Who is the manufacturer of Uro-N Cystoscope?

Uroviu Corporation filed the 510(k) submission for Uro-N Cystoscope (K182876).

What is the FDA product code for Uro-N Cystoscope?

FAJ. It is classified under 21 CFR 876.1500 as a Class 2 device in the Gastroenterology, Urology panel.

What is the regulatory pathway for Uro-N Cystoscope?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Uro-N Cystoscope?

Williams Cystoscopic Injection Needle (K171602); Uro-V Cystoscope (K171500).

Who can help prepare an FDA 510(k) submission like Uro-N Cystoscope?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Uro-N Cystoscope

K182876 · Uroviu Corporation · FAJ · Jul 2, 2019 · Gastroenterology, Urology

Device Facts

Record ID	K182876
Device Name	Uro-N Cystoscope
Applicant	Uroviu Corporation
Product Code	FAJ · Gastroenterology, Urology
Decision Date	Jul 2, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 876.1500
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope.

Device Story

Uro-N Cystoscope is a portable, battery-operated, hand-held endoscope system; consists of a reusable handle with a 3.5-inch integrated video screen and a disposable cannula with an integrated 23 Ga injection needle. Device provides visualization of the bladder and lower urinary tract via a camera and LED illumination at the cannula tip. Physician navigates the urinary tract using the real-time video feed; once the target site is visualized, the physician advances the needle through the working channel into the tissue. Therapeutic agents are injected via a syringe attached to the luer lock hub on the needle. Used in hospitals and physician offices. System enables targeted delivery of medications, potentially improving treatment precision for conditions like neurogenic bladder and overactive bladder.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including simulated use, mechanical testing (bending, pulling, torque, leak), temperature testing, field of view, direction of view, and image quality testing. Biocompatibility testing (cytotoxicity) was performed on the stainless steel needle. Electrical safety and EMC compliance were verified per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

System includes reusable handle and disposable cannula with 23 Ga stainless steel needle. Imaging via CMOS camera and LED illumination. 3.5-inch LCD monitor. Field of view: 140 degrees; focal length: 5-50 mm; direction of view: 15 degrees. Connectivity: standalone. Sterilization: Ethylene Oxide (cannula/needle). Electrical safety: Class I, Type CF, defibrillation proof (IEC 60601-1). EMC: IEC 60601-1-2. Software: Moderate level of concern.

Indications for Use

Indicated for injection of therapeutic agents in the bladder and lower urinary tract for neurogenic bladder, overactive bladder syndrome, increased frequency and urgency of urination, scarring of the bladder neck, and Hunner's ulcer.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Williams Cystoscopic Injection Needle (K171602)
Uro-V Cystoscope (K171500)

Related Devices

K243196 — Uro-G HD Cystoscope (1520) · Uroviu Corporation · Dec 13, 2024
K171500 — Uro-V Cystoscope · Uroviu Corporation · Jan 30, 2018
K202921 — Uro-G Cystoscope · Uroviu Corporation · May 4, 2021
K253598 — InjecSURE Injection System · Carbon Medical Technologies, Inc. · Mar 31, 2026
K180214 — Repris Bladder Injection System · Uro-1, Inc. · May 3, 2018

Submission Summary (Full Text)

