(130 days)
Not Found
No
The description focuses on the physical and functional characteristics of the endoscope and display unit, including image processing for display and recording, but does not mention any AI or ML capabilities for image analysis, diagnosis, or other functions. The performance studies listed are standard tests for endoscopes and display units, not AI/ML model validation.
No
The device is used for endoscopic surgery (diagnostic and interventional procedures) which is a medical procedure, but the device itself is not a therapeutic device because it does not directly treat or cure a disease.
No
The device is described as being used for "endoscopic surgery within the duodenum" and to "display live imaging data" from a visualization device. It performs functional tasks like suction, rinsing, and controls accessories, but its primary stated purpose isn't to diagnose a condition. While the imaging may be used during diagnosis, the device itself is for surgical procedures and visualization, not for providing a diagnostic interpretation or result.
No
The device description clearly outlines both a hardware component (the aScope™ Duodeno 2, a flexible endoscope) and a displaying unit (the aBox™ 2, a physical monitor). The performance studies also include hardware-specific testing like geometrical characteristics, functional performance, optical performance, electrical safety, and biocompatibility.
Based on the provided information, the Ambu® aScope™ Duodeno 2 Endoscopy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "endoscopic surgery within the duodenum" and displaying "live imaging data". This describes a device used for direct visualization and intervention within the body, not for examining specimens in vitro (outside the body).
- Device Description: The description details a flexible endoscope and a display unit. These are tools for internal examination and procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological specimens (blood, tissue, urine, etc.).
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis based on in vitro analysis.
The device is clearly designed for direct visualization and procedural use within the patient's body.
N/A
Intended Use / Indications for Use
The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum.
The aBox ™2 is intended to display live imaging data from compatible Ambu visualization devices.
Product codes
FDT, FET
Device Description
The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2.
The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum.
The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work.
The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
- · Can record, store and transport image data from Ambu® aScope™ Duodeno 2
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
Mentions image processing
Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
duodenum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 tests to verify/validate the design and evaluate the performance of the Ambu" aScope™ Duodeno 2 Endoscopy System were done.
- · Geometrical characteristics including
- Minimum working channel width
- Length of insertion tube,
- Maximum insertion portion width,
- Outer diameter of insertion tube,
- Bending performance/bending angles,
- · Functional performance including
- Suction,
- Rinsing,
- Elevator Lever bending capability,
- Guidewire lock performance
- · Optical performance/image quality including
- Field of view / Direction of View,
- Depth of field,
- Sharpness across the image,
- Image Intensity Uniformity,
- Color Performance,
- Noise Performance,
- Dynamic Range,
- Geometric distortion
- · Photobiological safety according to IEC 62471
- · Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization
- · Sterilization validation according to ISO 11135
- · Transport validation including packaging integrity
- · Stability study to document shelf life
- · Electrical Safety and performance according to IEC 60601-1 and IEC 60601-2-18
- · Electromagnetic Compatibility according to IEC 60601-1-2
- · System Performance Tests to confirm procedural performance
In all instances, the Ambu® aScope™ Duodeno 2 Endoscopy System performed as expected and met the set test specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
April 16, 2024
Ambu A/S % Sanjay Parikh Senior Director OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K233886
Trade/Device Name: Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FDT, FET Dated: December 8, 2023 Received: March 19, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Shanil P. Haugen -S
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
3
Indications for Use
510(k) Number (if known) K233886
Device Name Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2
Indications for Use (Describe)
The aScope™ Duodeno 2 is designed to be used with the aBox™2, endoscopic accessories (e.g., biopsy forceps) and other ancillary equipment (e.g., medical grade video monitor) for endoscopic surgery within the duodenum.
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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K233886 Page 1 of 3
510(k) Summary
21 CFR 807.92(a)(1)
21 CFR 807.92(a)
Prepared on: 2023-12-08
Contact Details
| Applicant Name | Ambu A/S | |
|---|---|---|
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark | |
| Applicant Contact Telephone | +4553813820 | |
| Applicant Contact | Mrs. Mette Andersen | |
| Applicant Contact Email | meta@ambu.com | |
| Correspondent Name | Ambu Inc. | |
| Correspondent Address | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046 | |
| United States | ||
| Correspondent Contact Telephone | +1 443 831 9844 | |
| Correspondent Contact | Mr. Sanjay Parikh | |
| Correspondent Contact Email | sap@ambu.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Ambu® aScope™ Duodeno 2; | |
| Ambu® aBox™ 2 | ||
| Common Name | Endoscope and accessories | |
| Classification Name | Duodenoscope And Accessories, Flexible/Rigid | |
| Regulation Number | 876.1500 | |
| Product Code | FDT | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K201098 | Ambu® aScope™ Duodeno | FDT |
| K143153 | EVIS EXERA II DUODENOVIDEOSCOPE OLYMPUS TJF TYPE | FDT |
| K230332 | Ambu® aBox™ 2 | FET |
Device Description Summary
The Ambu® aScope™ Duodeno 2 Endoscopy System is a combination of the duodenoscope, Ambu® aScope™ Duodeno 2 and the compatible displaying unit, Ambu® aBox™ 2.
