(84 days)
K173085 invendoscopy E210 System
No
The description focuses on standard endoscopic video imaging and control functions, with no mention of AI, ML, or advanced image analysis beyond basic display and capture.
No
Explanation: The device is described as an endoscope system used for diagnostics (collecting image data, endoscopy) and for facilitating endoscopic surgery by allowing the introduction of accessories like biopsy forceps. While surgery can be therapeutic, the device itself is an imaging and access tool, not directly performing a therapeutic action.
No
The device is described as being used for "endoscopy and endoscopic surgery" and has a working channel for the introduction of "additional instruments as biopsy devices." This indicates a primary use for visualization during procedures and facilitating interventions, rather than solely providing a diagnosis based on the device's output. While it collects image data, its stated purpose clearly extends beyond just diagnosis.
No
The device description clearly outlines both hardware components (aScope Duodeno, aBox Duodeno) and software/video processing functions. It is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopy and endoscopic surgery within the duodenum." This involves directly visualizing and potentially manipulating tissue inside the body.
- Device Description: The description details a flexible endoscope with a camera, light source, working channel, and functions for lens washing, insufflation, and suction. These are all components and functions of a device used for direct internal examination and intervention.
- IVD Definition: An In Vitro Diagnostic device is defined as a medical device intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic purposes. This device does not examine specimens in vitro. It is used in vivo to visualize and potentially interact with the duodenum.
The device is an endoscopic system used for direct visualization and intervention within the body, which falls under the category of medical devices used for diagnostic and therapeutic procedures in vivo, not IVDs.
N/A
Intended Use / Indications for Use
The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum.
The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum.
Product codes
FDT, FET
Device Description
The Ambu Duodeno System consists of a sterile single-use endoscope, the aScope Duodeno, and a processing unit, the aBox Duodeno.
The sterile single use duodenoscope aScope Duodeno consists of a flexible insertion tube with bendable tip, a control body and an umbilicus cord. The insertion tube has a bendable tip which is equipped with a camera to collect image data and a LED light source to illuminate the body cavity. The device contains a working channel through which additional instruments as biopsy devices may be introduced. The aScope Duodeno provides functions for lens washing, insufflation and suction.
The aBox Duodeno is an endoscopic video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface (GUI) to a connected external video monitor. It also provides signals to capture images by a connected external image capturing system. The aBox Duodeno also contains a peristaltic pump to provide water for the endoscope lens washing function. The peristaltic pump is controlled by the operator via the endoscope.
Mentions image processing
Yes
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)
Non-clinical testing was performed to validate the design and to evaluate substantial equivalency with the predicate device. This testing includes the following:
- Working length -
- -Insertion portion diameter
- -Diameter working channel
- -Bending angle endoscope tip
- -Bending angle elevator
- Insufflation flow rate -
- -Direction of view
- -Image resolution
- -Depth of field
- Image distortion0 -
- -Photobiological safety
- -Signal to noise ratio
- -Image illumination uniformity
- -Color performance
- Rinsing flow rateSuction flow rate -
- -Instruments compatibility test
- -System performance (functional performance)
The biocompatibility was evaluated in accordance with ISO 10993-1, including cytotoxicity; irritation and sensitization. The electrical safety of the system was tested according to IEC 60601-1 and IEC 60601-2-18. EMC was tested, in accordance with IEC 60601-1-2. The sterilization process was validated according to ISO 11135.
In all instances, the Ambu Duodeno System functioned as intended, performed as well as or better than the predicate and met individual test specifications.
An animal study with two independent sessions was conducted to evaluate the clinical performance of the device.
The first session was performed in a bench top model utilizing a modified porcine upper GI tract with a simulated major duodenal papilla (MDP). The second session consisted of in-vivo duodenoscopy with positioning for cannulation of the proximal duodena papilla (PDP) in a porcine model. In both sessions, the participants were asked to complete two separate runs, one using the Ambu Duodeno System and one using the predicate device.
For all test runs participants were asked to complete steps required for cannulation of the MDP/PDP using their standard technique. Both test sessions included evaluation of the following steps: intubation, navigation to the descending part of the duodenum, positioning for cannulation, tool insertion/retraction and withdrawal of duodenoscope. Furthermore, cannulation of the MDP was evaluated in the bench top test (first session), while procedure/device related tissue damage was recorded during the in vivo testing (second session). For all steps times from procedure start to step completed were recorded.
All participants were able to successfully complete all steps of both test sessions. The performance of the Ambu Duodeno System was comparable to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K143153 Olympus TJF-Q180V, K100584 EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180
Reference Device(s)
K173085 invendoscopy E210 System
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.
0
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July 17, 2020
Ambu Innovation GmbH % Sanjay Parikh Director QA/RA Ambu Inc. 6230 Old Dobbin Lane Suite 250 Columbia, MD 21045
Re: K201098
Trade/Device Name: Ambu Duodeno System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FDT, FET Dated: April 23, 2020 Received: April 24, 2020
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,
Shanil P. Haugen, PhD 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
2
Indications for Use
510(k) Number (if known)
Device Name Ambu Duodeno System
Indications for Use (Describe)
The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum.
The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopic surgery within the duodenum.
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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3
Traditional 510(k)
premarket notification Ambu Duodeno System
Image /page/3/Picture/3 description: The image shows the Ambu logo. The word "Ambu" is written in red, with the tagline "Ideas that work for life" written in a smaller, gray font below it. To the right of the word "Ambu" is a symbol that looks like three stylized arrows pointing towards a central point.