{0}------------------------------------------------ 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. July 2, 2019 UroViu Corporation Thomas Lawson, Ph.D. Vice President, Regulatory Affairs 5337 - 14th Place SE Bellevue, WA 98006 Re: K182876 Trade/Device Name: Uro-N Cystoscope Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, FBK Dated: June 4, 2019 Received: June 5, 2019 Dear Thomas Lawson: 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. 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 located 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. 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. {1}------------------------------------------------ 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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 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 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, Glenn B. Bell. Ph.D. Assistant Division 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K182876 Device Name Uro-N Cystoscope Indications for Use (Describe) The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope. | 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." {3}------------------------------------------------ K182876 # SECTION 5. 510(k) Summary ## General Information | Submitter | UroViu Corporation | |-------------------------|-------------------------------------------------------------------------------------| | Address | 5337 – 145th Place SE Bellevue, WA 98006 | | FDA Registration Number | 3007498664 | | Correspondence Person | Thomas Lawson, PhD Vice President, Clinical & Regulatory Affairs UroViu Corp. | | Contact Information | Email: thom@uroviu.com Phone: 510-206-1794 | | Date Prepared | 1 July 2019 | # Proposed Device | Trade Name | Uro-N Cystoscope | |----------------------------------------------|--------------------------------------------| | Common Name | Uro-N cystoscope | | Regulation Number and Classification Name | 21 CFR§876.1500, Endoscope and Accessories | | Product Code | FAJ, FBK | | Regulatory Class | II | # Predicate Device | Trade Name | Williams Cystoscopic Injection Needle | |------------------------------------------------------------------------------|--------------------------------------------| | Common Name | Williams injection needle | | Premarket Notification | K171602 | | Regulation Number and Classification Name | 21 CFR§876.1500, Endoscope and Accessories | | Product Code | FBK | | Regulatory Class | II | | Note: This predicate device has not been subject to a design-related recall. | | ## Predicate Device | Trade Name | Uro-V Cystoscope | |------------------------|--------------------------------------------| | Common Name | Uro-V cystoscope | | Premarket Notification | K171500 | | Regulation Number and | 21 CFR§876.1500, Endoscope and Accessories | | Classification Name | | {4}------------------------------------------------ | Product Code | FAJ | |------------------------------------------------------------------------------|-----| | Regulatory Class | II | | Note: This predicate device has not been subject to a design-related recall. | | #### Device Description The UroViu Uro-N Cystoscope System consists of (1) a hand-held, battery operated portable endoscope contained within a reusable handle and (2) a disposable cannula with an injection needle. The fully assembled Uro-N system has overall length of 522 mm (~21 inches). The disposable cannula working length is 269 mm (~11 inches) and total length is 388 mm (~15 inches). The injection needle is 23 Ga (OD 0.635mm, ID 0.318mm). The combined handle and cannula weigh less than 1 pound. The reusable handle has a connector and locking mechanism for attaching and detaching the cannula. The catheter is sterilized by electron beam and is intended for single use only. The Uro-N cystoscope's injection needle and cannula are in contact with patient tissue for less than 24 hours and are made of materials that are biocompatible. This Traditional 510(k) builds on the Uro-V cystoscope cleared in K171500 (predicate device), with the added component of an injection needle, which is equivalent to the intended use of the Williams injection needle (K171602), the other predicate device. #### Intended Use The Uro-N Cystoscope is intended for direction of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope. Both the subject device and the predicate device have the same intended use. #### Comparison of Technological Characteristics with the Predicate Devices The Uro-N Cystoscope System builds on the Uro-V cystoscope (K171500), which is a predicate device in this submission. The Williams Cystoscopic Injection Needle (K171602) is another predicate device for the injection needle component of the system that is supplied with the disposable cannula of the Uro-N cystoscope. The Williams Cystoscopic Injection Needle is used for cystoscopic-directed injection of medications and solutions into the urethra, bladder neck, and bladder wall, as is the needle component of the Uro-N cystoscope's disposable cannula. Both the Uro-N system's injection needle component of the cannula and the Williams Cystoscopic Injection Needle are designed to inject medications and solutions into tissue {5}------------------------------------------------ within the lower urinary system. Both devices are introduced into the urinary system through the working channel of a cystoscope that visualizes the target area for the injection and guides the needle into the target tissue. The needles for both devices are pushed into the tissue and then medication and solution are injected using a syringe that is attached to the luer lock hub at the proximal end of the needle. The imaging component of the Uro-N cystoscope system is the same as that of the predicate device, the Uro-V cystoscope. When the cannula of the system is attached to the handle, it forms a fully functional cystoscope that provides images on a screen that the user can reference as the device is being advanced within the urinary tract. As with the Uro-V cystoscope system, the Uro-N cystoscope system's cannula has a camera at its tip that transmits images to the viewing screen on the device's handle. In this way, the user can navigate the urinary tract with minimal contact or injury to the walls of the urethra and then permit the examination of the bladder and direct injection of therapeutic agents and solutions as needed. The imaging capability of the cannula of the Uro-N system is the same as that of the predicate device, the Uro-V system, and it is this imaging that permits direction of agents and solutions via the needle component that is housed in the