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™ RLS Slim is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.

Ambu® aScope™ RLS Slim 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
• Sterilized by Ethylene Oxide
• For single use

AI/ML Overview

The provided text describes the "Ambu® aScope™ RLS Slim" device, which is a sterile, single-use flexible endoscope. The document is a 510(k) summary submitted to the FDA, demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

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

The document doesn't explicitly present a table of "acceptance criteria" in the typical sense of numerical thresholds for clinical performance metrics (e.g., sensitivity, specificity). Instead, it lists various performance tests and regulatory compliances that the device underwent, with the universal result being "All tests were passed."

Here's a table summarizing the reported device performance based on the provided "Performance Data - Bench" section:

Acceptance Criteria (Test Category)	Reported Device Performance
Declaration of conformity to recognized consensus standards
ISO 8600-1 (Optics and optical instruments - Medical endoscopes and certain accessories)	All tests were passed.
ISO 8600-3 (Optics and optical instruments - Medical endoscopes and certain accessories)	All tests were passed.
ISO 8600-4 (Optics and optical instruments - Medical endoscopes and certain accessories)	All tests were passed.
Performance test reports
Length and diameters of insertion cord	All tests were passed.
Bending angle, endurance and radius	All tests were passed.
Manipulator bending force	All tests were passed.
Image Sharpness	All tests were passed.
Shelf life documentation
Performance test of Ambu® aScope™ RLS Slim Sterile Packaging Integrity (on finished, sterilized and aged products)	All tests were passed.
Biocompatibility tests (in compliance with 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.
Electromagnetic Compatibility and Electrical Safety
Electromagnetic Compatibility (in compliance with IEC 60601-1-2)	All tests were passed.
Electrical Safety (in compliance with IEC 60601-1 and IEC 60601-2-18)	All tests were passed.

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

The document mentions "Performance test reports" for various physical and performance characteristics, shelf life, and biocompatibility, but does not specify the sample size for any of these tests.

Regarding data provenance, the tests were conducted to document the performance of the Ambu® aScope™ RLS Slim. It is implied these are pre-market tests performed by the manufacturer (Ambu A/S in Denmark, with contact details provided). There is no explicit mention of the country of origin of the data beyond the manufacturer's location, nor is it specified if the tests were retrospective or prospective, though performance tests are typically prospective.

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

The document does not mention the use of experts in the context of establishing ground truth for the performance tests. The tests described are primarily focused on the physical, mechanical, and safety characteristics of the device itself (e.g., bending angle, image sharpness, sterility) rather than a diagnostic performance where expert interpretation would typically establish ground truth.

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

Since experts were not mentioned as being used to establish ground truth for a diagnostic performance test, there is no mention of an adjudication method. The tests described appear to be objective measurements against predefined specifications or standards.

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 MRMC comparative effectiveness study was done or mentioned. This device is a flexible endoscope for visualization, not an AI-powered diagnostic tool, so such a study would not be applicable in this context.

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

No standalone performance study of an algorithm was done. This device is a physical endoscope and does not contain artificial intelligence algorithms for standalone performance evaluation by itself.

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

The "ground truth" for the tests performed appears to be based on objective measurements against recognized industry standards and internal specifications. For example:

ISO 8600-1, ISO 8600-3, ISO 8600-4 for optical instruments.
IEC 60601-1-2 for electromagnetic compatibility.
IEC 60601-1 and IEC 60601-2-18 for electrical safety.
ISO 10993-1, ISO 10993-5, ISO 10993-10 for biocompatibility.
Internal specifications for physical characteristics like length, diameter, bending angle, manipulator force, and image sharpness.

There is no mention of ground truth established by expert consensus, pathology, or outcomes data, as these are typically associated with diagnostic accuracy claims.

8. The sample size for the training set:

Not applicable. This device is a traditional medical device (an endoscope), not a machine learning or AI algorithm, so there is no concept of a "training set."

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

Not applicable. As there is no training set mentioned, there is no discussion of how its ground truth was established.

Summary

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November 30, 2018

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

Re: K181286

Trade/Device Name: Ambu aScope RLS Slim Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) And Accessories Regulatory Class: Class II Product Code: EOB Dated: October 26, 2018 Received: October 29, 2018

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Srinivas Nandkumar -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)

Device Name Ambu aScope RLS Slim

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
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 SummaryPrepared	May 14, 2018
Device TradeName	Ambu® aScope™ RLS Slim
Device CommonName	Rhino-Laryngoscope
DeviceClassification	Nasopharyngoscopes (Flexible or Rigid)Product Codes: EOB21 CFR 874.4760Class II
LegallyMarketeddevices to whichthe device issubstantiallyequivalent	Predicate Device:Rhino-Laryngofiberscope Olympus ENF-GP (K011869), OlympusMedical Systems CorporationReference Device:Ambu® aScope™ 4 Broncho Slim (K173727), Ambu A/S

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Description ofthe Device	The Ambu® aScope™ RLS Slim is a sterile single use flexible endoscopefor examination of the nasal lumens and upper airway anatomy.Ambu® aScope™ RLS Slim has the following physical andperformance characteristics:• Maneuverable tip controlled by the user• Flexible insertion cord• Camera and LED light source at the distal tip• Sterilized by Ethylene Oxide• For single use
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.
Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices	Ambu® aScope™ RLS Slim is similar to the predicate device A andreference device B 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 the same "field of view" and "direction of view"• They all have insertion cord diameters within the same range.• They are all portable endoscopes.Technological characteristics of Ambu® aScope™ RLS Slim thatdiffers from predicate A in the following areas: Type of product(applicant device is a Videoscope, whereas predicate device A is aFiberscope, which can be used together with a camera andmonitor)• Bending angles• Length of insertion cord• Disposable after use (applicant device is Single Use, whereaspredicate device A is Reusable)Validation from non-clinical testing demonstrated that these technologicalfeatures do not raise any new issues of safety and effectiveness of theapplicant device.
PerformanceData -Bench	The following data have been submitted in the premarket notification:Declaration of conformity to the following recognized consensusstandards applicable for Ambu® aScope™ RLS Slim:ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and opticalinstruments - Medical endoscopes and certain accessories. Result: All tests were passed.
	Performance test reports to document the following properties of theAmbu® aScope™ RLS Slim:Length and diameters of insertion cord Bending angle, endurance and radius Manipulator bending force Image Sharpness Result: All tests were passed.
	Performance test report to document shelf life of Ambu® aScope™ RLSSlim. Tests were performed on finished, sterilized and aged products:Performance test of Ambu® aScope™ RLS Slim Sterile Packaging Integrity Result: All tests were passed.
	Biocompatibility tests reports to document that Ambu® aScope™ RLSSlim 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.
	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.
PerformanceData - Clinical	Not applicable.
Conclusion	Based on the indication for use, technological characteristics,performance data and comparison to predicate and reference devices ithas been concluded that the functionality and intended use of Ambu®aScope™ RLS Slim is equivalent to the predicate and reference devices.It is concluded that Ambu® aScope™ RLS Slim is as safe and as effectiveand perform as well as the predicate and reference devices.

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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.