(198 days)
No
The summary describes a standard flexible endoscope with a camera and light source, and there is no mention of AI, ML, image processing beyond basic visualization, or any data processing/analysis that would suggest the use of AI/ML. The performance studies focus on physical and electrical characteristics, not algorithmic performance.
No
The device is described for "examination" and "visualization" purposes, indicating it is a diagnostic tool, not one that delivers therapy.
No
The intended use states that the device is for "endoscopic procedures and examination within the nasal lumens and upper airway anatomy" and to "provide visualization via a monitor." It is not described as providing a diagnosis or diagnostic information based on the visualization.
No
The device description clearly outlines physical hardware components such as a maneuverable tip, flexible insertion cord, camera, and LED light source, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an endoscope used for visualization within the nasal lumens and upper airway anatomy. It provides images to a monitor for direct observation of the anatomy.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool for direct visual examination.
Therefore, the Ambu® aScope™ RLS Slim is a medical device used for direct visualization, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
EOB
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and upper airway anatomy
Indicated Patient Age Range
adults
Intended User / Care Setting
hospital environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following data have been submitted in the premarket notification:
Declaration of conformity to the following recognized consensus standards applicable for Ambu® aScope™ RLS Slim:
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 of the Ambu® 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™ RLS Slim. 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™ RLS Slim 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 Electrical Safety:
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.
Key Metrics
Not Found
Predicate Device(s)
Rhino-Laryngofiberscope Olympus ENF-GP (K011869)
Reference Device(s)
Ambu® aScope™ 4 Broncho Slim (K173727)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.
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.
1
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 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.
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/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Camilla Wismar
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2208
Fax number: +45 7225 2050 |
| Date Summary
Prepared | May 14, 2018 |
| Device Trade
Name | Ambu® aScope™ RLS Slim |
| Device Common
Name | Rhino-Laryngoscope |
| Device
Classification | Nasopharyngoscopes (Flexible or Rigid)
Product Codes: EOB
21 CFR 874.4760
Class II |
| Legally
Marketed
devices to which
the device is
substantially
equivalent | Predicate Device:
Rhino-Laryngofiberscope Olympus ENF-GP (K011869), Olympus
Medical Systems Corporation
Reference Device:
Ambu® aScope™ 4 Broncho Slim (K173727), Ambu A/S |
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| Description of
the Device | 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 |
|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The endoscope is a sterile, single-use, flexible 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. |
| Summary of the
technological
characteristics
in comparison to
the predicate
devices | Ambu® aScope™ RLS Slim is similar to the predicate device A and
reference 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 operator
ability 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 that
differs from predicate A in the following areas: Type of product
(applicant device is a Videoscope, whereas predicate device A is a
Fiberscope, which can be used together with a camera and
monitor)
• Bending angles
• Length of insertion cord
• Disposable after use (applicant device is Single Use, whereas
predicate device A is Reusable)
Validation from non-clinical testing demonstrated that these technological
features do not raise any new issues of safety and effectiveness of the
applicant device. |
| Performance
Data -Bench | The following data have been submitted in the premarket notification:
Declaration of conformity to the following recognized consensus
standards applicable for Ambu® aScope™ RLS Slim:
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 of the
Ambu® 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™ RLS
Slim. 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™ RLS
Slim 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 Electrical
Safety:
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. |
| Performance
Data - Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics,
performance data and comparison to predicate and reference devices it
has 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 effective
and perform as well as the predicate and reference devices. |
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