Ambu® aScope™ Gastro, Ambu® aBox™2

K212382 · Ambu A/S · FDS · Feb 3, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K212382
• Device Name: Ambu® aScope™ Gastro, Ambu® aBox™2
• Applicant: Ambu A/S
• Product Code: FDS · Gastroenterology, Urology
• Decision Date: Feb 3, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The aScope Gastro is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy. The aScope Gastro is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment. The aBox 2 is intended to display live imaging data from compatible Ambu visualization devices.

Device Story

System comprises sterile, single-use flexible gastroscope (aScope Gastro) and display unit (aBox 2). Scope features maneuverable tip controlled by handle-mounted wheels and Bowden wires; includes working channel for endotherapy accessories. aBox 2 processes and displays live video imaging data from scope. Used in clinical settings for upper GI examination. Physician operates scope; aBox 2 provides real-time visualization, brightness, contrast, sharpness, and zoom adjustments. Single-use design eliminates reprocessing requirements; portable aBox 2 integrates monitor, removing need for external display. System facilitates visualization of GI anatomy to support diagnostic and therapeutic procedures.

Clinical Evidence

Bench testing only. Verified geometrical characteristics, functional performance (insufflation, suction, rinsing, water jet), optical performance (FOV, depth of field, distortion, color, noise), photobiological safety, biocompatibility (ISO 10993-1), sterilization (ISO 11135), transport/packaging integrity, shelf life, electrical safety (IEC 60601-1, IEC 60601-2-18), and EMC (IEC 60601-1-2).

Technological Characteristics

Flexible endoscope with maneuverable tip; Bowden wire actuation. Video processor with integrated monitor. Connectivity: compatible Ambu visualization devices. Sterilization: Ethylene oxide (implied by ISO 11135). Standards: ISO 10993-1 (biocompatibility), ISO 11135 (sterilization), IEC 60601-1/2-18 (electrical safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for endoscopic access to and examination of the upper gastrointestinal anatomy in patients requiring gastrointestinal endoscopy.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• OLYMPUS EVIS EXERA II Gastrointestinal Videoscope GIF H180 (K100584)
• OLYMPUS EXERA II Light Source (CLV-180) and Video System Center (CV-180) (K100584)

Submission Summary (Full Text)

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February 3, 2022

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

Re: K212382

Trade/Device Name: Ambu® aScope™ Gastro, Ambu® aBox™2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDS, FET Dated: December 27, 2021 Received: January 4, 2022

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K212382

Device Name Ambu® aScope™ Gastro Ambu® aBox™ 2

Indications for Use (Describe)

The aScope Gastro is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.

The aScope Gastro is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.

The aBox 2 is intended to display live imaging data from compatible Ambu visualization devices.

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) Application – Ambu® Gastrointestinal (GI) Endoscopy System

