The Ambu® aScope™ 2 is intended for use as an aid in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non- difficult and difficult intubating procedures or for visualization of the airway during Percutaneous Tracheostomy (PT) procedures. The Ambu® aScope™ 2 achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu® aScope™ 2 is in the human anatomy. The flexible tip of the Ambu® aScope™ 2 allows the user to guide the ETT in the desired direction. The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

Device Description

Ambu aScope System consist of Ambu aScope 2 and Ambu aScope Monitor. Ambu aScope 2 is for viewing anatomical structures in the upper airways, and as an aid in placement of an endotracheal tube (ETT), an ETT size 6 or larger can be used. A camera at the distal tip of the aScope provides the user with an indication of the placement of the aScope. The manoeuvrable tip allows the user to guide the ETT in the desired direction. Ambu aScope is for single patient use and it is sterile. The Ambu aScope 2 must be connected to Ambu aScope Monitor. The monitor displays the image and it is reusable. Ambu aScope 2 has the following physical and performance characteristics: - Manoeuvrable tip controlled by the clinician - Flexible insertion cord - Camera and LED light source at the distal tip - Topical Anaesthetics can be administered to the patient via a channel, with standard Luer connector - Oxygen flow can be applied via a channel using a flow connector attached to the Luer connector - Sterile by Ethylene Oxide sterilisation - For Single Patient Use Ambu aScope Monitor has the following physical and performance characteristics: - Displays the image from Ambu aScope 2 on the screen. - Can be fixed to e.g. an IV pole. - By connecting a Video Out Cable to the Ambu aScope Monitor the image can be displayed and/or recorded on an external monitor and/or video recorder. - Reusable device.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Ambu® aScope™ 2 and Ambu® aScope™ Monitor, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Ambu aScope 2 (Single-Use):
Manoeuvrability of tip: 120 +/- 10° to each side	All tests were passed.
Endurance of bending section: 50 bends to each side of minimum 90° and 10 bends to each side of 120 +/- 10°	All tests were passed.
Luer channel for topical anaesthetics: When 1 ml is injected, at least 0.8 ml is expelled in the distal end	All tests were passed.
Luer channel for Oxygen: Compatible with 10 seconds oxygen flow at 5 bars and 3 L/min, followed by a 3 seconds blocking of working channel at 5 bars	All tests were passed.
Temperature at distal end: Below 41 °C	All tests were passed.
Shelf life: Product specifications fulfilled (based on Final Quality Inspection Procedure).	All tests were passed.
Sterile packaging integrity: Seal strength greater than 0.4 N when tested according to ASTM F88.	All tests were passed.
Ambu aScope Monitor (Reusable):
Imaging performance: Evaluation of colors, flickering, contrast, and brightness rated on a scale from 1-3 (1=best), with an accept criteria of rating 1 and a maximum of 2 ratings of 2 (out of 128 evaluations for 32 scopes across 4 properties).	All tests were passed.
Cleaning endurance: Withstand prescribed cleaning and disinfection method for 150 times reprocessing.	All tests were passed.
Battery capacity: At least 70% battery capacity after 150 times charging and discharging.	All tests were passed.
Environmental Tests (Transportation & Handling):
Packaging integrity and device performance maintained after: - EN 60068-2-27 (Shock: 500 repetitive shocks, 400 m/s^2) - EN 60068-2-64 (Vibration: 1.6 grms, 10-150Hz, 30 min/axis) - EN 60068-2-31 (Rough handling: 12 falls from 1.2m height)	All products and packaging passed the tests.
Device performance maintained after (without packaging): - EN 60608-2-6 (Vibration: 5Hz, 1grms, 1 hour) - EN 60068-2-31 (Free fall: Ambu aScope 2: 2 falls per relevant orientation from 1.2m to concrete; Ambu aScope Monitor: 2 falls per relevant orientation from 0.2m to concrete)	All products and packaging passed the tests.
Biocompatibility (ISO 10993-1):
Cytotoxicity (ISO 10993-5)	All tests were passed.
Sensitization (ISO 10993-10)	All tests were passed.
Intracutaneous reactivity test (ISO 10993-10)	All tests were passed.
General Requirements:
Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation (AAMI TIR12 and AAMI TIR30)	All tests were passed.
Electro Magnetic Compatibility (IEC 60601-1-2)	All tests were passed.
Electrical Safety (IEC 60601-1 and IEC 60601-2-18)	All tests were passed.

