(220 days)
Not Found
No
The summary describes a standard colonoscopy system with visualization and recording capabilities, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is intended for examination and visualization of the lower gastrointestinal anatomy, and provides a working channel for endotherapy accessories, but it does not perform therapy itself.
Yes
The device, aScope Colon, is intended for "examination of the lower gastrointestinal anatomy" and to "provide visualization," which are direct diagnostic functions.
No
The device description clearly outlines both hardware components (flexible endoscope with camera, LEDs, working channel, etc.) and a displaying unit (aBox™ 2). The performance studies also include verification and validation of physical and functional characteristics of the hardware.
Based on the provided information, the Ambu® aScope™ Colon Endoscopy System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic access to and examination of the lower gastrointestinal anatomy" and to "provide visualization". This describes a procedure performed on the patient's body for direct observation, not a test performed on a sample taken from the body.
- Device Description: The description details a flexible endoscope with a camera and a displaying unit. This aligns with the description of a medical device used for visualization within the body, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, urine, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Ambu® aScope™ Colon Endoscopy System is a medical device used for direct visualization and procedural intervention within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FDF, FET
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical (integrated camera module)
Anatomical Site
Lower gastrointestinal anatomy
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™ Colon Endoscopy System were done.
- Geometrical characteristics including
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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,
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
2
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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3
510(k) Summary
| Submitter | Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 | |
|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Name: Mette Andersen
Job Title: Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, 2750 Ballerup, Denmark
Business Phone: +45 5381 3820
Email: meta@ambu.com | |
| Date Summary
Prepared | February 7th, 2023 | |
| Device Trade
Name | Ambu® aScope™ Colon,
Ambu® aBox™ 2 | |
| Device Common
Name | Endoscopy System | |
| Device
Classification | Ambu® aScope™ Colon:
Colonoscope And
Accessories, Flexible/rigid
Product Codes: FDF
21 CFR 876.1500
Class II | Ambu® aBox™ 2:
Colonoscope And
Accessories, Flexible/rigid
Product Codes: FDF, FET
21 CFR 876.1500
Class II |
| Legally
Marketed
devices to which
the device is
substantially
equivalent | Predicate Device:
OLYMPUS EVIS EXERA II
Colonovideoscope CF-
H180AL
K100584 | Predicate Device:
OLYMPUS EVIS EXERA II Light
Source (CLV-180) and Video
System Center (CV-180)
K100584 |
| Description of
the Device | 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 | |
| Indications for
Use | The Ambu® 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 Ambu® aScope™ Colon 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. | |
| Summary of the
technological
characteristics
in comparison to
the predicate
devices | The Ambu® aScope™ Colon and its predicate device have the
following 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 following
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 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 | |
| Performance
Data -Bench | The following tests to verify/validate the design and evaluate the
performance of the Ambu® aScope™ Colon Endoscopy System
were done. | |
| • | Geometrical characteristics including | |
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5
- 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.