(88 days)
No
The summary describes a standard flexible endoscope with basic features and does not mention any AI/ML capabilities or image processing beyond basic visualization.
No.
The device is intended for examination and visualization, which are diagnostic purposes, not therapeutic. While it has a working channel, its stated primary use is for observation rather than active treatment.
Yes
Explanation: The "Intended Use / Indications for Use" states that the endoscope is intended for "examination" of nasal lumens and upper airway anatomy to provide visualization. Visualization for examination purposes is a diagnostic function, as it allows clinicians to observe and assess the condition of internal structures to identify abnormalities or disease states.
No
The device description clearly outlines physical hardware components such as a flexible insertion cord, camera, LED light source, and working channel, and performance studies include testing of physical properties and electrical safety.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endoscopic procedures and examination within the nasal lumens and upper airway anatomy" to "provide visualization via a monitor." This describes a device used for direct visualization of internal body structures, not for testing samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description focuses on the physical characteristics of an endoscope (flexible insertion cord, camera, light source, working channel) used for direct examination.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing materials in vitro to provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This endoscope is a medical device used for direct visualization and intervention, not for in vitro diagnostic testing.
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™ 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
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Performance test report to document shelf life. Tests were performed on finished, sterilized and aged products:
- Performance test
- Sterile Packaging Integrity
Result: All tests were passed.
Biocompatibility tests reports to document compliance 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Olympus XENF-TP (K013591)
Reference Device(s)
Ambu® aScope™ 4 Broncho Regular (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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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
1
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 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 | Description of
the Device | 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 |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Gurpreet Kaur Rehal
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2116
Fax number: +45 7225 2050 | 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. |
| Date Summary
Prepared | April 12, 2019 | Summary of the
technological
characteristics
in comparison to
the predicate
devices | Ambu® aScope™ 4 RhinoLaryngo Intervention is similar to the predicate
device 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 operator
ability 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 endoscopic
accessories. 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 Trade
Name | Ambu® aScope™ 4 RhinoLaryngo Intervention | | |
| 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:
Olympus XENF-TP (K013591), Olympus Medical Systems Corporation
Reference Device:
Ambu® aScope™ 4 Broncho Regular (K173727), Ambu A/S | | |
4
5
| | Subject
(K190972) | Predicate
(K013591) |
|------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------|
| Device Name | Ambu®
aScope™ 4
RhinoLaryngo
Intervention | Olympus XENF-TP |
| Type of product | Rhino-laryngo
videoscope | Rhino-laryngo
fiberscope |
| Design Concept | Portable design | Portable design |
| Separate Monitor required | Yes | Yes. |
| Connection to other devices | Monitor | Monitor |
| Delivered sterile | Yes | No, shall be
cleaned or
sterilized before
use by
user/hospital |
| Disposable after use | Yes | No |
| Field of view | 85° | 85° |
| Direction of View | 0° (forward
viewing) | 0° (forward
viewing) |
| Depth of field | 6-50 mm | 3-50 mm |
| Illumination method | LED | LED or halogen |
| Bending section | 130° up
130° down | 130° up
130° down |
| Maximum diameter of
insertion portion | 5.5 mm | 5.0 mm |
| Working Channel (Inner
diameter) | 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.
6
| Performance
Data - Clinical | Performance test report to document shelf life. Tests were performed on
finished, sterilized and aged products:
• Performance test
• Sterile Packaging Integrity
Result: All tests were passed.
Biocompatibility tests reports to document compliance 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. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Not applicable. |
| Conclusion | 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. |