Study Details

Sample size used for the test set and the data provenance:
- Ambu aScope 2 (Single-Use): Not explicitly stated how many individual devices were tested for "manoeuvrability," "endurance," "Luer channel," "temperature," and "shelf life." The shelf life testing was done on "finished, sterilized, shipped and aged products," implying a specific batch or set of products.
- Ambu aScope Monitor (Reusable): For imaging performance, 32 scopes were evaluated. For cleaning endurance and battery capacity, the reports state tests demonstrated the monitor "can withstand" or has "at least 70% battery capacity after 150 times reprocessing/charging," implying the test was conducted on at least one monitor undergoing 150 cycles.
- Environmental Tests: For transportation, the tests were conducted with dedicated packaging. For bounce and free fall, tests were conducted without packaging. The specific number of devices tested for these environmental assessments is not explicitly stated beyond "All products and packaging passed the tests."
- Biocompatibility & General Requirements: Standardized tests (e.g., ISO, AAMI, IEC) are mentioned, which would involve a defined number of samples per test, but the exact number isn't quantified in this summary.
- Data Provenance: The studies were conducted by Ambu A/S, indicating internal testing. The country of origin for the data (Denmark) is implied by the submitter's address. All studies appear to be prospective bench testing or product performance evaluations, not involving patient data or human subjects.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This submission describes bench testing and performance evaluations against engineering specifications and international standards, not clinical studies requiring expert ground truth for interpretation of medical images or outcomes. Therefore, no information on experts establishing ground truth for a test set is provided as it's not applicable to this type of submission.
Adjudication method for the test set:
- Not applicable, as this is a bench testing and performance evaluation summary, not a clinical study involving human interpretation or adjudication of medical findings.
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 MRMC or comparative effectiveness study involving human readers or AI assistance was conducted or reported in this 510(k) summary. The device is a physical endoscope and monitor system, not an AI-powered diagnostic tool. The focus is on demonstrating the safety, functionality, and performance of the hardware.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was conducted. This device is a manual endoscope system and does not involve an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance tests, the "ground truth" was the pre-defined engineering specifications and internationally recognized consensus standards (e.g., specific angles for tip manoeuvrability, volume expelled from a channel, temperature limits, seal strength, battery capacity, compliance with ISO, AAMI, IEC standards).
The sample size for the training set:
- Not applicable. This is a medical device hardware submission, not a machine learning or AI algorithm submission that would require a 'training set.'
How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI algorithm. The performance criteria were established through engineering design, risk analysis, and adherence to relevant industry standards for medical devices.

Summary

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Section 5: 510(k) Summary K-110962

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 2055
Date SummaryPrepared	March, 2011
Device Trade Name	Ambu® aScope™ 2Ambu® aScope™ Monitor
Device Common Name	Endoscope for endotracheal intubation
Device Classification	Tracheal TubeProduct Codes: BTR21 CFR 868.5730Class II
Legally Marketeddevices to which thedevice is substantiallyequivalent	Manufacturer	Trade Name	510k number
	Ambu A/S	Ambu® aScope™ andAmbu® aScope™ Monitor	K093186

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・・・ :

