(132 days)
aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.
The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney.
The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components.
Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.
The provided FDA 510(k) Clearance Letter for the Ambu® aScope™ 5 Cysto HD (K250269) does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.
This device is a physical endoscope, and the provided document focuses on its mechanical, optical, and safety characteristics following standard medical device testing procedures. There is no mention of an AI/ML component or associated performance metrics like sensitivity, specificity, or AUC.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/ML performance. The document only lists verification and optical performance tests for the physical device, and states that these tests were met.
Here's an analysis based on the information that is present in the document, acknowledging that it's not related to AI/ML performance:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that the device "met the test specifications set" and "passed the predefined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for most of these tests. For instance, for "Resolution," it doesn't state "Resolution shall be X lines per mm, and was Y lines per mm."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Verification Tests | Performed as expected and met test specifications. (e.g., Bending, Irrigation, Working Channel, Laser Fiber Activation Compatibility, High Frequency Tool Activation Compatibility, Functionality) |
| Optical Performance Tests | Performed as expected and met test specifications. (e.g., 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 | Met according to IEC 62471. |
| Transportation Study | Met according to ASTM D4169. |
| Sterilization Validation | Met according to ISO 11135. |
| Stability Study | Documented shelf life according to ASTM F1980. |
| Sterile Packaging Integrity | Met. |
| Biocompatibility | Met according to ISO 10993-1 (including Cytotoxicity, Irritation, Sensitization, Material-mediated pyrogenicity, Acute Systemic Toxicity). |
| Electrical Safety & Performance | Met according to IEC 60601-1 and IEC 60601-2-18. |
| Electromagnetic Compatibility | Met according to IEC 60601-1-2. |
2. Sample Size Used for the Test Set and Data Provenance
Since this is not an AI/ML clinical study, but rather engineering and bench testing of a physical device:
- Sample Size: Not specified for most tests. For physical device verification and optical performance tests, the "sample size" would typically refer to the number of physical devices or components tested. The document does not provide these numbers.
- Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. For physical device performance, "ground truth" is defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM, IEC). It does not involve expert readers establishing a medical diagnosis "ground truth."
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for AI/ML, to resolve discrepancies among human readers or validate AI outputs against human consensus. This device's testing involves objective measurements against engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document pertains to the clearance of a medical device (endoscope), not an AI/ML diagnostic software. There is no mention of human readers, AI assistance, or an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No. The device is a physical endoscope. There is no AI/ML algorithm described that would have standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Engineering Specifications: Internal design requirements for the device.
- International Standards: e.g., ISO 8600-3 (for field of view, direction of view), IEC 62471 (photobiological safety), ASTM D4169 (transportation), ISO 11135 (sterilization), ASTM F1980 (stability/shelf life), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-2-18 (electrical safety), IEC 60601-1-2 (EMC).
- Validated Test Methods: Procedures designed to objectively measure specific performance characteristics.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML component mentioned that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no AI/ML component or training set.
In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a physical endoscope (Ambu® aScope™ 5 Cysto HD). It successfully underwent a series of non-clinical (bench) tests to demonstrate its safety and performance in line with established engineering specifications and international standards, thereby proving substantial equivalence to a predicate device. However, it does not involve any AI/ML components or studies that would address acceptance criteria related to AI/ML performance, such as diagnostic accuracy, human reader improvement, or training/validation data characteristics.
FDA 510(k) Clearance Letter - Ambu aScope 5 Cysto HD
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 11, 2025
Ambu A/S
℅ Sanjay Parikh
Senior Director, QA/RA
Ambu Inc.
6721 Columbia Gateway Drive, Suite 200
Columbia, Maryland 21046
Re: K250269
Trade/Device Name: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FAJ
Received: May 16, 2025
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.
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"
Page 2
K250269 - Sanjay Parikh Page 2
(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 (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-reporting-combination-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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-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-devices/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
Page 3
K250269 - Sanjay Parikh Page 3
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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 J. Antonino -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250269
Device Name: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection)
Indications for Use (Describe)
aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.
The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
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."
Page 5
510(k) Summary
510(k) #: K250269
Prepared on: 2025-05-16
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | Ambu A/S |
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark |
| Applicant Contact Telephone | +4982332189113 |
| Applicant Contact | Ms. Martina Krautwald |
| Applicant Contact Email | maka@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)
| Field | Information |
|---|---|
| Device Trade Name | Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection) |
| Common Name | Endoscope and accessories |
| Classification Name | Cystoscope And Accessories, Flexible/Rigid |
| Regulation Number | 876.1500 |
| Product Code(s) | FAJ |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221683 | VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE | FAJ |
Device Description Summary
21 CFR 807.92(a)(4)
The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney.
The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components.
Page 6
Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.
The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The Ambu® aScope™ 5 Cysto HD has the same intended use as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
Ambu® aScope™ 5 Cysto HD 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 one inlet and outlet
- Both devices have a camera at the distal tip of the insertion cord.
- Both devices are designed to connect to a compatible monitor.
Ambu® aScope™ 5 Cysto HD differs from its predicate device in some technical specifications, including the insertion portion diameter. Furthermore, the Ambu® aScope™ 5 Cysto HD is a single-use device whereas the predicate device is reusable. The differences do not introduce issues for safety and performance. Ambu® aScope™ 5 Cysto HD has passed the performance testing. Ambu® aScope™ 5 Cysto HD is substantially equivalent to the predicate device in terms of safety and performance.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The following tests were performed to verify/validate the design and evaluate the performance of the Ambu® aScope™ 5 Cysto HD.
Verification tests including:
- Bending performance
- Irrigation performance
- Working channel performance
- Laser Fiber Activation Compatibility performance
- High Frequency Tool Activation Compatibility 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 according to ISO 10993-1 including tests for:
- Physical and/or chemical information
Page 7
-
Cytotoxicity
-
Irritation
-
Sensitization
-
Material-mediated pyrogenicity
-
Acute Systemic Toxicity
-
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 Cysto HD 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, documented, and have passed the predefined acceptance criteria.
As a result, it is concluded that the Ambu® aScope™ 5 Cysto HD meets the predefined specifications, performs as intended and is equivalent to the predicate device listed in the Predicates and Substantial Equivalence section.
§ 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.