The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.

The aScope 3 system is for use in a hospital environment.

The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:

	Minimum ETT inner diameter	Minimum DLT size
aScope 3 Slim 3.8/1.2	5.0 mm	37 Fr
aScope 3 Regular 5.0/2.2	6.0 mm	41 Fr
aScope 3 Large 5.8/2.8	7.0 mm	-

Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.

Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.

Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.

Device Description

The Ambu® aScope™ 3 System consists of:
Ambu® aScope™ 3 Regular 5.0/2.2
Ambu® aScope™ 3 Slim 3.8/1.2
Ambu® aScope™ 3 Large 5.8/2.8
Ambu® aView™ Monitor

Ambu® aScope™ 3 is a sterile single use flexible bronchoscope and Ambu® aView™ is a reusable monitor.

Ambu® aScope™ 3 endoscopes 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
Working channel
Sterilized by Ethylene Oxide
For single use

The differences between the Ambu® aScope™ 3 endoscope sizes are as follows:
Distal end outer diameter
Insertion tube outer diameter
Working channel inner diameter
Angulation range

Ambu® aView™ Monitor has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ 3 endoscope on the screen.
Can record snapshots or video of image from Ambu® aScope™ 3 endoscope.
Can connect to an external monitor.
Reusable device

AI/ML Overview

The provided document is a 510(k) summary for the Ambu® aScope™ 3 System, which includes flexible bronchoscopes and an associated monitor. It describes the device, its intended use, and a comparison to predicate devices, along with performance data.

However, the document states "Performance Data - Clinical: Not applicable." and focuses primarily on bench testing for the product line extension (Ambu® aScope™ 3 Large). This means that a clinical study to prove device performance in the context of patient outcomes or diagnostic accuracy in a clinical setting, or involving human readers and AI assistance, was not required or provided for this particular submission.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as they relate to clinical performance and AI algorithm evaluation, which are not detailed here.

Here's what can be extracted based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document primarily details bench testing for the "Ambu® aScope™ 3 Large" product line extension. Acceptance criteria are implied by the successful completion of these tests.

Acceptance Criteria (Implied by passed tests)	Reported Device Performance (Ambu® aScope™ 3 Large)
Compliance with ISO 8600-1, -3, -4, and ISO 594-1	Declaration of Conformity maintained
Acceptable Bending Angle Performance	Tests passed
Acceptable Bending Section Endurance	Tests passed
Acceptable Aging Performance	Tests passed
Acceptable Sterile Packaging Integrity	Tests passed
Electrical Compatibility with IEC 60601-1-2	Tests passed
Electrical Safety with IEC 60601-1 and IEC 60601-2-18	Tests passed

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for each bench test. It mentions "Performance tests to document the properties" and "Aging Performance Test", but not the number of units tested. This data is from bench testing, not human or clinical data. The submitter is Ambu A/S, based in Denmark.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The ground truth for bench tests would be defined by engineering specifications and objective measurements, not expert human assessment in a clinical context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication method is used for clinical data interpretation or image annotation, not for bench testing of device specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. The document explicitly states "Performance Data - Clinical: Not applicable," and this submission does not involve clinical performance evaluation or AI capabilities.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No. This device is a medical instrument (bronchoscope and monitor), not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the ground truth would be established by engineering standards, material specifications, and objective measurement tools. For example, a bending angle would be measured against a defined specification, not an expert's opinion.

8. The sample size for the training set

Not applicable. This document describes a medical device (endoscope and monitor), not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for an AI algorithm discussed in this document.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 1, 2016

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

Re: K161656

Trade/Device Name: Ambu Ascope 3 Regular 5.0/2.2, Ambu Ascope 3 Slim 3.8/1.2, Ambu Ascope 3 Large 5.8/2.8. Ambu Aview Monitor Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible Or Rigid) And Accessories Regulatory Class: Class II Product Code: EOQ Dated: August 5, 2016 Received: August 8, 2016

Dear Mr. 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K161656

Device Name

Ambu® aScope™ 3 Regular 5.0/2.2; Ambu® aScope™ 3 Slim 3.8/1.2; Ambu® aScope™ 3 Large 5.8/2.8 Ambu® aView™ Monitor

The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.

The aScope 3 system is for use in a hospital environment.

The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:

	Minimum ETT inner diameter	Minimum DLT size
aScope 3 Slim 3.8/1.2	5.0 mm	37 Fr
aScope 3 Regular 5.0/2.2	6.0 mm	41 Fr
aScope 3 Large 5.8/2.8	7.0 mm	-

Endoscopic accessories designed for a minimum working channel width up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.

Endoscopic accessories designed for a minimum working channel width up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.

Endoscopic accessories designed for a minimum working channel width up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.

