The endoscope is a sterile, single endoscope intended for endoscopic procedures and examination within the nasal lumens and upper airway anatomy. The endoscope is intended to provide visualization via a monitor.

The endoscope is intended for use in a hospital environment. It is designed for use in adults.

Device Description

The Ambu® aScope™ 4 RhinoLaryngo Intervention is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.

Ambu® aScope™ 4 RhinoLaryngo Intervention 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

AI/ML Overview

The acceptance criteria and the study proving the device meets them are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a dedicated table format. However, it indicates qualitative acceptance criteria by stating that "All tests were passed" for various performance characteristics when compared to recognized consensus standards and internal performance tests.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformity to ISO 8600-1, ISO 8600-3, ISO 8600-4	Result: All tests were passed.
Performance tests for Bending Endurance and Angle	Result: All tests were passed.
Performance tests for Image Sharpness and Resolution	Result: All tests were passed.
Performance tests for Length of Insertion Cord	Result: All tests were passed.
Performance tests for Suction Capability	Result: All tests were passed.
Shelf life (Performance test, Sterile Packaging Integrity) on finished, sterilized, and aged products	Result: All tests were passed.
Biocompatibility in compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity)	Result: All tests were passed.
Electromagnetic Compatibility in compliance with IEC 60601-1-2	Result: All tests were passed.
Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18	Result: All tests were passed.
Substantial Equivalence to Predicate Device (Olympus XENF-TP (K013591))	"Based on the indication for use, technological characteristics, performance data and comparison to predicate device it has been concluded that the functionality and intended use of Ambu® aScope™ 4 RhinoLaryngo Intervention is substantially equivalent to the predicate device. It is concluded that Ambu® aScope™ 4 RhinoLaryngo Intervention is as safe and as effective and perform as well as the predicate device."

2. Sample size used for the test set and the data provenance:

The document describes bench testing for various performance parameters, shelf-life, and biocompatibility. It also references conformity to ISO standards. However, it does not provide specific sample sizes for these tests. The data provenance is internal to the manufacturer ("Performance test reports," "Biocompatibility test reports") and relates to the device design and manufacturing process. There is no indication of clinical test sets with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The reported studies are primarily bench tests and conformity assessments, not clinical studies requiring expert ground truth establishment from patient data.

4. Adjudication method for the test set:

Not applicable. The reported studies are bench tests and conformity assessments, not clinical studies requiring expert adjudication of patient results.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical endoscope, and the submission focuses on its safety and performance characteristics compared to a predicate device, not on AI assistance for human readers.

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

No, a standalone algorithm performance study was not mentioned. The device is a physical endoscope for direct human use.

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

The "ground truth" for the reported studies appears to be based on:

Established engineering principles and metrology: For performance tests like bending endurance, image sharpness, length, and suction.
Recognized consensus standards: ISO 8600 series for optics, ISO 10993 series for biocompatibility, IEC 60601 series for electrical safety and EMC. These standards define criteria against which the device performance is measured.
Predicate device characteristics: For demonstrating substantial equivalence, the technological characteristics of the predicate device (Olympus XENF-TP) serve as a comparative reference.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

Summary

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July 12, 2019

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

Re: K190972

Trade/Device Name: Ambu aScope 4 RhinoLaryngo Intervention Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: April 12, 2019 Received: April 15, 2019

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia 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) K190972

Device Name

Ambu aScope 4 RhinoLaryngo Intervention

Indications for Use (Describe)

The endoscope is intended for use in a hospital environment. It is designed for use in adults.

