The aScope 3 endoscopes have been designed to be used with the aView monitor, endotherapy accessories and other ancillary equipment for endoscopy within 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:

Scope	Minimum ETT inner diameter	Minimum DLT, size
aScope 3 Slim3.8/1.2	5.0mm	37Fr
aScope 35.0/2.2	6.0mm	41Fr

Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5. Endoscopic accessories designed for a minimum working channel width up to 1.2mm can be used with the aScope 3-Slim.

Device Description

The system consists of Ambu aScope 3 ( Ambu aScope 3 5.0/2.2 or Ambu aScope 3 Slim 3.8/1.2) and Ambu aView Monitor. Ambu aScope 3 has been designed for airway management within the larynx and the tracheobronchial tree. This includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management. Ambu aScope 3 is for single use and it is sterile. The Ambu aScope 3 must be connected to Ambu aView Monitor. The monitor displays the image and it is reusable. Ambu aScope 3 has the following physical and performance characteristics; - Maneuverable tip controlled by the clinician ・ - Flexible insertion cord . - Camera and LED light source at the distal tip ・ - Working channel . - Sterile by Ethylene Oxide sterilization • - . For Single Use The differences between_Ambu aScope 3 5.0/2.2 and Ambu aScope 3 Slim 3.8/1.2 are as follows: - Distal end outer diameter י - -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 on the screen. - - Can record snapshot or video of image from aScope . - Can be fixed to e.g. an IV pole. . - Reusable device. -

AI/ML Overview

The provided 510(k) application describes the acceptance criteria and the studies conducted for the Ambu® aScope™ 3 and Ambu® aView™ Monitor.

It's important to note that this document is for a medical device (a flexible bronchoscope system), not an AI/ML powered device. Therefore, the questions related to AI/ML specific criteria (like multi-reader multi-case studies with AI assistance, standalone AI performance, training set details, or human expert involvement in ground truth for AI) are not applicable to this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria and reported performance are largely based on engineering and manufacturing specifications, as well as adherence to national and international standards for medical devices.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Material/Design Conformance Standards	Conformance to ISO 8600-1, ISO 8600-3, ISO 8600-4 (Optics and optical instruments - medical endoscopes and certain accessories)	All tests were passed.
	Conformance to ISO 594-1 (Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment)	All tests were passed.
Ambu aScope 3 (Single Use) Performance	Bending Angle & Endurance (aScope 3 Slim 3.8/1.2): Bending to maximum 130° up and down.	All tests were passed.
	Bending Angle & Endurance (aScope 3 5.0/2.2): Bending to maximum 150° up and 130° down.	All tests were passed.
	General Performance: Product specifications fulfilled according to Final Quality Inspection Procedure of Ambu aScope 3.	All tests were passed.
	Sterile Packaging Integrity: Seal strength > 0.4 N when tested per ASTM F88.	All tests were passed.
Ambu aView Monitor (Reusable) Performance	Imaging Performance: Evaluation of colors, flickering, contrast, and haze rated on a scale of 1-3 (1 being best). Acceptance: Rating 1 with a maximum of two ratings of 2.	All tests were passed.
	Chemical Endurance: Monitor can withstand contact with cleaning and disinfection chemicals (reprocessing).	All tests were passed.
	Battery Capacity: At least 70% battery capacity after 150 charging cycles.	All tests were passed.
Environmental Testing (Transportation & Handling)	Transportation (in packaging): Withstand EN 60068-2-27 (Shock: 500 repetitive shocks, 400 m/s^2), EN 60068-2-64 (Vibration: 1.6 grms), EN 60068-2-31 (Rough handling: 12 falls from 1.2m). Post-test: Packaging integrity and device inspection, performance test of device.	All products and packaging passed the tests.
	Handling (without packaging): Withstand EN 60608-2-6 (Vibration: 5Hz, 1grms, 1 hour), EN 60068-2-31 (Free fall: 2 falls per relevant orientation from 1.2m to concrete). Post-test: Device inspection, performance test of device.	All products and packaging passed the tests.
Biocompatibility	Compliance with ISO 10993-1, including specific tests for Cytotoxicity (ISO 10993-5), Ethylene oxide sterilization residuals (ISO 10993-7), Sensitization (ISO 10993-10), and Intracutaneous reactivity (ISO 10993-10).	All tests were passed.
General Requirements	Cleaning & Disinfection Validation: Compliance with AAMI TIR12 and AAMI TIR30 for Ambu aView Monitor.	All tests were passed.
	Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2.	All tests were passed.
	Electrical Safety: Compliance with IEC 60601-1 and IEC 60601-2-18.	All tests were passed.

Regarding AI/ML Specific Questions:

As this 510(k) application is for a conventional medical device (flexible bronchoscope and monitor) and does not involve AI/ML technology, the following questions are not applicable.

