(203 days)
Not Found
No
The summary describes a standard endoscopic system for visualization and image display/recording. There is no mention of AI/ML in the intended use, device description, or performance studies. The image processing mentioned is for display and recording, not analysis or interpretation using AI/ML.
No
The device is intended for endoscopic access to and examination of the lower urinary tract and to display live imaging data, which are diagnostic purposes, not therapeutic. While it 'can be used with endoscopic accessories and instruments,' its primary stated functions are visualization and examination.
Yes.
The device is intended for "examination of the lower urinary tract" and provides "visualization," which are diagnostic activities.
No
The device description clearly states that the system is a combination of an endoscope (hardware) and a displaying unit (hardware with software). The performance studies also include hardware-specific tests like bending performance, irrigation performance, and electrical safety.
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 to and examination of the lower urinary tract" and to "provide visualization". This describes a procedure performed in vivo (within the body) for direct observation.
- Device Description: The description details a flexible endoscope and a displaying unit used for visualization within the body. It mentions instillation of fluids and suctioning, which are part of an endoscopic procedure, not an in vitro test.
- Lack of In Vitro Elements: There is no mention of analyzing samples (like blood, urine, tissue) outside the body, which is the core characteristic of an IVD. The device is used to visualize the internal anatomy directly.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is a tool for direct visualization of internal structures.
N/A
Intended Use / Indications for Use
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Product codes
FAJ, FET
Device Description
The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2.
Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder.
The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 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 cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design.
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 Cysto HD to a monitor
- Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD
- 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
Endoscopic visualization
Anatomical Site
lower 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 design and evaluate the performance of the Ambu® aScope™ 5 Cysto HD System:
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
- Cytotoxicity
- Irritation
- Sensitization
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 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 Cysto HD System meet their predfications, 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)
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 16, 2024
Ambu A/S % Sanjay Parikh Senior Director, OA/RA Ambu Inc. 6721 Columbia Gateway Drive, Suite 200 Columbia, Maryland 21046
Re: K240849
Trade/Device Name: Ambu® aScope™ 5 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2 Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FAJ, FET Dated: March 27, 2024 Received: September 6, 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.
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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.
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-device-advicecomprehensive-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-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
2
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,
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 Cysto HD (Standard Deflection); Ambu® aScope™ 5 Cysto HD (Reverse Deflection); Ambu® aBox™ 2
Indications for Use (Describe)
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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K240849 Page 1 of 3
510(k) #: K240849
510(k) S narv
21 CFR 807.92(a)(1)
Prepared on: 2024-09-06
Contact Details
| Applicant Name | Ambu A/S | |
|---|---|---|
| Applicant Address | Baltorpbakken 13 Ballerup 2750 Denmark | |
| Applicant Contact Telephone | +45 2660 8888 | |
| Applicant Contact | Ms. Gurpreet Kaur Rehal | |
| Applicant Contact Email | gure@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 Cysto HD (Standard Deflection); | |
| Ambu® aScope™ 5 Cysto HD (Reverse Deflection); | ||
| Ambu® aBox™ 2 | ||
| Common Name | Endoscope and accessories | |
| Classification Name | Cystoscope And Accessories, Flexible/Rigid | |
| Regulation Number | 876.1500 | |
| Product Code(s) | FAJ, FET (CLASS 2) - ENDOSCOPIC VIDEO IMAGING SYSTEM/COMP | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K193095 | Ambu® aScope™ 4 Cysto | FAJ |
| K230332 | Ambu® aBox™ 2 | FET |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2.
Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder.
5
The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 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 cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design.
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 Cysto HD to a monitor
- · Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor
Intended Use/Indications for Use
aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.
The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.
Indications for Use Comparison
The Ambu® aScope™ 5 Cysto HD has the same intended use as the predicate device. The Ambu® aBox™ 2 has the same intended use as the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
Ambu® aScope™ 5 Cysto HD and its predicate device have the following same technological charateristics:
- 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 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 Cysto HD differs from its predicate device in some technical specifications, including insertion and camera chip type. 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.
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 design and evaluate the performance of the Ambu® aScope™ 5 Cysto HD System:
Verification tests including:
· Bending performance
• Irrigation performance
· Working channel performance
6
· 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 • Cytotoxicity • Irritation · Sensitization 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 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 Cysto HD System meet their predfications, perform as intended and are equivalent to the predicate devices listed in the Predicates and Substantial Equivalence section.