(29 days)
Not Found
No
The summary describes a standard digital video ureteroscope and a display unit. There is no mention of AI, ML, or any advanced image analysis beyond basic processing and display. The performance studies focus on optical and electrical characteristics, not algorithmic performance.
No.
The device is described as an endoscope and displaying unit intended for visual guidance and examination, not for direct therapeutic treatment or to restore function. While it can be used in conjunction with endoscopic instruments, the device itself is for visualization and access.
Yes
The device, Ambu® aScope™ 5 Uretero, is described as being used for "visualization and examination" of the upper urinary tract and for "endoscopic access and visual guidance". These functions are inherently diagnostic as they involve observing and assessing the internal condition of a patient to identify potential medical issues.
No
The device description clearly states it is a "combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance." Both the endoscope and the displaying unit are described as physical hardware components. The performance studies also include testing for optical performance, electrical safety, and electromagnetic compatibility, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "endoscopic access and visual guidance in the upper urinary tract" and for "visualization and examination" and "removal of renal and ureter calculi." This describes a device used for direct visualization and intervention within the body, not for testing samples taken from the body.
- Device Description: The description details a flexible video ureteroscope and a display unit. These are tools for internal examination and procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological specimens (like blood, urine, tissue, etc.) outside of the body to provide diagnostic information. IVDs are designed to perform tests on these types of samples.
The device is a medical device used for visualization and surgical procedures within the urinary tract.
N/A
Intended Use / Indications for Use
Ambu® aScope™ 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® aScope™ 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.
Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
Product codes
FGB, FET
Device Description
The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance.
The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual quidance to and in the upper urinary tract.
The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage of endoscopic instillation/ suction of fluids. The Ambu° aScope™ 5 Uretero is intended to be used with a compatible Ambu displaying unit, Ambu° aView™ 2 Advance.
The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8″ LCD screen. The displaying unit is powered by a rechargeable lithium-ion battery and includes a power supply with region-specific power cable.
The Ambu® aView™ 2 Advance has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
- · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Upper urinary tract
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 Tests:
- Optical performance tests:
- Field of view and Direction of view
- Sharpness and Depth of field
- Image intensity uniformity
- Geometric distortion
- Resolution
- Color performance
- Noise performance
- Dynamic range
- Software verification testing
- Electrical Safety according to IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 and IEC 60601-2-18:2009 Ed. 3.0
- Electromagnetic Compatibility according to IEC 60601-1-2:2014+A1:2020 Ed. 4.1
Key Results: Overall, the Ambu® aScope™ 5 Ureteroscopy System performed as expected and met the test specifications set.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 16, 2024
Ambu A/S % Sanjay Parikh Senior Director, OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K242108
Trade/Device Name: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™M 2 Advance Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: FGB, FET Dated: July 3, 2024 Received: July 18, 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.
U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov
1
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" (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 QS 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-regulatoryinformation/postmarketing-safety-reporting-combination-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 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-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).
2
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/medicaldevices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumereducation-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sharon M. Andrews -S
Sharon M. Andrews Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aView™ 2 Advance
Indications for Use (Describe)
Ambu® aScope™ 5 Uretero is a sterile, single-use, flexible, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® aScope™ 5 Uretero is intended for patients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization and examination with a flexible ureteroscope, and for removal of renal and ureter calculi.
Ambu® aView™ 2 Advance 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)
ver-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
K242108 Page 1 of 3
510(k) Sun narv
21 CFR 807.92(a)(1)
Prepared on: 2024-08-15
Contact Details
| Applicant Name | Ambu A/S | |
|---|---|---|
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark | |
| Applicant Contact Telephone | +4572252679 | |
| Applicant Contact | Ms. Gamze Yilan | |
| Applicant Contact Email | gayi@ambu.com | |
| Correspondent Name | Ambu Inc. | |
| Correspondent Address | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046 | |
| United States | ||
| Correspondent Contact Telephone | +1 443 367 4502 | |
| Correspondent Contact | Mr. Sanjay Parikh | |
| Correspondent Contact Email | sap@ambu.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Ambu® aScope™ 5 Uretero (Standard Deflection); | |
| Ambu® aScope™ 5 Uretero (Reverse Deflection); | ||
| Ambu® aView™ 2 Advance | ||
| Common Name | Ureteroscope and Accessories | |
| Classification Name | Endoscope and Accessories | |
| Regulation Number | 876.1500 | |
| Product Code(s) | FGB, FET (CLASS 2) - ENDOSCOPIC VIDEO IMAGING SYSTEM/COME | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K233630 | Ambu® aScope™ 5 Uretero | FGB |
| K233671 | Ambu® aView™ 2 Advance | EOQ |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aView™ 2 Advance.