Description of theDevice	Ambu aScope System consist of Ambu aScope 2 and AmbuaScope Monitor.Ambu aScope 2 is for viewing anatomical structures in the upperairways, and as an aid in placement of an endotracheal tube(ETT), an ETT size 6 or larger can be used. A camera at thedistal tip of the aScope provides the user with an indication ofthe placement of the aScope. The manoeuvrable tip allows theuser to guide the ETT in the desired direction. Ambu aScope isfor single patient use and it is sterile.The Ambu aScope 2 must be connected to Ambu aScopeMonitor. The monitor displays the image and it is reusable.
	Ambu aScope 2 has the following physical and performancecharacteristics:- Manoeuvrable tip controlled by the clinician- Flexible insertion cord- Camera and LED light source at the distal tip- Topical Anaesthetics can be administered to the patient viaa channel, with standard Luer connector- Oxygen flow can be applied via a channel using a flowconnector attached to the Luer connector- Sterile by Ethylene Oxide sterilisation- For Single Patient UseAmbu aScope Monitor has the following physical andperformance characteristics:- Displays the image from Ambu aScope 2 on the screen.- Can be fixed to e.g. an IV pole.- By connecting a Video Out Cable to the Ambu aScopeMonitor the image can be displayed and/or recorded on anexternal monitor and/or video recorder.- Reusable device.
Indications for Use	The Ambu® aScope™ 2 is intended for use as an aid in theplacement of an Endotracheal Tube (ETT) directly or through anintubating laryngeal mask during non- difficult and difficultintubating procedures or for visualization of the airway duringPercutaneous Tracheostomy (PT) procedures. The Ambu®aScope™ 2 achieves its purpose by providing the user with avisual confirmation of where the tip of the Ambu® aScope™ 2 isin the human anatomy.The flexible tip of the Ambu® aScope™ 2 allows the user toguide the ETT in the desired direction. The system is for use in ahospital environment.The target population is adults/children that have been clinicallyevaluated for ETT size 6 or larger.

Description of theDevice

Ambu aScope 2 has the following physical and performancecharacteristics:- Manoeuvrable tip controlled by the clinician- Flexible insertion cord- Camera and LED light source at the distal tip- Topical Anaesthetics can be administered to the patient viaa channel, with standard Luer connector- Oxygen flow can be applied via a channel using a flowconnector attached to the Luer connector- Sterile by Ethylene Oxide sterilisation- For Single Patient UseAmbu aScope Monitor has the following physical andperformance characteristics:- Displays the image from Ambu aScope 2 on the screen.- Can be fixed to e.g. an IV pole.- By connecting a Video Out Cable to the Ambu aScopeMonitor the image can be displayed and/or recorded on anexternal monitor and/or video recorder.- Reusable device.

Indications for Use

The Ambu® aScope™ 2 is intended for use as an aid in theplacement of an Endotracheal Tube (ETT) directly or through anintubating laryngeal mask during non- difficult and difficultintubating procedures or for visualization of the airway duringPercutaneous Tracheostomy (PT) procedures. The Ambu®aScope™ 2 achieves its purpose by providing the user with avisual confirmation of where the tip of the Ambu® aScope™ 2 isin the human anatomy.The flexible tip of the Ambu® aScope™ 2 allows the user toguide the ETT in the desired direction. The system is for use in ahospital environment.The target population is adults/children that have been clinicallyevaluated for ETT size 6 or larger.

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510(k) Application – Ambu® aScope™ 2 and Ambu® aScope™ Monitor

Summary of the technological characteristics in comparison to the predicate devices

Ambu aScope 2 is similar to predicate device:

They possess a similar Intended Use. ●
They both are flexible scopes with a manoeuvrable tip. .
They are single-use devices, which are delivered sterile. ●
They both use a LED-light source located at the tip of . the scopes
They possess a CMOS camera located at the distal tip to . provide an image
They have a handle with a control button giving the . operator the ability to steer the tip of the scope up and down
In both devices, an image is provided on a separate . monitor

Ambu concludes that the Ambu aScope 2 and Ambu aScope Monitor is substantially equivalent to the predicate device.

