(220 days)
Ambu® aScope™ Colon:
The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy.
The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
Ambu® aBox™ 2:
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
The Ambu® aScope™ Colon 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™ Colon, and a displaying unit, the Ambu® aBox™ 2.
The Ambu® aScope™ Colon is a sterile, single-use flexible colonoscope for accessing and examining the lower gastrointestinal anatomy. The endoscope provides a working channel for use of endotherapy accessories, as well as insufflation suction, rinsing and a water jet function. Visualization is realised via an integrated camera module with bulit-in LEDs for illumination.
The Ambu® aBox™ 2 displaying unit has the following physical and performance characteristics:
Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device
Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:
The provided FDA 510(k) Summary for the Ambu® aScope™ Colon and Ambu® aBox™ 2 is for a medical device, not a software AI algorithm. Therefore, the device performance is evaluated based on bench testing of physical and functional characteristics, rather than AI performance metrics like sensitivity, specificity, or AUC, which are common for AI/ML-based medical devices.
Consequently, many of the requested categories (e.g., effect size of human readers with AI, standalone performance, training set details, expert qualifications for ground truth, adjudication methods) are not applicable to this type of device submission. The safety and effectiveness are established through engineering and biological testing, demonstrating that the device performs as intended and is safe for its stated indications.
Acceptance Criteria and Study Details for Ambu® aScope™ Colon Endoscopy System
Due to the nature of this submission being for a physical medical device (an endoscope and its display unit) rather than an AI/ML algorithm, the concept of "acceptance criteria" and "study" differs significantly. The acceptance criteria here refer to the successful completion of various engineering, performance, safety, and biocompatibility tests. The "study" is a compilation of these various tests and validations confirming the device's adherence to established standards and specifications.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Tests/Evaluations Performed | Reported Device Performance |
|---|---|---|
| Geometrical Characteristics | - Length of insertion tube, umbilical cord, tip | Performed as expected and met set test specifications. |
| - Outer diameter of bending section, insertion tube, and overlap | ||
| - Tip reach | ||
| - Bending angles | ||
| - Working channel width | ||
| Functional Performance | - Insufflation | Performed as expected and met set test specifications. |
| - Suction | ||
| - Rinsing | ||
| - Water Jet | ||
| Optical Performance | - Field of view | Performed as expected and met set test specifications. |
| - Direction of view | ||
| - Sharpness and Depth of field | ||
| - Geometric distortion | ||
| - Image intensity uniformity | ||
| - Color performance | ||
| - Noise characterization | ||
| - Dynamic range | ||
| - Camera view orientation | ||
| Safety & Biocompatibility | - Photobiological safety (according to IEC 62471) | Performed as expected and met set test specifications. |
| - Biocompatibility (according to ISO 10993-1, including cytotoxicity, irritation, and 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) | ||
| Procedural Performance | - Tests to confirm procedural performance | Performed as expected and met set test specifications. |
Overall Conclusion: "In all instances, the Ambu® aScope™ Colon Endoscopy System performed as expected and met the set test specifications."
2. Sample size used for the test set and the data provenance
This information is not provided in the summary. For a physical device, the "test set" would refer to the number of devices or components subjected to each specific test. The provenance would refer to the manufacturing site and conditions, not typically specified in such detail in a 510(k) summary. Given this is a sterile, single-use device, extensive bench testing would typically be performed on a statistically relevant sample size from manufacturing lots, although the exact numbers are not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the device is not an AI/ML algorithm requiring expert ground truth for classification. Ground truth for a physical device is established by engineering specifications, validated test methods, and compliance with recognized standards.
4. Adjudication method for the test set
This is not applicable as the device is not an AI/ML algorithm requiring expert consensus for annotation or diagnosis. Performance is based on objective measurements against predefined specifications.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. The device is a direct visualization tool without AI assistance. Its effectiveness is based on its ability to provide clear visualization and facilitate endoscopic procedures, not on enhancing human interpretation through AI.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical endoscope and a display unit, not an algorithm. Its performance is inherently tied to human operation and observation.
7. The type of ground truth used
For physical device testing, the "ground truth" is established by:
- Engineering Specifications: Designed performance parameters (e.g., length, diameter, bending angles, optical characteristics).
- Validated Test Methods: Standardized procedures to objectively measure these parameters.
- Recognized Standards: Compliance with international and national standards for safety, biocompatibility, sterilization, electrical safety, and electromagnetic compatibility (e.g., IEC 62471, ISO 10993-1, ISO 11135, IEC 60601 series).
8. The sample size for the training set
This is not applicable. The device is not an AI/ML algorithm; therefore, there is no "training set" in the machine learning sense. Design and development are based on engineering principles and preclinical testing.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as #8.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 15, 2023
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K230332
Trade/Device Name: Ambu® aScope™ Colon; Ambu® aBoxTM 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FDF, FET Dated: August 11, 2023 Received: August 15, 2023
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
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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,
Sivakami Venkatachalam -S
for
Shani 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
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Indications for Use
510(k) Number (if known) K230332
Device Name Ambu® aScope™ Colon Ambu® aBox™ 2
Indications for Use (Describe)
Ambu® aScope™ Colon:
The aScope™ Colon is a sterile, single-use, flexible colonoscope intended to be used for endoscopic access to and examination of the lower gastrointestinal anatomy.
