(28 days)
K18128
K01186, K17372
No
The summary focuses on the physical characteristics, performance testing, and sterilization of the endoscope. There is no mention of AI, ML, image processing for analysis, or any data training/testing related to algorithms.
No
The device is described as an endoscope intended for visualization and examination, not for treating any condition.
No
Explanation: The endoscope is intended for visualization of anatomical structures, not for the diagnosis of a specific condition or disease. It provides visual information rather than analytical diagnostic data.
No
The device description clearly outlines physical hardware components such as a flexible insertion cord, camera, LED light source, and a maneuverable tip. The performance studies also focus on physical characteristics and bench testing of these hardware components.
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) 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, maneuverable tip) used for visualization.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples, detect analytes, or provide diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This endoscope's function is purely for visualization during a medical procedure.
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 Slim is a sterile single use flexible endoscope for examination of the nasal lumens and upper airway anatomy.
Ambu® aScope™ 4 RhinoLaryngo 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 bench data are described for the product line extension in the premarket notification:
- Declaration of Conformity with the following product specific standards ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 594-1. Result: All tests were passed.
- Performance test has been conducted to document the following properties of Ambu® aScope™ 4 RhinoLaryngo Slim: Length and diameters of insertion cord, Bending angle, endurance and radius, Image Sharpness. Result: All tests were passed.
- Performance test has been conducted to document the shelf life and sterile barrier of Ambu® aScope™ 4 RhinoLaryngo Slim, where the aging and sterile Packaging Integrity testing is carried out in accordance with: ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems, ASTM F1886/F1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection, ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (Test Method B - Procedure for Porous Packaging.), Seal Strength tests performed based on: EN 868-5: Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods and ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials. Result: All tests were passed.
- Test reports that verify the Electromagnetic Compatibility and Electricial 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)
K18128
Reference Device(s)
K01186, K17372
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 22, 2019
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, Maryland 21045
Re: K191080
Trade/Device Name: Ambu aScope 4 RhinoLaryngo Slim Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (flexible or rigid) and accessories Regulatory Class: Class II Product Code: EOB Dated: April 23, 2019 Received: April 24, 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.
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 mediation-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,
for Michael Ryan 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191080
Device Name Ambu aScope 4 RhinoLaryngo 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 Special 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: 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 | | | |
| Date Summary
Prepared | April 19, 2019 | | | |
| Device Trade
Name | Ambu® aScope™ 4 RhinoLaryngo Slim | | | |
| Device Common
Name | Rhino-Laryngoscope | | | |
| Device
Classification | Nasopharyngoscopes (Flexible or Rigid)
Product Codes: EOB
21 CFR 874.4760
Class II | | | |
| Legally
Marketed | | Manufacturer | Trade Name | 510k
number |
| devices to which
the device is
substantially | Predicate
C: | Ambu A/S | Ambu® aScope™ RLS
Slim | K18128 |
| equivalent | Reference:
A: | Olympus
Medical
Systems
Corporation | Olympus ENF-GP | K01186 |
| | Reference
B: | Ambu A/S | Ambu® aScope™ 4
Broncho Slim | K17372 |
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| Description of
the Device | The Ambu® aScope™ 4 RhinoLaryngo Slim is a sterile single use flexible
endoscope for examination of the nasal lumens and upper airway
anatomy. | | |
|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------|
| | Ambu® aScope™ 4 RhinoLaryngo 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 | Specification | Ambu® aScope™
RLS Slim | Ambu® aScope™ 4
RhinoLaryngo Slim |
| | Distal end diameter | 4.2 mm (0.16") | 3.5 mm (0.14") |
| | Insertion cord
diameter | 3.8 mm (0.15") | 3.0 mm (0.12") |
| | Working length | 600 mm (23.6") | 300 mm (11.8") |
| | Bending section | 180° up, 180° down | 130° up, 130° down |
| | Max diameter of
insertion portion | 4.3 mm (0.17") | 3.5 mm (0.14") |
| | Ambu® aScope™ 4 RhinoLaryngo Slim is similar to the predicate device C
and reference A and B devices 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. The Ambu® aScope™ 4 RhinoLaryngo Slim diameter is similar to the
predicate and reference device:
Predicate C has a larger diameter. Reference A has the same working length. Predicate C
and reference B have a longer working length Predicate C and Reference A have same intended use. Predicate C and reference B are single-use device, which are
delivered sterile | | |
5
. They are all portable endoscopes. Validation from non-clinical testing demonstrated that these technological features do not raise any new issues of safety and effectiveness of the applicant device. Overall, the line extension scope is narrower in diameter and shorter in length than the predicate device. Furthermore, the following non-dimensional changes are made: . The color of the control lever and tube connection has been changed from gray to purple, to indicate the product variant. The control lever and tube connector are components on the handle and do not have direct or indirect contact with the patient and do not raise new questions of safety and effectiveness. ● The type of Tyvek primary packaging material has been changed to Tyvek 2FS with EP 1250 film. Packaging integrity testing and sterilization validation report have been updated and do not raise new questions of safety and effectiveness. . Adhesive used for water tightness of the camera is changed. Tests that documents compliance with design requirements are performed, including verification using ISO10993 tests for cytotoxicity, irritation and sensitization, and do not raise new questions of safety and effectiveness. Ambu® aScope™ 4 RhinoLaryngo Slim has been successfully tested for its Performance functions, performance and safety as per FDA recognized consensus Data -Bench standards. The following bench data are described for the product line extension in the premarket notification: Declaration of Conformity with the following product specific standards ISO 8600-1, ISO 8600-3, ISO 8600-4 and ISO 594-1 ● Result: All tests were passed. Performance test has been conducted to document the following properties of Ambu® aScope™ 4 RhinoLaryngo Slim: ● Length and diameters of insertion cord ● Bending angle, endurance and radius . Image Sharpness Result: All tests were passed. Performance test has been conducted to document the shelf life and sterile barrier of Ambu® aScope™ 4 RhinoLaryngo Slim, where the aging and sterile Packaging Integrity testing is carried out in accordance with: ● ASTM F1980: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices ● ASTM D4169: Standard Practice for Performance Testing of Shipping Containers and Systems
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| Performance
Data - Clinical | ASTM F1886/F1886M: Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection ASTM F2096: Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) (Test Method B - Procedure for Porous Packaging.) Seal Strength tests performed based on: EN 868-5: Packaging for terminally sterilized medical devices – Part 5: Sealable pouches and reels of porous materials and plastic film construction - Requirements and test methods and ASTM F88: Standard Test Method for Seal Strength of Flexible Barrier Materials Test reports that verify the Electromagnetic Compatibility and Electricial 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.
Similar requirements and test methods are used in the bench test for the predicate device, which supports the determination of substantial equivalence.
The line extension Ambu® aScope™ 4 RhinoLaryngo Slim and predicate device have the same intended use fundamental technology and there are no significant differences that raise different questions of safety and effectiveness.
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™ 4 RhinoLaryngo Slim is substantially equivalent to the predicate device.
It is concluded that Ambu® aScope™ 4 RhinoLaryngo Slim is as safe and as effective and perform as well as the predicate device. |