The Ambu® aScope™ 5 Uretero is a sterile, digital video ureteroscope. The Ambu® aScope™ 5 Uretero can be used in retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for providing endoscopic access and visual
5
quidance to and in the upper urinary tract.
The Ambu® aScope™ 5 Uretero is available in one size and can be operated by either left or right hand. The Ambu® aScope™ 5 Uretero can be used with endoscopic accessories. The working channel system allows the passage of endoscopic instillation/ suction of fluids. The Ambu° aScope™ 5 Uretero is intended to be used with a compatible Ambu displaying unit, Ambu° aView™ 2 Advance.
The Ambu® aView™ 2 Advance, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a 12.8″ LCD screen. The displaying unit is powered by a rechargeable lithium-ion battery and includes a power supply with region-specific power cable.
The Ambu® aView™ 2 Advance has the following physical and performance characteristics:
- · Can process and display live imaging data from Ambu® aScope™ 5 Uretero to a monitor
- · Can record, store and transport image data from Ambu® aScope™ 5 Uretero
- Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
The predicate device Ambu® aScope™ 5 Uretero (K233630) has not been subject to a design related recall. The predicate device Ambu® aView™ 2 Advance (K233671) has been subject to a design related recall, which was resolved via a labeling update.
Intended Use/Indications for Use
Ambu® aScope™ 5 Uretero is a sterile, single, digital video ureteroscope intended to be used for endoscopic access and visual guidance in the upper urinary tract. Ambu® aScope™ 5 Uretero is intended to be used with the compatible Ambu displaying unit and can be used in conjunction with endoscopic instruments via its working channel. Ambu® a matients requiring retrograde (transurethral) and/or antegrade (percutaneous) ureteroscopy procedures for visualization with a flexible ureteroscope, and for removal of renal and ureter calculi.
Ambu® aView™ 2 Advance is intended to display live imaging data from compatible Ambu visualization devices.
Indications for Use Comparison
Ambu® aScope™ 5 Uretero has the same intended use as its predicate device (Ambu® aScope™ 5 Uretero cleared in K233630). Ambu® aView™ 2 Advance has the same intended use as the predicate device (Ambu® aView™ 2 Advance cleared in K233671).
Technological Comparison
Ambu® aScope™ 5 Uretero has similar technological characteristics as its predicate device. The only difference is that the applicant device is compatible with Ambu® aView™ 2 Advance in additional compatibility to Ambu® aView™ 2 Advance does not affect the safety or effectiveness of the Ambu® aScope™ 5 Uretero.
Ambu® aView™ 2 Advance and its predicate device have the following same 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 such as brightness contrast and sharpness adjustment as well as zoom function.
· Both devices are portable and have an integrated monitor and offers the possibility of connection to an external monitor.
ln conclusion, the different technological characteristics of the subject device do not raise different questions of safety and effectiveness.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
ln addition to the performance testing described in the original 510(k)s (K233671), additional testing has been performed to address the risks associated with the additional compatibility and to support substantial equivalence to the predicate devices:
• Optical performance tests:
- o Field of view and Direction of view
- o Sharpness and Depth of field
- o Image intensity uniformity
- o Geometric distortion
- o Resolution
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
o Color performance
o Noise performance
o Dynamic range
• Software verification testing
• Electrical Safety according to IEC 60601-1:2005+A1:2012+A2:2020 Ed. 3.2 and IEC 60601-2-18:2009 Ed. 3.0
· Electromagnetic Compatibility according to IEC 60601-1-2:2014+A1:2020 Ed. 4.1
Overall, the Ambu® aScope™ 5 Ureteroscopy System performed as expected and met the test specifications set.
In conclusion, Ambu® aScope™ 5 Uretero and Ambu® aView™ 2 Advance constituting the Ambu® aScope™ 5 Ureteroscopy System, have the same intended use/indications for use and similar technological characteristics as the predicate devices.
The minor technological differences between Ambu® aView™ 2 Advance and their respective predicate device do not raise any different questions safety or effectiveness and have been addressed in the performance testing listed above.
Therefore, it is concluded that the devices in the subject Ambu® aScope™ 5 Ureteroscopy System is substantially equivalent to the legally marketed predicates.