The aScope™ Colon is intended to provide visualization via a compatible Ambu displaying unit and to be used with endotherapy accessories and other ancillary equipment.
Ambu® aBox™ 2:
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
| Submitter | Ambu A/SBaltorpbakken 13DK-2750 BallerupDenmarkTel.: +45 7225 2000Fax.: +45 7225 2050 | |
|---|---|---|
| Contact Person | Name: Mette AndersenJob Title: Regulatory Affairs ProfessionalAddress: Ambu A/S, Baltorpbakken 13, 2750 Ballerup, DenmarkBusiness Phone: +45 5381 3820Email: meta@ambu.com | |
| Date SummaryPrepared | February 7th, 2023 | |
| Device TradeName | Ambu® aScope™ Colon,Ambu® aBox™ 2 | |
| Device CommonName | Endoscopy System | |
| DeviceClassification | Ambu® aScope™ Colon:Colonoscope AndAccessories, Flexible/rigidProduct Codes: FDF21 CFR 876.1500Class II | Ambu® aBox™ 2:Colonoscope AndAccessories, Flexible/rigidProduct Codes: FDF, FET21 CFR 876.1500Class II |
| LegallyMarketeddevices to whichthe device issubstantiallyequivalent | Predicate Device:OLYMPUS EVIS EXERA IIColonovideoscope CF-H180ALK100584 | Predicate Device:OLYMPUS EVIS EXERA II LightSource (CLV-180) and VideoSystem Center (CV-180)K100584 |
| Description ofthe Device | The Ambu® aScope™ Colon Endoscopy System is a system usedfor endoscopic procedures in the gastrointestinal anatomy. Itconsists of a sterile, single-use, flexible endoscope, the Ambu®aScope™ Colon, and a displaying unit, the Ambu® aBox™ 2.The Ambu® aScope™ Colon is a sterile, single-use flexiblecolonoscope for accessing and examining the lowergastrointestinal anatomy. The endoscope provides a workingchannel for use of endotherapy accessories, as well as insufflationsuction, rinsing and a water jet function. Visualization is realised | |
| via an integrated camera module with bulit-in LEDs forillumination. | ||
| The Ambu® aBox™ 2 displaying unit has the following physical andperformance characteristics: | ||
| Displays the image from Ambu® aScope™ Colon endoscope on the screen Can record snapshots or video of image from Ambu® aScope™ Colon endoscope Can connect to an external monitor Is a reusable device | ||
| Indications forUse | The Ambu® aScope™ Colon is a sterile, single-use flexiblecolonoscope intended to be used for endoscopic access to andexamination of the lower gastrointestinal anatomy.The Ambu® aScope™ Colon is intended to provide visualization viaa compatible Ambu displaying unit and to be used withendotherapy 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™ Colon and its predicate device have thefollowing technological characteristics: | |
| Both are flexible endoscopes with maneuverable tip, a control section (handle) and an umbilical cord Both control the tip bending via two wheels at the handle and bowden wires. Both provide a working channel Both have same technological characteristics as insertion portion length, working channel diameter, direction of view and bending angels Unlike the predicate device, the Ambu® aScope™ Colon is a sterile, single-use device and not intended to be reprocessed. | ||
| The Ambu® aBox™ 2 and its predicate device have the followingtechnological 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 as well as 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® aScope™ Colon Endoscopy Systemwere done. | |
| • | Geometrical characteristics including |
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- Length of insertion tube, umbilical cord, tip O
- Outer diameter of bending section, insertion tube O and overlap of both
- Tip reach O
- Bending angles o
- Working channel width о
- Functional performance including .
- Insufflation o
- Suction o
- Rinsing о
- Water Jet O
- Optical performance including
- Field of view o
- Direction of view O
- Sharpness and Depth of field O
- Geometric distortion o
- Image intensity uniformity O
- Color performance O
- Noise characterization O
- Dynamic range O
- Camera view orientation O
- Photobiological safety according to IEC 62471 ●
- Biocompatibility according to ISO 10993-1 including ● cytotoxicity, irritation, and 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
- Tests to confirm procedural performance ●
In all instances, the Ambu® aScope™ Colon Endoscopy System performed as expected and met the set test specifications.
Conclusion
The Ambu® aScope™ Colon Endoscopy System, consisting of Ambu® aScope™ Colon 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™ Colon Endoscopy System and its predicate devices raise no new concerns regarding safety or effectiveness.
Thus, the Ambu® aScope™ Colon Endoscopy System, consisting of Ambu® aScope™ Colon and Ambu® aBox™ 2, is substantially equivalent to its 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.