronchoSampler 60.
BronchoSampler 60
Biological Evaluation	Performed. Results indicate successful verification (implied to meet biocompatibility/safety standards).
Sterilization Validation	Performed. Results indicate successful verification (ensuring sterility for single-use device).
Overall Conclusion	All requirements are verified successfully. The device has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not specified. The document only mentions "bench testing" without detailing the number of units or tests conducted for each category.
Data Provenance: The testing was "bench testing," meaning it was conducted in a laboratory setting, likely at the manufacturer's facility (Ambu A/S, Denmark) or a contracted lab. The data is prospective in the sense that the tests were designed and executed to verify the new product's performance.

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

Not applicable. This device is a medical instrument (bronchoscope and sampling set), not an AI/diagnostic software. Ground truth in this context would refer to objective physical and chemical measurements or engineering standards, not expert medical consensus on images or data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth from multiple expert opinions, which is not relevant for bench testing of a physical medical device.

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

No. This is a physical medical device, not an AI software intended to assist human readers in interpreting cases.

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

Not applicable. This is not an algorithm. The device, as a physical product, operates as described (e.g., provides visualization, allows instrument passing, enables aspiration), and its performance is verified through physical and functional testing.

7. The Type of Ground Truth Used

The ground truth used for bench testing typically involves:

Engineering specifications and design input requirements.
Industry standards (e.g., ISO for biological evaluation, sterilization).
Physical measurements (e.g., suction pressure, flow rates, dimensions).
Functional checks (e.g., maneuverability, connectivity).

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

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

Not applicable. There is no training set for a physical medical device.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

September 20, 2023

Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046

Re: K232582

Trade/Device Name: Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOO Dated: August 25, 2023 Received: August 25, 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,

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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Indications for Use

510(k) Number (if known)

K232582

Device Name

Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set

Indications for Use (Describe)

Ambu® aScope™ 5 Broncho Sampler Set is intended for endoscopic procedures and examination within the airways and tracheobronchial tree.

Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit, and to allow passing of endotherapy instruments via its working channel.

Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

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

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) 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: Eva Lind RasmussenJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, 2750 BallerupTelephone number: Tel.: +45 7225 2000
Date Summary Prepared	August 22, 2023
Device Trade Name	Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set
Device Common Name	Flexible Endoscope and Specimen Sampling System - Single Use
Device Classification	Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II
Legally Marketed devices to which the device is substantially equivalent	Predicate Manufacturer Trade Name 510(k) number Ambu A/S Ambu A/S Ambu® aScope™ 5 Broncho 4.2/2.2 K230428

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Description of
the Device

The Ambu® aScope™ 5 Broncho Sampler Set consists of:

Ambu® aScope™ 5 Broncho endoscope .
Two Sample Containers (Ambu® aScope BronchoSampler™ 60 ટેટો
. Suction Connection Tube (SCT)
. Bronchoscope Attachment Part (BAP)
2 Luer lock adapters (Introducers) .

The Ambu® aScope BronchoSampler™ 60 SC is a 510(k)-exempt device, also sold alone under the trade name Ambu® aScope BronchoSampler™ SC.

The combination of the Ambu® aScope BronchoSampler™ 60 SC, the Bronchoscope Attachment Part (BAP) and Suction Connection Tube (SCT) is collectively referred to as the BronchoSampler 60.

The Ambu® aScope BronchoSampler™ 60 SC can be removed and replaced by the user to support multiple samples being taken during the same procedure.

The Suction Connection Tube (SCT) facilitates connection to suction tubing.

The Ambu® aScope BronchoSampler™ 60 SC plus an additional Sample Container, BAP, SCT and two introducers will be packaged

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and sterilized together with Ambu® aScope™ 5 Broncho endoscope to form a self-contained set, the Ambu® aScope™ 5 Broncho Sampler Set.

Ambu® aScope™ 5 Broncho Sampler Set has the following physical and performance characteristics:

Maneuverable Ambu® aScope™ 5 Broncho endoscope tip . controlled by the user
Flexible Ambu® aScope™ 5 Broncho endoscope insertion . cord
. Camera and LED light source at the distal tip of the Ambu® aScope™ 5 Broncho endoscope
. Sterilized by Ethylene Oxide
. For single use
. Enables aspiration and sample collection in BAL and BW procedures

Indications for	Ambu® aScope™ 5 Broncho Sampler Set is intended for
Use	endoscopic procedures and examination within the airways andtracheobronchial tree.

Ambu® aScope™ 5 Broncho Sampler Set is intended to provide visualization via a compatible Ambu displaying unit and to allow passing of endotherapy instruments via its working channel.

Ambu® aScope™ 5 Broncho Sampler Set enables aspiration and collection of fluid samples.

Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices	The Ambu® aScope™ 5 Broncho endoscope in the Ambu®aScope™ 5 Broncho Sampler Set is identical to the predicatecleared under K230428.Ambu® aScope™ 5 Broncho Sampler Set differs from thepredicate in the following areas:The exempt device, Ambu® aScope BronchoSampler™ 60 SC,BAP, SCT and two introducers are added to the Ambu® aScope™5 Broncho endoscope.Ambu® aScope BronchoSampler™ 60 SC, BAP, SCT and twointroducers are packaged and sterilized together with aScope™ 5Broncho to form a self-contained set, the Ambu® aScope™ 5Broncho Sampler Set.
PerformanceData - Bench	Bench testing has been performed in accordance with ISO 14971 asDesign Verification of those Design Input requirements that arespecified as risk control measures for those risks arising from theaddition of sampling functionality to the endoscope.A summary of the activities carried out to verify the additionalrequirements and identified risks arising from the risk controlmeasures are as follows:• Transportation testing• Packaging testing• Suction Testing• Connectivity testing• Tests for basic function of BronchoSampler 60• Biological evaluation• Sterilization ValidationResult: All requirements are verified successfully.
PerformanceData - Clinical	Not applicable.
Conclusion	The Ambu® aScope™ 5 Broncho Sampler Set has the sameintended use and indications for use, and similar technologicalcharacteristics and principles of operation as the predicate device.The minor differences between the Ambu® aScope™ 5 BronchoSampler Set and its predicate device, namely the addition of the510(k)-exempt device Ambu® aScope BronchoSampler™ 60 SC andthe BAP, SCT and introducers do not raise any new concernsregarding safety or effectiveness.It is concluded that Ambu® aScope™ 5 Broncho Sampler Set issubstantially equivalent to its 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.