# 510(k) Summary

| Submitter | Ambu A/S<br>Baltorpbakken 13<br>DK-2750 Ballerup<br>Denmark<br>Tel.: [phone]<br>Fax.: [phone] | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Sanjay Parikh<br>Job Title: Director, QA/RA<br>Address: Ambu Inc. / 6230 Old Dobbin Lane, Suite 250 / 21045<br>Columbia / USA<br>Business Phone: [phone]<br>Email: [e-mail] | |
| Date Summary<br>Prepared | July 29, 2021 | |
| Device Trade<br>Name | Ambu® aScope™ Gastro<br>Ambu® aBox™ 2 | |
| Device Common<br>Name | Endoscopy System | |
| Device<br>Classification | Ambu® aScope™ Gastro:<br>Gastroscope And<br>Accessories, Flexible/rigid<br>Product Codes: FDS, FET<br>21 CFR 876.1500<br>Class II | Ambu® aBox™ 2:<br>Endoscopic Video Imaging<br>System/Component,<br>Gastroenterology-Urology<br>Product Codes: FET, FDS<br>21 CFR 876.1500<br>Class II |
| Legally<br>Marketed<br>devices to which<br>the device is<br>substantially<br>equivalent | Predicate Device:<br>OLYMPUS EVIS EXERA II<br>Gastrointestinal<br>Videoscope GIF H180<br>K100584 | Predicate Device:<br>OLYMPUS EXERA II Light Source<br>(CLV-180) and Video System Center<br>(CV-180)<br>K100584 |
| Description of<br>the Device | The Ambu® Gastrointestinal (GI) Endoscopy System is a system<br>used for endoscopic procedures in the gastrointestinal anatomy. It<br>consists of a sterile, single-use, flexible endoscope, the Ambu®<br>aScope™ Gastro, and a displaying unit, the Ambu® aBox™ 2. | |
| Indications for<br>Use | The aScope Gastro is a sterile, single-use flexible gastroscope<br>intended to be used for endoscopic access to and examination of<br>the upper gastrointestinal anatomy.<br>The aScope Gastro is intended to provide visualization via a<br>compatible Ambu displaying unit and to be used with endo-<br>therapy accessories and other ancillary equipment.<br>The aBox 2 is intended to display live imaging data from<br>compatible Ambu visualization devices. | |
| Summary of the<br>technological<br>characteristics<br>in comparison to<br>the predicate<br>devices | The Ambu® aScope™ Gastro and its predicate device have the<br>following same technological characteristics:<br>Both are flexible endoscopes with maneuverable tip, a<br>control section (handle) and an umbilical cord Both control the tip bending via two wheels at the handle<br>and bowden wires. Both provide a working channel Both have same technological characteristics as insertion<br>portion length, working channel diameter, direction of view<br>and bending angels Unlike the predicate device, the Ambu® aScope™ Gastro is<br>a sterile, single-use device and not intended to be<br>reprocessed.<br>The Ambu® aBox™ 2 and its predicate device have the following<br>same technological characteristics: Both are video processors displaying live video-imaging data of the connected visualization device to a monitor. Both provide video output formats, recording and data storage and data transport functions. Both share certain technical functionalities as brightness control, image contrast and sharpness adjustment and zoom function. Contrary to the predicate device, the Ambu® aBox™ 2 is portable and has an integrated monitor, therefore, an external monitor is not necessary | |
| Performance<br>Data -Bench | The following tests to verify/validate the design and evaluate the<br>performance of the Ambu® GI Endoscopy System were done. Geometrical characteristics including Length of insertion tube, umbilical cord, tip Outer diameter of bending section, insertion tube and overlap of both Tip reach Bending angles Functional performance including | |
| | Insufflation Suction Rinsing Water Jet Optical performance including Field of view Direction of view Sharpness and Depth of field Geometric distortion Image intensity uniformity Color performance Noise characterization Dynamic range Camera view orientation Photobiological safety Biocompatibility according ISO 10993-1 including cytotoxicity, irritation, and sensitization Sterilization validation according ISO 11135 Transport validation including packaging integrity Stability study to document shelf life Electrical Safety and performance according IEC 60601-1 and IEC 60601-2-18 Electromagnetic Compatibility according IEC 60601-1-2 Tests to confirm procedural performance<br>In all instances, the Ambu® GI Endoscopy System performed as expected and met the set test specifications. | |
| <b>Conclusion</b> | The Ambu® Gastrointestinal (GI) Endoscopy System, consisting of Ambu® aScope™ Gastro and Ambu® aBox™2, has the same intended use and indications for use, and similar technological characteristics and principles of operation as the predicate devices.<br>The minor technological differences between the Ambu® Gastrointestinal (GI) Endoscopy System and its predicate devices raise no new concerns regarding safety or effectiveness.<br>Thus, the Ambu® Gastrointestinal (GI) Endoscopy System, consisting of Ambu® aScope™ Gastro and Ambu® aBox™ 2, is substantially equivalent to its predicate devices | |

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510(k) Application – Ambu® Gastrointestinal (GI) Endoscopy System