working channel of the Uro-N system. Similarly, the second predicate device, the Williams cystoscopic injection needle, is advanced via the working channel of a cystoscope and using the images generated by the cystoscope, the Williams needle can be directed to the place within the bladder or urinary tract that is to receive the injection. | | Subject Device | Predicate Device | Predicate Device | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Uro-N Cystoscope system with injection cannula (UroViu Corp.) (This Submission) | Williams Cystoscopic Injection Needle (Cook Medical) K171602 | Uro-V Cystoscope with diagnostic cannula (UroViu Corp.) K171500 | | Indication for Use | The Uro-N cystoscope is indicated for injection of | The Williams Cystoscopic Injection Needle is | The Uro-V cystoscope is indicated for diagnostic | | | | | | | | indicated for injection of therapeutic agents in the bladder and lower urinary tract for neurogenic bladder, overactive bladder syndrome, increased frequency and urgency of urination, scarring of the bladder neck, and Hunner's ulcer. | indicated for injection of therapeutic agents in the bladder and lower urinary tract. | cystoscopy of symptomatic voiding dysfunction, hematuria, bladder tumor surveillance, recurrent lower urinary tract infections, and pelvic pain syndromes. | | Intended use | Directed injection of therapeutic agents and solutions into target areas of the bladder and the lower urinary tract via a cystoscope | Directed injection of therapeutic agents into the urethra, bladder neck, and bladder wall via a cystoscope | Endoscopic diagnosis and infusion of irrigating fluid within the bladder and urethra | | Route of Advancement | The cannula of the cystoscope is advanced to the bladder via the urethra, with the injection needle advanced to the bladder via a working channel of the cystoscope | The injection needle is advanced to the bladder via the working channel of a cystoscope | The cannula of the cystoscope is advanced to the bladder via the urethra | | Site of Use | Hospitals and physician offices | Same | Same | | Device Features | | | | | Components of the System | Reusable handle with a video screen that acts as an endoscope Attachable cannula with an injection | Injection Needle with a hub | Reusable handle with a video screen that acts as an endoscope Attachable cannula with a working | | | needle, a working channel along its | | channel along its length and an | | | length, and an illumination source and camera at its tip | | illumination source and camera at its tip | | Imaging Transmission | Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle | No imaging component | Image transmitted from a video camera at the tip of the cannula to a video monitor on the handle | | Illumination Light Source | LEDs | N/A | LEDs | | LCD Monitor Display Size | 3.5 inches (diagonal) on the handle | N/A | 3.5 inches (diagonal) on the handle | | Field of View | 140 degrees | N/A | 140 degrees | | Focal Length | 5 to 50 mm | N/A | 5 to 25 mm | | Direction of View from Center Axis | 15 degrees | N/A | 30 degrees | | Electrical Safety | Class I, Type CF, defibrillation proof IEC 60601-1 | N/A | Class I, Type CF, defibrillation proof IEC 60601-1 | | Electromagnetic compatibility | IEC 60601-1-2 | N/A | IEC 60601-1-2 | | Software Level of Concern | Moderate | N/A | Moderate | | Sterilization method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | | Sterility Assurance Level | 10-6 | Same | Same | | Biocompatibility of Materials | Meets ISO 10993 requirements | Same | Same | | Operational Characteristics | | | | | Length of cannula | 269 mm | N/A | 254 mm | | Working Channel Inner Diameter | 2.6 mm | N/A | 2.8 mm | | Needle Gauge | 23 gauge | 23 gauge | N/A | | Needle Tip Length | 12 mm | 8 mm | N/A | | Needle Bevel Type | Standard | Standard | N/A | | Needle Material | Stainless Steel | Stainless Steel | N/A | | Length of Needle Assembly | 35 cm | 35 cm | N/A | | Procedure Site | | | | | | Hospitals, clinics, and physician offices | Same | Same | | Anatomical Site of Use | Bladder and lower urinary tract | Same | Same | | Duration of Use | < 24 hours | Same | Same | | Provided Sterile? | Yes | Yes | Yes | | Sterilization Method | Disposable cannula and needle are sterile following exposure to ethylene oxide (EO) The handle is not provided sterile. The handle is cleaned and disinfected following company instructions. | Disposable needle is sterile following exposure to ethylene oxide (EO) | Disposable cannula is sterile following exposure to ethylene oxide (EO) The handle is not provided sterile. The handle is cleaned and disinfected following company instructions. | | Single-use | Yes, for the cannula and the needle | Yes | Yes, for the cannula | Comparison of the Uro-N Cystoscope System to the two predicate devices, the Williams Cystoscopic Injection Needle, and the Uro-V Cystoscope. {6}------------------------------------------------ {7}------------------------------------------------ # Traditional 510(k) Notification Uro-N Cystoscope System {8}------------------------------------------------ # Performance Data The performance testing conducted establishes that the Uro-N Cystoscope and cannula do not raise new questions of the safety and effectiveness from those noted for the Uro-V Cystoscope cleared under K171500. # Biocompatibility testing The Uro-N Cystoscope and cannula are manufactured from materials reviewed in K171500. The only new material is a stainless steel needle, which passed cytotoxicity testing. {9}------------------------------------------------ K182876 #### Electrical safety and electromagnetic compatibility (EMC) The predicate and subject devices comply with IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC, which was reviewed and cleared in K171500. #### Software Verification and Validation Testing There was no change to the software for the subject device from the predicate device reviewed and cleared in K171500. ## Mechanical Testing The mechanical testing of the subject device included: - Simulated use testing; ● - Mechanical testing (bending, pulling, torque, and presence of leaks); ● - Temperature at the surface of the tip testing; . - Field of view testing; ● - Direction of view testing; and ● - Image quality testing. # Animal Testing No animal testing of the subject device was necessary. #### Clinical Studies No clinical testing of the subject device was necessary. #### Conclusion The information submitted in this premarket notification confirms that the Uro-N Cystosope raises no new questions of safety and effectiveness and that it is substantially equivalent to the predicate devices.