(149 days)
No
The device description and performance studies focus on the physical and functional aspects of the cystoscope and monitor, with no mention of AI/ML, image processing beyond display, or data analysis.
No.
The device, Ambu® USR, is a flexible cystoscope with an integrated grasper designed for removal of ureteral stents, which is a functional intervention, not a therapeutic treatment.
No
The device is described as a sterile, single-use flexible cystoscope designed for the removal of double loop ureteral stents, indicating a therapeutic or interventional purpose rather than a diagnostic one. While it visualizes observations, the primary stated use is for removal, not diagnosis.
No
The device description clearly outlines physical hardware components: a flexible cystoscope with an integrated grasper, camera, LED light source, and a monitor. The performance studies also include testing of physical characteristics and hardware functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ambu® USR is a flexible cystoscope designed for the physical removal of ureteral stents from the bladder. It is a surgical/interventional device used for a procedure, not for analyzing a sample in vitro.
- Intended Use: The intended use clearly states "removal of double loop ureteral stents accessible in the bladder via a urethral insertion." This describes a procedural action, not a diagnostic test performed on a sample.
- Device Description: The description details a physical device with a grasper, camera, and light source for visualization and manipulation within the body.
- Lack of Sample Analysis: There is no mention of collecting or analyzing any biological samples.
Therefore, the Ambu® USR falls under the category of a medical device used for a therapeutic/interventional procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Ambu® USR is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion in adults.
Ambu® USR has been designed to be used with the reusable Ambu® M to visualize the observations obtained by Ambu® USR.
Product codes
FAJ, OCZ
Device Description
The system consists of Ambu® USR and Ambu® M Monitor. Ambu® USR is a single use flexible cystoscope with an integrated grasper designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion. Ambu® USR is connected to the reusable Ambu® M Monitor that displays the video image from Ambu® USR. Ambu® USR has the following physical and performance characteristics: Maneuverable tip controlled by the user. Integrated grasper controlled by the user. Flexible insertion cord. Camera and LED light source at the distal tip Luer lock connector for irrigation and aspiration Sterilized by Ethylene Oxide sterilization. For single use Ambu® M Monitor has the following physical and performance characteristics: Displays the image from Ambu® USR on the screen. Records snapshots or video of image from Ambu® USR.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder via a urethral insertion
Indicated Patient Age Range
adults
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
The following data has been submitted in the premarket notification: Declaration of conformity to the following recognized consensus standards applicable for Ambu® USR: ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments – Medical endoscopes and certain accessories. ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Result: All tests were passed. Performance test reports to document the following properties of the Ambu® USR: Length and diameters of insertion cord Bending angle and durability of bending section Image quality during 1 hour operation Irrigation system functionality Grasper functionality and image quality Grasper stent pull force Result: All tests were passed. Performance test report to document shelf life of Ambu® USR. Tests were performed on finished, sterilized, shipped and aged products: Performance test of Ambu® USR Sterile Packaging Integrity Result: All tests were passed. Biocompatibility tests reports to document that Ambu® USR complies with the requirements of ISO 10993-1: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed. Performance test report to document the following properties of the Ambu® M monitor (reusable): Cleaning and Low Level Disinfection validation Result: The test was passed. Test reports that verify the Electromagnetic Compatibility and Electrical Safety: Electromagnetic Compatibility in compliance with IEC 60601-1-2. Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18. Result: All tests were passed.
Key Metrics
Not Found
Predicate Device(s)
K021074, K133538, K072180, K130845
Reference Device(s)
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/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus-like symbol with three figures in profile, representing health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17, 2016
Ambu A/S % Sanjay Parikh Director, QA/RA Ambu, Inc. 6230 Old Dobbin Lane, Suite 250 Columbia, MD 21045
Re: K160766 Trade/Device Name: Ambu® USR, Ambu® M Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, OCZ Dated: July 11, 2016 Received: July 12, 2016
Dear Sanjay Parikh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name Ambu® USR Ambu® M
Ambu® USR is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion in adults.
Ambu® USR has been designed to be used with the reusable Ambu® M to visualize the observations obtained by Ambu® USR.
| 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) |
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Section 5 510(k) Summary
This 510(k) summary has been prepared in accordance with 21 CFR 807.87(h) and the content and format of the 510(k) summery has been prepared in accordance with 21 CFR 807.92.
