(224 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 physical, optical, and safety characteristics, not algorithmic performance.
Yes.
The device is used for visualization and examination of the urinary tract and for removal of renal and ureter calculi, which are therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section states: "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." The phrase "visualization and examination" indicates a diagnostic purpose.
No
The device description clearly states that the system is a combination of an endoscope (hardware) and a displaying unit (hardware). The performance studies also include extensive testing of physical and optical performance characteristics of the hardware components.
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 surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a "flexible, digital video ureteroscope" and a "displaying unit." These are tools for direct visualization and intervention within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide diagnostic information based on such analysis. The focus is on providing visual access and facilitating procedures.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
The 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.
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.
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.
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)
FGB
Device Description
The Ambu® aScope™ 5 Ureteroscopy System is a combination of an endoscope, Ambu® aScope™ 5 Uretero and a displaying unit, the Ambu® aBox™ 2.
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 guidance 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 instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2.
The Ambu® aBox™ 2, 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 base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 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
Not Found
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)
The following tests were performed to verify/validate the performance of the Ambu® aScope™ 5 Ureters System:
Verification tests including:
- Insertion portion dimensions and performance
- Working channel performance
- Bending performance
- Irrigation performance
- Suction performance
- Functionality
Optical performance tests including:
- Field of view (ISO 8600-3)
- Direction of view (ISO 8600-3)
- Sharpness and Depth of field
- Image intensity uniformity
- Geometric distortion
- Resolution
- Color performance
- Noise performance
- Dynamic range
Photobiological safety according to IEC 62471
Transportation study according to ASTM D4169
Sterilization validation according to ISO 11135
Stability study to document shelf life according to ASTM F1980
Sterile packaging integrity
Biocompatibility has been assessed according to:
- Physical and/or chemical information addressed according to ISO 10993-1
- Cytotoxicity tested according to ISO 10993-5
- Irritation tested according to ISO 10993-23
- Sensitization tested according to ISO 10993-10
- Material-mediated pyrogenicity tested according to ISO 10993-11
- Acute Systemic Toxicity tested according to ISO 10993-11
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™ 5 Uretero System performed as expected and met the test specifications set.
All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria.
As a result, it is concluded that the devices constituting the Ambu® aScope™ 5 Ureteroscopy System meet their predefined specifications, perform as intended and are equivalent to the predicate devices listed in the Predicates and Substantial Equivalence section.
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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 24, 2024
Ambu A/S Sanjay Parikh Senior Director, OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K233630
Trade/Device Name: Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: November 13, 2023 Received: May 28, 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.
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-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
2
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,
Mark R. Kreitz -S
for Mark J. Antonino, M.S. Assistant 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
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Ambu® aScope™ 5 Uretero (Standard Deflection); Ambu® aScope™ 5 Uretero (Reverse Deflection); Ambu® aBox™ 2
Indications for Use (Describe)
The 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.
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.
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.
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)
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."
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| K233630, Page 1 of 3 | |||
|---|---|---|---|
| 510(k) #: K233630 | 510(k) Summary | Prepared on: 2024-05-26 | |
| Contact Details | 21 CFR 807.92(a)(1) | ||
| Applicant Name | Ambu A/S | ||
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark | ||
| Applicant Contact Telephone | +4542940776 | ||
| Applicant Contact | Mrs. Mingye Zhang | ||
| Applicant Contact Email | mzha@ambu.com | ||
| Correspondent Name | Ambu Inc. | ||
| Correspondent Address | 6721 Columbia Gateway Drive, Suite 200 Columbia MD 21046 | ||
| United States | |||
| Correspondent Contact Telephone | +1 443 831 9844 | ||
| 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® aBox™ 2 | |||
| Common Name | Endoscope and accessories | ||
| Classification Name | Ureteroscope And Accessories, Flexible/Rigid | ||
| Regulation Number | 876.1500 | ||
| Product Code | FGB | ||
| Legally Marketed Predicate Devices | |||
| 21 CFR 807.92(a)(3) | |||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |
| K153049 | LithoVue Single-Use Digital Flexible Ureteroscope | FGB | |
| K230332 | Ambu® aBox™ 2 | FET | |
| 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® aBox™ 2.
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
guidance 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 instruments, instillation/ suction of fluids. The aScope 5 Uretero is intended to be used with a compatible Ambu displaying unit - Ambu® aBox™ 2.
The Ambu® aBox™ 2, 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 base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.
The Ambu® aBox™ 2 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
Intended Use/Indications for Use
The aScope 5 Uretero is a sterile, single, digital video ureteroscope intended to be used for endoscopic access and visual quidance in the upper urinary tract.
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.
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.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Indications for Use Comparison
Ambu® aScope™ 5 Uretero has the same indications for use as the predicate device. Ambu® aBox™ 2 has the same indications for use as the predicate device.
Technological Comparison
Ambu® aScope™ 5 Uretero and its predicate device have the following same technological characteristics:
• Both devices control the maneuverable distal end by moving the control button at the handle.
- · Both devices have a working channel with two inlets.
- · Both devices have a camera at distal tip of insertion cord and use LED light source to illuminate.
- · Both devices are designed to connect to a compatible monitor.
- Both devices are sterilized by Ethylene Oxide.
Ambu® aScope™ 5 Uretero differs from its predicate device in some technical specifications, including insertion portion and field of view. The differences do not introduce issues for safety and performance. Ambu® aScope™ 5 Uretero has passed the performance testing.
Ambu® aBox™ 2 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.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following tests were performed to verify/validate the performance of the Ambu® aScope™ 5 Ureters System:
Verification tests including:
- · Insertion portion dimensions and performance
- · Working channel performance
- · Bending performance
- Irrigation performance
- · Suction performance
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
· Functionality
Optical performance tests including:
- · Field of view (ISO 8600-3)
· Direction of view (ISO 8600-3)
• Sharpness and Depth of field
- · Image intensity uniformity
- · Geometric distortion
- · Resolution
- Color performance
- Noise performance
- Dynamic range
Photobiological safety according to IEC 62471 Transportation study according to ASTM D4169 Sterilization validation according to ISO 11135 Stability study to document shelf life according to ASTM F1980 Sterile packaging integrity
Biocompatibility has been assessed according to:
· Physical and/or chemical information addressed according to ISO 10993-1
· Cytotoxicity tested according to ISO 10993-5
· Irritation tested according to ISO 10993-23
- · Sensitization tested according to ISO 10993-10
- · Material-mediated pyrogenicity tested according to ISO 10993-11
· Acute Systemic Toxicity tested according to ISO 10993-11
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™ 5 Uretero System performed as expected and met the test specifications set.
N/A
All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria.
As a result, it is concluded that the devices constituting the Ambu® aScope™ 5 Ureteroscopy System meet their predefined specifications, perform as intended and are equivalent to the predicate devices listed in the Predicates and Substantial Equivalence section.