Sample size used for the test set and the data provenance: Not applicable, as there is no "test set" in the context of an AI/ML algorithm. Performance tests are done on physical devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device ground truth is based on engineering specifications and standard measurements.
Adjudication method for the test set: Not applicable.
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: Not applicable. No AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. No AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for this device is based on objective measurements against engineering specifications, adherence to recognized consensus standards (ISO, ASTM, IEC), and physical performance tests (e.g., bending angles, battery life, resistance to chemicals/environmental stresses).
The sample size for the training set: Not applicable. No training set for an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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510(k) Application; K130845 – Ambu® aScope™ 3 and Ambu® aView

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 2055
Contact Person	Name: Kaja TengbjergJob Title: Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2215Fax number: +45 7225 2050
Date SummaryPrepared	October 29, 2013
Device TradeName	Ambu® aScope™ 3 5.0/2.2Ambu® aScope™ 3 Slim 3.8/1.2Ambu® aView™ Monitor
Device CommonName	Flexible Bronchoscope
DeviceClassification	Bronchoscope (flexible or rigid) and accessoriesProduct Codes: EOQ21 CFR 874.4680Class II
Legally Marketeddevices to whichthe device issubstantiallyequivalent		Manufacturer	Trade Name	510k number
	A:	OlympusCorporation	Olympus BF Type 160 VideoBronchoscope	K023984
	B:	OlympusCorporation	Olympus LF-TP TrachealIntubation Fiberscope	K981543
	C:	OlympusCorporation	Olympus LF-DP TrachealIntubation Fiberscope	K981543
	D:	VisionSciences	BRS-5000 Flexible DigitalVideo Bronchoscope	K091768
	E:	Ambu A/S	Ambu aScope 2and Ambu aScope Monitor	K110962

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Description of the Device

The system consists of Ambu aScope 3 ( Ambu aScope 3 5.0/2.2 or Ambu aScope 3 Slim 3.8/1.2) and Ambu aView Monitor.

Ambu aScope 3 has been designed for airway management within the larynx and the tracheobronchial tree. This includes endoscopic observation to assess airway anatomy, endotracheal/endobronchial intubation and management. Ambu aScope 3 is for single use and it is sterile.

The Ambu aScope 3 must be connected to Ambu aView Monitor. The monitor displays the image and it is reusable.

Ambu aScope 3 has the following physical and performance characteristics;

Maneuverable tip controlled by the clinician ・
Flexible insertion cord .
Camera and LED light source at the distal tip ・
Working channel .
Sterile by Ethylene Oxide sterilization •
. For Single Use

The differences between_Ambu aScope 3 5.0/2.2 and Ambu aScope 3 Slim 3.8/1.2 are as follows:

Distal end outer diameter י
-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 on the screen. -
Can record snapshot or video of image from aScope .
Can be fixed to e.g. an IV pole. .
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 within 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:

Scope	Minimum ETT inner diameter	Minimum DLT, size
aScope 3 Slim3.8/1.2	5.0mm	37Fr
aScope 35.0/2.2	6.0mm	41Fr

Version 3.0

Section 5 - Page 2 of 6

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510(k) Application; K130845 - Ambu® aScope™ 3 and Ambu® aView™ Monitor

Summary of the technological characteristics in comparison to the predicate devices

Performance Data -

Bench

The Ambu aScope 3 System, consisting of Ambu aScope 3 and Ambu aView Monitor, is similar to the predicate devices in the following areas:

They are all flexible endoscopes with a maneuverable tip -
Predicate D and E are single-use devices, which are delivered . sterile
Predicate D and E use a LED-light source located at the tip of the scopes
Predicate A, D and E possess a camera located at the distal tip to provide an image
They all have a handle with a control button giving the operator the ability to steer the tip of the scope up and down
All devices can display an image on a separate monitor -
Predicate device A, B, C, and D possess a suction port . equivalent to aScope 3
The aScope 3's inner and outer diameters are within the same range as the predicate devices

Furthermore, Ambu aView Monitor is equivalent to aScope monitor, predicate E, on the following parameters:

Both display a live image on a TFT-screen .
Power is supplied to the endoscope via the connection to the . monitor
Both are powered by a rechargeable battery or a power supply -Both systems can be operated either on battery or on mains . Dower
Both monitors are portable

Ambu concludes that the Ambu aScope 3 and Ambu aView Monitor is substantially equivalent to the predicate devices.

The following data has been submitted in the premarket notification:

Ambu has provided declaration of conformity to the following recognized consensus standards applicable for this type of device:

ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments - medical endoscopes and certain accessories.
- ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment.

The declaration of conformity is based on test data. Result: All tests were passed.

Performance test report was submitted to document the following properties of the Ambu aScope 3 (single use):

Bending angle and endurance of the bending section (accept criteria: bending to the maximum bending angle aScope 3 Slim 3.8/1.2; 130° up and down, aScope 3 5.0/2.2; 130° down and 150° up)
Result: All tests were passed.