| Submitter | Ambu A/S
Baltorpbakken 13
DK-2750 Ballerup
Denmark
Tel.: +45 7225 2000
Fax.: +45 7225 2050 | | |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|---------------------|
| Contact Person | Name: Camilla Wismar
Job Title: Senior Regulatory Affairs Professional
Address: Ambu A/S, Baltorpbakken 13, DK-2750 Ballerup
Telephone number: +45 7225 2208
Fax number: +45 7225 2050 | | |
| Date Summary
Prepared | August 17, 2016 | | |
| Device Trade
Name | Ambu® USR
Ambu® M | | |
| Device Common
Name | Flexible Cystoscope | | |
| Device
Classification | Cystoscope and Accessories, Flexible/Rigid
Product Codes: FAJ
Endoscopic grasping/cutting instrument, non-powered
Product Codes: OCZ
21 CFR 876.1500
Class II | | |
| Legally Marketed devices to which the device is substantially equivalent | Manufacturer | Trade Name | 510k number |
| A: | Olympus Corporation | VISERA Cystovideoscope
CYF-V/VA
and CYF-V2/VA2 | K021074 and K133538 |
| B: | Vision Sciences | CST-5000 Flexible Video Cystoscope | K072180 |
| C+E: | Ambu A/S | Ambu® aScope 3™ 5.0/2.2
and Ambu® aView | K130845 |
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D: Olympus FG-4L-1 K955066 Olympus Corporation Grasping Forceps The system consists of Ambu® USR and Ambu® M Monitor. Ambu® USR is Description of the Device a single use flexible cystoscope with an integrated grasper designed for removal of double loop ureteral stents accessible in the bladder via a urethral insertion. Ambu® USR is connected to the reusable Ambu® M Monitor that displays the video image from Ambu® USR. Ambu® USR has the following physical and performance characteristics: Maneuverable tip controlled by the user ● . Integrated grasper controlled by the user . Flexible insertion cord . Camera and LED light source at the distal tip ● Luer lock connector for irrigation and aspiration ● Sterilized by Ethylene Oxide sterilization . For single use Ambu® M Monitor has the following physical and performance characteristics: . Displays the image from Ambu® USR on the screen. Records snapshots or video of image from Ambu® USR. . Indications for Ambu® USR is a sterile, single use flexible cystoscope designed for removal of double loop ureteral stents accessible in the bladder via a Use urethral insertion in adults. Ambu® USR has been designed to be used with the reusable Ambu® M to visualize the observations obtained by Ambu® USR. Ambu® USR is similar to the predicate devices in the following areas: Summary of the technological They are all flexible endoscopes with a maneuverable tip ● characteristics . They all have a handle with a control button giving the operator in comparison to ability to steer the tip of the scope up and down the predicate . They are all video scopes with a camera located in the distal tip devices to provide an image on a separate monitor ● They all provide illumination from the distal tip ● They are all connected to a monitor by a cable Ambu® USR has an integrated grasper. Predicate A, B and C . have a working channel that can be used for graspers or other instrumentation. . Grasper in Ambu® USR and Predicate D are rat tooth designs with two jaws in a V-shape and teeth at the end.
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| Grasper in Ambu® USR and Predicate D are made of stainless steel components They all allow for irrigation | |
|---|---|
| Ambu® M Monitor is similar to Predicate E in the following areas: Both display a live image on a TFT-screen Both supply power to the endoscope via a connection to the monitor Both are powered by a rechargeable battery or by a power supply Both systems are operated either on battery or standard wall outlet Both monitors are portable | |
| Performance | |
| Data -Bench | The following data has been submitted in the premarket notification: |
| Declaration of conformity to the following recognized consensus standards applicable for Ambu® USR: ISO 8600-1, ISO 8600-3 and ISO 8600-4 Optics and optical instruments – Medical endoscopes and certain accessories. ISO 594-1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment. Result: All tests were passed. | |
| Performance test reports to document the following properties of the Ambu® USR: Length and diameters of insertion cord Bending angle and durability of bending section Image quality during 1 hour operation Irrigation system functionality Grasper functionality and image quality Grasper stent pull force Result: All tests were passed. | |
| Performance test report to document shelf life of Ambu® USR. Tests were performed on finished, sterilized, shipped and aged products: Performance test of Ambu® USR Sterile Packaging Integrity Result: All tests were passed. | |
| Biocompatibility tests reports to document that Ambu® USR complies with the requirements of ISO 10993-1: Cytotoxicity (ISO 10993-5) Sensitization (ISO 10993-10) Intracutaneous reactivity test (ISO 10993-10) Result: All tests were passed. | |
| Performance test report to document the following properties of the Ambu® M monitor (reusable): Cleaning and Low Level Disinfection validation Result: The test was passed. | |
| Test reports that verify the Electromagnetic Compatibility and Electrical Safety: Electromagnetic Compatibility in compliance with IEC 60601-1-2. Electrical Safety in compliance with IEC 60601-1 and IEC 60601-2-18. | |
| Result: All tests were passed. | |
| Performance | |
| Data – Clinical | Not applicable. |
| Conclusion | Based on the indication for use, technological characteristics, |
| performance data and comparison to predicate devices it has been | |
| concluded that the functionality and intended use of Ambu® USR and | |
| Ambu® M is equivalent to the predicate devices. |
It is concluded that Ambu® USR and Ambu® M are as safe and as
effective and perform as well as or better than the chosen legally
marketed predicate devices. |
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