(199 days)
Ambu® aScope™ Gastro Large:
The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The endoscope 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.
The Ambu® aScope™ Gastro Large Endoscopy System is a system used for endoscopic procedures in the upper gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2.
The provided text does NOT describe an AI/ML-driven device or study. It is a 510(k) summary for a medical device called the Ambu® aScope™ Gastro Large Endoscopy System. This system is an endoscope and a display unit used for examining the upper gastrointestinal anatomy.
The document discusses various performance tests relevant to a physical medical device (e.g., geometrical characteristics, functional performance of insufflation/suction, optical performance, biocompatibility, sterilization, electrical safety, etc.). It explicitly states that the device has "similar technological characteristics and principles of operation" to its predicate devices, with only "minor technological differences" that "raise no new concerns regarding safety or effectiveness."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria from an AI/ML perspective, as the provided text pertains to a traditional, non-AI medical device. The information you requested (sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are specific to the evaluation of AI/ML algorithms, which are not mentioned or implied in this document.
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April 5, 2024
Ambu A/S % Sanjay Parikh Senior Director, OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K232919
Trade/Device Name: Ambu® aScope™ Gastro Large; Ambu® aBox™ 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FDS, FET Dated: March 5, 2024 Received: March 5, 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"
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(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).
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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
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Indications for Use
510(k) Number (if known) K232919
Device Name Ambu® aScope™ Gastro Large Ambu® aBox™ 2
Indications for Use (Describe) Ambu® aScope™ Gastro Large:
The endoscope is a sterile, single-use, flexible gastroscope intended to be used for endoscopic access to and examination of the upper gastrointestinal anatomy.
The endoscope 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)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary – Ambu® aScope™ Gastro Large Endoscopy System
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summary has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/SBaltorpbakken 132750 BallerupDenmarkTel.: +45 7225 2000Fax: +45 7225 2050 |
|---|---|
| Contact Person | Name: Mette AndersenJob Title: Senior Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, 2750 Ballerup, DenmarkBusiness Phone: +45 5381 3820Email: meta@ambu.com |
| Date Summary Prepared | September 19, 2023 |
| Device Trade Name | Ambu® aScope™ Gastro Large andAmbu® aBox™ 2 |
| Device Common Name | Endoscopy System |
| Device Classification | 21 CFR 876.1500Gastroscope and Accessories, Flexible/rigid and Endoscopic VideoImaging System/Component, Gastroenterology-UrologyClass IIProduct code: FDS, FET |
| Legally MarketedDevices to whichthe Device isSubstantially Equivalent | Predicate Device for Ambu®aScope™ Gastro Large:Ambu® aScope™ GastroK212382Predicate Device for Ambu®aBox™ 2:Ambu® aBox™ 2K212382 |
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| Description ofthe Device | The Ambu® aScope™ Gastro Large Endoscopy System is a system usedfor endoscopic procedures in the upper gastrointestinal anatomy. Itconsists of a sterile, single-use, flexible endoscope, the Ambu®aScope™ Gastro Large, and a displaying unit, the Ambu® aBox™ 2. |
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| IntendedUse/Indicationsfor Use | Ambu® aScope™ Gastro Large:The endoscope is a sterile, single-use, flexible gastroscope intended tobe used for endoscopic access to and examination of the uppergastrointestinal anatomy.The endoscope is intended to provide visualization via a compatibleAmbu displaying unit and to be used with endotherapy accessories andother ancillary equipment.The aBox™ 2 is intended to display live imaging data from compatibleAmbu visualization devices. |
| Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices | The Ambu® aScope™ Gastro Large and its predicate device have thefollowing same technological characteristics:Both are sterile, single-use devices and are not intended to bereprocessed.Both are flexible endoscopes with a maneuverable tip, a controlsection (handle) and an umbilical cord.Both control the tip bending via two wheels at the handle andBowden wires.Both provide a working channel with the same working length.Both have the same technological characteristics of the opticalsystem.Unlike the predicate device, the Ambu® aScope™ Gastro Largehas a higher downwards bending angle and a larger workingchannel, outer diameter of the insertion tube, distal end andmax. insertion portion.The Ambu® aBox™ 2 and its predicate device have the following sametechnological characteristics:Both are video processors displaying live video-imaging data ofthe connected visualization device to a monitor.Both provide video output formats, recording and data storageand data transport functions.Both share certain technical functionalities such as brightnesscontrol, image contrast and sharpness adjustment as well aszoom function.Both devices are portable and have an integrated monitor andoffers the possibility of connection to an external monitor. |
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The following tests were performed to support the substantial Performance Data - Bench equivalence of the Ambu® aScope™ Gastro Large Endoscopy System to the predicate device. Geometrical characteristics including . Dimensions of insertion portion (e.g., length, diameter) o
- Tip reach o
- Bending angles o
- Functional performance including ●
- Insufflation o
- Suction O
- Rinsing o
- Water Jet O
- Optical performance comparison of .
- Field of view o
- Sharpness and Depth of field O
- Image intensity uniformity O
- Color performance o
- Noise characterization O
- Dynamic range O
- Geometric distortion
- Field of view o
- Photobiological safety ●
- Biocompatibility according to ISO 10993-1 including cytotoxicity, ● irritation, and sensitization
- Sterilization validation according to ISO 11135 ●
- Transport validation
- Stability study ●
- Electrical Safety and performance according to IEC 60601-1 and ● IEC 60601-2-18
- . Electromagnetic Compatibility according to IEC 60601-1-2
In all instances, the Ambu® aScope™ Gastro Large Endoscopy System performed as expected and met the set test specifications.
Conclusion
The Ambu® aScope™ Gastro Large Endoscopy System, consisting of Ambu® aScope™ Gastro Large and Ambu® aBox™ 2, has the same intended use and indications for use, and similar technological characteristics and principles of operation as the respective predicate devices.
The minor technological differences between the Ambu® aScope™ Gastro Large Endoscopy System and its predicate devices raise no new concerns regarding safety or effectiveness.
Thus, the devices constituting the Ambu® aScope™ Gastro Large Endoscopy System, Ambu® aScope™ Gastro Large and Ambu® aBox™ 2, are substantially equivalent to the respective predicate devices.
§ 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.