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 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/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050	Description ofthe Device	The Ambu® aScope™ 4 RhinoLaryngo Intervention is a sterile single useflexible endoscope for examination of the nasal lumens and upper airwayanatomy.Ambu® aScope™ 4 RhinoLaryngo Intervention has the following physicaland 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
Contact Person	Name: Gurpreet Kaur RehalJob Title: Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, DK-2750 BallerupTelephone number: +45 7225 2116Fax number: +45 7225 2050	Indications forUse	The endoscope is a sterile, single-use, flexible endoscope intended forendoscopic procedures and examination within the nasal lumens andupper airway anatomy. The endoscope is intended to providevisualization via a monitor.The endoscope is intended for use in a hospital environment. It isdesigned for use in adults.
Date SummaryPrepared	April 12, 2019	Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices	Ambu® aScope™ 4 RhinoLaryngo Intervention is similar to the predicatedevice and reference device in the following areas:They are all flexible endoscopes with a maneuverable tip. They all have a handle with a control lever giving the operatorability to steer the tip of the scope up and down. They all provide illumination from the distal tip. They all have a working channel for insertion of endoscopicaccessories. They all have the same "field of view" and "direction of view" They all have insertion cord diameters within the same range. They are all portable endoscopes.
Device TradeName	Ambu® aScope™ 4 RhinoLaryngo Intervention
Device CommonName	Rhino-Laryngoscope
DeviceClassification	Nasopharyngoscopes (Flexible or Rigid)Product Codes: EOB21 CFR 874.4760Class II
LegallyMarketeddevices to whichthe device issubstantiallyequivalent	Predicate Device:Olympus XENF-TP (K013591), Olympus Medical Systems CorporationReference Device:Ambu® aScope™ 4 Broncho Regular (K173727), Ambu A/S

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	Subject(K190972)	Predicate(K013591)
Device Name	Ambu®aScope™ 4RhinoLaryngoIntervention	Olympus XENF-TP
Type of product	Rhino-laryngovideoscope	Rhino-laryngofiberscope
Design Concept	Portable design	Portable design
Separate Monitor required	Yes	Yes.
Connection to other devices	Monitor	Monitor
Delivered sterile	Yes	No, shall becleaned orsterilized beforeuse byuser/hospital
Disposable after use	Yes	No
Field of view	85°	85°
Direction of View	0° (forwardviewing)	0° (forwardviewing)
Depth of field	6-50 mm	3-50 mm
Illumination method	LED	LED or halogen
Bending section	130° up130° down	130° up130° down
Maximum diameter ofinsertion portion	5.5 mm	5.0 mm
Working Channel (Innerdiameter)	2.2 mm	2.2 mm
Working length	350 mm	365 mm

Performance Data -Bench

The following data have been submitted in the premarket notification:

Declaration of conformity to the following applicable recognized consensus standards:

ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments – Medical endoscopes and certain accessories.
Result: All tests were passed.

Performance test reports to document the following properties:

Bending Endurance and Angle .
Image Sharpness and Resolution .
. Length of Insertion Cord
Suction Capability .

Result: All tests were passed.

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PerformanceData - Clinical	Performance test report to document shelf life. Tests were performed onfinished, sterilized and aged products:• Performance test• Sterile Packaging IntegrityResult: All tests were passed.Biocompatibility tests reports to document compliance with therequirements of ISO 10993-1:• Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• Intracutaneous reactivity test (ISO 10993-10)Result: All tests were passed.Test reports that verify the Electromagnetic Compatibility and ElectricalSafety:• Electromagnetic 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.
	Not applicable.
Conclusion	Based on the indication for use, technological characteristics,performance data and comparison to predicate device it has beenconcluded that the functionality and intended use of Ambu® aScope™ 4RhinoLaryngo Intervention is substantially equivalent to the predicatedevice.It is concluded that Ambu® aScope™ 4 RhinoLaryngo Intervention is assafe and as effective and perform as well as the predicate device.

PerformanceData - Clinical

Performance test report to document shelf life. Tests were performed onfinished, sterilized and aged products:• Performance test• Sterile Packaging IntegrityResult: All tests were passed.Biocompatibility tests reports to document compliance with therequirements of ISO 10993-1:• Cytotoxicity (ISO 10993-5)• Sensitization (ISO 10993-10)• Intracutaneous reactivity test (ISO 10993-10)Result: All tests were passed.Test reports that verify the Electromagnetic Compatibility and ElectricalSafety:• Electromagnetic 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.

Not applicable.

Conclusion

Based on the indication for use, technological characteristics,performance data and comparison to predicate device it has beenconcluded that the functionality and intended use of Ambu® aScope™ 4RhinoLaryngo Intervention is substantially equivalent to the predicatedevice.It is concluded that Ambu® aScope™ 4 RhinoLaryngo Intervention is assafe and as effective and perform as well as the predicate device.

Regulation Number and Section

§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.

(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.