Performance test report was submitted to document the following properties of the Ambu aView Monitor (reusable):

Imaging performance; evaluation of colors, flickering, contrast l and haze, rated on a scale from 1-3, where 1 is best. (accept
Section 5 - Page 3 of 6

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criteria: rating 1 and with a maximum of two ratings of 2) Chemical endurance of Ambu aView Monitor (accept criteria: monitor can withstand the chemicals in contact with the monitor including cleaning and disinfection chemicals for reprocessing)

Battery capacity of Ambu aView Monitor (accept criteria: at least 70% battery capacity after 150 charging cycles) Result: All tests were passed.

Performance test report was submitted to document Shelf life of Ambu aScope 3. Testing was done on finished, sterilized, shipped and aged products:

Performance test of the Ambu aScope 3. Test according to Final । Quality Inspection Procedure of Ambu aScope 3. Accept criteria: Product specifications fulfilled
Sterile packaging integrity of the Ambu aScope 3 pouch. ー Accept criteria: The seal strength must be greater than 0.4 N when tested according to ASTM F88.

Result: All tests were passed

Since the device is in compliance with the listed standards and has passed the listed performance tests, it is concluded that technological characteristics of Ambu aScope 3 and Ambu aView Monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate devices.

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Environmental tests performed on aScope 3 5.0/2.2. aScope 3 Slim 3.8/1.2 and aView Monitor to demonstrate the compliance to the following standards:

Transportation in designated packaging:

EN 60068-2-27 Basic environmental testing procedures Part 2: Tests - Test Ea and guidance: Shock: 500 repetitive shocks (bump) in each of 6 directions 400 m/s2 (40g)
EN 60068-2-64 Environmental testing Part 2-64: Tests Test Fh: Vibration, broadband random and guidance: Random vibration 1.6 grms, 10-150Hz, 30 min/axis
EN 60068-2-31 Environmental testing Part 2-31: Tests Test Ec: Rough handling shocks, primarily for equipment-type specimens: 12 falls from 1.2m height

Tests performed with the product without its packaging: Bounce

EN 60608-2-6 Environmental testing Part 2-6: Tests Test Fc: Vibration (sinusoidal): Sinus vibration 5Hz, 1grms, 1 hour. Free fall
EN 60068-2-31 Environmenta! testing Part 2-31: Tests Test -Ec: Rough handling shocks; primarily for equipment-type specimens:

Ambu aScope 3: 2 falls per relevant orientation from 1.2m height to a smooth concrete surface.

After each of the above environmental tests, the packaging integrity and the device were inspected, and performance test of the device was performed.

Result: All products and packaging passed the tests.

Based on the above environmental testing Ambu has concluded that Ambu aScope 3 and Ambu aView Monitor, can withstand the stresses applied to the product during transport and handling prior to the use of the device, and is as safe and effective and performs as well as or better than the chosen legally marketed predicate device.

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Data for compliance to the general requirements for the device were submitted:

Biocompatibility tests shows that the device complies with the requirements of ISO 10993-1:

Cytotoxicity (ISO 10993-5) :
Ethylene oxide sterilization residuals (ISO 10993-7) *
Sensitization (ISO 10993-10)
Intracutaneous reactivity test (ISO 10993-10)

Result: All tests were passed.

Tests that verify the following properties:

Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation of the Ambu aView Monitor according to AAMI TIR12 and AAMI TIR30, to validate the prescribed method of cleaning and disinfection.
Electro Magnetic Compatibility in compliance with IEC 60601-1-2.
Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18.

Result: All tests were passed.

Since the device passed all the tests to demonstrate compliance to the general requirements for this kind of device, it is concluded that Ambu aScope 3 and Ambu aView monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate devices.

Not applicable.

Based on the indication for use, technological characteristics, performance data and comparison to predicate devices it has been concluded that the functionality and intended use of Ambu aScope 3 and Ambu aView Monitor is equivalent to the predicate devices.

It is concluded that Ambu aScope 3 and Ambu aView Monitor are as safe and effective and perform as well as or better than the chosen legally marketed predicate devices.

Performance Data -Clinical

Conclusion

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black. The logo is simple and recognizable, representing the department's role in protecting the health of all Americans.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 1, 2013

Ambu A/S c/o Mr. Sanjay Parikh -VP Operations 6740 Baymeadow Dr. Glen Burnie, MD 21060

Re: K130845 ·

Trade/Device Name: Ambu® aScope™ 3 5.0/2.2, Ambu® aScope™ 3 Slim 3.8/1.2, Ambu® aView™ Monitor Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) Regulatory Class: Class II Product Code: EOO Dated: September 27, 2013 Received: September 30, 2013

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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Page 2 - Mr. Sanjay Parikh

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 device-related 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;

lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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): K130845

. Device Name: Ambu aScope™ 3 5.0/2.2 ... Ambu® aScope™ 3 Slim 3.8/1.2 Ambu a View ™

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 within 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:

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Endoscopic accessories designed for a minimum working channel width up to 2.0mm can be used with the aScope 3-5.

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

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Sunny Park

Page 1 of 1

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.