Who is the manufacturer of Ambu aScope 4 RhinoLaryngo Intervention?

Ambu A/S filed the 510(k) submission for Ambu aScope 4 RhinoLaryngo Intervention (K190972).

What is the FDA product code for Ambu aScope 4 RhinoLaryngo Intervention?

EOB. It is classified under 21 CFR 874.4760 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Ambu aScope 4 RhinoLaryngo Intervention?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Ambu aScope 4 RhinoLaryngo Intervention?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Ambu aScope 4 RhinoLaryngo Intervention

K190972 · Ambu A/S · EOB · Jul 12, 2019 · Ear, Nose, Throat

Device Facts

Record ID	K190972
Device Name	Ambu aScope 4 RhinoLaryngo Intervention
Applicant	Ambu A/S
Product Code	EOB · Ear, Nose, Throat
Decision Date	Jul 12, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.4760
Device Class	Class 2

Intended 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.

Device Story

Sterile, single-use flexible endoscope for visualization of nasal lumens and upper airway anatomy; used in hospital environments by clinicians. Device features maneuverable distal tip controlled by handle lever; integrated LED light source; working channel for accessory insertion. Input: optical images of airway anatomy. Output: real-time video feed displayed on external monitor. Clinician uses visual output to guide procedures and examinations. Single-use design eliminates reprocessing requirements, reducing cross-contamination risk compared to reusable endoscopes.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including ISO 8600-1/3/4 compliance, bending endurance, image sharpness/resolution, suction capability, shelf-life/packaging integrity, biocompatibility (ISO 10993-1), and electrical/EMC safety (IEC 60601-1, 60601-2-18, 60601-1-2).

Technological Characteristics

Flexible endoscope; maneuverable tip; LED illumination; 5.5 mm insertion diameter; 2.2 mm working channel; 350 mm working length. Sterilized by Ethylene Oxide. Complies with ISO 8600-1, ISO 8600-3, ISO 8600-4, ISO 10993-1, IEC 60601-1, IEC 60601-2-18, and IEC 60601-1-2.

Indications for Use

Indicated for endoscopic procedures and examination of nasal lumens and upper airway anatomy in adults in a hospital environment.

Regulatory Classification

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.

Predicate Devices

Olympus XENF-TP (K013591)

Reference Devices

Ambu aScope 4 Broncho Regular (K173727)

Related Devices

K191080 — Ambu aScope 4 RhinoLaryngo Slim · Ambu A/S · May 22, 2019
K221581 — Single-Use Flexible Rhinolaryngoscope · Hunan Vathin Medical Instrument Co., Ltd. · Nov 18, 2022
K181286 — Ambu aScope RLS Slim · Ambu A/S · Nov 30, 2018
K192090 — CMOS Video Rhino-Laryngoscope SSU · Karl Storz SE & CO. KG · Jan 27, 2020
K232435 — Rhinolaryngoscope system · Shenzhen HugeMed Medical Technical Development Co., Ltd. · Apr 26, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text. 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 {2}------------------------------------------------ # 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): | <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | |----------------------------------------------------------------------------------------------------------------------------------------------| | <div> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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. |