(185 days)
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.
The Ambu® Gastrointestinal (GI) Endoscopy System is a system used for endoscopic procedures in the gastrointestinal anatomy. It consists of a sterile, single-use, flexible endoscope, the Ambu® aScope™ Gastro, and a displaying unit, the Ambu® aBox™ 2.
The provided text describes the 510(k) premarket notification for the Ambu® aScope™ Gastro and Ambu® aBox™ 2, an endoscopic system. However, it does not contain information about a study that proves a device meets acceptance criteria related to an AI/ML algorithm or its performance in detection/diagnosis as is typically associated with the requested criteria (e.g., sensitivity, specificity, expert ground truth, MRMC studies).
The "Acceptance Criteria" listed in the document refer to general performance tests for the endoscopic system (e.g., geometrical characteristics, functional performance, optical performance, safety, etc.) rather than the performance of an AI/ML algorithm in a clinical setting for a specific diagnostic task.
Therefore, I cannot fulfill the request to provide details about a study that proves an AI/ML-enabled device meets acceptance criteria based on the provided text, as the text describes a conventional medical device submission without mention of an AI/ML component.
The following table and subsequent sections would be populated if the document contained information about an AI/ML component and its performance study.
Based on the provided text, the device is a standard endoscope system, not one that utilizes AI/ML for diagnostic or detection purposes. Therefore, the requested information regarding AI/ML-specific acceptance criteria and performance studies (like sensitivity, specificity, MRMC studies, ground truth establishment for AI training/testing) is not present in the document.
The "Performance Data - Bench" section in the document lists the following types of tests, which are typical for an endoscope:
| Acceptance Criteria (as gathered from "Performance Data - Bench") | Reported Device Performance |
|---|---|
| Geometrical Characteristics: | Performed as expected and met the set test specifications. |
| - Length of insertion tube, umbilical cord, tip | |
| - Outer diameter of bending section, insertion tube and overlap | |
| - Tip reach | |
| - Bending angles | |
| Functional Performance: | Performed as expected and met the set test specifications. |
| - Insufflation | |
| - Suction | |
| - Rinsing | |
| - Water Jet | |
| Optical Performance: | Performed as expected and met the set test specifications. |
| - 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 | |
| Safety and Other Performance: | Performed as expected and met the set test specifications. |
| - Photobiological safety | |
| - Biocompatibility (cytotoxicity, irritation, sensitization) | |
| - Sterilization validation | |
| - Transport validation (packaging integrity) | |
| - Stability study (shelf life) | |
| - Electrical Safety and performance (IEC 60601-1, IEC 60601-2-18) | |
| - Electromagnetic Compatibility (IEC 60601-1-2) | |
| - Procedural performance |
The document states: "In all instances, the Ambu® GI Endoscopy System performed as expected and met the set test specifications."
Given the content, I cannot provide the following requested information, as it pertains to AI/ML algorithm validation, which is not described in this submission:
- Sample sizes for test set and data provenance: Not applicable, as this is for a traditional medical device, not an AI/ML algorithm detection study.
- Number of experts and qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study: Not mentioned or applicable for this device.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable for AI/ML validation. Ground truth for an endoscope's performance would be physical measurements and established engineering standards.
- Sample size for training set: Not applicable (no AI/ML training dataset).
- How ground truth for training set was established: Not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050 | |
|---|---|---|
| Contact Person | Name: Sanjay ParikhJob Title: Director, QA/RAAddress: Ambu Inc. / 6230 Old Dobbin Lane, Suite 250 / 21045Columbia / USABusiness Phone: +1 443 367 4502Email: sap@ambu.com | |
| Date SummaryPrepared | July 29, 2021 | |
| Device TradeName | Ambu® aScope™ GastroAmbu® aBox™ 2 | |
| Device CommonName | Endoscopy System | |
| DeviceClassification | Ambu® aScope™ Gastro:Gastroscope AndAccessories, Flexible/rigidProduct Codes: FDS, FET21 CFR 876.1500Class II | Ambu® aBox™ 2:Endoscopic Video ImagingSystem/Component,Gastroenterology-UrologyProduct Codes: FET, FDS21 CFR 876.1500Class II |
| LegallyMarketeddevices to whichthe device issubstantiallyequivalent | Predicate Device:OLYMPUS EVIS EXERA IIGastrointestinalVideoscope GIF H180K100584 | Predicate Device:OLYMPUS EXERA II Light Source(CLV-180) and Video System Center(CV-180)K100584 |
| Description ofthe Device | The Ambu® Gastrointestinal (GI) Endoscopy System is a systemused for endoscopic procedures in the gastrointestinal anatomy. Itconsists of a sterile, single-use, flexible endoscope, the Ambu®aScope™ Gastro, and a displaying unit, the Ambu® aBox™ 2. | |
| Indications forUse | The aScope Gastro is a sterile, single-use flexible gastroscopeintended to be used for endoscopic access to and examination ofthe upper gastrointestinal anatomy.The aScope Gastro is intended to provide visualization via acompatible Ambu displaying unit and to be used with endo-therapy accessories and other ancillary equipment.The aBox 2 is intended to display live imaging data fromcompatible Ambu visualization devices. | |
| Summary of thetechnologicalcharacteristicsin comparison tothe predicatedevices | The Ambu® aScope™ Gastro and its predicate device have thefollowing same technological characteristics:Both are flexible endoscopes with maneuverable tip, acontrol section (handle) and an umbilical cord Both control the tip bending via two wheels at the handleand bowden wires. Both provide a working channel Both have same technological characteristics as insertionportion length, working channel diameter, direction of viewand bending angels Unlike the predicate device, the Ambu® aScope™ Gastro isa sterile, single-use device and not intended to bereprocessed.The Ambu® aBox™ 2 and its predicate device have the followingsame 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 | |
| PerformanceData -Bench | The following tests to verify/validate the design and evaluate theperformance 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 performanceIn all instances, the Ambu® GI Endoscopy System performed as expected and met the set test specifications. | ||
| Conclusion | 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.The minor technological differences between the Ambu® Gastrointestinal (GI) Endoscopy System and its predicate devices raise no new concerns regarding safety or effectiveness.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
§ 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.