The Ambu® aScope™ Duodeno 2, is a sterile and single-use medical device for endoscopic surgery within the duodenum.
5
K233886 Page 2 of 3
The Ambu® aScope™ Duodeno 2 is a flexible endoscope) with side viewing optics, deflectable tip and an elevator to control the position of inserted accessories. The angulation of the endoscope tip is wheels, whereby the angulation can be locked via levers. The elevator (Albarran lever) is also controlled via a lever. Insufflation, suction and rinsing functions are activated via user controls. The product contains remote switches / programmable buttons of the connected Displaying Unit (Ambu® aBox™ 2). The Ambu® aScope™ Duodeno 2 must be connected to the Ambu® aBox™ 2 to be able to work.
The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8" LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ Duodeno 2 to a monitor
- · Can record, store and transport image data from Ambu® aScope™ Duodeno 2
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
Intended Use/Indications for Use
The aScope™ Duodeno 2 is designed to be used with the aBox™ 2, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopic surgery within the duodenum.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Indications for Use Comparison
The Ambu® aScope™ Duodeno 2 has the same intended use as the predicate devices. The Ambu® aBox™ 2 has the same intended use as the predicate device.
Technological Comparison
The Ambu® aScope Duodeno 2 and its predicate devices have the following same technological characteristics:
• Both are flexible endoscopes with maneuverable tip, a control section body (handle) and an umbilical cord
· Both control the tip bending via two wheels at the handle and Bowden wires.
· Both provide a working channel and an elevator (Albarran lever)
· Both have same technological characteristics as insertion portion channel diameter, direction of view and bending angels
As the predicate device Ambu® aScope™ Duodeno 2 is a sterile, single-use device and not intended to be reprocessed and is equipped with LEDs for light illumination and does not need an additional light source. Like the predicate device EVIS EXERA II Duodenovideoscope Olympus TJF Type Q180V, the Ambu® aScope™ Duodeno 2 is equipped with a guidewire locking function.
The Ambu® aScope™ Duodeno 2 differs from its predicate devices in some technical on including Field of View and Depth of Field. The differences do not introduce issues for safety and performance. The Ambu® aScope™ Duodeno 2 has passed the performance testing.
Ambu® aBox™ 2 and its predicate device have the following 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 such as brightness contrast and sharpness adjustment as well as zoom function.
· Both devices are portable and have an integrated monitor and offers the possibility of connection to an external monitor.
Non-Clinical and/or Clinical Tests Summary & Conclusions
The following tests to verify/validate the design and evaluate the performance of the Ambu" aScope™ Duodeno 2 Endoscopy System were done.
· Geometrical characteristics including
- Minimum working channel width
- Length of insertion tube,
- Maximum insertion portion width,
- Outer diameter of insertion tube,
- Bending performance/bending angles,
- · Functional performance including
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807 92(a)(5)
6
- Suction,
- Rinsing,
- Elevator Lever bending capability,
- Guidewire lock performance
- · Optical performance/image quality including
- Field of view / Direction of View,
- Depth of field,
- Sharpness across the image,
- Image Intensity Uniformity,
- Color Performance,
- Noise Performance,
- Dynamic Range,
- Geometric distortion
- · Photobiological safety according to IEC 62471
- · Biocompatibility according to ISO 10993-1 including cytotoxicity, irritation, sensitization
- · Sterilization validation according to ISO 11135
- · Transport validation including packaging integrity
- · Stability study to document shelf life
- · Electrical Safety and performance according to IEC 60601-1 and IEC 60601-2-18
- · Electromagnetic Compatibility according to IEC 60601-1-2
- · System Performance Tests to confirm procedural performance
In all instances, the Ambu® aScope™ Duodeno 2 Endoscopy System performed as expected and met the set test specifications.
Not Applicable
The Ambu® aScope™ Duodeno 2 Endoscopy System, consisting of Ambu® aScope™ Duodeno 2 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. The minor technological differences between the Ambu® aScope™ Duodeno 2 Endoscopy System and its predicate devices raise no new concerns regarding safety or effectiveness.
Thus, the Ambu® aScope™ Duodeno 2 Endoscopy System, consisting of Ambu® aScope™ Duodeno 2 and Ambu® aBox™2, is substantially equivalent to its predicate devices.