Applicant Information
| Name: | Ambu Innovation GmbH |
|---|---|
| Address: | Peterhofstr. 3b |
| 86438 Kissing | |
| Germany | |
| Contact: | Oliver v. Ruepprecht |
| Director QA/RA | |
| Phone : +49 (8233) 2189028 | |
| Mail : OLRU@AMBU.COM |
- Date Prepared: June 23″, 2020
Identification of the proposed device
| Device Name | Ambu Duodeno System |
|---|---|
| Components | Ambu aScope Duodeno |
| Ambu aBox Duodeno | |
| Common Name | Duodenoscope and Accessories |
| Classification | Endoscope and Accessories |
| Regulation | 21 CFR 876.1500 |
| Device Class | II |
| Product Code | FDT, FET |
| Review Panel | Gastroenterology/Urology |
| Predicate Devices | |
| K143153 | Olympus TJF-Q180V |
| K100584 | EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS |
| CV-180 | |
| Reference Devices | |
| K173085 | |
| Confidential | invendoscopy E210 System |
4
Traditional 510(k) premarket notification Ambu Duodeno System - 510k Summary
Indication for Use/Intended Use
The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. video monitor) for endoscopy and endoscopic surgery within the duodenum.
The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum.
Device Description
The Ambu Duodeno System consists of a sterile single-use endoscope, the aScope Duodeno, and a processing unit, the aBox Duodeno.
The sterile single use duodenoscope aScope Duodeno consists of a flexible insertion tube with bendable tip, a control body and an umbilicus cord. The insertion tube has a bendable tip which is equipped with a camera to collect image data and a LED light source to illuminate the body cavity. The device contains a working channel through which additional instruments as biopsy devices may be introduced. The aScope Duodeno provides functions for lens washing, insufflation and suction.
The aBox Duodeno is an endoscopic video imaging system that receives video signals from the connected endoscope, controls the light at the endoscope tip and outputs this signal including a graphical user interface (GUI) to a connected external video monitor. It also provides signals to capture images by a connected external image capturing system. The aBox Duodeno also contains a peristaltic pump to provide water for the endoscope lens washing function. The peristaltic pump is controlled by the operator via the endoscope.
Comparison of Technological Characteristics with the Predicate Device
Both the aScope Duodeno and the Olympus TJF-Q180V consist of a flexible insertion tube with bendable tip, a control body and an umbilicus cord.
Both devices are equipped with working channel and an elevator.
Bending of the Tip and elevator of both devices, the aScope Duodeno and its predicate device, are controlled via bowden wires.
The aScope Duodeno and the Olympus TJF-Q180V share similar technological characteristics as working length, diameter, direction of view and bending angles.
Both devices are equipped with a HD camera whereby the field of view of the aScope Duodeno is bigger than the field of view of the Olympus TJF-Q180V.
Unlike the Olympus TJF-Q180V, the aScope Duodeno is a sterile, single-use device and not intended to be reprocessed.
Confidential
5
Traditional 510(k) premarket notification Ambu Duodeno System - 510k Summary
Unlike the Olympus TJF-Q180V, the aScope Duodeno is equipped with LEDs for light illumination and does not need an additional light source.
Both the aBox Duodeno and the EVIS EXERA II VIDEO SYSTEM CENTER OLYMPUS CV-180 (Olympus CV-180) are video processing systems. The aBox Duodeno and Olympus CV-180 share similar video output formats and are connectable to medical grade monitors.
Performance testing
Non-clinical testing was performed to validate the design and to evaluate substantial equivalency with the predicate device. This testing includes the following:
- Working length -
- -Insertion portion diameter
- -Diameter working channel
- -Bending angle endoscope tip
- -Bending angle elevator
- Insufflation flow rate -
- -Direction of view
- -Image resolution
- -Depth of field
- Image distortion0 -
- -Photobiological safety
- -Signal to noise ratio
- -Image illumination uniformity
- -Color performance
- Rinsing flow rateSuction flow rate -
- -Instruments compatibility test
- -System performance (functional performance)
The biocompatibility was evaluated in accordance with ISO 10993-1, including cytotoxicity; irritation and sensitization. The electrical safety of the system was tested according to IEC 60601-1 and IEC 60601-2-18. EMC was tested, in accordance with IEC 60601-1-2. The sterilization process was validated according to ISO 11135.
In all instances, the Ambu Duodeno System functioned as intended, performed as well as or better than the predicate and met individual test specifications.
Animal Testing
An animal study with two independent sessions was conducted to evaluate the clinical performance of the device.
The first session was performed in a bench top model utilizing a modified porcine upper GI tract with a simulated major duodenal papilla (MDP). The second session consisted of
Confidential
6
Traditional 510(k) premarket notification Ambu Duodeno System - 510k Summary
in-vivo duodenoscopy with positioning for cannulation of the proximal duodena papilla (PDP) in a porcine model. In both sessions, the participants were asked to complete two separate runs, one using the Ambu Duodeno System and one using the predicate device.
For all test runs participants were asked to complete steps required for cannulation of the MDP/PDP using their standard technique. Both test sessions included evaluation of the following steps: intubation, navigation to the descending part of the duodenum, positioning for cannulation, tool insertion/retraction and withdrawal of duodenoscope. Furthermore, cannulation of the MDP was evaluated in the bench top test (first session), while procedure/device related tissue damage was recorded during the in vivo testing (second session). For all steps times from procedure start to step completed were recorded.
All participants were able to successfully complete all steps of both test sessions. The performance of the Ambu Duodeno System was comparable to that of the predicate device.
Substantial Equivalence
The Ambu Duodeno System 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 Duodeno System and its predicate devices raise no new issues of safety or effectiveness.
Thus, the Ambu Duodeno System is substantially equivalent to its predicate devices.