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Performance Data -Bench	The following data has been submitted in the premarket notification:
	Ambu has provided declaration of conformity to the followingrecognized consensus standards applicable for this type of device:ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and opticalinstruments - 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 followingproperties of the Ambu aScope 2 (single use):Manoeuvrability of tip (accept criteria: 120+/- 10 ° to each side)Endurance of the bending section (accept criteria: 50 bends toeach side of minimum 90° and 10 bends to each side of 120+/-10 °)Luer channel when used for topical anaesthetics (accept criteria:
	verification of ability to administer topical anaesthetics throughthe channel – when 1 ml is injected at least 0.8 ml was expelledin the distal end)Luer channel when used for Oxygen (accept criteria: Luerchannel is compatible with 10 seconds oxygen flow at 5 bars and3 L/min. followed by a 3 seconds blocking of working channel ata pressure of 5 bars)Temperature at distal end of Ambu aScope (accept criteria:temperature below 41 °C)Result: All tests were passed.
	Performance test report was submitted to document the followingproperties of the Ambu aScope Monitor (reusable):Imaging performance; evaluation of colours, flickering, contrastand brightness, rated on a scale from 1-3, where 1 is best.(accept criteria: rating 1 and max 2 ratings of 2, when 32 scopesare evaluated for all 4 properties (128 evaluations))Cleaning endurance of Ambu aScope Monitor (accept criteria:monitor can withstand the prescribed cleaning and disinfectionmethod for 150 times reprocessing)Battery capacity of Ambu aScope Monitor (accept criteria: atleast 70% battery capacity after 150 times charging and de-charging)Result: All tests were passed.
	Performance test report was submitted to document Shelf life ofAmbu aScope 2. Testing was done on finished, sterilized, shippedand aged products:Performance test of the Ambu aScope 2. Test according to FinalQuality Inspection Procedure of Ambu aScope 2.Accept criteria: Product specifications fulfilledSterile packaging integrity of the Ambu aScope 2 pouch.Accept criteria: The seal strength must be greater than 0.4 Nwhen tested according to ASTM F88.Result: All tests were passed
	Since the device is in compliance with the listed standards and havepassed the listed performance tests, it is concluded thattechnological characteristics of Ambu aScope 2 and Ambu aScopeMonitor is as safe and effective and performs as well as or betterthan the chosen legally marketed predicate device.

Section 5 - Page 4 of 6

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Environmental tests to demonstrate the compliance to the following standards:

Transportation in designated packaging:

EN 60068-2-27 Basic environmental testing procedures l 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 -ー Test Ec: Rough handling shocks, primarily for equipmenttype 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 l Fc: Vibration (sinusoidal): Sinus vibration 5Hz, 1grms, 1 hour.
Free fall
EN 60068-2-31 Environmental testing Part 2-31: Tests l Test Ec: Rough handling shocks, primarily for equipmenttype specimens:
Ambu aScope: 2 falls per relevant orientation from 1.2m height to a smooth concrete surface.

Ambu aScope Monitor: 2 falls per relevant orientation from 0.2m 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 2 and Ambu aScope 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)
	- Sensitization (ISO 10993-10)
	- Intracutaneous reactivity test (ISO 10993-10)
	Result: All tests were passed.
	Tests that verifies the following properties:
	- Cleaning validation and Liquid Chemical Sterilization and Disinfection Validation of the Ambu aScope 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 2 and Ambu aScope monitor is as safe and effective and performs as well as or better than the chosen legally marketed predicate device.
Performance Data - Clinical	Not applicable.
Conclusion	Based on the indication for use, technological characteristics, performance data and comparison to predicate devices it has been concluded that the Ambu aScope 2 and Ambu aScope Monitor has equivalent functionality and intended use as the predicate device. It is concluded that Ambu aScope 2 and Ambu aScope Monitor are as safe and effective and performs as well as or better than the chosen legally marketed predicate device.

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Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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

Mr. Sanjay H. Parikh Vice President Operations US Agent Ambu Incorporated 6740 Baymeadow Drive Glen Burnie, Maryland 21060

NOV 1 8 2011

Re: K110962

Trade/Device Name: Ambu aScope 2 Ambu aScope Monitor Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: II Product Code: BTR Dated: November 14, 2011 Received: November 15, 2011

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. 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 (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Wh for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Application - Ambu® aScope™ 2 and Ambu® aScope™ Monitor

Section 4: Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Indications for Use:

The Ambu@ aScope™ 2 is intended for use as an ald in the placement of an Endotracheal Tube (ETT) directly or through an intubating laryngeal mask during non- difficult intubating procedures or for visualization of the airway during Percutaneous Tracheostomy (PT) procedures.

The Ambu® aScope™ 2 achieves its purpose by providing the user with a visual confirmation of where the tip of the Ambu@ aScope™ 2 is in the human anatomy. The flexible tip of the Ambu® aScope™ 2 allows the user to guide the ETT in the desired direction.

The system is for use in a hospital environment. The target population is adults/children that have been clinically evaluated for ETT size 6 or larger.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER

PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

y Archittin

(Division Sian-Off) Division of Anesthesiology, General Hospital Infection Control. Dental Devices

510(k) Number: K110962

Section 4 - Page 1 of 1

Version 1.0

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).