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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Section 5 510(k) Summary

This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the 510(k) 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: Camilla WismarJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2208Fax number: +45 7225 2050
Date Summary Prepared	June 7, 2016
Device Trade Name	Ambu® aScope™ 3 Regular 5.0/2.2Ambu® aScope™ 3 Slim 3.8/1.2Ambu® aScope™ 3 Large 5.8/2.8Ambu® aView™ Monitor
Device Common Name	Flexible Bronchoscope
Device Classification	Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II
Legally Marketed devices to which the device is substantially equivalent	A+B:	ManufacturerAmbu A/S	Trade NameAmbu® aScope 3™ 5.0/2.2, Ambu®aScope™ 3 Slim 3.8/1.2and Ambu® aView	510k numberK130845
	C:	Olympus Corporation	Olympus BF-1TH190Video Bronchoscope	K121959

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Description of the Device	The Ambu® aScope™ 3 System consists of:Ambu® aScope™ 3 Regular 5.0/2.2 Ambu® aScope™ 3 Slim 3.8/1.2 Ambu® aScope™ 3 Large 5.8/2.8 Ambu® aView™ Monitor Ambu® aScope™ 3 is a sterile single use flexible bronchoscope and Ambu® aView™ is a reusable monitor.Ambu® aScope™ 3 endoscopes 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 Working channel Sterilized by Ethylene Oxide For single use The differences between the Ambu® aScope™ 3 endoscope sizes are as follows:Distal end outer diameter Insertion tube outer diameter Working channel inner diameter Angulation range Ambu® aView™ Monitor has the following physical and performance characteristics:Displays the image from Ambu® aScope™ 3 endoscope on the screen. Can record snapshots or video of image from Ambu® aScope™ 3 endoscope. Can connect to an external monitor. Reusable device
Indications for Use	The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy with the airways and tracheobronchial tree.The aScope 3 system is for use in a hospital environment.The aScope 3 is a single-use device designed for use in adults. It has been clinically evaluated for the following minimum endotracheal tubes (ETT) and double lumen tubes (DLT) sizes:
	Minimum ETT inner diameter Minimum DLT size aScope 3 Slim 3.8/1.2 5.0 mm 37 Fr aScope 3 Regular 5.0/2.2 6.0 mm 41 Fr aScope 3 Large 5.8/2.8 7.0 mm -

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Summary of thetechnologicalcharacteristicsin comparisonto the predicatedevices	Endoscopic accessories designed for a minimum working channelwidth up to 1.2 mm can be used with the aScope 3 Slim 3.8/1.2.Endoscopic accessories designed for a minimum working channelwidth up to 2.0 mm can be used with the aScope 3 Regular 5.0/2.2.Endoscopic accessories designed for a minimum working channelwidth up to 2.6 mm can be used with the aScope 3 Large 5.8/2.8.Ambu® aScope™ 3 Regular, Ambu® aScope™ Slim and Ambu®aView™ are similar to predicate devices described in K130485.The product line extension Ambu® aScope™ 3 Large 5.8/2.8 is similarto the predicate devices in the following areas:They are all flexible endoscopes with a maneuverable tip Predicate A and B has same intended use. Reference C has a similar intended use. Predicate A and B are single-use device, which are delivered sterile. Predicate A and B uses a LED-light source located at the tip of the endoscopes. They are all video endoscopes with a camera located in the distal tip to provide an image on a separate monitor. They all have the same insertion tube working length. They all have suction functionality. Predicate A and B possess a suction port equivalent to aScope 3 Large. The aScope 3 Large inner and outer diameters are equivalent to the reference device: Reference C have the same distal end outer diameter as aScope 3 Large. Predicate A and B have a smaller diameter. Reference C has the same working channel inner diameter as aScope 3 Large. Predicate A and B have a smaller working channel inner diameter
PerformanceData -Bench	The following data are described for the product line extension Ambu®aScope™ 3 Large in the premarket notification:Declaration of Conformity with the product specific standards ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 594-1 Performance tests to document the properties of bending angle and endurance of the bending section Aging Performance Test Sterile Packaging Integrity Test Electrical Compatibility according to IEC 60601-1-2 Electrical Safety according to IEC 60601-1 and IEC 60601-2-18. Results: All tests were passed.
PerformanceData - Clinical	Not applicable.
Conclusion	Based on the indication for use, technological characteristics,performance data and comparison to predicate devices it has beenconcluded that the functionality and intended use of Ambu® aScope™3 Regular 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aScope™3 Large 5.8/2.8 and Ambu® aView™ Monitor is equivalent to thepredicate devices.It is concluded that Ambu® aScope™ 3 Regular 5.0/2.2, Ambu®aScope™ 3 Slim 3.8/1.2, Ambu® aScope™ 3 Large 5.8/2.8 andAmbu® aView™ Monitor are as safe and effective and perform as wellas or better than the chosen legally marketed predicate devices.

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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.